MS 31 Series Syringe Pump User's Manual: Version 1.0

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MS 31 Series Syringe Pump User’s Manual

Version:1.0

2018.10
MS 31-CETF-005
CONTENTS
1 SYMBOLS, GRAPHICS AND WARNINGS................................................... 5
1.1 SYMBOL AND G RAPHIC D EFINITION ............................................................... 5
1.2 WARNING ............................................................................................................5
1.3 WARNING ............................................................................................................7
1.4 ATTENTION ......................................................................................................... 7
2 TERMINOLOGY AND DEFINITION.................................................................8
3 INTRODUCTIONS AND SCOPES................................................................... 8
3.1 INTRODUCTION ................................................................................................... 8
3.2 INTENDED USE................................................................................................... 9
3.3 MODEL NAMING CONVENTION .......................................................................10
4 MAIN FEATURES.............................................................................................. 10
5 SPECIFICATION, ESSENTIAL PERFORMANCE AND MAIN FEATURES
11
5.1 SPECIFICATION ................................................................................................ 11
5.2 MAIN P ERFORMANCE ..................................................................................... 12
5.3 MAIN AND F REQUENTLY USED FEATURES ...................................................14
6 PRODUCT STRUCTURE AND OPERATION INTERFACE.....................14
6.1 MAIN C OMPONENTS........................................................................................14
6.2 O PERATION INTERFACE ..................................................................................16
7 OPERATION INSTRUCTION.......................................................................... 17
7.1 SET UP S YRINGE PUMP................................................................................. 17
7.1.1 Mount the Clamp................................................................................ 17
7.1.2 Install the Syringe Pump.................................................................17
7.1.3 Stack the pump...................................................................................18
7.2 POWER ON AND S ELF S AFETY TEST ............................................................18
7.2.1 Power on............................................................................................... 18
7.2.2 Device Self Safety Test.................................................................... 19
7.3 INSTALL S YRINGE ........................................................................................... 19

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MS 31-CETF-005
7.4 SET PARAMETERS .......................................................................................... 20
7.4.1 Select Syringe.....................................................................................20
7.4.2 Select Infusion Mode........................................................................21
7.4.3 Set Volume to Be Infused (VTBI).................................................. 22
7.4.4 Set up Rate...........................................................................................23
7.4.5 Set up Time.......................................................................................... 23
7.4.6 Set Purge Parameters...................................................................... 23
7.4.7 Set up Occlusion Alarm Threshold............................................. 24
7.5 START I NJECTION ............................................................................................24
7.5.1 Automatic Purge and Start Infusion........................................... 24
7.5.2 Manual Purge and Start Infusion................................................. 26
7.5.3 Injection in progress........................................................................ 26
7.6 STOP THERAPY AND CLEAR A LARM ............................................................ 27
7.7 MUTE ALARM S OUND ..................................................................................... 28
7.8 PURGE AND B OLUS ........................................................................................ 28
7.9 INFUSION COMPLETE...................................................................................... 30
7.10 AUTOMATIC VOLUME ACCUMULATION AND RESET .................................. 31
7.11 LOCK AND UNLOCK ..................................................................................... 32
7.12 P OWER O FF .................................................................................................. 32
7.13 UNINSTALL SYRINGE P UMP........................................................................ 33
7.14 BODY WEIGHT M ODE .................................................................................. 33
7.15 DRUG LIBRARY SET UP.............................................................................. 34
7.16 DRUG LIBRARY .............................................................................................35
7.17 LOG ................................................................................................................35
8 ALARM FUNCTION.......................................................................................... 36
8.1 SYRINGE SIZE MISMATCH ALARM ..................................................................37
8.2 PLUNGER ERROR ALARM .............................................................................. 38
8.3 O CCLUSION ALARM ........................................................................................ 39
8.4 VTBI COMPLETE ALARM ............................................................................... 40

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8.5 O UT OF BATTERY ALARM ..............................................................................41
8.6 BATTERY /M AINS P OWER DOUBLE DISCONNECTION ALARM ....................42
8.7 SYSTEM ERROR ALARM .................................................................................42
8.8 PAUSE O VERTIME ALARM ..............................................................................43
8.9 INTERNAL BATTERY LOW ALARM ................................................................. 44
8.10 INJECTION NEAR E ND A LARM ....................................................................45
9 SETTING SYSTEM PARAMETERS.............................................................. 46
9.1 BRIGHTNESS....................................................................................................46
9.2 ALARM S OUND ................................................................................................ 46
9.3 PURGE SETTING ..............................................................................................47
9.4 PURGE INDICATION .........................................................................................48
9.5 LOAD S ETTINGS FROM LAST USE................................................................48
9.6 WIFI..................................................................................................................49
9.7 SYRINGE TYPE.................................................................................................50
9.8 SCREEN A UTO-LOCK TIME.............................................................................50
9.9 DAYTIME /N IGHTTIME S ETTING ...................................................................... 51
9.10 S YSTEM MAINTENANCE ............................................................................... 52
9.11 RESTORE FACTORY D EFAULT .................................................................... 52
10 PARAMETERS SETTING FOR SYRINGE.................................................. 53
10.1 E NTER S YRINGE CALIBRATION S ETUP SCREEN ...................................... 53
10.2 S YRINGE CALIBRATION (M ETHOD O NE )...................................................53
10.3 S YRINGE CALIBRATION (M ETHOD TWO)...................................................54
11 NOTES ON DISPOSABLE SYRINGE...........................................................55
12 TECHNICAL SPECIFICATIONS.................................................................... 55
13 USE AND MAINTENANCE OF INTERNAL BATTERY............................ 58
14 PRODUCT SERVICE AND MAINTENANCE.............................................. 59
15 INSTALLATION OF THE REMOVABLE BATTERY................................. 60
16 WASTE DISPOSAL........................................................................................... 61
16.1 BATTERY ....................................................................................................... 61

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16.2 S YRINGE........................................................................................................ 61
16.3 MS 31 S YRINGE P UMP............................................................................... 61
17 ELECTROMAGNETIC COMPATIBILITY..................................................... 61
18 ANTI-STATIC PRECAUTIONS.......................................................................66
19 PACKAGE AND ACCESSORIES..................................................................67

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MS 31-CETF-005
1 Symbols, graphics and warnings
1.1 Symbol and Graphic Definition

Caution! Read included files. Type CF Device

Compliant to ROHS standards. Date of Manufacturing

Serial Number Manufacturer

Power On/Power Of Start/Stop

Bolus Mute alarm sound

Ingress Protection Grade 2 AC Power

Classified collection, uncontrolled discard not


allowed

Class II device Be cautious with your hands when


injection comes to the end

1.2 Warning

Please read the following warnings carefully. Any operation that does
not strictly follow the guidance will possibly damage the device or do
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MS 31-CETF-005
harm to patients’ health.
 The MS 31 syringe pump is intended for intravenous therapy.
 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 Syringe Set
to select the correct type for syringe and use the recommended
syringes that have been calibrated.
 Using other syringe that are not among the list of recommended
syringes will result in greater error in infusion 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 syringe 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 be MDK
recommended or approved.
 If sustained a severe impact or drop, the device 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.
Other parts shouldn’t be maintain or repaired.
 The battery must be replaced and maintained by a trained
professional technician in accordance with the procedure defined in

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MS 31-CETF-005
"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.
 The alarm sound may fail to alert the operator if the acoustic
pressure level is lower than that of the ambient noise. The operator
should always adjust the volume of the alarm sound to an audible
level that is greater than that of the ambient noise.

