Syringe Pump

4000D Series User Manual

Medsure Medical Technology Co., Ltd.

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Chapter 1 Warnings and Cautions
This User Manual was published by Medsure Medical Technology Co., Ltd. and contains
information about the safe use of this product. Users of this product (including 4000D A,
4000D AP, 4000D B, 4000D BP) shall be trained to use the pump and read this User Manual,
including warnings and cautions before using it. Key aspects of the training included how to
install the syringe; Setting of parameters, such as infusion rate; Conventional troubleshooting
methods. In case fails to follow these warnings, cautions, and instructions may result in serious
injury or death.
Although the User Manual has been considered as thoroughly as possible in preparation
for publication, Medsure Medical Technology Co., Ltd. assumes no responsibility for any
inaccuracies that may occur.
The copyright of this User Manual belongs to Medsure Medical Technology Co., Ltd.
Without the approval of our company, any unit or individual is not allowed to copy, modify or
translate the contents speculated in this User Manual.

1.1 Warnings

If the operator does not follow the instructions in this User

Manual, the user or patient may be seriously injured or killed.
1. The user shall confirm that the performance provided by this product is in accordance
with the intended use, and shall not be used for any unexpected purpose in any way or for
any purpose. Failure to do so will result in a decline in functionality of the product,
resulting in death or injury to the patient or user.
2. The clinician shall ensure that he or she is within the visual and audible range of the
device so that he or she can quickly respond to any critical alarms. Failure to quickly
respond to an alarm can result in patient injury or death.
3. This product is not suitable for using in environments where flammable anesthetic gases
are mixed with air, oxygen or nitrous oxide. Using in environments where such mixtures
are present may result in an explosion or fire.
4. Portable RF communications equipment(including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm(12 inches) to any part of the
pump,including cables specified by the manufacturer, otherwise degradation of the
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 performance of this equipment could result. To avoid possible malfunction of this
equipment, do not expose this equipment to X-rays, gamma rays, or ionizing radiation, or
subject it to radio frequency interference or strong electric/magnetic fields generated by a
heat transfer device or mobile phone. If the equipment is to be used or used in
conjunction with a magnetic resonance imaging (MRI) device, the equipment shall be
protected from the magnetic field generated by such device. Failure of the syringe pump
can result in erroneous infusions or insufficient infusions, resulting in patient casualties.
5. To avoid malfunction of this equipment or its adjacent equipment, do not use the syringe
pump near or on other equipment in the case without the assessment of the impact of
qualified personnel in the hospital. If they shall be close to or stacked, make sure they can
work normally.
6. To ensure the electrical safety and electromagnetic compatibility (EMC) performance of
this device, use only the power cord supplied with the device. If other power cords are
used, the safety and EMC performance of the device may be degraded and the user or
patient may be killed or injured.
7. This equipment can only be connected to a power socket with protective grounding. If
the power socket is not connected to the grounding wire, please do not use the socket and
use the rechargeable battery to supply power to the device.
8. While the syringe pump is injecting, in order to ensure electrical safety, only the
components of the equipment complying with IEC60950-1:2005 can be connected to the
USB interface at the back end of the syringe pump, otherwise the patient's life safety will
be threated.
9. To prevent the device from falling off the infusion pole or bed rail, make sure that the
device is reliable and securely mounted on the infusion pole or bed rail. If the warning is
not observed, it may damage the pump, even cause the user or patient casualties.
10. Properly charging the battery is necessary to ensure that the product operates by the
internal battery for the specified period of time. Failure to properly power the battery can
result in damage to the product and cause patient casualties.
11. In order to maintain the performance of the syringe pump, Medsure Medical Technology
Co., Ltd. recommends to use the qualified syringes which have a registration certificate
and are supported by this equipment, otherwise the infusion accuracy may exceed ±2%.
If other syringes are used or if the specification of the syringe listed in this User Manual
is changed, it shall be calibrated before it is used to infusion (4000D B, 4000D BP only).
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12. To avoid the siphoning (free flow) of the fluid in syringe, make sure to clamp the tube
before installing or removing the syringe and make sure the syringe is properly seated in
the syringe pump jaw and the syringe pump shall be installed at the infusion site within
80cm range. Siphoning can cause over-infusions, causing death.
13. For safe operation of the syringe pump, the syringe and the tube shall be compatible and
shall be properly installed according to the syringe installation instructions. Make sure
there are no additional labels on the outer casing of the syringe (which can affect the
identification of the syringe). The inside of the syringe casing is placed properly in the
front casing groove, and the tube is passed through the tube fixing clip of the
corresponding channel on the syringe pump to prevent the tube from accidentally falling
out. Failure to do so may result in an infusion error and cause injury or death to the
patient.
14. In order to avoid over-infusion or under-infusion, make sure to confirm that the installed
syringe is consistent with the recognized syringe by the displayed syringe brand and size
before infusion. Otherwise, the infusion may be inaccurate and cause injury or death.
15. Supported syringes are disposable. Use syringes according to local clinical guidelines and
product instructions. Misusing syringe may be inaccurate or even cause injury.
16. The volume in the tubing is the residual volume and will not be injected. This part extra
volume shall be taken into account when filling the syringe and priming at the first time.
Patients cannot get effective treatment because of the under-infusion.
17. To avoid over-infusion, do not prime the tubing while the tubing is connected to the
patient. Over-infusion can cause injury or death.
18. To avoid embolism, it is important to ensure that air in the tubing shall be primed out
before it is connected to patient. The syringe pump has a priming function to assist this
process.
19. To achieve the intended infusion, the data must be entered correctly. Before the user
performs the infusion, the correctness of the displayed data shall be confirmed to avoid
the patient to get ineffective treatment due to incorrect data.
20. The occlusion level shall be checked before infusion to make sure that it meets the
requirement of infusion. Otherwise, the patient may be injured or die due to the delay of
the occlusion alarm.
21. If a tube occlusion alarm occurs, immediately clamp the tube clamp and press the push
rod release handle to reduce the tube pressure to prevent accidental infusion of the drug
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 into the patient, and then check the tube for bending or occlusion. Occlusion must be
removed before reinfusion, and accidental drug infusion can cause injury to the patient.
22. When the syringe pump is infusing, shall avoid to hit or press the push rod release
handle, otherwise it may cause additional infusions, and result in patient casualties.
23. Do not use defective syringe pumps. If the syringe pump detects a system failure, the
syringe pump will issue an alarm and display an associated alarm message. If this
happens, turn off the syringe pump and disconnect the power supply and transfer it to a
qualified engineer for inspection and repair. The syringe pump which has any system
error is forbidden to inject, it can cause the patient cannot get the treatment in time, and
cause injury or death.
24. If the working temperature isn’t among the operating temperature specified in this User
Manual, the performance of the product will be reduced. Make sure the temperature is
within the specified range, otherwise it may cause injury or death to the patient.
25. If you do not follow the instructions of cleaning and maintaining the device in this User
Manual, the functionality of device may be reduced, and cause injury or death.
26. If a large amount of liquid is spilled on the device, in order to avoid accidents, wipe it off
in time and have it checked by a professional before returning to use.
27. This equipment requires special precautions. Please read the “EMC Statement” for
electromagnetic compatibility requirements and before installation and using it.
28. Although the device itself is designed to protect against electromagnetic interference, if it
is used in conjunction with a radio frequency point surgical device, if electromagnetic
interference occurs, restart the device. If it still cannot be solved, please increase the
distance from the RF housing device as appropriate.
29. Except the transducers and cables which are sold by the manufacturer as spare parts, the
use of other accessories, transducers and cables may result in the increase of emission or
the decrease of immunity interference.
30. The maximum volume for the single fault condition of the device is 0.6mL.
31. The pump will check the alarm system every time while powering on self-test. If the
alarm system is abnormal, the pump is forbidden to use. The user shall make sure the
alarm system can work normally before infusing.
32. A potential hazard can exist if different alarm pre-sets are used for the same or similar
equipment in any single area.

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33. The factors which could greatly reduce the performance of infusion accuracy could be
misusing of syringe, using incorrect syringe, air in pipeline or too much driving
resistance.
34. The pump use mains plug as the isolation means from supply mains. It should not be
positioned in a way that makes it difficult to disconnect from mains power if necessary.
Disconnect from supply mains by removing the mains plug from the wall outlet.

1.2 Cautions

If you do not follow all the instructions in this User Manual.

