Infusion pump

5000 series User Manual

Medsure Medical Technology Co., Ltd.

1 / 62
Chapter 1 Warnings and Cautions
This User Manual was published by Medsure Medical Technology Co., Ltd. and contains
information on the safe use of this product. Users of this product (including 5000A, 5000A
Plus, 5000B, 5000B Plus) 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 IV set; 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.

2 / 62
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
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 infusion 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 infusion
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 infusion pump is in infusion, 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 infusion 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. In order to maintain the performance of the infusion pump, Medsure Medical Technology
Co., Ltd. recommends to use the qualified IV sets which have a registration certificate
and are supported by this equipment, otherwise the infusion accuracy may exceed ±5%.
11. The IV set shall be calibrated by professionals (including the manufacturer), otherwise
the flow will be inaccurate, the occlusion will be misreported or the IV set will be

3 / 62
 damaged. For the designated IV set, we only identify its shape, structure and size, other
performance parameters including biochemical, physical, measurement shall be qualified
by the relevant supervision departments
12. In order to maintain the performance of the infusion pump, it is necessary to pay attention
to the viscosity of the infusion drug, otherwise it will reduce the accuracy of infusion,
drop rate and occlusion alarm.
13. The resilience of tubing will be poor after being used for a period of time. To ensure the
infusion accuracy, it is recommended that the infusion pump be injected at a rate of
below 300ml/h, and the continuous using time of a single IV set shall not be over 8 hours
or the infusion volume shall not be over 2L.If the rate is higher than 300ml/h, the
recommended infusion time shall be shortened relatively.
14. When reinstalling the IV set, do not install the squeezed tubing at the position of the
bubble sensor, otherwise it will cause bubble alarm incorrectly.
15. Air in the tubing between the bubble sensor and the patient cannot be detected, shall be
primed out manually.
16. When the temperature of working environment is below 18 ℃ or the infusion rate is
greater than 300 ml/h, in general the occlusion level is recommended not to be low.
(When the temperature is low, the tubing will be hardened and cause occlusion alarm
easily).
17. Do not press the head of pressure sensor heavily, otherwise the pressure sensor may be
damaged.
18. When installing the IV set, the roller clip of the IV set shall be located between the
infusion pump and the patient, and ensure roller clip is clamped the tubing before
installing or removing the IV set to prevent over-infusion caused by leakage and avoid
accidental injury to the patient.
19. In order to avoid over-infusion, please do not prime the air in tubing while the tubing
connects with the patient. The over-infusion of drugs will cause patient casualties.
20. In order to avoid over-infusion or under-infusion, make sure to confirm that the installed
IV set is consistent with the recognized IV set by the displayed IV set brand and size
before infusion. Otherwise, the infusion may be inaccurate and cause injury or death.
21. The supported IV sets are disposable. Please use the IV set and relevant products
according to the local clinical guidelines and product instructions. Misusing IV sets may
be inaccurate or even cause injury.

4 / 62
22. The volume in the tubing is the residual volume and will not be infused. This part extra
volume shall be taken into account when filling the IV set and priming at the first time.
Patients cannot get effective treatment because of the under-infusion.
23. To avoid embolism, it is important to ensure that air in the tubing shall be primed out
before it is connected to patient. The infusion pump has a priming function to assist this
process.
24. 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.
25. If occlusion alarm occurs, immediately clamp the tubing clamp, open the door and fluid
clamp of pump to reduce the pressure in tubing to prevent accidental infusion, then check
the tubing for bending, occlusion or infusion protecting cap is not removed, etc.,
eliminate the occlusion before reinfusion, and accidental drug infusion can cause patients
casualties.
26. Do not use defective infusion pump. If the infusion pump detects system error, the pump
will issue an alarm and display associated alarm message. If this happens, turn off the
pump, disconnect the power supply, and transfer it to a qualified engineer for inspection
and repair. The pump which has any system error is forbidden to infuse, it can cause the
patient cannot get the treatment in time, and cause injury or death.
27. 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.
28. 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.
29. 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.
30. This equipment requires special precautions. Please read the “EMC Statement” for
electromagnetic compatibility requirements and before installation and using it
31. 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 to the RF housing device as appropriate.