1.3 Warning

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.
 Operator must ensure there is no free-flow once the syringe is
loaded. If free-flow is observed, the operator must stop the therapy
and contact customer service.
 Pump operator must strictly follow doctor’s prescriptions to set the
infusion parameters, otherwise patient’s health may be harmed.
 After setting injection parameters, operator must make sure that the
infusion set is correctly installed on the pump before the pump is
started.
 The device will automatically stop operation if an alarm is triggered.

After the alarm condition is cleared, press to continue the


therapy.
 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 Attention

 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.

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MS 31-CETF-005
 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.
 A statement that mobile RF communications equipment can effect
medical electrical equipment.
2 Terminology and Definition
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 5ml/h.
Minimum Rate: A flow of 1ml/h.
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 an
already existing danger is confirmed.
Calibration: To ensure the syringe pump to meet its designed high
accuracy, calibration and proper parametric compensation have to be
done on the syringes. Calibration has to be performed only by trained
professionals.
VTBI: Volume to be infused.

3 Introductions and Scopes


3.1 Introduction

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MS 31-CETF-005
MS31 syringe pump is a smart high-accuracy infusion device. It
is consisted of a control system based on an ARM Cortex
microcontroller, a pumping actuation system, a monitoring system, an
alarm system, an input interface and a display.
The operation of manual injection of drug solution is lacking of
consistency in flow rate, nor it has functions like occlusion alarm or
injection 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 drug injection.
Users will gain the following 4 benefits in using the MS 31 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
will be ensured when using MS 31 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
2100ml/h. Unless a syringe pump is to be used, otherwise the flow
rate requirements cannot be met by using the gravity or manual
injection methods.
3. Providing enough pressure: The necessary pressure for infusion
cannot be reached by manual injection, while the injection pressure
is controllable by using a syringe pump. Syringe pump works well in
both vein and arterial intervention treatments.
4. Automatic monitoring: Light and sound alarms are available when
injection 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

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MS 31-CETF-005
Intended use of product: By controlling the flow rate, MS 31
syringe pump is intended to be used for Intravenous therapy at
clinical service facilities on adults and pediatrics. Light and sound
alarms help the users use the pumps properly.
Contraindication: NO.

3.3 Model Naming Convention

MS 3 1

Secondary identification code for product series

Product series identification code

Product Platform code for Syringe Pump

4 Main Features
 A wide range of syringes are supported: Automatic syringe size
identification and 6 different models of syringes are supported: 2ml,
5ml, 10ml, 20ml, 30ml, and 50/60ml.
 High accurate: When the recommended syringes are used the
accuracies for both flow rate and volume are within 2%.
 High flow rate: Injection flow rate can be adjusted from 0.1ml/h to
2100ml/h in a continuous manner, which makes MS 31 capable of
meeting various flow rate requirements in different injection therapy
cases.
 Portable: As thin as 8 cm, and as light as 1.5 kg.
 Stackable: MS 31 pump is stackable. It can also be stacked with
MI20 infusion pump for operation. The miniature design of MS 31 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 injection unit.
 Easy to operate: Operator can use the touch screen on MS 31 to
set parameters, which will still function with gloves on. A key pad is
also available to ensure usability in different usage scenarios.
 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

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MS 31-CETF-005
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 built-in 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: a mutual monitoring
dual-CPU architecture design. Ensure the control to the motor and
sensor.
 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 Specification, Essential Performance and Main


Features
5.1 Specification

Dimension 270mm×140mm×80mm(W x D x H)
Weight 1.5 Kg
Power Adaptor A.C. input 100V-240V~ 50/60Hz 0.7-0.35A,
rate voltage and D.C. output 15V-1.66A max
frequency
Syringe Pump DC 15V
Power Supply
Power <55VA
Consumption
Syringe Refer to “Section 11 Notes on Disposable
Requirement Syringes”
Maximum Flow 2100 (ml/h)
Rate

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MS 31-CETF-005

5.2Main Performance

0.01-2100ml/h, step size 0.01ml/h.


2ml syringe: 0.01-100ml/h
5ml syringe: 0.01-150ml/h
Rate Range 10ml syringe: 0.01-400ml/h
20ml syringe: 0.01-600ml/h
30ml syringe: 0.01-1000ml/h;
50/60ml syringe: 0.01-2100ml/h;
Rate Accuracy ±2%
(Essential Note: One pump and twenty syringes for the
Performance) accuracy test.
Volume Range 0.01~9999.99ml,step size 0.01ml
Volume Accuracy ±2%
(Essential Note: One pump and twenty syringes for the
Performance) accuracy test.
1ml/h~2100ml/h continuously adjustable
Maximum Flow Rate Limitation:
2ml syringe: 100ml/h;
5ml syringe:150ml/h;
High Rate
10ml syringe: 400ml/h;
20ml syringe: 600ml/h;
30ml syringe: 1000ml/h;
50/60ml syringe: 2100ml/h;
Supported Syringe
2ml, 5ml, 10ml, 20ml, 30ml and 50/60ml
Size
Maximum infusion
140kPa
pressure
Occlusion alarm
threshold
Maximum 130 kPa, Minimum 26 Kpa. 9 adjustable
(Pressure)
setting. Accuracy ±20kPa
(Essential
Performance)

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MS 31-CETF-005
Under Minimum rate and maximum occlusion
alarm threshold, the alarm trigger time: 3h30
m
Under Minimum rate and minimum occlusion
alarm threshold, the alarm trigger time: 1h
Under intermediate rate and maximum
occlusion alarm threshold, the alarm trigger
Time to activate time and bolus volume: 45m, 2mL
the occlusion Under intermediate rate and minimum
alarm; max bolus occlusion alarm threshold, the alarm trigger
(Essential time: 15m
Performance) The minimum selectable rate is the minimum
flow rate. It equals to 1 mL/h. The time to
activate the occlusion alarm is the same as
minimum flow rate.
(Tested with KANGJIN(KJ) syringes. The
occlusion is introduced at the end of the
syringe. Measure environment is 20 ℃ ,and
patient line is 1 meter.)
3mL for Rate≥ 10ml/h
KVO Rate 1mL for 1ml/h ≤ Rate < 10ml/h
KVO Rate = Rate for Rate < 1ml/h
Alarm sound
recover time for 1min50s~ 2min
recoverable alarm
Overtime alarm
1min50s~ 2min
suspension time
Syringe size error, Plunger Error, Occlusion
High priority alarm
Alarm, VTBI complete alarm, out of battery alarm,
(Essential
battery/mains power double disconnect alarm,
Performance)
malfunction alarm
Classification Class II, CF continuously volume syringe pump
with internal power supply

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MS 31-CETF-005
IPX2
Storage Temperature: -30℃~+55℃
Operation Temperature: 5℃~+40℃
Environmental
Storage relative humidity: ≤75%;
Requirement
Operating relative humidity: 20%~90%;
Barometric pressure range: 80.0kPa~106.0kPa;
Software Version V1.0.0
Product lifetime 5 years

5.2 Main and Frequently used Features

 Automatic identification of syringe size;


 Set injection flow rate, set VTBI and display real-time data;
 Display the completed 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;
 Display the TVI;
 Clear the TVI data;
 Various brands of syringes are supported;
 Internal battery
 External DC adapter;
 Wi-Fi connectivity.