The pump may be damaged or an unexpected dangerous situation
may occur.
1. Do not use this pump if it is found to be damaged after unpacking. Please contact the after-
sales service department of Medsure Medical Technology Co., Ltd.
2. Please have qualified technicians complete all services, repairs, and calibrations.
Unauthorized modifications are prohibited.
3. Do not use the syringe pump if an error is displayed after powering on and it is still
displayed after the pump is restarted. Give the pump to a qualified technician for
inspection.
4. Do not use cleansers or disinfectants other than those specified in this User Manual.
5. Do not immerse the syringe pump in any liquid or expose it to strong organic solvents.
Immediately wipe off the spill and do not leave liquid or residue on the syringe pump. In
addition, the syringe pump shall not be autoclaved, steam sterilized, sterilized with
ethylene oxide or placed in an environment above 55 ° C (131 F). If this precaution is not
followed, it may cause serious damage to the syringe pump.

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Contents
Chapter 1 Warnings and Cautions..............................................................2
1.1 Warnings .......................................................................................2
1.2 Cautions.........................................................................................6
Chapter 2 Introduction .............................................................................10
2.1 Working principle and structure .................................................10
2.2 Syringe pump function ................................................................10
2.3 Basic product configuration ........................................................11
2.4 External characteristics of the syringe pump ..............................11
2.4.1 Front of syringe pump......................................................11
2.4.2 Rear of syringe pump .......................................................13
Chapter 3 Installation ...............................................................................14
3.1 Pole clamp installation ................................................................14
3.2 Fixation of the syringe pump.......................................................15
Chapter 4 Basic Operations ......................................................................17
4.1 Position of the operator and the syringe pump ..........................17
4.2 Operation workflow ....................................................................18
4.3 Operation steps ...........................................................................19
4.3.1 Power on ..........................................................................19
4.3.2 Install syringe ...................................................................19
4.3.3 Select syringe brand .........................................................21
4.3.4 Select infusion mode........................................................21
4.3.5 Priming .............................................................................22
4.3.6 Set infusion parameters ...................................................22
4.3.7 Start infusion ....................................................................22
4.3.8 Infusion completed ..........................................................23
4.3.9 Unload or replace syringe ................................................24
4.3.10 Power off .........................................................................24
Chapter 5 Features ...................................................................................25
5.1 Infusion mode .............................................................................25
5.1.1 Rate Mode .......................................................................25
5.1.2 Time Mode .......................................................................25
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 5.1.3 Weight Mode ...................................................................25
5.2 Bolus infusion ..............................................................................27
5.3 KVO (keep vein open) ..................................................................27
5.4 Sleep ............................................................................................28
5.5 Syringe calibration .......................................................................28
5.6 History Log...................................................................................29
Chapter 6 Functional setting interface .....................................................30
Chapter 7 Alarm System...........................................................................32
7.1 Alarm System Description ...........................................................32
7.2 Failure Analysis and Troubleshooting .........................................36
Chapter 8 Battery .....................................................................................38
8.1 Working with internal battery .....................................................38
8.2 Battery Performance ...................................................................39
8.3 Battery charging ..........................................................................39
8.4 Battery Replacement...................................................................40
8.4.1 Battery replacement frequency .......................................40
8.4.2 Battery Replacement Method .........................................40
8.5 Battery recycling..........................................................................41
Chapter 9 Cleaning and Maintenance ......................................................42
9.1 Cleaning .......................................................................................42
9.2 Maintenance ...............................................................................42
Chapter 10 Transportation and Storage.....................................................45
Chapter 11 Symbols Description ................................................................45
Chapter 12 Specifications ...........................................................................48
12.1 Product ........................................................................................48
12.2 Classification................................................................................49
12.3 Power supply ...............................................................................49
12.4 Infusion rate ................................................................................49
12.5 Maximum infusion rate and KVO rate .........................................50
12.6 Infusion pressure .........................................................................50
12.7 Infusion accuracy.........................................................................50
12.8 Occlusion – Occlusion level .........................................................51
12.9 Occlusion – Occlusion time .........................................................51
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 12.10 Occlusion release - Bolus volume ............................................52
12.11 Basic performance ...................................................................52
12.12 Supported syringe brands and sizes ........................................53
12.13 Curves ......................................................................................55
Chapter 13 Electromagnetic Compatibility Statement ..............................58
13.1 EMC performance .......................................................................58
13.2 Product use precautions .............................................................59
13.3 Electromagnetic environment requirements ..............................60

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Chapter 2 Introduction

2.1 Working principle and structure

This product includes 4000D A, 4000D AP, 4000D B, 4000D BP four models (referred to
as 4000D series), which is a Syringe Pump in medical equipment developed and produced by
Medsure Medical Technology Co., Ltd.
Working principle: The syringe pump controls the liquid flow into the patient through two
single-action syringes. The microcontroller drives the step motor to rotate, then the motor
drives the half nuts to move linearly by the drive system, finally the syringe plunger is driven
by the leadscrew and half nuts mechanism to infuse the drug in the container into the patient.
The infusion rate is set by the operator, and the device indicates the flow rate per unit time.
Structure: The pump consists of pump cover, motor drive system, input system, storage
system, control system, display system, sensing monitoring system, and alarm system.

2.2 Syringe pump function

Application scope: use in conjunction with disposable syringe for precise quantitative
control of intravenous infusion solution.
Expected working environment: An institution or unit with health care capabilities,
including but not limited to: hospital, emergency room, general ward, ICU, operating room,
observation room, clinic, nursing home, etc.
The product can continuously infuse the drug solution by the set rate which can be from
0.1 mL/h to 1500 mL/h (for the 4000D A, it is from 0.1 mL/h to 1200 mL/h). The maximum
rate is depended on the size of the syringe.
If desired, the volume to be infused can be pre-set prior to the infusion; during the
infusion, the clinician can infuse the drug solution at the maximum rate of syringe pump.
The main functions of the pump are as follows:
Infusion mode: Rate Mode, Time Mode and Body Weight Mode (only for 4000D AP and
4000D BP)
Bolus infusion: Manual Bolus and Auto Bolus
Sleep: unused channels can sleep
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 Syringe calibration (only for 4000D B and 4000D BP)
This product does not have network and mobile computing capabilities.
The pump does not use latex.
Contraindications: None

2.3 Basic product configuration

Check the basic configuration list of the product after unpacking: See the attached list of
“Syringe Pump Product Packing List” for details.

2.4 External characteristics of the syringe pump

2.4.1 Front of syringe pump

The external features of the 4000D series are similar. with only minor differences in the
characters used for the product model identification and part of the button pattern. This section
uses 4000D BP as an example to introduce the main components of the series of syringe
pumps, including the keys, operation interface and back of the syringe pump.

display screen of alarm indicator of

channel 2 channel 2
display screen of
channel 1
crimp groove
pusher
alarm indicator
of channel 1

pusher
handle
tubing
retaining clip

syringe jaw
mains power
indicator charging syringe clamp
indicator

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Operation Interface Description
The description of the operation interface of this product is shown by above figure. The
two channels of the product can be operated and displayed independently.
Key Description
The following table is the main functional description of each key. The function of each
key can be executed according to the prompt of the functional interface.
Key symbol Description

Power key is used to power on or off pump.

Start/Stop key is used to start or stop infusion.

1) Prime/Bolus key is used to prime out the air in the tubing before it
is connected to the patient.
2) During the infusion, it can also be used to quickly give additional
dose.
Pause key is used to pause the alarm audio for 2 minutes.

1) Select key is used to select or confirm the set parameters;

2) If the accumulated volume isn’t zero, it can also be used to set the
accumulated volume to be zero.
Mode key is used to change the infusion mode or exit the function
interface.
Menu key is used to change the interface among the infusion program
interface, functional setting interface and history log interface.

1) Number setting keys are used to set various parameters;

2) While pump isn’t infusing and there isn’t any alarm, it can also be
used to make to specified channel to enter or exit sleep;

3) While the parameter is in editable state, if both and are

pressed simultaneously, the parameter is set to zero or its minimum
value.

4) When infusion, press and simultaneously to lock or

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 unlock.

2.4.2 Rear of syringe pump

Specification USB
battery cover label handle Pole Clamp interface

AC power interface

Name Description

Specification The back label contains product information, including product name,
label model number, service life, input power, etc. For more information, see
the back label of the product.
AC power The pump shall be connected to a suitable AC power source using a
interface power cord.
Pole Clamp Use the pole clamp to fix the pump to a vertical infusion pole or a
horizontal railing.
USB interface The pump has two USB ports, each channel has its own USB port. The
USB port is sealed off by a soft plastic cover. It is only used for
debugging by the manufacture.

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 Speaker The bottom of the syringe pump is equipped with a speaker that can
generate a self-test tone, a key pressed tone and an alarm audio.