5 / 62
32. 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.
33. The maximum volume for the single fault condition of the device is 0.8ml.
34. 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.
35. A potential hazard can exist if different alarm pre-sets are used for the same or similar
equipment in any single area.
36. The factors which could greatly reduce the performance of infusion accuracy could be
misusing of IV sets, using incorrect IV sets, air in pipeline, too much driving resistance,
too low or high ambient temperature.

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 infusion 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 infusion 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 infusion pump. In
addition, the infusion 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 infusion pump.

6 / 62
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 Infusion pump function ...............................................................10
2.3 Basic configuration .....................................................................11
2.4 External characteristics of the infusion pump .............................11
2.4.1 front of infusion pump .....................................................11
2.4.2 Rear of infusion pump......................................................13
Chapter 3 Installation ...............................................................................14
3.1 Pole clamp installation ................................................................14
3.2 Fixation of the infusion pump .....................................................15
Chapter 4 Basic operations ......................................................................16
4.1 Position of the operator and the infusion pump ...........................16
4.2 Operation workflow....................................................................17
4.3 Operation steps ...........................................................................18
4.3.1 Power on ..........................................................................18
4.3.2 Install IV set ......................................................................18
4.3.3 Select IV set brand ...........................................................23
4.3.4 Select infusion mode........................................................23
4.3.5 Priming .............................................................................23
4.3.6 Set infusion parameters ...................................................24
4.3.7 Start infusion ....................................................................24
4.3.8 Infusion completed ..........................................................25
4.3.9 Unload or replace IV set ...................................................25
4.3.10 Turn off ............................................................................26
Chapter 5 Features ...................................................................................26
5.1 Infusion Mode .............................................................................26
5.1.1 Rate mode ........................................................................26
5.1.2 Time mode .......................................................................27

7 / 62
 5.1.3 Weight mode ...................................................................27
5.2 Bolus infusion .............................................................................28
5.3 KVO (keep vein open) ................................................................29
5.4 Drip detection ..............................................................................29
5.5 IV set accuracy calibration ..........................................................29
5.6 History Log .................................................................................30
Chapter 6 Functional setting interface .....................................................30
Chapter 7 Alarm system ...........................................................................34
7.1 Alarm system description ............................................................34
7.2 Failure Analysis and Troubleshooting.........................................38
Chapter 8 Battery .....................................................................................40
8.1 Working with internal battery .....................................................40
8.2 Battery performance ....................................................................40
8.3 Battery charge .............................................................................41
8.4 Battery Replacement ...................................................................41
8.4.1 Battery replacement frequency ........................................41
8.4.2 Battery Replacement Method...........................................42
8.5 battery recycling ..........................................................................43
Chapter 9 Cleaning and Maintenance ......................................................43
9.1 Cleaning .......................................................................................43
9.2 Maintenance ...............................................................................43
Chapter 10 Transportation and storage .....................................................45
Chapter 11 Symbols description ................................................................46
Chapter 12 Specifications ...........................................................................49
12.1 Product ........................................................................................49
12.2 Classification ...............................................................................49
12.3 Power supply ...............................................................................50
12.4 Infusion rate ................................................................................50
12.5 KVO rate .....................................................................................50
12.6 Infusion accuracy ........................................................................50
12.7 Occlusion – Occlusion level ........................................................51
12.8 Maximum infusion pressure ........................................................51
12.9 Occlusion - Occlusion time .........................................................51

8 / 62
 12.10 Occlusion release - Bolus volume ...........................................52
12.11 Air detection sensitivity ...........................................................52
12.12 Supported IV sets ....................................................................52
12.13 Normal infusion set .................................................................53
12.14 Curve drawing .........................................................................53
Chapter 13 Electromagnetic Compatibility Statement ..............................56
13.1 EMC performance .......................................................................56
13.2 Product use precautions .............................................................57
13.3 Electromagnetic environment requirements ..............................57