6 Product Structure and Operation Interface


6.1 Main Components

The device is mainly consisted of a user interface panel, a pump


housing, a mechanical actuation system, and an electrical control
system.
The font view and back view are illustrated in Figure 6-1-1 and

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MS 31-CETF-005
Figure 6-1-2.
Descriptions for components
External
Charging Working
1 2 Power 3
Indicator Indicator
Indicator
4 Touch Screen 5 Keypad 6 Plunger
Syringe Push
7 Syringe Clamp 8 9 Foot
Handle
Battery
Power Supply
10 Compartment 11 12 Fixation Pole
Port
Cover
Clamping Port
13 Positioning Pin 14
for Stacking

Figure 6-1-1 Front View

Figure 6-1-2 Back View

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MS 31-CETF-005

Figure 6-1-3 Side View

6.2 Operation Interface

The display interface is shown in Figure 6-2. The keypad


interface is shown in Figure 6-4.

Figure 6-2 Display Screen


Display Component:
1 Time 2 Status Indication 3 Mute Icon
Internal Power
4 Screen Lock Icon 5 WIFI Icon 6
Status
Parameters Return to Return to Home
7 8 9
Setting Area Previous Menu Menu

Figure 6-4 Keypad Interface


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MS 31-CETF-005
Key Definition
1 Start/Stop 2 Increase 3 Decrease
4 Left/Right 5 OK to confirm 6 Mode
7 Purge/Bolus 8 Mute/Cancel 9 Power on/off

7 Operation Instruction
======================================================

Attention
--------------------------------------------------------------------------------------------
All syringes must follow Section 10 Syringe Pump Parameter Set Up
before they can be used on this device for the first time.
======================================================
Operation Instructions
Install syringe pump -> Power up -> Safety self-test -> Install
syringe -> Set up parameter -> Clear air bubble by purge -> Start
therapy -> Complete therapy -> Uninstall accessory -> Power off.
Make sure the installed syringe is consistent with the syringe
setting on the device.

7.1 Set up Syringe Pump

7.1.1 Mount the Clamp

The fixation clamp is a separate accessory. First loosen the


locking screw, fix the clamp to the pole, adjust the height of clamp,
and then tighten the locking screw. Stainless steel poles with coating
or other protective layers should not be used as the material for the
infusion stand(The installation of the clamping device might damage
the protective layer on the pole surface).

7.1.2 Install the Syringe Pump

As shown in Figure 7-1-1, fix the fixation clamp onto the fixation
pole, make sure the positioning pin is inside the correct hole
accordingly, and make sure the injection pump is installed in an
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MS 31-CETF-005
upright position.
The operator must make sure that the injection pump is
positioned and fixed in a secure, stable and reliable manner.

Figure 7-1-1 Install the syringe pump

7.1.3 Stack the pump

Multiple MS 31 pumps can be used when stacked together.


Press down the release button to unstack a pump from a stack.

Figure 7-1-2 Stack the Syringe Pump

7.2 Power on and Self Safety Test

7.2.1 Power on

Connect to mains power, check the power indicator on the pump


front panel. If the indicator is not lit up, check the connection of
power cable and the pump, or check if there is a power outage.

Then press the button on the front panel to turn the power
on.

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MS 31-CETF-005
======================================================

Caution
--------------------------------------------------------------------------------------------
Before connecting the mains power, check if there is foreign matter
inside the power outlets (such as drug solution residue).
======================================================

7.2.2 Device Self Safety Test

Device self-test: the pump will perform an automatic safety


self-test after power on, if the test is passed then it will be followed
by two short beeps “Deeh, deeh” as an acoustic reminder. If a
continuous alarming sound is initiated or there is no any sound at all,
then the device cannot be used, contact MDK customer service
immediately.

7.3 Install Syringe

Open the pump door; squeeze and hold the finger grips on the
plunger holder to open the claws, pull the plunger out to an
appropriate position and release the finger grips.
Pull the syringe holder out and turn it in either direction for 90°
to horizontal position, place the syringe barrel flange in the slot
between the plunger holder and the claws, pull the syringe holder
out again, turn it back for 90 ° to upright position and release it to
clamp the syringe tight; straighten the syringe extension line, place it
inside the hook behind the pump door to prevent the extension line
from being pressed, then close the pump door.
Squeeze and hold the finger grips on the plunger holder, slide it
to the left until it reaches the plunger end. Release the finger grips.
Make sure that the plunger claws are securing the plunger in place
and the finger grip returns to its original position.

If there is bubble in the syringe pump set, press the button “ ”

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MS 31-CETF-005
twice within 1 second. The device will enter the purge mode and

clear the air bubble. Press “ ”to exit the purge mode.

7.4 Set Parameters

7.4.1 Select Syringe

Power on the device and install the syringe, the brand and
model of syringe will be displayed in the setup screen.

Figure 7-4-1 Identify syringe model


Please check to make sure the brand displayed is correct. If
the brand needs to be changed, select the correct brand in the Home
– Settings – Brand, then go back to the HOME page. No selection or
modification is needed if the syringe set used in current use is the
same as the last time.

Figure 7-4-2 Select Syringe

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MS 31-CETF-005
======================================================

Caution
--------------------------------------------------------------------------------------------
When syringes from the same brand but different lots are used,
calibration of the syringe is recommended, which is described in Section
10.2 Syringe Calibration. It is possible that the syringes from the same
brand but different lots have different characteristics, which will affect
their injection accuracy if they are not calibrated before use.
======================================================
7.4.2 Select Infusion Mode
MS 31 supports 6 injection modes in total, including R+V, R+T,
V+T, R, Drug Library and Body Weight.
Press Home-Select Infusion Mode

Figure 7-4-2-1 Select Infusion Mode


Once the selected infusion mode is entered, transitions between
modes can be done by clicking on the R+V、R+T、V+T、R buttons
listed in the parameters setting area.

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MS 31-CETF-005

Figure 7-4-2-2 Switch Injection Mode

7.4.3 Set Volume to Be Infused (VTBI)

When pump is in standby, a keypad will show up when the


volume parameter on touch screen is pressed. Input VTBI and
confirm to complete the setting.

Figure 7-4-3-1 Set the Volume

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MS 31-CETF-005

Figure 7-4-3-2 Input the number with on-screen key board

7.4.4 Set up Rate

Same as 7.3.3.

7.4.5 Set up Time

Same as 7.3.3.

Figure 7-4-5 Set up injection time.

7.4.6 Set Purge Parameters

Click on HOME-Settings-Purge Setting to set speed and volume


for purge.

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MS 31-CETF-005

Figure 7-4-6 Purge setting.

7.4.7 Set up Occlusion Alarm Threshold

Enter the occlusion pressure setting screen by pressing the


upside-down triangle shape icon on touch screen. The occlusion
pressure has 9 levels, with the maximum pressure being
130kPa±30kPa and minimum pressure being 26 kPa±20kPa. Drag
the slider along the horizontal axis to adjust the pressure levels of
occlusion pressure alarm. This is can also be done by clicking on the
+ or – sign on the two upper corners. Click on “Back” to go back to
the parameter setting page for infusion mode.

Figure 7-4-7 Set occlusion pressure level.

