MDK Med MI 20 Series User manual

MI 20-CETF-005
1/ 83
MI 20 Series Infusion Pump User’s Manual
Version：1.0
Zhejiang MDKingdom Technology co., Ltd.
2017.11

MI 20-CETF-005
2/ 83
Contents
1SYMBOLS, GRAPHICS AND WARNINGS .......................................... 6
1.1 DESCRIPTIONS OF GRAPHICS AND SYMBOLS .......................... 6
1.2 WARNINGS .................................................................................... 7
1.3 CAUTIONS ..................................................................................... 8
1.4 NOTES ........................................................................................... 9
2TERMS AND DEFINITIONS .............................................................. 10
3INTRODUCTIONS AND SCOPES ......................................................11
3.1 INTRODUCTIONS .........................................................................11
3.2 INTENDED USE ........................................................................... 12
3.3 PRODUCTS NAMING ................................................................... 12
4IMPORTANT FEATURES .................................................................. 13
5BASIC PARAMETERS, MAIN PERFORMANCES AND
FUNCTIONALITIES ............................................................................... 14
5.1 BAISC PARAMETERS.................................................................. 14
5.2 MAIN PERFORMANCE ................................................................ 15
5.3 MAIN AND FREQUENTLY USED FUNCTIONALITIES ................. 17
6PRODUCT STRUCTURE AND OPERATION INTERFACE ................ 18
6.1 PRODUCT STRUCTURE .............................................................. 18
6.2 DISPLAY AND OPERATION INTERFACE .................................... 20
7INSTRUCTION FOR OPERATION .................................................... 22
7.1 INSTALLATION OF INFUSION PUMP .......................................... 22
7.1.1 INSTALLATIOIN OF FIXATION CLAMP ................................ 22
7.1.2 INSTALLATION OF INFUSION PUMP................................... 23
7.1.3 STACKING OF INFUSION PUMPS ....................................... 23
7.2 POWER ON AND SYSTEM SELF-TEST ....................................... 24

MI 20-CETF-005
3/ 83
7.2.1 POWER ON........................................................................... 24
7.2.2 SYSTEM SELF-TEST ............................................................ 24
7.3 SETTING PARAMETERS ............................................................. 25
7.3.1 INFUSION SET SELECTION ................................................. 25
7.3.2 INFUSION MODE SELECTION ............................................. 26
7.3.3 SETTINGVolume to Be Infused (VTBI) ................................ 27
7.3.4 SETTING INFUSION FLOW RATE ........................................ 27
7.3.5 SETTING INFUSION TIME .................................................... 27
7.3.6 PURGE SETTING.................................................................. 28
7.3.7 SETTING OCCLUSION PRESSURE LEVELS ....................... 29
7.4 INSTALLATION AND UNINSTALLATION OF INFUSION SET ...... 30
7.4.1 INSTALLATION OF INFUSION SET ...................................... 30
7.4.2 INFUSION SET REPLACEMENT .......................................... 31
7.5 START INFUSION ........................................................................ 31
7.5.1 AUTOMATIC PURGE AND START INFUSION ...................... 31
7.5.2 MANUAL PURGE AND START INFUSION............................ 33
7.5.3 INFUSION IN PROGRESS .................................................... 33
7.6 STOP AND CLEAR ALARMS ....................................................... 34
7.7MUTE ALARM SOUND................................................................. 35
7.8 PURGE AND BOLUS MODE ........................................................ 35
7.9 INFUSION COMPLETE ................................................................ 37
7.10AUTOMATIC INFUSION ACCUMULATION AND ACCUMULATIOIN
ZEROING ........................................................................................... 39
7.11 LOCK AND UNLOCK ................................................................. 39
7.12 POWER OFF .............................................................................. 40
7.13 UNINSTALLATION OF INFUSION PUMP ................................... 41