9 / 62
Chapter 2 Introduction

2.1 Working principle and structure

This product includes 5000A, 5000A Plus, 5000B, 5000B Plus four models (referred to as
5000 series), which is an infusion pump developed and produced by Medsure Medical
Technology Co., Ltd.
Structure: The pump consists of a control system, motor drive system, peristaltic
extrusion system, detection system (the liquid drop detection sensor sub-assemly is only
suitable for 5000B and 5000B Plus), alarm system, input and display system, enclosure support
structure, and software component. The IV set isn’t a part of the pump.
Working principle: The pump calculates the parameters which are used to control motor
by the programmed infusion parameters. The motor drive unit drive the extrusion system to
move regularly, and the twelve press plates extrude the tubing between the clamp and press
plates so that the liquid in the tubing flows at the set rate and direction continuously.

2.2 Infusion pump function

Application scope: use with infusion apparatus, do not contact the infusion liquid, adopt
by hospital for intravenous infusion fluid/drug for patient with adjustable mode.
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 1200 mL/h.
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 infusion pump.
The main functions of the pump are as follows:
1. Infusion mode: Rate Mode, Time Mode and Weight Mode (only for 5000A Plus and
5000B Plus)
2. Bolus infusion: Manual Bolus and Auto Bolus
3. Accuracy calibration for IV set
4. Liquid drop detection (only for 5000B and 5000B Plus)
This product does not have network and mobile computing capabilities.
10 / 62
 The pump does not use latex.
Contraindications: blood transfusion is strictly prohibited

2.3 Basic configuration

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

2.4 External characteristics of the infusion pump

2.4.1 front of infusion pump
The external features of the four types of infusion pumps are basically similar, with only
minor differences in the characters used for the product model identification, part of the key
pattern and the liquid drop detection sensor. This section uses 5000B Plus as an example to
introduce the main components of infusion pump, including the keys, operation interface and
the back side of infusion pump.

Rate Unit Volume unit

Seven-segment drop sensor
Indicator indicator
display digital display
infusion screen
indicator

alarm
indicator

mains
power
indicator

Infusion direction door

charging
indicator indication

Operation Interface Description

The description of the operation interface of this product is shown by above figure.
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.

11 / 62
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.

Select key is used to select or confirm the set parameters, or set the
accumulated volume to zero if the accumulated volume isn’t 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) Press + simultaneously to set the accumulative volume

to be zero while it is in the selected state.
3) When infusion, press them at the last position simultaneously to
lock or unlock.

12 / 62
 2.4.2 Rear of infusion pump

USB
battery cover Specification Pole Clamp interface
label

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 an USB port, the USB port is sealed off by a soft plastic
cover, it is only used for debugging by the manufacture.
Speaker The bottom of the infusion pump is equipped with a speaker that can
generate a self-test tone, a key pressed tone and an alarm audio.

13 / 62
Chapter 3 Installation
Each infusion 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 7.6kg, and the total load is less than 1.8kg. 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 infusion
pump as need.
Horizontal direction：

Vertical direction：

Pole clamp installation：

1. Unscrew the hexagon socket set screw with a hex wrench.
2. Place the pole clamp against the infusion pump in the desired direction so that the screw

14 / 62
 holes in the pole clamp align with the holes on the back of the infusion pump.
3. Install the pole clamp onto the infusion 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 infusion pump

The pump can be placed on a stable surface, such as a tabletop where the infusion 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).

Clipped to the infusion pole

15 / 62
 Clipped onto the bed rail
Fix infusion pump using pole clamp：
1. Unscrew the clamp 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 infusion pump to the desired position.
3. Hold the infusion pump with one hand at the bottom and the screw with the other
hand until the infusion pump is securely fastened.

Chapter 4 Basic operations

4.1 Position of the operator and the infusion pump

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

16 / 62
4.2 Operation workflow

Press 2S to power on, then pump

Power on
enters the infusion interface after self-test
finish
Install IV set Install IV set following section 4.3.2

Choose the IV set brand according to the using

Select IV set brand IV set 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 IV set tubing to patient

Start infusion Press to start infusion

The VTBI Setted completed or press to

Infusion completed stop infusion

Disconnect to patient Disconnect the IV set tubing to patient

Refer to section 4.3.9 to remove or change

Unload or replace IV set IV set

Keep press , then display the powering

Power off
off interface , and shut down after 2 seconds

17 / 62
 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 IV set 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, infusion indicator flashes in turn from right to left, the red and
yellow alarm indicator flash once one by one, then the motor moves for self-test, the Unit light
and digital tube flicker one time in turn, at last a “di” sound reminds the self-test is over.