7.5 Start Injection

7.5.1 Automatic Purge and Start Infusion

After the correct installation of infusion set is confirmed, press

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MS 31-CETF-005

the button, MS 31 pump will show the following message


“Purge or Not?” on screen. If YES is selected, the pump will run
based on the fast infusion rate and volume values that are set in the
HOME-System Settings-Purge Setting, pushing the air inside the
syringe set out. See HOME-Settings-Purge Operation Indication
page to learn how to turn off the purge operation indication page.

Figure 7-5-1

Purge operation indication page.

Figure 7-5-2 Purging in progress


When purge is completed, the screen returns to the previous
parameter setting page. Confirm that the drug solution is flowing
normally from the needle tip, insert the needle into patient’s vein and

fix the needle. Press the button to start infusion. From right to

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MS 31-CETF-005
left, the operation indicator arrow on the bottom of the screen will
start to flash continuously in a cyclic manner.

7.5.2 Manual Purge and Start Infusion

When the purge indication page is turned off, press the


button to manually purge the air bubble in line after the syringe set is
installed, or use the roller clamp on the syringe set to purge the air in
line before installing the syringe set onto pump.
After the syringe set is installed correctly onto the pump and the
air in line is purged out, confirm that the drug solution is flowing
normally from the needle tip, insert the needle into patient’s vein and

fix the needle. Press the button to start infusion. From right to
left, the operation indicator arrow on the bottom of the screen will
start to flash continuously in a cyclic manner.

7.5.3 Injection in progress

The status of normal infusion operation is shown in Figure 7-5-3.


The two display windows on the bottom show remaining volume and
time. When the pump is currently in drug library mode, the display
window on top shows the type of infusion set and the drug name.
When occlusion pressure exceeds 80% of the preset value for
alarming pressure, the alarm will be activated by showing a yellow
triangle on screen. When occlusion pressure exceeds the preset
alarm pressure value, a red triangle will be displayed on the screen,
and an occlusion alarm message will be shown at the same time.

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Figure 7-5-3 Injection in progress.

7.6 Stop Therapy and Clear Alarm

The button can be pressed to stop an alarm, or to stop


injection, while the operation indicator will stop flashing as well.
======================================================

Caution
--------------------------------------------------------------------------------------------

If the is pressed to stop injection, but the is not pressed

to reset the accumulated volume back to zero, then if the is


pressed again the injection task will resume from where it left last time.
======================================================

Injection will be stopped if the button is pressed when


injection operation is in progress. If no injection parameters are
changed during the stop, the injection will pick up from where it left

last time and continue to run when the is pressed again. If any
injection parameter is modified, such as rate, volume or time, then a

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new injection task is established. When the is pressed down


again, injection will run based on the newly set parameters.

7.7 Mute Alarm Sound

When an alarm is triggered, the device will annunciate an alarm

sound. The alarm sound can be muted temporarily when


button is pressed. But if the alarm source has not been removed
after two minutes, the system will automatically turn the alarm on
again.

7.8 Purge and Bolus

Based on the different working mode of the device, there will be

three different responses When the key is pressed.


 Automatic purge mode: in the injection mode parameter setting

page, double click on will make the injection pump go into


the automatic purge mode based on the rate and volume values
set in the HOME-Settings-Purge Setting page. The pump will
stop automatically after the operation is completed, and the
screen will return to the parameter setting page. The total
volume for purge is not included in the accumulated volume.
The alarm function enable in automatic purge mode as injection
in progress.

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Figure 7-8-1 Purge in progress
 Automatic bolus mode: when injection operation is in progress,
bolus speed and bolus volume setting page will be entered by a

single click on button. Set the parameters on this page


and press the “Ok” button on the lower right corner on screen,
the pump will go into an automatic bolus mode. The bolus
operation will stop when the preset bolus volume has been
completed, the pump will return to normal injection operation,
and the bolus volume will be included in the accumulated
injection volume. Under the injection operation state, double

click on will make the pump go into an automatic bolus


operation state and run based on the bolus rate and volume that
were set last time.
 Manual bolus mode: when injection operation is in progress,
bolus speed and bolus volume setting page will be entered by

clicking on button once. Set the bolus parameters and

continuously press down the button, the pump will enter


manual bolus mode. Bolus operation will run based on the set
bolus speed (total bolus volume is not effective during manual

bolus mode) until the button is released. Pump will return


to where it left before manual bolus was entered and continue to
run injection. The manual bolus volume is included in the
accumulated injection volume.

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Figure 7-8-2 Bolus in progress

Figure 7-8-3 Bolus in progress

7.9 Infusion Complete

When the injected volume (the incremental of accumulated


injection volume) has reached the set value, the injection preset
volume complete alarm will be triggered. The pump will annunciate
an alarm sound and display a “VTBI Infused” alarm message in the
alarm indication area. Then the device will automatically switch to
KVO speed to continue to operate.

Press the button to clear the VTBI infused alarm and to


exit the KVO injection state.

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Figure 7-9 Infusion Complete


The screen will show information such as the accumulated

injection volume and speed. Press and hold the button for 3
seconds will clear the accumulated injection volume. Click on the
“Back” button on the lower left corner to go back to the injection
parameters setting page, then a new round of injection operation can
be initiated.
======================================================

Caution
--------------------------------------------------------------------------------------------
When KVO is entered, a KVO indication message will be shown on top of
the injection speed numbers, indicating the device has entered the KVO
state. However, the KVO speed will not be shown on the screen.
======================================================

7.10 Automatic volume accumulation and Reset

When pump is at stop, press and hold the button for 3


seconds to clear the accumulated infusion volume.
The accumulated injection volume shows the total injected
drug solution volume received by a patient. For example: Drug A is
given to patient during the first injection with a preset volume of 1ml.
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When the accumulated volume reaches 1ml, the pump will
annunciate preset volume complete alarm, which means 1ml of Drug
A has been injected into patient. And when Drug B of 2ml is given to
patient without clearing the accumulated injection volume. Then the
pump will annunciate preset volume complete alarm when the
accumulated injection volume reaches 3ml, meaning 2ml of Drug B
has been injected into patient. In total, the patient has been given
3ml of drug solutions, including 1ml of Drug A and 2ml of Drug B.

7.11 Lock and Unlock

The device will be locked automatically after running for a


certain period of time. When under operation mode, press and hold

the button for 3 seconds to unlock.


See the automatic locking time setting in HOME - Settings -
Auto-Lock Time.

Figure 7-11 Screen auto-lock time setting.

When not in operation mode, click the button once the


device will switch to R+V mode parameter setting page.

7.12 Power Off

Press and hold the button for 3 seconds, the device will

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be powered off.

Figure 7-12 Power off count down.


======================================================

Caution
--------------------------------------------------------------------------------------------
Do not power off the pump when injection operation is in progress,
otherwise the device will stop injection.
======================================================

7.13 Uninstall Syringe Pump

To uninstall the pump, pull the ring on the fixation base up and
pull the pump outward while holding it.

7.14 Body Weight Mode

Select to enter the body weight mode setting screen, as shown


in Figure 7-14-1. Based on the prescriptions given by doctor, input
information such as Dose, D. Volume, Solvent, and Weight and etc..
The device will then automatically calculate concentration and flow
rate. Click the “Ok” button to enter R+V mode parameter setting
page, where the flow rate and the total volume are displayed are the
ones that are calculated under the body weight mode setting page.

Press the button to start injection under the body weight mode.

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Figure 7-14 -1 Body weight mode setting.