Chapter 3 Installation
Each syringe pump has a pole clamp that is mounted on the pump. The pump can be
mounted on a horizontal or vertical railing via the pole clamp.
The safe load of the pole clamp is 13kg, and the total load is less than 3.0±0.5kg. The
safety factor of all supports is designed to be 4 times in terms of wear, corrosion, material
fatigue and aging without compromising the performance of the supports.

3.1 Pole clamp installation

The pole clamp can be mounted horizontally (pre-installed) or vertically on the syringe
pump as need.
Horizontal direction:

Vertical direction:

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 Pole clamp installation:
1. Unscrew the hexagon socket set screw with a hex wrench.
2. Place the pole clamp against the syringe pump in the desired direction so that the screw
holes in the pole clamp align with the holes on the back of the syringe pump.
3. Install the pole clamp onto the syringe pump with two socket head cap screws and tighten
the screws with an Allen key until the pole clamp is securely fastened.

3.2 Fixation of the syringe pump

The pump can be placed on a stable surface, such as a tabletop where the syringe pump
does not slide or creep down. It can also be fixed to a stable infusion pole (rods suitable for
sizes 15mm to 30mm) or the bed rail (shown below).

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 Clipped to the infusion pole

Clipped onto the bed rail

Steps of fixing syringe pump:
1. Unscrew the clamping screw of the pole clamp to allow enough space.
2. Grasp the pump with both hands to snap the infusion rod or bed rail into the pole clamp
slot and adjust the syringe pump to the desired position.
3. Hold the syringe pump with one hand at the bottom and the screw with the other hand
until the syringe pump is securely fastened.

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Chapter 4 Basic Operations

4.1 Position of the operator and the syringe pump

The operator (such as a doctor or nurse) shall be in the range of half the arm directly in
front of the syringe pump when operating the pump.
When the syringe pump is infusing, the operator should not be away from the syringe
pump, to make sure that the alarm sound of the syringe pump can be heard. If you want to see
the visual alarm message from the syringe pump, the operator needs to observe within 1 meter
directly in front of the syringe pump.

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 4.2 Operation workflow

Press 2S to power on, then pump enters

Power on the infusion interface after self-test

Install syringe Install Syringe following section 4.3.2

Choose the syringe brand according to the

Select syringe brand using syringe brand

Select infusion mode Choose infusion mode according to need

Press to start priming, detail refer

Priming to section 4.3.5 priming

Set infusion parameters Refer to section 4.3.6 to set infusion

parameters
Connect to patient Connect tubing to patient

Start infusion Press to start infusion

Press to stop infusion

Infusion completed

Disconnect with the patient disconnect the tubing from the patient

Refer to section 4.3.9 to remove or change

Unload or replace syringe syringe

Keep press , then display the interface

Power off of shut off, and will shut off after 2 seconds

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 4.3 Operation steps

4.3.1 Power on

1. Plug it into mains power supply.

2. Press and hold the power key for 2 seconds to turn it on.
3. After powered on, the pump starts self-test.
4. After self-test if there isn't any alarm，you can install the syringe for the pump to be used.
Note: The self-test process is as follows:
The pump starts the power on self-test procedure after hearing a “di” sound, the screen
shows the logo of Medsure, the red and yellow alarm indicator flash once one by one, then the
motor moves for self-test, at last a “di” sound reminds the self-test is over.

4.3.2 Install syringe

1. Take a syringe filled with solution, connect a compatible tubing correctly, and make sure
the tubing is securely connected.

2. Open the syringe clamp, press the pusher handle, and pull the pusher to the far end.

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3. Install the syringe into the syringe holder and ensure that the syringe casing curls
into the crimp groove of the front casing of the syringe pump and close the syringe
clamp.

4. Press the pusher handle to fully open the syringe jaw and move the pusher to snap
the syringe jaw into the pusher.

5. Pass the tubing from bottom to top through the tubing retaining clip on the side of
the syringe pump. (as the picture shows)

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 4.3.3 Select syringe brand

1. After the pump is powered on and the syringe is properly installed, the brand selection
interface will appear on the screen of the corresponding channel.
2. Check that the automatically identified syringe size is correct and select the syringe brand
which is actually being used.
3. The title bar of the interface shows the brand and size of the currently selected syringe.
For details of the supported syringe, please refer to the “12.12 Supported Syringe Brands
and Sizes” section of this User Manual.

4.3.4 Select infusion mode

The syringe pump totally supports three infusion modes. They are rate mode, time mode
and body weight mode (Body weight mode is supported only by 4000D AP and 4000D BP).
The user can select the desired mode by the mode key. See “5.1 Infusion Mode” for the
detailed description of each mode.

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 4.3.5 Priming

The air remaining in the tubing shall be primed out and the mechanical clearance between
the pusher handler and the push head of syringe shall be eliminated before starting infusion to
ensure that the syringe pump begins the infusion at its best.
1. Ensure the tubing is not connected to the patient, if there is a tubing clip, loose the tubing
clip first.
2. In stop state, press the prime/bolus key and set the desired prime rate of the interface. If
pressing and holding the prime/bolus key, the syringe pump will prime the air in the tubing
at the set rate.
3. The screen displays the priming interface. Press and hold the prime/bolus key until the air
has been primed out and the liquid begins to drip from the end of the tubing.
4. After the air in the tubing is primed out, connect it to the patient and prepare to begin the
infusion.
Note 1: The maximum priming volume of each time is about 2mL. After 2mL volume has been
primed out, the syringe pump stops priming and triggers the alarm “Purge vol. to limit.!” to
notify the user that the priming volume has been to its limitation.
Note 2: The priming volume is not included in the total volume of infusion.

4.3.6 Set infusion parameters

In each infusion mode, the user can set the infusion parameters via the number setting
keys and selection key. See “5.1 Infusion Mode” for the detailed programming instructions.

4.3.7 Start infusion

1. Connect the tubing to the patient.

2. If there is a tubing clip, first loose the tubing clip, then press the start key to start the
infusion.
3. While the syringe pump is infusing, at the bottom of the screen there is a specific dynamic
icon to indicate this status.
4. Bolus infusion is enabled while infusing. For detailed operation, please refer to “5.2 Bolus
Infusion”.

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5. For 4000D AP and 4000D BP models, while infusing the flow rate can be changed
directly (Don’t need to stop infusion firstly).

6. When infusion and no alarm except “AC disconnected”, press and

simultaneously to lock all keys of corresponding channel except the Power key, and the
lock symbol will be displayed on the screen. Or after 2 minutes of infusion, the system
will automatically lock the keys. When locking, the keys of corresponding channel will

not work except the Power key to prevent accidental operation, press and

simultaneously to unlock.

BD Preci. 50mL 1

Rate 100.0 mL/h

Infused volume 10.0mL

4.3.8 Infusion completed

1. Infusion completed - set volume to be infused (VTBI)

While the remaining infusion time is no more than the set nearly empty time, the syringe
pump will trigger an alarm "nNear complete!" or "syringe Syringe near empty!" and continue
to infuse at the set rate. The infusion stops and triggers an alarm “completeComplete!!!” or
“syringe Syringe empty!!!” when the remaining volume is zero or the syringe is empty, then
automatically enters the KVO infusion.
2. Infusion completed - no limitation
The syringe pump will continue to infuse until the fluid in the syringe has been totally
injected or the stop key is pressed.
While the remaining infusion time is no more than the set near complete time, the syringe
pump will trigger an alarm "nNear complete!" and continue to infuse at the set rate. The
infusion stops and triggers an alarm “completeComplete!!!” when the syringe is empty, then
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automatically enters the KVO infusion. For details of the KVO infusion, please refer to “5.3
KVO”.
3. Stop infusion
Press the stop key to stop the infusion at any time.

4.3.9 Unload or replace syringe

1. Press the stop key to stop infusion.

2. Clamp the tubing clip and disconnect the tubing from the patient.
3. Loose the tube from the tube retaining clip of the syringe pump.
4. Open the syringe clamp and the pusher jaws.
5. Remove the syringe.
6. Install another syringe as described in “4.3.2 Installing Syringe” and continue the infusion
according to the infusion procedure, or turn off the syringe pump after closing the syringe
clamp.

4.3.10 Power off

1. While the syringe pump is infusing, press the stop key.

2. Press and hold the power key, the shutdown screen appears and the pump will be shut
down after 2 seconds. If the power key is released midway, the pump automatically
returns to the previous interface.
3. If pump halted, press and hold the power key for more than 6 seconds to shut down the
pump abnormally.

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Chapter 5 Features

5.1 Infusion mode

5.1.1 Rate Mode

Rate mode
Rate ---.-
---.- mL/h
VTBI ---.- mL
Accum. vol. 0.0 mL

Set Sel

5.1.2 Time Mode

Time mode

VTBI ---.-
---.- mL
Infusion time 00 hr 00
Rate ---.- mL/h
Accum. vol. 0.0 mL
Set Sel

Note: The infusion rate is automatically calculated according to the VTBI and the infusion
time. The infusion rate = VTBI / infusion time.