MI 20-CETF-005
4/ 83
7.14 BODY WEIGHT MODE SETTING ............................................... 41
7.15 DRUG LIBRARY MODE ............................................................. 42
7.16 DRUG LIBRARY ........................................................................ 43
7.17 VIEWING LOG ........................................................................... 44
8ALARMS ........................................................................................... 44
8.1 DOOR OPEN ALARM ................................................................... 46
8.2 DOWNSTREAM OCCLUSION ALARM ......................................... 46
8.3 UPSTREAM OCCLUSION ALARM ............................................... 47
8.4 VTBI COMPLETE ALARM ............................................................ 48
8.5 AIR IN LINE ALARM..................................................................... 49
8.6 OUT OF BATTERY ALARM .......................................................... 50
8.7 BATTERY/MAINS POWER DOUBLE DISCONNECTION ALARM. 51
8.8 SYSTEM ERROR ALARM ............................................................ 51
8.9 PAUSE OVERTIME ALARM ......................................................... 52
8.10 INTERNAL BATTERY LOW VOLTAGE ALARM ......................... 53
8.11 INFUSION NEAR END ALARM .................................................. 54
9SETTING SYSTEM PARAMETERS................................................... 54
9.1 BRIGHTNESS .............................................................................. 54
9.2 ALARM SOUND VOLUME .................................................................. 55
9.3 AIR IN LINE DETECTION SENSITIVITY LEVEL ........................... 55
9.4 PURGE SETTING ......................................................................... 56
9.5 PURGE INDICATION .................................................................... 57
9.6 LOAD SETTINGS FROM LAST USE ............................................ 58
9.7 WIFI.............................................................................................. 58
9.8 TYPES OF INFUSION SETS......................................................... 59
9.9 SCREEN AUTO-LOCK TIME ........................................................ 60
9.10DAYTIME/NIGHTTIME SETTING ................................................. 60

MI 20-CETF-005
5/ 83
9.11 SYSTEM MAINTENANCE .......................................................... 61
9.12 RESTORE TO FACTORY SETTINGS ......................................... 62
10 PARAMETERS SETTING FOR INFUSION SET ................................ 63
10.1 ENTER INFUSION SET CALIBRATION SETTING SCREEN....... 63
10.2 CALIBRATION FOR INFUSION SET ACCURACY ..................... 63
11 CAUTIONS FOR USING DISPOSIBLE INFUSION SET .................... 64
12 TECHNICAL SPECIFICATIONS ........................................................ 65
13 USE AND MAINTENANCE OF INTERNAL BATTERY....................... 68
14 PRODUCT SERVICE AND MAINTENANCE...................................... 69
15 INSTALLATION OF THE REMOVABLE BATTERY ........................... 70
16 WASTE DISPOSAL ........................................................................... 70
16.1 BATTERY................................................................................... 70
16.2 INFUSION SET........................................................................... 70
16.3 MI 20 INFUSION PUMP .............................................................. 71
17 ELECTROMAGNETIC COMPATIBILITY ........................................... 71
18 ANTI-STATIC PRECAUTIONS .......................................................... 81
19 PACKAGING AND ACCESSORIES................................................... 82

MI 20-CETF-005
6/ 83
1 Symbols, graphics and warnings
1.1 DESCRIPTIONS OF GRAPHICS AND SYMBOLS
Caution! Read included files Type CF device
Compliant to ROHS standards Date of manufacturing
Serial Number Manufacturer
Power On/Power Off Start/Stop
BOLUS Mute alarm sound.

MI 20-CETF-005
7/ 83
AC (Alternating Current) Classified collection,
uncontrolled discard not allowed.
Ingress Protection Grade 2. Class II
device
1.2 WARNINGS
Please read the following warnings carefully. Any operation that
does not strictly follow the guidance will possibly damage the device
or do harm to patients’ health.
➢The MI 20 infusion pump is intended for IV infusion, but is not
intended for the transfusion of blood.
➢Only trained and qualified healthcare givers are allowed to operate
this pump. This user manual must be read carefully before using the
pump.
➢To avoid fire or explosion, this infusion pump should not be operated
in an environment where flammable materials are stored.
➢To ensure safe operation of this pump, do not stack the pump with
other equipment that has electromagnetic emission.
➢This pump is an IPX2 type device. Do not immerse pump into liquid.
➢Operator must follow Section 10 Parameters Setting for Infusion
Set to select the correct type for infusion set and use the
recommended infusion sets that have been calibrated.
➢Using other infusion sets that are not among the list of
recommended infusion sets will result in greater error in infusion