On the body weight mode setting page, click the “Units” button
on the upper right corner to change between different units, which
will in turn change the units of parameters such as dosage and
concentration accordingly.
Concentration and Rate Calculation:
Concentration = dosage (mg)/solution volume (ml)
Rate = dosage(mg/kg/h) * body weight(kg) * solution volume(ml)
/dosage(mg)

7.15 Drug Library Set up

On the drug library mode setting page, click on the first column
of letters on the left, the pump will display drug names that begin
with the same initial letter and their corresponding flow rates in their
last infusion. Click on the “>” (Page Down) button on the lower right
corner, the pump will show more drug names that begin with the
same initial letters.
Confirm the drug name, click once to select, the device goes
into R+V mode parameter setting page, where speed shows the flow
rate value of this drug during last injection, and total volume shows

the solution volume during last injection. Click on the button,


the pump will run injection under the drug library mode, while the
drug name is shown on top of the injection speed number during
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operation.

Figure 7-15 Drug Library Set up

7.16 Drug Library

Both MS 31 and MI20 pumps can be installed and operated on


the MX infusion work station made by the MDK, which will enable
them to work in corporation with the work station to realize advanced
features such as relayed injection/infusion and drug library
management and etc.
Inside HOME-Drug Library, the operator can perform operations
like adding new drugs or setting injection speed for each drug. Tasks
like importing drug information in volume, or setting upper/lower
thresholds for dosage can be done by using the MX infusion work
station.

7.17 Log

In HOME-Log page, 200 log messages are shown, including


information such as time, speed, and volume for each injection
event.
Using the MX infusion work station, injection and alarm log
information can be saved and inquired without capacity limitations.
All logs can also be transferred via network and be printed out,
helping care providers in managing their work.

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Figure 7-17 Log

8 Alarm Function
Alarm is activated when there is either abnormality in the
injection liquid path or failure within the pump itself that will cause
the device fails to carry out injection correctly. Sound and light
alarms are used to draw attentions from the care givers. All alarms of
infusion pump are technical alarms.
The alarm sound and the acoustic reminder have the same
acoustic pressure level and their minimum acoustic pressure level is
greater than 60 dB.
MS 31 alarm priority levels:
Alarm Priority Type of Alarm Conditions
Syringe size error, Plunger Error, Occlusion Alarm,
VTBI complete alarm, out of battery alarm,
High Priority
battery/mains power double disconnect alarm,
malfunction alarm
Pause over time alarm, internal battery low voltage
Low Priority
alarm, injection near to end alarm.
High priority and low priority alarms are distinguished by
different sound and light indications according to the standards

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requirements. High priority alarm is indicated by red light and low
priority alarm is indicated by yellow light.
The following alarms are defined as latching and unlatching
alarms:
Latching alarms: VTBI complete alarm, out of battery alarm,
battery error alarm, occlusion alarm, syringe plunger alarm, and
malfunction alarm.
Unlatching alarms: Pause over time alarm, internal battery low
voltage alarm, near to end alarm, and battery/mains power double
disconnect alarm.
All the alarm settings will remain the same if the power is turned
back on within 30 seconds after it was turned off.
======================================================

Caution:
--------------------------------------------------------------------------------------------
Latching alarm: alarm remains even though the event that triggered
the alarm does not exist anymore, until the operator intentionally ends

the alarm (press the button); unlatching alarm: alarm stops


automatically when the alarm causing event is not there anymore.
======================================================

8.1 Syringe size mismatch alarm

Trigger conditions: When the device detects that the syringe size is not
among the supported 6 sizes, an alarm will be activated and the injection
will be terminated. An error message “Syringe Holder” will be displayed in
the alarm indication area. The alarm can be triggered if the syringe push
handle is accidently pulled out, or a nonstandard syringe is used.

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Solution: When the “Syringe Holder” alarm is triggered, press to


clear the alarm. Check the syringe plunger and the size of syringe.
Reinstall the syringe and continue the operation.
Alarm test: Install a 50ml syringe. Add an 2mm paper between the
syringe and syringe holder. When start the syringe pump, an alarm will
be activated and the injection will be terminated. An error message
“Syringe Holder” will be displayed in the alarm indication area. The alarm
can be triggered if the syringe push handle is accidently pulled out, or a
nonstandard syringe is used.

Figure 8-1 Syringe holder error alarm.

8.2 Plunger Error Alarm

Trigger Condition: When the syringe plunger is detached from the pump
plunger pressure sensor, the device will initiate an alarm and stop
infusion. “Plunger Error” will be displayed in the alarm indication area.

Solution: When the plunger error alarm is triggered, press to clear


the alarm. Check the syringe plunger and the size of syringe. Reinstall
the syringe and continue the operation.
Alarm test: Start the syringe pump. Squeeze and hold the finger grips on
the plunger holder to open the claws, pull the plunger out. The device will
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initiate an alarm and stop infusion. “Plunger Error” will be displayed in the
alarm indication area. This indicates that the Plunger Error alarm is
correct.

Figure 8-2 Plunger error alarm.

8.3 Occlusion Alarm

Trigger condition:
When the syringe set line is occluded, the occlusion sensor will detect
this condition and activate an alarm. A message “Occlusion” will be
displayed in the alarm indication area and the pump will stop injection. As
a safety measure at the same time, the motor will rotate in the opposite
direction to retrieve a small amount of drug solution to reduce the bolus
volume before occlusion is removed.
Solution:

1) When occlusion alarm is activated, press the button to clear


the alarm sound, the “Occlusion” alarm message will disappear.
2) Check if the syringe set line is kinked, or if the patient is pressing on
the line by accident. Restart injection operation when occlusion is
removed.
Alarm test: Install the syringe pump and syringe. Set the infusion

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parameter and start injection. Clamp the end of patient line and an
occlusion will be detected after a while. A message “Occlusion” will be
displayed in the alarm indication area and the pump will stop injection.
This indicates that the Occlusion alarm is correct.

Figure 8-3 Occlusion alarm.

8.4 VTBI Complete Alarm

Trigger Condition:
When the accumulated injection volume shown in the current display
window reaches the preset value, the pump will annunciate an alarm
sound, stop injection based on the preset speed, and display a “VTBI
Infused” alarm message in the alarm indication area on screen. As a
safety and protection measure, the pump will automatically switch to
KVO mode to continue injection.
Solution:

During VTBI infused alarm, press the button to clear alarm sound,
and the “VTBI Infused” alarm message will disappear. Then follow the
operation steps to reset the pump and start to use.
Alarm test: Install the syringe pump and syringe. Set the infusion
parameter and start infusion. A message “VTBI Infused” will be displayed
in the alarm indication area and the pump will stop infusion. This
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indicates that the VTBI Complete alarm is correct.

Figure 8-4 VTBI complete alarm.

8.5 Out of Battery Alarm

Trigger Condition:
When the battery is used up, the device will initiate a high-priority alarm
sound and red light alarm signal, while displaying an “Out of Battery”
alarm message in the alarm indication area on screen. The injection will
stop, and the pump operation will remain in stop and it will completely
shut down in 3 minutes.
Solution:
Connect to mains power for power supply. When connected to mains
power, the battery charging indicator will be lit up while the battery is
being charged. The battery charging indicator will go off when battery is
fully charged.
Alarm test: Install an used up battery in the syringe pump. A message
“Out of Battery” will be displayed in the alarm indication area. This
indicates that the Out of Battery Alarm is correct.