5.1.3 Body Weight Mode

Only applicable to the configuration of 4000D AP and 4000D BP

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 Weight mode Weight mode

Rate ---.- mL/h Rate ---.- mL/h

Dose --.-- mg/kg/h Volume ---.-
--.-- mL
Weight ---.- kg VTBI 0.0 mL
Dosage ---.- mg Accum. vol. ---.- mL
Set Sel Set Sel
Note: The infusion rate is automatically calculated according to Dose, Weight, Drug Mass, and
volume. The formula is as below.
When the dosage unit is mg/kg/h, the infusion rate = Dose * Weight / Drug Mass * Volume.
When the dosage unit is mcg/kg/min, the infusion rate = Dose * Weight / Drug Mass * Volume
* 0.06.

The setting parameters in the infusion mode are as follows:

Programmable Descriptions
parameters

Rate Please refer to the maximum infusion rate and KVO rate
(<1000mL/h, the minimum step is 0.1mL/h, ≥1000mL/h , the
minimum step is 1mL/h)

VTBI 0.0-9999mL, the minimum step is 0.1mL

Infusion time 00hr00-99hr59, the minimum step is 1 minute

Dose 0.01-99.99, the minimum step is 0.01mg/kg/h or mcg/kg/min

Weight 0.1-999.9, the minimum step is 0.1kg

Drug Mass 0.1-999.9, the minimum step is 0.1mg

Volume 0.1-999.9, the minimum step is 0.1mL

Accumulated Volume Non editable, 0.0mL~9999mL, press the select key to set it to zero
when it is selected.

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 5.2 Bolus infusion
1. While infusing, press the prime/bolus key to enter bolus infusion setting interface and can
edit the bolus rate and the bolus volume. Press the select key to select parameters.

Size Bolus Rate Bolus Volume

10mL The current infusion rate -300.0mL / h 1.0-10mL

20mL The current infusion rate -400.0mL / h 1.0-20mL

30mL The current infusion rate -600.0mL / h 1.0-30mL

The current infusion rate -1500.0mL / h

50mL (4000D A is the current infusion rate - 1.0-50mL
1200mL/h)
2. Press the menu key to start an automatic bolus and the bolus infusion will end
automatically and returns to the infusion interface after the bolus infusion volume is equal
to the set bolus volume.
3. Press and hold the prime/bolus key to start a manual bolus. If the prime/bolus key is
released midway, the bolus infusion will be terminated and return to the infusion interface.
4. The bolus infusion volume will be added to the accumulated volume.
5. When Bolus infusion, the “Near complete!” or “Syringe near empty!” alarm is blocked
and will not be triggered until the bolus volume is infused completely.

5.3 KVO (keep vein open)

If the set KVO rate isn’t zero, while the infusion complete alarm or syringe empty alarm is
triggered, the pump will automatically start the KVO infusion, or the pump will stop infusion.
If the set KVO rate is less than the previous infusion rate, the set KVO rate will be used. But if
the set KVO rate is greater than the previous infusion rate, the previous infusion rate will be
used. The maximum time of KVO infusion is 30 minutes. After that the pump will stop
infusion automatically.
The KVO infusion is also stopped due to occlusion. In this case pressing the stop key to
stop the infusion and the alarm is cleared.

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 5.4 Sleep

While sleeping, the display is off. Except , and , other keys are disable.

When a channel of the syringe pump is in stop state and except the AC disconnected

alarm there isn’t other alarm, press and key of the corresponding channel at the same

time to manually set the channel to sleep. The same keys can also be used to exit sleeping.

5.5 Syringe calibration

In addition to the syringes listed in the User Manual, the 4000D B and 4000D BP can also
support the syringe calibration function. Five calibrated brands can be saved in the pump
separately to ensure the delivery accuracy in clinical use case.
The syringe calibration procedure is as follows:
1. While the pump is in the stop state, press the menu key to display the functional setting
interface, select the syringe calibration item, and enter the syringe calibration interface
according to the prompts.
2. Install the syringe to be calibrated correctly and check that the recognized syringe size is
correct.
3. Press the select key to display the custom brand selection interface, press the number
setting key to navigate the custom brands, and then press the select key to confirm the
selection.
4. Press the pusher handle according to the prompt of interface, and pull the pusher to move
the syringe piston to the nominal scale accurately, then press the select key to confirm.
5. Push the pusher to move the syringe piston to the 0 mark, then press the select key to
confirm.
6. If the calibration is successful, press the mode key to exit the calibration. The calibrated
scale length and tail length can be manually modified if necessary.
7. Select the save soft key to save the calibrated result and the title bar will display a prompt
to mark this custom brand has been calibrated.
8. If calibration is completed, press the mode key to exit the functional setting interface.

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 5.6 History Log
If the device has been used to infuse, some critical infusion data will be saved in the
history log. The pump can store up to 5000 history logs. In the case the stored history log to the
limitation, the first one will be overwritten. For each log, the pump only displays infusion time,
rate and infused volume, and the latest log is displayed at the top line. For the details of the log,
the biomed or service engineers can use the compatible PC application to retrieve them from
the pump by communication cable.
Press the menu key to view the history log, and navigate other logs by pressing up or
down key.

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Chapter 6 Functional setting interface
The following parameters are the functional parameters of the 4000D BP model syringe
pump. Some parameters are not applicable to other models. See the descriptions in the
parameter list section for details. The default values for the Menu parameters are shown below:

Menu

Occlusion Level Medium

Change rate on
Nearly empty time 3 min
KVO 0.2 mL/h
Dose unit mg/kg/h
Sel Ok Exit

Menu
Alarm volume 6
Alarm type type1
Date 2017 - 01 - 01
Time 00 : 00 : 00
Syringe cali.
Sel Ok Exit

Menu
Night Mode Off
18 : 00 - 07 : 00
Recommended brands
Alarm reset
Version 4D BP V1.0.0.R
Sel OK Exit

Press the menu key to display the menu setting interface, press the number setting key to
navigate parameters, and press the selection key to select the parameter. If the parameter is
selected, press the number setting key to modify its value, then press the select key to save the
setting or press the mode key to give up the setting.
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Parameters Attributes

Occlusion There are low, medium and high levels. It is recommended to choose the
level appropriate occlusion level according to the actual requirements of the clinic.

Change rate There are on and off options. If the setting is on, the infusion rate can be changed
directly while infusing and don’t need to stop infusion firstly. Otherwise the
infusion rate cannot be changed directly. (only for 4000D AP and 4000D BP)

Nearly The time for setting the near complete alarm or syringe near empty alarm. It is
empty time adjustable from 1 to15 minutes. For 4000D A and 4000D AP models, it is a fixed
value, 3 minutes.

KVO Setting the KVO infusion rate. It is used to keep the patient line open.

Dose unit The unit of Dose in body weight mode is mcg/kg/min, mg/kg/h, which can be
selected according to actual requirements. (only for 4000D AP and 4000D BP)

Alarm Setting the audio volume for alarm. It shall be adjusted only by biomed technician.
volume While changing the alarm volume, if the auditory alarm signal sound pressure
levels are less than ambient levels, it will impede the operator to recognize the
alarm condition and the potential risk could occur. The biomed technician shall
avoid this dangerous case.
It is adjustable from 1 to 10. 1 is the lowest alarm volume, 10 is the highest alarm
volume. For 4000D A and 4000D B models, it is fixed to 10. This parameter can be
modified only after inputting the authorization code 123.

Alarm type The audio type for alarm. It is fixed to type 1.

Date The range is 2017-2099

Time 24-hours system

Syringe It is used to calibrate the syringes of custom 1~5 to ensure the accuracy of infusion
calibration and meet the requirements of clinical use. (only for 4000D B and 4000D BP)

Night mode There are on and off options. If the setting is on, the night mode is enabled. In night
mode the display backlight is automatically turned off and the alarm volume is
automatically set to 1. Otherwise the night mode is disable. (only for 4000D AP
and 4000D BP)

Night time Setting the night time. The first part is for the start time, and the last part is for the
end time. (only for 4000D AP, 4000D BP)

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 Parameters Attributes

Recommend Configuring the commonly used syringe brands. Only the selected syringe brand
ed brands may be displayed in the syringe selection interface while the syringe is installed.