MI 20-CETF-005
8/ 83
accuracy and eventually lead to operation failures.
➢While being used, the height of the infusion set can neither be
placed lower or higher than 1 meter from the patient’s heart.
➢Do not use the same infusion set on more than one machine.
➢Do not press the buttons with finger nails or other sharp objects.
➢Only fully trained maintenance staffs are allowed to repair and
calibrate this pump. The power cable must be unplugged before
repair. Untrained personnel are not allowed to remove the cover,
otherwise the warranty coverage for this pump will be lost.
➢The parts and accessories for this device must not be MDK
recommended or approved.
➢If sustained a severe impact or dropped, the pump should not be
used until it has been checked by trained technical staff.
➢According to 14 PRODUCT SERVICE AND MAINTENANCE, user
can wipe the shell of pump. And battery replacement is allowed. The
battery must be replaced and maintained by a trained professional
technician in accordance with the procedure defined in "Section 13:
Use and Maintenance of Internal Battery". Replacement of the
battery by unauthorized personnel without adequate training will
lead to overheating, fire, explosion or other risks.
1.3 CAUTIONS
Please read the following information carefully, otherwise the
usability of this device may be affected.
➢Fix the pump in a level and secured position before and during
operation.

MI 20-CETF-005
9/ 83
➢Fix the pump in a level and secured position before and during
operation
➢Pump operator must strictly follow doctor’s prescriptions to set the
infusion parameters, otherwise patient’s health may be harmed.
➢After setting infusion parameters, operator must make sure that the
infusion set is correctly installed on the pump before the pump is
started.
➢In order to maintain a high infusion accuracy, the contacting spot of
compression on an infusion set should be changed every 8 to 10
hours, if the same set is used continuously for a long period of time.
The roller clamp on the pump should be turned off before this
changing operation, and it should be turned back on after the
changing is done.
➢To maintain high infusion accuracy, the pump needs to be re-
calibrated when there is a significant change in ambient
temperature.
➢The pump will stop operation automatically when there is an alarm.
Please press “ ” to resume operation after alarm is cleared.
➢To avoid failure or false alarms caused by a dirty occlusion sensor
or the air in line sensor, operator should wipe clean the pump on a
regular basis to keep it clean.
1.4 NOTES
➢Pump or accessories may not be usable if their lifetime for use has
expired (the lifetime for use is 5 years). Contact MDK to upgrade to
new products.

MI 20-CETF-005
10 / 83
➢Please check the voltage of the internal battery before using it for
pump operation.
➢Please do not connect any other device to the USB port other than
the included DC adapter shipped with the pump.
➢When using the power plug or other separable plug as the isolation
means from the main power, please do not position the device so
that it is difficult to operate the disconnection device.
➢Infusion sets are the applied part of the device.
2 TERMS AND DEFINITIONS
Operator: A professionally trained and qualified member of medical
staff.
KVO: After infusion is completed based on the preset parameters,
the pump will automatically switch to a mode with extremely low flow
rate and continue to run (this mode virtually does not have any
treatment effect), which is to keep the infusion set and vein
unobstructed and to avoid the blood flowing backwards.
Intermediate Rate: A flow rate of 25ml/h.
Minimum Rate: A flow of 1ml/h.
Free-flow: Drug solution is flowing in an uncontrolled manner under
the effect of gravity.
Operation State: After all needed parameters are set, the pump
enters operation state when “ ”button is pressed.
Alarm State: A state that the pump will enter when a potential or

MI 20-CETF-005
11 / 83
an already existing danger is confirmed.
Calibration: To ensure the infusion pump to meet its designed high
accuracy, calibration and proper parametric compensation have to
be done on the infusion sets. Calibration has to be performed only
by trained professionals.
VTBI: Volume to be infused.
3 INTRODUCTIONS AND SCOPES
3.1 INTRODUCTIONS
MI 20 infusion pump is a smart infusion device. It is consisted of
a control system based on an ARM Cortex microcontroller, a
peristaltic pump actuation system, a monitoring system, an alarm
system, an input interface and a display.
The operation of traditional IV infusion is depending on the
pressure gradient cause by gravity to infuse drug solutions into
patient’s body. The operation is all manual, the infusion flow rate is
controlled by a roller clamp and it has to be monitored by human
eyes of the care givers. The gravity infusion does not have
occlusion alarm, air in line alarm, or infusion near end alarm, which
places a big burden on care givers and fails to meet the demand for
high-accuracy, small amount and fast speed in infusion.
Users will gain the following 4 benefits in using the MI 20 pump:
1. Ensured accuracy: The drug concentration in patient’s blood
has to be within a certain range when medication treatment is given.
If the upper limit of drug concentration is exceeded, the patient’s
organs, such as liver, will be harmed. But if the concentration is too
low, the medication treatment will not be effective. Infusion accuracy