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Figure 8-5 Out of battery alarm.

8.6 Battery/Mains Power Double Disconnection Alarm

Trigger condition:
When pump is in operation, and when the mains power is disconnected
and the battery is completely out or disconnected, the device will initiate
high-priority sound and light alarms.
Solution:
Connect to mains power or use battery to supply power.
Alarm test: First, disconnected the mains power. Then start the syringe
pump and disconnect the battery. The syringe pump will initiate
high-priority sound and light alarms. This indicates that the Battery/Mains
Power Double Disconnection Alarm is correct.

8.7 System Error Alarm

Reason: Infusion will stop when there is a system error in the device
hardware. A high priority alarm will be activated and the error name will
be displayed accordingly. The following errors are defined as system
errors: motor error, communication error, and the internal battery
communication error.
Solution:

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Press the button to clear alarm sound. Check if syringe set is


installed correctly. Restart injection after corrections are made. Contact
the MDK customer service if alarm remains.
Alarm test: Error Alarm can’t be simulated. If there is an error alarm,
please call for our service engineer.

Figure 8-6 Motor error alarm.

8.8 Pause Overtime Alarm

Trigger Condition:
When system is in a pause state for more than 2 minutes after device is
powered on and parameter settings are done, a pause overtime alarm
will be initiated. The pump will give out an alarm sound and display a
“Pause Overtime” alarm message in the alarm indication area.
Solution:
Press any key or rotate the dial will clear the alarm sound, and the
“Pause Overtime” message will disappear.
Alarm test: Don’t touch the infusion pump for 2 minutes. A message
“Pause Overtime” will be displayed in the alarm indication area. This
indicates that the Pause Overtime Alarm is correct.

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Figure 8-7 Pause overtime alarm.

8.9 Internal Battery Low Alarm

Trigger Condition:
When internal battery is low, the device will annunciate a low-priority
alarm sound, and display a “Low Battery” alarm message in the alarm
indication area. If injection is in progress, the pump will not stop
operation.
Solution:
Connect to mains power immediately. When connected to mains power,
the battery charging indicator will be lit up, the battery will start to be
charged, and the “Low Battery” message will disappear. The battery
charging indicator will go off when battery is fully charged.
Alarm test: Install a battery with less than 20% charge in the syringe
pump. A message “Low Battery” will be displayed in the alarm indication
area. This indicates that the Internal Battery Low Voltage Alarm is
correct.

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Figure 8-8: Low battery alarm.

8.10 Injection Near End Alarm

Trigger Condition:
When the remaining time is less than the preset alarm time, the device
will initiate a low-priority alarm sound, and display a “Near End” alarm
message in the alarm indication area on screen. Injection will not stop.
Solution:

Press the button to clear alarm sound. Check remaining drug


solution and the remaining time, wait for injection to complete.
Alarm test: Install the syringe pump and syringe. Set the infusion
parameter and start injection. A message “Near End” will be displayed in
the alarm indication area. This indicates that the Injection Near End
Alarm is correct.

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Figure 8-9 Injection near end alarm.

9 Setting System Parameters


System parameters can be set in the HOME-Settings page.

9.1 Brightness

Brightness of the screen can be set in HOME-Settings-Light.


Brightness can be adjusted by dragging the slider along the
horizontal axis, or it can be done by clicking on the + or – signs on the
upper left and right corners. After brightness setting is completed,
click on the “Back” button on the lower left corner to return to the
previous menu.

Figure 9-1 Brightness setting.

9.2 Alarm Sound

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Alarm sound level can be set in the HOME-Settings-Alarm
Volume page. Drag the slider along the horizontal axis to adjust the
volume of alarm sound, which can also be done by clicking on the +
or – signs. After sound level setting is completed, click on the “Back”
button on the lower left corner to return to the previous menu.
The default setting for alarm sound volume level is low level. The
alarm sound volume level will be reset to the default setting when the
device is restored to the default factory settings. The alarm sound
volume level will remain the same as the most recent set value if the
device is restarted.

Figure 9-2 Alarm sound volume setting.

9.3 Purge Setting

The speed and volume for purge can be set in the


HOME-Settings-Purge Setting page. Click on the speed or volume to
set their value respectively. The parameter set in the Purge Setting
will not affect the speed and volume in bolus mode.

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Figure 9-3 Purge setting.

9.4 Purge Indication

Whether or not to turn on the purge indication page can be set in


the HOME-Settings-Purge Indication Page. The icon means
the purge indication page is turned on. With purge indication page
turned on, the pump will ask operator if the syringe set needs to be

purged when is pressed after all injection related parameters


have been set. The icon means the purge indication page is
turned off.

Figure 9-4 Purge indication page setting.

9.5 Load Settings from Last Use

In the HOME-Settings-Load Settings from Last Use page,

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operator can decide whether to load the parameters from last use.
The icon means that the feature to load parameters from last
use is turned on. When power is turned on, the pump will show an
indication page reminding the operator that parameters from last use
are being loaded. Information such as injection mode, speed,
volume and time will be displayed on pump screen. When YES is
pressed, the pump will go into the corresponding injection mode,
load and use the parameters from last use accordingly, which will
help the operator quickly start the injection task.

Figure 9-5 The reminding page for loading the parameters from last use.

9.6 WIFI

In the HOME-Settings-Wi-Fi page, operator can decide whether


to turn on Wi-Fi connection. The icon means Wi-Fi connection
is turned on. A symbol will appear on the upper right corner of
the screen, which means Wi-Fi is on and other devices can be
connected with the pump via Wi-Fi. The icon means Wi-Fi is
turned off. When MI20 is used together with an MX injection work
station, please read the MX’s user’s manual for directions on how to
set up the connection between the two and how to perform relayed
injection operations.

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Figure 9-6 Wi-Fi on/off setting.

9.7 Syringe Type

The type of the syringe set for the current use can be set in the
HOME-Settings-Brand page. Click on the check box on the right to
choose syringe set brand. When completed, click on the “Back”
button on the lower left corner to return to the previous menu.
The selected syringe set type will be shown on the page for
injection mode setting, which can remind the operator to use the
right syringe set to maintain injection accuracy.
The operation of syringe calibration can be found in Section
10.2 Syringe Calibration.

Figure 9-7 Syringe brand configuration.

9.8 Screen Auto-lock Time

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The time for locking the screen or the keypad can be set in the
HOME-Settings-Auto-Lock Time page. Drag the slider along the
horizontal axis to adjust the time that is allowed to elapse before the
screen or keypad is locked, which can also be done by clicking on
the + or – signs. After setting is completed, click on the “Back” button
on the lower left corner to return to the previous menu.

Figure 9-8 Screen auto-lock time setting.

9.9 Daytime/Nighttime Setting

In HOME-Settings-Daytime/Nighttime Setting, set different


values for brightness and sound volume for daytime and nighttime.
Drag the slider along the horizontal axis to adjust the numbers for
alarm sound volume and screen brightness. When completed, click
on the “Back” button on the lower left corner to return to the previous
menu.
The brightness and alarm sound volume settings in
HOME-Settings-Light and HOME-Settings-Alarm Volume have a
higher priority than the ones in Daytime/Nighttime setting. When it is
the time for the Daytime Start Time or Nighttime Start Time, the
device will automatically adjust brightness and alarm sound volume
to the level where it has been defined in the
HOME-Settings-Daytime/Nighttime setting. The brightness and
sound volume can be adjusted either in HOME-Settings-Light and
HOME-Settings-Alarm Volume, or in

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HOME-Settings-Daytime/Nighttime page.