Alarm reset Restore the alarm-related values to the default state. The alarm-related values
contain “Occlusion Level”, “Nearly empty time”, “Alarm volume”.

version A version that identifies the current software used by the syringe pump.
Description:
1. For the KVO adjustable range, please refer to the maximum infusion rate and KVO rate.
2. Night time can only be adjusted while the setting of night mode is on.
3. The alarm type has the following features:

Alarm type High Low

Type 1 DiDiDi-DiDi- DiDiDi-DiDi- DnDnDn

4. For 4000D AP and 4000D BP, the alarm volume can be adjusted, the minimum alarm tone
is no less than 45 dB(A), the highest alarm tone is no less than 65dB (A); For 4000D A
and 4000D B, the alarm tone is fixed to the highest alarm tone, and no less than 65dB (A).
5. Passwords are only available to responsible organizations and cannot be communicated to
operators.
6. Alarm settings are restored automatically after power is interrupted for ≤ 30 s.

Chapter 7 Alarm System

7.1 Alarm System Description

This alarm system only contains high priority and low priority alarm. While there is any
alarm, the pump will generate alarm audio signal, the corresponding alarm text information
will be displayed on the interface. The alarm text information of a high priority contains a
symbol and !!! mark, and it is red. The low priority alarm text information contains a
symbol and ! mark, and it is yellow.
Press the pause key, the alarm audio will be paused for 2 minutes, and the audio pause
symbol will be displayed on the screen. The alarm interface is as below.

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 Alarm

Complete!!!
Accum. Vol. 1.0mL
Alarm duration 00h 00min
KVO infusion 0.2mL/h
Turn off
In alarm state the corresponding alarm indicator will be light on. If the alarm is a high
priority alarm, the red indicator will flash. If the alarm is a low priority alarm, the yellow
indicator will be light on constantly. The characteristics of the alarm visual indicator signal is
as below.
Alarm Alarm Sound signal Lighting flashing duty ratio
level light period frequency
High Red 15s~17s 1.67Hz 33.30%

Low Yellow 15s~17s Constantly 100%

The alarm visual indicator signal and audio signal comply with the requirements of IEC
60601-1-8：2012 and IEC 60601-2-24:2012. When multiple alarms occur simultaneously,
each individual alarm information will be automatically alternate and circularly displayed on
the screen. All alarms of this alarm system are technical alarms. The alarm system will be in
the technical alarm state after any alarm is triggered.
If there is nonsystematic alarm and the Start/Stop key is pressed, the alarm will be cleared
(the sound and indicator of alarm will be close) and exit from the alarm interface.
The list of all alarms is as follows:

Alarm text Description Priority Maximum Solution

information inherent alarm
response time
System Error No motor rotation detected High 16 seconds Restart the
01!!! while pump is powered on pump
System Error Besides the power key High 16 seconds Restart the
02!!! there is any other key in pump

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 the pressed state.
System Error Travel sensor system High 100 Restart the
03!!! disconnected milliseconds pump
System Error Syringe size recognition High 100 Restart the
04!!! sensor system milliseconds pump
disconnected
System Error Pressure sensor abnormal High 100 Restart the
05!!! milliseconds pump
System Error Syringe plunger detection High 100 Restart the
06!!! system disconnected milliseconds pump
System Error Transmission monitoring High 100 Restart the
07!!! system disconnected milliseconds pump
System Error Speed sensor system High 100 Restart the
08!!! disconnected milliseconds pump
System Error While infusing High 120 Restart the
09!!! transmission system failed milliseconds pump
System Error While travel sensor failed High 100 Restart the
10!!! milliseconds pump
System Error While syringe size High 100 Restart the
11!!! detection sensor failed milliseconds pump
System Error While the external flash High 2 seconds Restart the
12!!! module failed pump
System Error While there isn’t kick High 3 seconds Restart the
13!!! signal from another pump
channel
System Error While there isn’t kick High 3 seconds Restart the
14!!! signal to another channel pump
System Error While the communication High 3 seconds Restart the
15!!! between these two pump
channels cannot work
normally
Battery empty!!! Battery Depleted High 1 second Connect to the

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 AC power
Drive error!!! Abnormal motor speed High 9 minutes Press the
"Stop" key to
clear this
alarm
Occlusion!!! While infusing, if the High See 12.9 Press the
tubing or patient line is Occlusion "Stop" key to
blocked, the pressure in sensoring- clear this
the tubing will exceed the Time to alarm
set occlusion threshold. Occlusion
Complete!!! Infusion complete High 200 Press the stop
milliseconds key to clear
the alarm
Syringe In the case the volume to High 200 Press the stop
empty!!! be infused is more than the milliseconds key to clear
actual volume in syringe. the alarm
Syringe loaded The syringe push head is High 100 Press the stop
error!!! not installed or disengaged milliseconds key to clear
while infusing the alarm
Syringe Syringe clamp is removed High 100 Press the stop
unloaded!!! while infusing milliseconds key to clear
the alarm
Transmission The clutch handle is High 100 Press the stop
error!!! opened while infusing milliseconds key to clear
the alarm
Syringe is Syringe is moved while High 100 Press the stop
moved!!! infusing milliseconds key to clear
the alarm
Purge vol. to The priming volume of low 200 Press the stop
limit.! single time is to 2mL milliseconds key to clear
the alarm
Near In the case the remaining low 200 Press the stop

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 complete! infusion time is no more milliseconds key to clear
than the set near complete the alarm
time
Syringe near While the set volume to be low 200 Press the stop
empty! infused is more than the milliseconds key to clear
actual volume in syringe, the alarm
in the case the remaining
infusion time is no more
than the set nearly
complete time.
Low Battery! Low battery low 1 second Connect to the
AC power
Operation In stop state during 2 low 2 minutes Press any key
reminders! minutes there isn’t any
operation.
AC AC disconnected low 1 second Connect to the
disconnected AC power
Note 1: If there are two or more alarms, the alarm signal is issued according to its sequence of
triggering.
Note 2: The high priority alarm flashing frequency is 1.67Hz and the duty ratio is 33.3%.
Notice: If the alarm indicator is not lighted on, there is no alarm tone or the alarm information
is wrong (including no alarm text message), it means alarm system is abnormal, and the pump
shall be sent to a qualified technician for repairing.

7.2 Failure Analysis and Troubleshooting

During the warranty period (the warranty period is subject to the sales contract), if the
product fails, Medsure Medical Technology Co., Ltd. is responsible for the maintenance costs
(the freight user takes care of himself: man-made damage, the repair fee is charged as
appropriate). Products that exceed their service life shall be disposed. Product scrapping needs
to be handled in accordance with the requirements of the National Environmental Protection
Law. Please contact the company for more information. The battery warranty is only one year.

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Medsure Medical Technology Co., Ltd. can provide the documents listed in 7.9.3 IEC 60601-
1:2012 to the designated qualified technicians.

Fault phenomenon Measure

1. If the tubing is connected to the patient, clamp the

Can't turn on normally
tubing clip, remove the syringe, and then take the
syringe pump away from the clinical environment for
troubleshooting and cause analysis.
2. Check whether the power cable is connected, the
power cable performance is good, and mains power
indication interface is displayed. If you still can't
solve the problem, please contact with the after-sales
service department of Medsure Medical Technology
Co., Ltd.
1. If the tube is connected to the patient, clamp the tube
System error occurs after
clamp, remove the syringe, and then take the syringe
powered on
pump away from the clinical environment for
troubleshooting and cause analysis.
2. Turn off the syringe pump.
3. Press and hold the Power Key for 2 seconds (do not
press another key) to turn on the syringe pump. If the
system error alarm does not reappear, you can
continue to use the syringe pump.
4. If the system error alarm reappears, please contact
with the after-sales service department of Medsure
Medical Technology Co., Ltd.
1. If the tube is connected to the patient, clamp the tube
The recognized syringe size
clamp and verify that the patient is not at risk.
does not match that of the
2. Remove and re-seal the syringe and select the correct
syringe being loaded. syringe brand.
3. If this situation occurs again, please contact with the
after-sales service department of Medsure Medical
Technology Co., Ltd.

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 The casing or other parts of
the syringe pump are
damaged
No flow after starting
infusion
Please contact the after-sales service department of
Medsure Medical Technology Co., Ltd.
1. Verify that the syringe pump infusion indicator is
flashing normally, otherwise refer to the instructions
in the user manual for infusion settings and initiating
an infusion.
2. If the infusion indicator indicates that the syringe
pump is running and the tube is connected to the
patient, clamp the tube clip to disconnect the tubing
from the patient.
3. Make sure the tubing is not blocked. If the tubing is
clogged, stop the syringe pump, check the occlusion
position and clear it, and press the push rod release
handle to release the pressure from the tubing, then
release the tubing clip and restart the syringe pump.
4. Please contact with the after-sales service department
of Medsure Medical Technology Co., Ltd.