4.3.2 Install IV set

upstream
pump pressure door lock
clamp bubble sensor downstream hook drop sensor
sensor
pressure
sensor
door lock
hook

door clamp

door door
clamp

Note: The upstream pressure sensor in above figure is only applicable to 5000A Plus and
5000B Plus models, the liquid drop detection sensor is only applicable to 5000B and 5000B
Plus models.
18 / 62
 IV set installation steps：
1. Preparation: hang the infusion bottle (bag) on the IV pole (note: the infusion bottle or bag
shall be at the 20cm ~ 80cm position above the heart of the patient), open the package of
IV set, then close the roller clamp of IV set to avoid free flow. After the IV set is
connected, squeeze the drip chamber of the IV set manually to make it filled with liquid
(the appropriate filling volume is between 1/3 to 1/2 height of drip chamber)
2. Lift the door up and open it.
使用方法

3. Open the pump clamp, install the IV set tubing from right to left according to the
direction indicated by the arrow, and press the tubing into the upstream pressure sensor,
the downstream pressure sensor, the bubble sensor and pump clamp in turn.

19 / 62
 The IV set tubing installation
direction
pump bubble IV set
downstream upstream
clamp sensor tubing
pressure sensor pressure sensor

4. After the tubing is installed, lift the door up to ensure that the hook of door has been
locked into lock pin, then press down the door to close the pump door, the door surface
shall be flush with the enclosure. Then open the roller clamp.

20 / 62
5. If the liquid drop detection component is used, it shall be installed correctly before use. It
shall be installed between the top of the nozzle and the liquid surface in drip chamber of
IV set. make the drip chamber in the vertical position as far as possible so that the sensor
can detect the liquid drop correctly.

21 / 62
 Drip chamber
Drop sensor

Drip
Drip direction

Drip detection position

Liquid level

Attention:
1、 The liquid surface in drip chamber of IV set shall be lower than the liquid drop detection
sensor, and the liquid surface is between 1/3 ~ 1/2 height of the drip chamber.
2、 The drip chamber of IV set shall be inserted into the positioning slot of the liquid drop
detection sensor vertically.
3、 During infusion the liquid drop detection sensor shall be not too tilted and direct sunlight,
otherwise the detection accuracy will be affected.
4、 Avoid the drip chamber of the IV set to be clamped too tight by the liquid drop detection
sensor.
5、 The liquid drop detection sensor shall be cleaned regularly to avoid stains affecting the
drop-rate detection.
6、 The liquid drop detection sensor is not applicable to detect the liquid with excessive
viscosity.
7、 recommend to replace the interface signal line of the liquid drop detection sensor once a
year.

22 / 62
 4.3.3 Select IV set brand

1. After the pump is powered on and the IV set is properly installed, the brand selection
interface will appear on the screen.
2. Select the brand and type of the IV set that is actually being used and confirm the
selection.
3. The title bar of the interface shows the brand and type of the currently selected IV set.
For details of the supported IV set, please refer to the “12.12 Supported IV sets” section
of this User Manual.

4.3.4 Select infusion mode

The infusion pump totally supports three infusion modes. They are rate mode, time mode
and weight mode (weight mode is supported only by 5000A Plus and 5000B Plus). The user
can select the desired mode by the mode key. See “5.1 Infusion Mode” for the detailed
description of each mode.

4.3.5 Priming

The air remaining in the tubing shall be primed out before starting infusion to ensure that
the infusion 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 infusion 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 6mL. After 6mL volume has been
primed out, the infusion pump stops priming and triggers the alarm “Purge vol. to
limit.!” to notify the user that the priming volume has been to its limitation.