Figure 9-9 Daytime/Nighttime setting.

9.10 System Maintenance

System maintenance can be performed in the


HOME-Settings-Maintenance page, including the calibration of
infusion set, system time setting, system language setting, and etc..
A password is required to enter the system maintenance page.
Contact the customer service at MDK for password assistance.
Read Section 10 in this manual for the procedure of performing
calibration for syringe sets.

Figure 9-10 System maintenance setting.

9.11 Restore Factory Default

Factory settings can be restored in the HOME-Settings-Restore

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to Factory Settings page. The settings that can be restored are all of
the parameters described in Section 9 in this manual, including the
accuracy value for the default syringe set. Please take caution when
decide whether or not to perform a restoration to the factory default
settings.

Figure 9-11 Restore to factory settings.

10 Parameters Setting for Syringe


10.1 Enter Syringe Calibration Setup Screen

Follow Section 9 Setting System Parameters to enter the


syringe set calibration setting screen. Select the brand name of the
syringe set accordingly, as it is shown in the following figure.

Figure 10-1 Calibration for syringe set accuracy.

10.2 Syringe Calibration (Method One)


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1) Like performing a normal injection operation procedure, install
the syringe set first, place the scalp needle into a measuring
tube with scales. Enter the HOME-Settings-System
Service-Calibration page.
2) Click on Brand and select the brand name that needs to be
calibrated. Return to the Calibration page.
3) Click on Model and select the type that needs to be calibrated.
Return to the Calibration page.
4) Press the “Size Confirm” button on the touch screen and press
the “Start/Stop” key on the keypad to start injection. Wait until
the injection is completed.
5) Read the injected volume in the measuring tube. Press the “Real
Volume” button on the touch screen and input the volume data.
Click on the “BACK” button to complete the syringe calibration.

10.3 Syringe Calibration (Method Two)

1) Like performing a normal injection operation procedure, install


the syringe set first, place the scalp needle into a measuring
tube with scales. Enter the HOME-Settings-System
Service-Calibration page.
2) Click on Brand and select the brand name that needs to be
calibrated. Return to the Calibration page.
3) Click on Model and select the type that needs to be calibrated.
Return to the Calibration page.
4) Use a caliper to measure the length between the 0ml mark to the
mark of full scale on the syringe. For example, on a 20ml syringe,
the length between 0ml to 20ml is 68.0mm, as shown in the
figure below.
5) Click on the data input area next to L1 to enter the measured
length and press the Back button to complete the syringe
calibration.

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68.0mm

Figure 10-2 Syringe accuracy measurement

11 Notes on Disposable Syringe


The ambient temperature should be kept at least at 5 ℃ or
above when a recommended syringe set is used. The injection
accuracy will be compromised if ambient temperature is lower than
5℃.
When there is significant variation in ambient temperature, the
device shall be recalibrated to ensure the accuracy. The syringe
calibration procedure is described in Section 10 e Parameters
Setting for Syringe.
Strictly follow the requirements described in Section 10
Parameters Setting FOR Syringe to calibrate the syringe set before
use when change to a new syringe set from a different manufacturer.
The recommended syringe brand list is as follows:
No. Brand Name Accuracy
1 KANGJIN 2%

12 Technical Specifications
1) The methods of controlling bolus volume before occlusion is
removed: control bolus volume by making the stepper motor to
rotate in the opposite direction to reduce the pressure in syringe
line after it has been occluded.
2) Storage time for the electronic memory after power off: 100 years.
3) The maximum volume that may be infused under single fault
conditions is 30%. Note: Accuracy test under the motor error.
4) Unit used in device calibration: ml (milliliter).
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5) Medium flow rate performance curve(20mL syringe)
a.The waveform for medium flow rate during the first two hours of
operation.

In the above figure, the dashed line shows the set flow rate
(5ml/h in this figure), and the solid line is the continuous connection
line for the average flow rate during a sampling period.
b.The trumpet curve for medium flow rate during the second hour of
operation.

The dashed line is the final value that the error of the device is
eventually converging to. The solid line above the dashed line is
the maximum positive deviation during the second hour of
operation. The solid line below the dashed line is the maximum
negative deviation during the second hour of operation.
6) minimum flow rate performance curve(20mL syringe)
a. The waveform for minimum flow rate during the first two hours of
operation.

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b.The trumpet curve for minimum flow rate during the second hour of
operation.

7) medium flow rate and back pressure +13.3kPa performance


curve (5mL syringe)
a. The waveform for 2.5ml/h flow rate and at back pressure of
+13.3kPa during the first two hours of operation.

b.The trumpet curve for 2.5ml/h flow rate and at back pressure of
+13.3kPa during the second hour of operation.

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8) medium flow rate and back pressure performance curve ( 5mL


syringe)
a. The waveform for 2.5ml/h flow rate and at back pressure of
-13.3kPa during the first two hours of operation.

b.The trumpet curve for 2.5ml/h flow rate and at back pressure of
-13.3kPa during the second hour of operation.

13 Use and Maintenance of Internal Battery


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The MS 31 syringe pump has an internal rechargeable Lithium
battery with the following specification: DF18650/2200mAh
/1P3S/10.8V. When connected to mains power, the internal battery
charging management module inside the pump will control the
charging process of the Lithium battery automatically. When
disconnected from the mains power, the system will automatically
switch to the internal battery as its power source.
When fully charged, the internal battery can support the pump to
operate continuously for at least 7 hours with an intermediate
injection speed.
Battery Maintenance:
1) When the pump is not used for a long period of time, it is
recommended to charge the internal battery every 3 months or
remove the battery, in order to save the battery life.
2) Contact MDK customer service immediately if the internal
battery cannot be charged normally or cannot work normally. Do
not tamper with the battery. For the medical agencies with the
ability to repair a device, MDK will provide the necessary
technical documents after giving the related personnel from
these agencies the proper training. Then a device can be
disassembled and the battery can be changed by these agencies
on their own.
MS 31 is installed with one internal single use button battery.
The battery life is larger than 5 years. When the battery is expired,
the device should be disposed according to the instruction in section
16, “Wast Disposal”.

14 Product Service and Maintenance


Inspection before use:
1)Check if there are foreign objects inside the power outlet (such
as drug solution residue). Confirm that the system has passed the
self-test after the pump is powered on.
2)Select the correct type for syringe set. Check the battery level.

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MS 31-CETF-005
Charge the battery if necessary.
During operation
3)To prevent giving an incorrect dosage of drug solution to patient,
disconnect the pump from patient before changing a device,
4)Make sure the injection line is not kinked. Insert the needle to the
vein on a patient’s body part that is not likely to be squeezed or
pressed.
5)To prevent the spilled drug solution on pump surface from
entering the device, wipe it dry immediately.
Storage and Cleaning
6)To keep the device clean, wipe clean it at least once a month,
which can prevent the corrosion caused by the drug solution and
avoid the mobility of the mechanical parts to be affected by the
dried-up solution.
7)Use a clean and dampened cloth or an alcohol pad to wipe clean
the device. Take caution to avoid any liquid from entering the device.
8)Keep the surface of the air bubble sensor probe clean. A dirty
probe will reduce the sensor’s sensitivity in air bubble detection or
cause false alarm. Take caution when cleaning the probe to avoid
damaging it.
The manufacture will provide the schematics, parts list and other
documents to facilitate the maintenance.