Chapter 8 Battery

8.1 Working with internal battery

This product is usually powered by mains power supply. In daily use, the syringe pump
shall be connected to a suitable mains power source so that the battery can be fully charged for
emergency use.
However, once the power is cut off or the power is temporarily turned off (such as the
power cord is disconnected), it will automatically switch to the internal battery operation,
mains power indicator will go out, and alarm will be triggered, indicating that the syringe
pump is running on the internal battery.
When the syringe pump is running on battery power, the corresponding battery level is
roughly displayed on the syringe pump display.

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 If the power supply is not connected when the syringe pump is turned on, the syringe
pump will automatically trigger AC disconnected alarm after the self-test, and automatically
switch to the internal backup battery. After the syringe pump is reconnected to mains power
supply or mains power supply resumes, it will automatically switch back to mains power
supply.

8.2 Battery Performance

The battery of this product is a lithium-ion battery with 2150mAh capacity and the model
number is ICR 18650 2150mAh 10.95V.
Charging the battery while the device is off, it takes at least 7 hours to charge it to be full.
After the battery is fully charged, both channel of the pump can continuously infuse for at
least 5.5 hours at 5mL/h rates, or at least 4 hours at the maximum rate.
If a low battery alarm occurs, it means the current power of battery is too low, and in
about 30 minutes later (5mL/h) the battery will run out. When the battery is exhausted, the
infusion stops, the syringe pump triggers the battery empty alarm. In order to avoid over
discharge of the battery, the pump will shut down after 5 minutes automatically.
Battery damage or incomplete charging, the performance of battery will not be
guaranteed.
Please check the battery regularly. It is recommended to charge and discharge (charging is
no less than 7 hours) once a month. If the power supply time of battery is significantly
shortened during the discharge process, please replace the battery in time.

8.3 Battery charging

For the first time to use or if the battery is depleted, the syringe pump must be connected
to mains power supply (no less than 7 hours) to charge the battery.
When the syringe pump is connected to mains power, the mains power indicator lights up,
indicating that mains power is being used. When the charging indicator of the pump is lit and
the battery charging icon is also displayed on the screen, it means the battery is being charged.
The charging indicator will off when the battery is fully charged.

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 While pump is being used, if the battery is depleted, the alarm audio and alarm indicator
is activated, please connect mains power supply in time to charge, so as to avoid the battery
being over-discharged and damaged.
If the pump will not be used for a long time, do not connect to mains power supply, but it
shall be charged every three months and stored in a fully charged state to prevent the battery
from being damaged due to long-term non-use.
Before returning to use, the syringe pump shall be connected to mains power supply until
the battery is fully charged.

8.4 Battery Replacement

8.4.1 Battery replacement frequency

The service life of the battery depends on the using frequency and times. The capacity of
the battery will decrease as the increase of the number of charge and discharge. If the battery is
properly maintained and stored, the service life of the lithium battery is about not less than 300
full charge and discharge. Improper use of the battery will shorten its life or enter a state of
failure. It is recommended to replace the lithium battery every 3 years.
If the battery is depleted and has not been charged for more than 2 months, the battery will
fail. Do not charge the failed battery and replace the failed battery as soon as possible.

8.4.2 Battery Replacement Method

The battery of this device is not removable, and the replacement of the battery must be
performed by a maintenance personnel authorized by the company.

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 Steps to replace the battery:
1. Use a screwdriver to remove the battery cover fixing screw.
2. Remove the battery cover;
3. Remove the battery cushion;
4. Remove the battery and disconnect the battery outlet from the battery inlet.
5. Connect the replaced battery output to the battery inlet and place the battery in the battery
compartment;
6. Install the battery cushion and battery cover to the battery compartment in turn, then tighten
the screws.

8.5 Battery recycling

Do not disassemble the replaced battery, do not put it into fire or short circuit it. Burning,
exploding, or leaking batteries can cause injury.
The failed battery shall be delivered to the designated location of the environmental
protection department, or sent back to the company for uniform treatment to prevent from
polluting environment.

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Chapter 9 Cleaning and Maintenance

9.1 Cleaning
The syringe pump can prevent accidental spatter. Please wipe the pump's casing and
surface with a rag, or if necessary, with a rag coated with 75% medical alcohol.
If a spray cleaner is used, please spray it on a rag instead of spraying it on the syringe
pump directly.
If you need to store the syringe pump for a long time, please clean it first, then store it in a
clean and dry environment at room temperature. If possible, use the original packaging when
storing to protect the syringe pump.
Cleaning the syringe pump periodically by following steps:
1. Disconnect the syringe pump from the mains power supply.
2. Wipe the external surface of the syringe pump, pay attention to the syringe clamp and the
edge groove of the syringe.
3. After cleaning, disinfect the syringe pump with appropriate disinfectant and wipe it with a
clean damp cloth to remove any residual disinfectant.

9.2 Maintenance
Hospitals or medical institutions that use this equipment shall establish a comprehensive
maintenance plan, otherwise it may cause equipment failure and unpredictable consequences,
and may endanger personal safety.
In addition to cleaning and disinfection, this equipment requires the following inspections
and maintenance before it can be used in the ward.

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Inspection/maintenanc
Maintenance content Frequency
e project
Environment and power supply
meet the requirements.
The power cord has no wear and
good insulation performance.
After continuous used for
No mechanical damage to
Comprehensive one year, repaired or
equipment.
inspection upgraded，check by
The alarm system is functioning
biomed or service engineer.
normally.
Battery performance is normal.
Self-test function and infusion
function are normal.
Every two years, or
suspected that the occlusion
alarm is abnormal, the
infusion flow is not
Preventive Pressure calibration, sensor
accurate, and the syringe is
maintenance calibration
recognized incorrectly,
calibrate only by service
engineer according to the
service manual.
According to the description of
chapter 7 alarm system, check
whether it can work normally or Every two years, either
Alarm system not, during the inspection, after repaired or upgraded,
inspection occlusion and syringe empty check by biomed or service
alarms shall be triggered correctly engineer.
at least. See “Note4” for
examples.

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 Every two years, or after
Safety inspection the replacement of the
according to IEC board or the syringe pump,
60601-1:2012 it needs to be done, check
　 by service engineer.

Note:
1. The above maintenance items should be carried out by technicians or professional
maintenance personnel approved by the company. If any damage or abnormality is found,
please do not use it and contact the company immediately.
2. The maintenance of the syringe pump does not require lubrication. In fact, any lubricant
containing organic solvents can damage the pump housing plastic.
3. Take it out every three months. Charge the battery, turn on the syringe pump and perform
a functional test to make sure it can work normally when needed.
4. The examples of checking alarm system are as below:

Confirm item Confirmation methods

Self-test while When the pump starts the power on self-test procedure, check a
powering on “di” sound, the screen shows the logo of Medsure, the red and
yellow alarm indicator flash once one by one, at last a “di”
sound reminds the self-test is over, no system error alarm
display on screen.
Occlusion!!! While infusing, after blocking the tubing, the pump shall trigger
“Occlusion!!!” alarm correctly. There shall be high priority
audio and visual alarm signal.
Syringe empty!!! In the case the set volume to be infused is more than the actual
volume in syringe, when the volume in syringe is infused
totally, the pump shall trigger “Syringe empty!!!” alarm
correctly. There shall be high priority audio and visual alarm
signal.
For more details, please refer to "7.2 Failure Analysis and Troubleshooting".

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 Chapter 10 Transportation and Storage
1. Do not throw during loading and unloading, avoid strong vibration during transportation;
2. Prevent heavy pressure, without direct sunlight, rain and snow;
3. It shall be stored in an environment where the relative humidity is not higher than 95%,
non-corrosive gas, cool, dry, well ventilated and clean.

Chapter 11 Symbols Description

Symbols Description

Conformité Européenne Complies with medical device

directive 93/42/EEC.

IPX4 IPX4 water proof

REF Catalogue number

Rechargeable battery

Type CF equipment

Date of manufacture

Manufacturer

Serial Number.

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Authorized representative in the European Community.

Caution! : (read important information in the operating

instructions)

Refer to the Instruction Manual

Return to a collection site intended for waste electrical and

electronic equipment (WEEE). Do not dispose of in unsorted
trash.

Temperature limitation
Numerical display upper and lower temperature limits (°C)

Humidity limitation
The numerical value shows the upper and lower humidity
limits (%)
Atmospheric pressure limitation
Numerical values show upper and lower atmospheric
pressure (kPa)

Fragile, handle with care.

Keep away from rain.

This way up.

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Keep away from sunlight

Recycle or dispose of properly.

Alternating current (ac).

Protective earth (ground).

Alarm symbol

Alarm audio is currently paused.

Battery charging status.