MI 20-CETF-005
12 / 83
will be ensured when using MI 20 pump.
2. Meeting flow rate requirements: A certain flow rate has to be
met for a given medication treatment, which can range from 1ml/h
to 1800ml/h. Unless infusion pump is to be used, otherwise the flow
rate requirements cannot be met by using the gravity or manual
infusion methods.
3. Providing enough pressure: The necessary pressure for
infusion cannot be reached by adjusting the height of drug solution
bag or bottle, while the infusion pressure is controllable by using
infusion pump. Infusion pump works well in both vein and arterial
intervention treatments.
4. Automatic monitoring: Light and sound alarms are available
when infusion pump is in use. They inform the care givers with these
alarms by automatically monitoring the infusion pressure and the air
bubbles in line during operation, which not only improves the quality
of care but also serves as a basic source of patient data for the
hospital.
3.2 INTENDED USE
Intended use of product: By controlling the flow rate, MI 20
infusion pump is intended to be used for IV treatment at clinical
service facilities. Light and sound alarms help the users use the
pumps properly.
Contraindications：The MI 20 infusion pump is not suitable for
transfusion of blood.
3.3 PRODUCTS NAMING

MI 20-CETF-005
13 / 83
MI 2 0
Secondary identification code for product series
Product series identification code
Product platform code for infusion pump
4 IMPORTANT FEATURES
➢High accuracy: The accuracy for both infusion flow rate and volume
are kept within 3% when the MDK recommended infusion set is
used.
➢High flow rate: Infusion flow rate can be adjusted from 0.1ml/h to
1800ml/h in a continuous manner, which makes MI 20 capable of
meeting various flow rate requirements in different infusion cases.
➢Small size: Just 6.8cm tall and 1.5kg in weight, MI 20 is not only
very small in dimension but also very light.
➢Stackable: MI 20 pump is stackable. It can also be stacked with
MS31 syringe pump for operation. The miniature design of MI 20 is
a room saver for the wards where space is very limited. It can also
be inserted onto an MX infusion work station as an infusion unit.
➢Easy operation: Operator can use the touch screen on MI 20 to set
parameters, which will still function with gloves on. A key pad is also
available to ensure usability in different usage scenarios.
➢Powered free-flow clamp: MI 20 has a powered free-flow clamp that
saves several steps in the infusion set installation process. To
complete the installation process, the operator only needs to
straighten the infusion set with both hands, clamp it at two ends,
and close the pump door.
➢Upstream occlusion alarm: MI 20 has upstream occlusion alarm in

MI 20-CETF-005
14 / 83
addition to downstream occlusion alarm. When infusion bag is
running out or the free-flow clamp is not turned on by mistake, the
embedded internal pressure sensor will detect these problems
automatically and an alarm will be initiated accordingly.
➢Fast installation: Patented QuikMount system, which requires only
one click to complete the pump installation.
➢External power source: An external power adapter is used, which
not only removes the safety concerns of using an internal power
source but also makes the device lighter, safer, and more portable.
➢High battery capacity: The rechargeable internal high-capacity
Lithium battery can support normal operation for 7 hours, which is
conveniently helpful during patient transport or power outage.
➢Highly secure STM32 microcontroller: dual-CPU architecture
design.
➢No false alarm in air-in-line detection: Based on ultrasonic
technology and with the help from a unique algorithm, the air-in-line
detection is accurate and reliable, which eliminates false alarms.
➢LCD screen: A 2.8-inch TFT LCD display offers high contrast and
visibility, which is sharp and clear even from a distance of 5 meters
away.
➢Smart occlusion removal: When the infusion line is occluded, the
stepper motor will rotate reversely to release the pressure
accumulated in the infusion line after it has been occluded.
5 BASIC PARAMETERS, MAIN PERFORMANCES AND
FUNCTIONALITIES
5.1 BAISC PARAMETERS