15 Installation of the Removable Battery


Connect the battery to device before use, as shown in Figure
15-1.

(a) (b) (c)

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MS 31-CETF-005
Figure 15-1 Install the internal battery.

16 Waste Disposal
16.1 Battery

Follow the local laws and regulations to dispose the expired old
battery.

16.2 Syringe

Follow the local laws and regulations to dispose the syringe set
after use.

16.3 MS 31 Syringe Pump

The product lifetime of this device is 5 years. Dispose the device


after its lifetime has expired. The disposed SYRINGE PUMP can be
returned to MDK or its distributors to be recycled properly.

17 Electromagnetic Compatibility
Guidance and MANUFACTURER’S declaration –
ELECTROMAGNETIC EMISSIONS – for all ME EQUIPMENT and
ME SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The SYRINGE PUMP MS 31 is intended for use in the electromagnetic
environment specified below. The customer or the user of the SYRINGE PUMP
MS 31 should assure that it is used in such and environment.
Electromagnetic environment –
Emission test Compliance
guidance
The SYRINGE PUMP MS 31 uses RF
energy only for its internal function.
RF emissions Therefore, its RF emissions are very
Group 1
CISPR 11 low and are not likely to cause any
interference in nearby electronic
equipment.
RF emission Class A The SYRINGE PUMP MS 31 is
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MS 31-CETF-005
CISPR 11 suitable for use in all
Harmonic emissions establishments other than domestic
N/A
IEC 61000-3-2 and those directly connected to the
Voltage public low-voltage power supply
fluctuations/ flicker network that supplies building used
N/A
emissions for domestic purposes.
IEC 61000-3-3
Guidance and MANUFACTURER’S declaration – electromagnetic
IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The SYRINGE PUMP MS 31 is intended for use in the electromagnetic
environment specified below. The customer or the user of SYRINGE PUMP MS
31 should assure that it is used in such an environment.
IEC 60601 Compliance Electromagnetic
Immunity test
test level level environment - guidance
Electrostatic 6 kV 6 kV Floors should be wood,
discharge (ESD) contact contact concrete or ceramic tile. If
IEC 61000-4-2 15 kV air 15 kV air floor are covered with
synthetic material, the
relative humidity should be
at least 30%.
Users must eliminate static
in their hands before use it.
Electrical fast 2 kV for 2kV for Mains power quality should
transient/burst power power be that of a typical
IEC 61000-4-4 supply lines supply lines commercial or hospital
environment.
Make sure there is not
impulse interference >1kV
in use environment.
Surge 1 kV 1 kV Mains power quality should
IEC 61000-4-5 differential differential be that of a typical
mode mode commercial or hospital
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MS 31-CETF-005
environment.
Voltage dips, short <5% UT <5% UT Mains power quality should
interruptions and (>95% dip in (>95% dip in be that of a typical
voltage variations UT) UT) commercial or hospital
on power supply for 0.5 cycle for 5 sec environment. If the user of
input lines 40% UT the SYRINGE PUMP MS 31
IEC 61000-4-11 (60% dip in requires continued
UT) operation during power
for 5 cycles mains interruptions, it is
70% UT recommended that the
(30% dip in SYRINGE PUMP MS 31 be
UT) powered from an
for 25 cycles uninterruptible power
<5% UT supply or a battery.
(>95% dip in
UT)
for 5 sec
Power frequency 3A/m 3A/m If image distortion occurs,
(50Hz) magnetic it may be necessary to
field position the SYRINGE
IEC 61000-4-8 PUMP MS 31 further from
sources of power
frequency magnetic fields
or to install magnetic
shielding. The power
frequency magnetic field
should be measured in the
intended installation
location to assure that it is
sufficiently low.
NOTE UTis the a.c. mains voltage prior to application of the test level.
Guidance and MANUFACTURER’S declaration – electromagnetic
IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not

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MS 31-CETF-005
LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The SYRINGE PUMP MS 31 is intended for use in the electromagnetic
environment specified below. The customer or the user of SYRINGE PUMP MS
31 should assure that it is used in such an environment.
IEC 60601 Compliance Electromagnetic environment -
Immunity test
test level level guidance
Portable and mobile RF
communications equipment
should be used no closer to any
part of the P15G including cables,
than the recommended
separation distance calculated
from the equation applicable to
Conducted RF 3 Vrms 3V the frequency of the transmitter.
IEC 61000-4-6 150 kHz to Recommended separation
80 MHz distance
Radiated RF 3 V/m
IEC 61000-4-3 3 V/m
80 MHz to
2.5 GHz

80 MHz to 800
MHz

800 MHz to 2.5


GHz
WhereP is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and is
the recommended separation

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MS 31-CETF-005
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.
a
Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the SYRINGE PUMP MS 31 is
used exceeds the applicable RF compliance level above, the SYRINGE PUMP MS
31 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or
relocating the SYRINGE PUMP MS 31.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
Recommended separation distances between portable and mobile RF
communications equipment and the ME EQUIPMENT or ME SYSTEM –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between
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MS 31-CETF-005
portable and mobile RF communications equipment and the SYRINGE PUMP
MS 31
The SYRINGE PUMP MS 31 is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or
the user of the SYRINGE PUMP MS 31 can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the MS 31 as recommended
below, according to the maximum output power of the communications
equipment.
Rated Separation distance according to frequency of transmitter
maximum (m)
output power 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2.5
of transmitter MHz GHz
(W)

0.01 0.117 0.117 0.234


0.1 0.370 0.370 0.740
1 1.170 1.170 2.340
10 3.700 3.700 7.400
100 11.7 11.7 23.4
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.

18 Anti-static Precautions

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MS 31-CETF-005
The MS 31 syringe pump has been tested and conforms to the
medical equipment standard YY0505-2012.
When used by an operator, the pump should not be contacted with
connector pins that have electrostatic discharge warning signs. Unless
electrostatic discharge prevention measures are taken, the pump should
not be contacted with these connectors.
The operator should be aware of the following things:
a) Unless appropriate preventive measures have already been taken,
do not use hand or hand tool to touch connectors with electrostatic
discharge warning signs. Preventive measures include: 1 Methods for
preventing electrostatic charge accumulation (such as air conditioning,
air humidification, floor conductive coating, synthetic clothing);2
Discharge electrostatic charge from human body to the framework of
equipment , or to the ground, or to a large piece of metal; 3 Use a wrist
band to connect human body to the equipment or to the ground.
b) All staffs who may be in contact with connectors with electrostatic
discharge warning signs should receive training, including all
clinical/biomedical engineering and healthcare personnel.
c) Electrostatic discharge training should include the introduction of
static charges in the theory of physics, the voltage that may be produced
in normal practice, and the damage to the electronic components caused
by the electrostatic charge from an operator. Further, methods for how to
prevent electrostatic charge accumulation should be provided, as well as
how and why to discharge the electrostatic from human body to the
framework of equipment or to the ground, and how to use wrist band to
connect someone’s body to the equipment or to the ground.

19 Package and Accessories


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MS 31-CETF-005
Recommended Accessory List for MS 31 (One Unit)

Accessory Name quantity Unit

User’s Manual 1 Book

DC Adapter 1 Set

fixation clamp 1 PCs

Refer to the packing slip for all other accessories.

68 / 68

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