Battery level indication

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Chapter 12 Specifications

12.1 Product

weight 3.0kg (including pole clamp)

Size Length 290* Width 145* Height 190（mm）

Direction Horizontal

The configuration parameters in the syringe pump menu and

Data Save Time
syringe pump infusion history log are not lost after shutdown.

Working Temperature +5℃～+40℃

Working relative humidity Not higher than 90%

Atmospheric pressure 70kPa～106kPa(700hPa～1060hPa)

Temperature for
Transportation and -40℃～+55℃
Storage
Relative Humidity for
Transportation and Not higher than 95%
Storage
Atmospheric Pressure for
Transportation and 50kPa～106kPa(500hPa～1060hPa)
Storage

Expected service life 5 years (excluding battery)

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 12.2 Classification

Class I, internal power supply, suitable for direct application to the CF type of the heart,
continuous operation, cannot be used in the flammable anesthetic gas mixed with air or
flammable anesthetic environment combined with oxygen or nitrous oxide, This device is a
portable device and is not recommended for use as a portable device.

12.3 Power supply

Mains power AC voltage 100-240V~; power frequency 50Hz/60Hz; input current

0.45-0.20A. (The factory setting, the user is not adjustable.)
Fuse F2AH250V
power cable 3×1.0mm2×3m，250V/10A
type of battery DC 10.95V rechargeable ternary lithium battery pack
(Users are not replaceable. If they need to be replaced, they must be
carried out by qualified maintenance personnel for one year
warranty)
Battery working Simultaneous infusion of two channels, continuous operation of no
time less than 5.5 hours at an infusion rate of 5 mL/h
Battery charging At least 7 hours
time (A temperature below 15 ° C or above 25 ° C is not conducive to
battery charging)
Operating mode continue to operate

12.4 Infusion rate

Normal Infusion rate 0.1mL / h ~ 1500mL / h (4000D A is 0.1mL / h ~ 1200mL / h), the
maximum rate depends on the size of the syringe
Priming rate The default rate is 1000mL/h, but does not exceed the maximum
rate supported by the syringe.
User can set, set the range of 100 mL / h ~ the maximum infusion
rate of the syringe

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Bolus rate The default rate is 1000mL/h, but does not exceed the maximum
rate supported by the syringe.
User can set, see "5.2 Bolus Infusion" for the range of settings.

12.5 Maximum infusion rate and KVO rate

Syringe size Maximum infusion rate KVO rate

specification
10mL 300.0mL/h (minimum step 0～2.0mL/h (step 0.1mL/h)
0.1mL/h)
20mL 400.0mL/h (minimum step 0～3.0mL/h (step 0.1mL/h)
0.1mL/h)
30mL 600.0mL/h (minimum step 0～4.0mL/h (step 0.1mL/h)
0.1mL/h)
1500mL/h (4000D A is 1200mL/h)
<1000ml/h minimum step is
50mL 0～5.0mL/h (step 0.1mL/h)
0.1mL/h，≥1000mL/h minimum
step is 1mL/h

12.6 Infusion pressure

Maximum infusion Description

pressure
Not more than The maximum pressure that the device can generate if the end of the
160kPa patient's tubing is completely blocked.

12.7 Infusion accuracy

Check item Precision value Detection demand

Mechanical Accuracy ±1%
Infusion Accuracy ±2% Measured at a 5 mL/h
infusion rate while the back
pressure is no more than
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 +13.33 kPa and no less than -
13.33 kPa.
Bolus Accuracy ±2% Measured at the supported
maximum bolus rate while
the bolus volume is 1mL or
the maximum volume.
Note 1: ±2% of the infusion accuracy is the nominal infusion accuracy, which may affect the
infusion accuracy due to factors such as syringe differences.
Note 2: When the infusion rate is < 5mL/h, the infusion accuracy will be reduced. It is
recommended to use a smaller size syringe, and the user should carefully monitor the actual
infusion rate.

12.8 Occlusion – Occlusion level

Occlusion level Pressure range

Low 300mmHg±100mmHg (40.0kPa±13.3kPa)
Medium 500mmHg±150mmHg (66.7kPa±20.0kPa)
High 800mmHg±200mmHg (106.7kPa±26.7kPa)

12.9 Occlusion – Occlusion time

Infusion rate Occlusion level Longest occlusion time

Low 65 minutes
1mL/h
High 90 minutes
Low 15 minutes
5mL/h
High 25 minutes
Low 5 seconds
The maximum rate
High 6.5 seconds
Note 1: The above results were determined by a BD Plastipak 50 mL syringe and the values are
approximate.
Note 2: The above results apply to a 50 mL syringe. For smaller syringes, the smaller the value.

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Note 3: The response time of occlusion alarm may be affected by the ambient temperature and
the length of the tubing between the blocked part and the syringe interface. The above test
results are tested at the temperature of 23±2℃ and the tubing of 1 m.

12.10 Occlusion release - Bolus volume

When an occlusion alarm occurs, the corresponding channel of the syringe pump is
reversed by the motor, reducing the pressure in the tube to reduce the potential occlusion Dose.
The drive error alarm will be suppressed during the block release process. The tube must be
clamped before checking for the cause of the occlusion (see Warning 21).
After the occlusion, the dose of the bolus is determined by the method (IEC 60601-2-
24:2012). For the low occlusion level, it is no more than 0.3 mL at the intermediate rate. For
the high occlusion level, it is no more than 0.5mL at the intermediate rate.
Note: The above results were measured by a BD Plastipak 50 mL syringe.

12.11 Basic performance

Name Description
Infusion accuracy The actual infusion rate and the set infusion rate error do
not exceed ± 2%
Occlusion alarm Alarm when the pressure in the pipeline reaches the set
value
Infusion completed alarm or An alarm that occurs after the infusion of the drug
Syringe empty alarm solution in the syringe tube is completed;
Or set the VTBI of alarms that occur after the infusion is
completed.

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 12.12 Supported syringe brands and sizes
The syringe required to be used is a syringe that has been registered with the FDA and
obtained a registration certificate, and the syringes supported by the three infusion modes are
identical. Among them, the syringes of Romsons Junior 50mL, NIPRO 50mL, BD Precise
20mL and B Braun 50mL have passed the accuracy test according to the "IEC 60601-2-
24:2012 medical electrical equipment Part 2-24: Particular requirements for the basic safety
and essential performance of infusion pump and controller ".
Code Syringe brand 10mL 20mL 30mL 50mL
01 AYSET -- √ -- √
02 Fresenius -- -- -- √
Injectomat®
03 BD Plastipak™ -- √ √ √
04 Romsons Junior -- -- -- √
05 B Braun -- -- -- √
Omnifix®
06 NIPRO -- √-- √ √
07 Polfa -- √ -- --
08 TERUMO® -- √ √ √
09 Apexmed -- √ -- √
10 Unolok -- √ -- √
11 BD Precise -- √ -- √
12 Dispovan -- √ -- --
13 Custom 1 √ √ √ √
14 Custom 2 √ √ √ √
15 Custom 3 √ √ √ √
16 Custom 4 √ √ √ √
17 Custom 5 √ √ √ √
Note 1: Only 4000D B, 4000D BP supports custom brand calibration. For 4000D A and 4000D
AP, only syringes with the specified brand and specification in the table above can be
used.

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Note 2: The 4000D B and 4000D BP custom brands can be used after the calibration function.
Only the syringes that can be supported by the 4000D B and 4000D BP syringe pumps
can be calibrated. If the accuracy is over the defined specification, the user can
calibrate the syringe before using it.
Note 3: The infusion accuracy of the calibrated brand may be over ±2%.
Note 4: This product is recommended to use BD Plastipak syringes.
Note 5: While replacing syringe, please make sure to select the syringe whose brand and
specification is same as the actual installed one, otherwise forbid to use it.

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 12.13 Curves
According to the "IEC 60601-2-24:2012 medical electrical equipment Part 2-24:
Particular requirements for the basic safety and essential performance of infusion pump and
controller " in the 201.12.1 Accuracy of controls and instruments to test. The curve is drawn
according to the data collected during the two-hour measurement period.