23 / 62
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 IV set 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 infusion pump is infusing, the infusion indicator lights up as the horse-running
to indicate this status.

4. Bolus infusion is enabled while infusing. For detailed operation, please refer to “5.2
Bolus Infusion”.
5. For 5000A Plus and 5000B Plus 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 at the last

position simultaneously to lock all the keys 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 will not work except the Power key

to prevent accidental operation, press and at the last position simultaneously

to unlock.

24 / 62
 B.Braun 20d/mL 1

Rate 100.0 mL/h

Infused volume 10.0mL

Stop Ch. rate

4.3.8 Infusion completed

1. While the remaining infusion time is no more than the set nearly empty time, the infusion
pump will trigger an alarm "Near complete!" and continue to infuse at the set rate. The
infusion stops and triggers an alarm “Complete!!!” when the remaining volume is zero,
then the infusion pump will automatically enter the KVO infusion. For details of the
KVO infusion, please refer to “5.3 KVO”.
2. Press the stop key to stop the infusion at any time.

4.3.9 Unload or replace IV set

1. Press the stop key to stop infusion.

2. Close the roller clamp on IV set to avoid free flow.
3. Disconnect IV set tubing from the patient.
4. Open the door of pump.
5. Open the pump clamp.
6. Remove the IV set.
7. Install another IV set as described in “4.3.2 Install IV set” after removed the old IV set
and press the start key to continue infusion, or close the pump door directly and press the
power key for 2 seconds to close the infusion pump.

25 / 62
 4.3.10 Turn off

1. While the infusion pump is infusing, please 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.
Note: Do not use the infusion 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.
Note：Only allow qualified technicians to complete all services, repairs, and calibrations.
Unauthorized modifications are prohibited.

Chapter 5 Features

5.1 Infusion Mode

5.1.1 Rate mode

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

Sel Adj

26 / 62
 5.1.2 Time mode

Time mode

VTBI ---.-
---.- mL
Infusion time 00 hr 00
Rate ---.- mL/h
Accum. vol. 0.0 mL
Sel Adj
Note: The infusion rate is automatically calculated according to the VTBI and the
infusion time. The infusion rate = VTBI / infusion time.

5.1.3 Weight mode

Only applicable to the configuration of 5000A Plus and 5000B Plus

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
Sel Adj Sel Adj
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：

27 / 62
Programmable Descriptions
parameters

0.1mL/h～1200mL/h (<1000mL/h, the minimum step is 0.1mL/h, ≥1000mL/h ,

Rate the minimum step is 1mL/h) or 1d/min-400d/min (the minimum step is 1d/min,
only applicable to 5000B and 5000B Plus)

0.1mL～9999mL(<1000mL, the minimum step is 0.1mL, ≥1000mL , the

VTBI
minimum step is 1mL)

Infusion time 00hr01～99hr59, the minimum step is 1 minute

0.01mg/kg/h（or mcg/kg/min）～99.99mg/kg/h（or mcg/kg/min），the

Dose
minimum step is 0.01mg/kg/h or mcg/kg/min

Weight 0.1kg～999.9kg，the minimum step is 0.1kg

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

Volume 0.1mL～999.9mL，the minimum step is 0.1mL

Non editable, 0.0mL~9999mL，When the accumulated volume is not zero and

Accumulated
the pump is on the status of stop, press the select key to select the accumulated
Volume
volume. Press + simultaneously to reset the accumulated volume to zero

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.

Bolus Rate Bolus volume

The current infusion rate -1200 mL/h 1.0～60mL

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.

28 / 62
5. When Bolus infusion, the “Near complete!” 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 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.

5.4 Drip detection

This product can select the drop as the rate unit for infusion, the rate will be converted
automatically.
When the liquid drop sensor is set to on, the liquid drop detection sensor will monitor
whether the rate is normal synchronously by drop sensor. If the liquid drop detection sensor is
installed incorrectly, installed too obliquely, or removed during infusion, it detects there is a
significant deviation between the actual infusion rate and the programmed infusion rate
because the detected drops are wrong or even it cannot detect any drops. In this case the pump
triggers a high priority alarm “Drop rate deviation!!!”.
For detailed setting method, please refer to “chapter 6 Functional setting interface".
Note: drip detection is only applicable to 5000B and 5000B Plus.