MI 20-CETF-005
15 / 83
Dimensions
215mm×129mm×80mm(width x depth x height)
Weight
1.5 Kg
Power Adaptor
rate voltage and
frequency
A.C100V～240V 47-63Hz 0.7-0.35A，
D.C15V 1.66A
A.C. input 100V～240V 47-63Hz 0.7-0.35A,
D.C. output 15V 1.66A
Input voltage to
infusion pump
D.C：15V
Power
<55VA
Requirements
for infusion sets
See Section 11: CAUTIONS FOR USING
DISPOSIBLE INFUSION SET
Maximum flow
rate
1800（ml/h）
5.2 MAIN PERFORMANCE
Range of flow
rate setting
0.01-1800ml/h，
with resolution 0.01ml/h；
）
Flow rate
accuracy
±3%

MI 20-CETF-005
16 / 83
(Essential
Performance)
VTBI range
0.01~9999.99ml，
with resolution 0.01ml
Infusion volume
accuracy
(Essential
Performance)
±3%
Purge speed
1ml/h～1800ml/h；±20%；
Occlusion
alarm(pressure)
(Essential
Performance)
High: 100kPa±30kPa middle 60 kPa ±20kPa
Low: 40kPa±20kPa
Maximum
infusion
pressure
>160kPa
Time to activate
the occlusion
alarm; max
bolus
(Essential
Performance)
Minimum flow rate: occlusion alarm is activated
when pressure is within 40kPa±20kPa for 13
minutes, or when pressure is within 100kPa±30kPa
for 14 seconds.
Intermediate flow rate: occlusion alarm is activated
when pressure is within 100kPa±30kPa and the
bolus produced is less or equal than 0.3ml.
(Jerry infusion set is used to create occlusion at the
end of infusion line during verification test.)
KVO flow rate
KVO=3ml/h when flow rate≥10ml/h;

MI 20-CETF-005
17 / 83
KVO=1ml/h when flow rate ≥1ml/h and
<10ml/h;
KVO=the set infusion flow rate when flow rate
<1ml/h.
Recover time
after the
recoverable
alarm sound is
cleared.
1min50s～2min
Time for pause
over time alarm.
1min50s～2min
High priority
alarm
(Essential
Performance)
Door open alarm, occlusion alarm, VTBI complete
alarm, air in line alarm, out of battery alarm,
battery/mains power double disconnect alarm,
malfunction alarm.
Classification
Class II Type CF, capacity infusion pump with
internal power source for continuous operation
Environmental
Requirement
Operation Temperature: 5℃~＋40℃;
Storage relative humidity: ≤75%;
Operating relative humidity: 20%～90%;
Barometric pressure range: 80.0kPa～106.0kPa.
Software
Version
V1.0.0
Product lifetime
5 years.
5.3 MAIN AND FREQUENTLY USED FUNCTIONALITIES
➢Set infusion flow rate, set VTBI, and display real-time data;

MI 20-CETF-005
18 / 83
➢Display the already infused volume;
➢Purge/bolus;
➢Alarms;
➢Automatically change the flow rate to KVO rate after the VTBI
complete alarm is activated;
➢Temporary mute for alarm sound and timer for recovering alarm
sound;
➢Automatic free-flow stopping function;
➢Display the TVI;
➢Clear the TVI data;
➢Support various brands of infusion sets;
➢Internal battery;
➢External DC adapter;
➢Wi-Fi connectivity.
6 PRODUCT STRUCTURE AND OPERATION INTERFACE
6.1 PRODUCT STRUCTURE
MI 20 pump is mainly consisted of a user interface panel, a
pump housing, a mechanical actuation system, and an electrical
control system.
The front and back of the pump are shown in Figure 6-1-1 and
Figure 6-1-2.
Descriptions for parts and components:
1
Charging
indicator
2
External power
indicator
3
Working
indicator
4
Touch screen
5
Keypad
6
Pump door
button

MI 20-CETF-005
19 / 83
7
Pump door
8
Foot
9
Battery
compartment
cover
10
DC power port
11
Fixation pole
12
Positioning pin
13
Clamping port
for stacking
14
On/off button
for infusion set
test
15
Powered free-
flow clamp
16
Downstream
occlusion
sensor
17
Pumping
operation
device
18
Air in line
sensor
19
Upstream
occlusion
Front view.

MI 20-CETF-005
20 / 83
Back view.
Side view.
Pump door open view.
6.2 DISPLAY AND OPERATION INTERFACE
The display interface is shown in Figure 6-3. The keypad