Startup curve
Rate : 1mL/h
Syringe brand : BD Plastipak
Sampling equipment : 3 sets
Sampling interval : △t = 0.5 min
Syringe size : 50mL
Sampling syringes : 3 pcs
Experimental period : 120min

Rate : 5mL/h
Syringe brand : BD Plastipak Syringe size : 50mL
Sampling equipment : 3 sets Sampling syringes : 3 pcs
Sampling interval : △t = 0.5 min Experimental period : 120min

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Trumpet curve
Rate 1.0 mL/h (Overall percentage error is 0.60%)
Syringe brand : BD Plastipak Syringe size : 50mL
Sampling equipment : 3 sets Sampling syringes : 3 pcs
Sampling interval : △t = 0.5 min
Duration of observation window: p△t = 2, 5, 11, 19, 31 min

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Rate 5.0mL/h (Overall percentage error is 0.28%)
Syringe brand : BD Plastipak Syringe size : 50mL
Sampling equipment : 3 sets Sampling syringes : 3 pcs
Sampling interval : △t = 0.5 min
Duration of observation window: p△t = 2, 5, 11, 19, 31 min

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Chapter 13 Electromagnetic Compatibility

Statement
This product has passed the electromagnetic compatibility test to meet the requirements of
the IEC 60601-1-2:2014 standard for medical device equipment. These limits provide
reasonable protection against harmful interference in a typical medical installation.

13.1 EMC performance

This device may be subject to interference from other medical devices and radio
communications. In order to prevent such interference, the equipment has been tested and met
according to IEC 60601-1-2:2014. However, the company does not guarantee that it will never
be disturbed in a separate installation environment.
If the equipment is found to be subject to interference (which can be determined by
turning the equipment on and off), the user (or qualified service personnel) should attempt to
resolve the interference by taking one or more of the following actions:
 Adjust the direction or position that affects the device;
 Increase the distance between the device and the device that affects it;
 Use other power sources instead of powering the device to supply power to the
device;
 Consult your supplier or service representative for additional advice.
The manufacturer is not responsible for any interference caused by: changing or
modifying the device without permission. Unauthorized changes or modifications may void the
user's authority to operate this equipment.
Portable and mobile RF communications equipment may affect the equipment. Do not use
devices that emit RF signals near the device, such as cellular phones, transceivers, or radio
control products, as this may cause the performance of the device to fail to meet specified
specifications. When such devices are near the device, turn off the power to these devices. The
medical personnel in charge of this device should instruct technicians, patients, and other
personnel who may be close to the device to fully comply with the above requirements.
All types of electronic equipment may cause electromagnetic interference to other
equipment through air or other cables connected to them. The term EMC (electromagnetic
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compatibility) means that a device is not affected by electromagnetic interference generated by
other devices, and does not affect the capabilities of other devices through similar
electromagnetic radiation.
In order to fully achieve the specified EMC performance, the user should properly install
and use the device in accordance with the procedures described in the instruction manual and
the electromagnetic compatibility information. If you have problems with EMC, please contact
your service representative.

13.2 Product use precautions

Separation distances and effects of fixed radio communication equipment: the strength of
the magnetic field generated by fixed transmitters, such as base stations for wireless
(cellular/cordless) telephones, land mobile radio receivers, amateur radio receivers, AM and
FM radio broadcasts, and television broadcasts Generators, etc., cannot be accurately measured
theoretically. To assess the electromagnetic environment generated by a fixed RF transmitter,
consideration should be given to measuring the electromagnetic field. If the measured magnetic
field strength at the location of the device exceeds the corresponding RF level specified in the
Anti-Jamming Statement, the device should be checked to ensure that it is operating properly.
If abnormal operating conditions are found, additional measurements should be considered,
such as reorienting the device's orientation or position, or using an anti-radio room.
This equipment should not be used in close proximity or stacked with other equipment. If
it must be used close to or stacked, it should be observed that it will function properly in the
configuration in which it is used.
The user may not modify the product, otherwise the EMC performance of the product may
be degraded.
Product modifications include the following changes:
a) Equipment configuration / components;
b) Equipment protection components (cover open/closed and cover fasteners).

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 13.3 Electromagnetic environment requirements
This product is intended to be used in the electromagnetic environment specified below,
and the purchaser and user of this product should ensure that it is used in this electromagnetic
environment——Professional healthcare facility environment.
Table 1 Guidance and Manufacturer's Declaration - Electromagnetic Emissions

Guide and manufacturer's statement - electromagnetic emissions

This product is intended to be used in the electromagnetic environment specified below, and
the purchaser or user should ensure that it is used in this electromagnetic environment.
Emission test Compliance Electromagnetic environment - guide
RF emissions Group 1 This product uses RF energy only for its internal
CISPR 11 functions. Therefore, its RF emissions are low and
there is little chance of interference with nearby
electronic equipment.
RF emissions Class A
This product is suitable for use in all facilities that are
CISPR 11
not directly connected to the home and to the public
Harmonic Not
low-voltage power supply network of the home.
emissions applicable
IEC 61000-3-2
Voltage Not
fluctuations/ applicable
flicker
emissions
IEC 61000-3-3

Table 2 Guidance and Manufacturer's Declaration - Electromagnetic Immunity

Guide and manufacturer's statement - electromagnetic immunity

Immunity test IEC 60601 test level Compliance level

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Electrostatic discharge
±8kV contact discharge ±8kV contact discharge
(ESD)
±15kV air discharge ±15kV air discharge
IEC 61000-4-2

Electrical fast
2 kV , 1KV 2 kV , 1kV
transient/burst
100kHz repetition frequency 100kHz repetition frequency
IEC 61000-4-4

Surge ±1kV line to line ±1kV line to line

IEC 61000-4-5 ±2kV line to ground ±2kV line to ground

0% UT ;0.5 cycle 0% UT ;0.5 cycle

At 0°, 45°, 90°, 135°, At 0°, 45°, 90°, 135°,
180 ° , 225 ° , 270 ° and 180 ° , 225 ° , 270 ° and
Voltage dips 315° 315°

IEC 61000-4-11 0% UT ;1 cycle and 70% 0% UT ;1 cycle and 70%

UT;25/30 cycles UT;25/30 cycles
Single phase :at 0° Single phase :at 0°

Voltage interruptions
0 % UT; 250/300 cycle 0 % UT; 250/300 cycle
IEC 61000-4-11

Power frequency
30A/m 30A/m
(50Hz/60Hz) magnetic
50Hz/60Hz 50Hz/60Hz
Field IEC 61000-4-8

Note: UT refers to the grid voltage before the test voltage.

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 Table 3 Guidance and Manufacturer's Declaration - Electromagnetic Immunity

Guide and manufacturer's statement

Immunity test IEC60601 test level Compliance level

3Vrms
0.15MHz-80MHz
Conducted RF 3Vrms
6Vrms in ISM bands between 0.15 MHz and
IEC 61000-4-6
80MHz
6Vrms
80% AM at 1 kHz
Radiated RF 3V/m 3V/m
IEC 61000-4-3 80MHz-2.7GHz
80% AM at 1 kHz
NOTE 1: At 80 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.

Table 4 Test Specifications for Enclosure Port Immunity to RF wireless communications

equipment.
Test Banda) Servicea) Modulationb) Maximum Distance Immunity
Frequency (MHz) Power (m) Test
(MHz) (W) Level
(V/m)
385 380- TETRA Pulse 1,8 0,3 27
390 400 modulationb)
18Hz
430- GMRS
450 470 460, FM c) 2 0,3 28
FRS 460 ± 5 kHz
deviation
1kHz sine
710 704- LTE Band Pulse 0,2 0,3 9

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745 787 13, modulation b)
780 17 217 Hz
810 800- GSM Pulse 2 0,3 28
870 960 800/900 modulation b)
930 TETRA 18 Hz
800
iDEN 820
CDMA
850
LTE Band
5
1720 1700- GSM 1800 Pulse 2 0,3 28
1990 CDMA modulation b)
1845
1970 1900 217 Hz
GSM 1900
DECT,
LTE Band
1, 3,
4,25;
UMTS
2450 2400- Bluetooth, Pulse 2 0,3 28
2570 WLAN, modulation b)

802.11 217 Hz
b/g/n
RFID 2450
LTE Band
7
5240 5100- WLAN Pulse 0,2 0,3 9
5500 5800 802.11 modulation b)
5785 a/n 217 Hz

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 Medsure Medical Technology Co.,Ltd.

Register/manufacturer: Medsure Medical Technology Co.,Ltd.

EC REP
Luxus Lebenswelt GmbH Kochstr. 1,47877, Willich, Germany

Manufacturer/after-sales address: Building 2, No.8 Keling Road, Suzhou

New District, 215163 Suzhou, PEOPLE'S REPUBLIC OF CHINA
After-sales unit: Medsure Medical Technology Co.,Ltd.
Contact:
Phone：0512-66919880
Fax：0512-66916865
Zip：215163
E-mail：service@medsure.cn
URL：www.medsure.cn
Manufacture date：refer to the product label
Service life: 5 years
Compile date: 2019-03
©2019 all rights belong to Medsure Medical Technology Co., Ltd.
All rights reserved.
Part number：7000016
File number：MS-TCF-03_8.2
Revise date: 2019 - 08
Version: A

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