5.5 IV set accuracy calibration

IV set accuracy calibration steps:
1. When the pump is in stop state, press the menu key to enter the functional setting
interface, select the accuracy calibration item and enter its functional interface.
2. After installing the calibrated IV set correctly, the pump will display the IV set
selection interface automatically, select and confirm the corresponding IV set brand.
3. Set the calibration rate and volume. The calibration rate unit is mL/h or d/min (d/min is
only applicable for 5000B and 5000B Plus). The unit of calibration volume is mL. Press the
select key to confirm setting parameters.
4. Press the start/stop key to enter the infusion calibration interface to start the calibration.
29 / 62
 5. After the set calibration volume is infused, the pump will display the calibration
confirmation interface. Input the actual infused volume in mL, accurate to 0.1ml.
6. Press the select key to confirm the input parameters.
7. If the calibration is successful, the calibration factor will be saved automatically. The
pump displays the prompt “Calibration succeed” or “Calibration failed” based on the
calibration result, then pump returns to the functional setting interface after 3 seconds.

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.

Chapter 6 Functional setting interface

The following parameters are the functional parameters of the 5000B Plus model infusion
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
Air detection Medium
Change rate on
Nearly empty time 3 Min
KVO 2.0 mL/h
Sel Ok Exit

30 / 62
 Menu
Dose unit mg/kg/h
Rate unit mL/h
Drop sensor off
Alarm volume 6
Alarm type type1
Sel Ok Exit

Menu
Accuracy calibration
Date 2017 - 01 - 01
Time 00 : 00 : 00
Night Mode off
18 : 00 - 07 : 00
Sel Ok Exit

Menu

Recommended brands
Alarm reset
Version 5B Plus 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.

31 / 62
 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.
Air detection There are low, medium and high levels. It is recommended to choose the
appropriate air detection according to the actual requirements of the clinic. For
5000A and 5000B models, it is fixed to low.
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 5000A Plus
and 5000B Plus)

Nearly empty The time for setting the near complete alarm. It is adjustable from 1 to15
time minutes. For 5000A and 5000B 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 weight mode is mcg/kg/min, mg/kg/h, which can be
selected according to actual requirements. (only for 5000A Plus and 5000B
Plus)

Rate unit have two types: mL/h and d/min, could select the proper unit according to
actual needs. (only for 5000B and 5000B Plus)

Drop sensor There are on and off options. If the setting is on, the drop rate can be detected
by the liquid drop detection sensor, otherwise, the liquid drop detection sensor
is useless. (only for 5000B and 5000B Plus)

Alarm volume Setting the audio volume for alarm. It shall be adjusted only by biomed
technician. 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 5000A and 5000B 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

32 / 62
 Parameters Attributes

Time 24-hours system

Accuracy Use to calibrate the accuracy of the supported IV sets

calibration

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
5000A Plus and 5000B Plus)

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 5000A Plus and 5000B Plus)

Recommende Configuring the commonly used IV set brands

d brands

Alarm reset Restore the alarm-related values to the default state. The alarm-related values
contain “Occlusion level”, “Air detection”, “Nearly empty time”, “Drop
sensor”, “Alarm volume”.

Version A version that identifies the current software used by the infusion 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 5000A Plus and 5000B Plus, 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 5000A
and 5000B, 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.

33 / 62
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.

Alarm

Complete!!!
Accum. Vol. 1.0mL
Alarm duration 00h 00min
KVO infusion
Turn off the alarm
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
34 / 62
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:

Priority Maximum
Alarm text
Description inherent alarm Solution
information
response time
No motor rotation High 16 seconds Restart the
System error
detected while pump is pump
01!!!
powered on
Besides the power key High 16 seconds Restart the
System error
there is any other key in pump
02!!!
the pressed state.
System error Downstream pressure High 100 Restart the
03!!! sensor lost milliseconds pump
System error Pump door detection High 100 Restart the
04!!! system lost milliseconds pump
System error Downstream pressure High 100 Restart the
05!!! sensor exception milliseconds pump
Upstream pressure sensor High 100 Restart the
System error exception (only milliseconds pump
06!!! applicable to 5000A Plus
and 5000B Plus)
liquid drop detection High 100 Restart the
System error sensor lost (only milliseconds pump
07!!! applicable to 5000B and
5000B Plus)
System error Infusion rate sensor lost High 100 Restart the
08!!! milliseconds pump
System error While the external flash High 2 seconds Restart the
09!!! module failed pump

35 / 62
System error While there isn’t kick High 3 seconds Restart the
10!!! signal from security chip pump
System error While there isn’t kick High 3 seconds Restart the
11!!! signal from main chip pump
System error While the bubble sensor High 3 seconds Restart the
12!!! failed pump
Battery Depleted High 1 second Connect to
Battery the AC
empty!!! power

Abnormal motor speed High 9minutes (For Press the

0.1ml/h) "Stop" key to
Drive error!!!
clear this
alarm
While infusing, if the High See 12.9 Press the
tubing or patient line is Occlusion "Stop" key to
Downstream blocked, the pressure in induction- Time clear this
occlusion!!! the tubing will exceed to Occlusion alarm
the set occlusion
threshold.
Infusion complete High 200 Press the
milliseconds "Stop" key to
Complete!!!
clear this
alarm
While infusing, if the High Press the
tubing or patient line is "Stop" key to
blocked, the pressure in clear this
Upstream the tubing will drop to alarm
occlusion!!! exceed the set occlusion
threshold. (only
applicable to 5000A
Plus and 5000B Plus)

36 / 62
 Detect bubble in infusion High 100 Press the
tubing during pump milliseconds "Stop" key to
Air alarm!!!
infusion clear this
alarm
Pump door is opened High 100 Press the
during pump infusion milliseconds "Stop" key or
close the
Door opened!!!
door to
clear this
alarm
Detect the actual drop High 15 minutes Press the
rate is significant "Stop" key to
difference to the setting clear this
Drop rate
value (only applicable alarm
deviation!!!
to 5000B and 5000B
Plus), the rate is lower,
the delay time is longer.
The priming volume of High 200 Press the
Purge vol. to single time is to 6mL milliseconds "Stop" key to
limit.! clear this
alarm
In the case the remaining low 200 Press the
infusion time is no more milliseconds "Stop" key to
than the set near clear this
complete time (the near alarm
Near complete!
completion time 5000A
and 5000B is not
adjustable and fixed to 3
minutes).
Low battery low 1 second Connect to
Low Battery! the AC
power

37 / 62
 In stop state during 2 low 2 minutes Press any key
Operation
minutes there isn’t any to clear the
reminders!
operation. alarm
AC disconnected low 1 second Connect to
AC
the AC
disconnected
power
Note 1: If there are two or more same priority 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.
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 Action

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

Can't turn on normally
and remove the IV set.
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 tubing is connected to the patient, clamp the tubing clip
System error occurs
and remove the IV set.
38 / 62
after powered on 2. Turn off the infusion pump.
3. Press and hold the Power Key for 2 seconds (do not press
another key) to turn on the infusion pump. If the system error
alarm does not reappear, you can continue to use the infusion
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 clamp
The recognized IV set
and verify that the patient is not at risk.
brand and type does not
2. Remove and reload the IV set, and select the correct IV set
match that of the IV set brand.
3. 3. If this situation occurs again, please contact with the after-
being loaded.
sales service department of Medsure medical technology co.,
Ltd.

The casing or other please contact the after-sales service department of Medsure

parts of the infusion medical technology co., LTD.

pump are damaged

1. Confirm that the infusion indicator light of infusion pump is

No flow after starting
flashing normally, otherwise, please refer to the instructions
infusion
in the user manual for infusion settings and initiating an
infusion.
2. If the infusion indicator light indicates that the infusion
pump is running and the infusion tubing has been connected
to the patient, clamp the tube clip and disconnect the tubing
from the patient.
3. Make sure the tubing is not occluded. If the tubing is
occluded, please stop running the infusion pump, check the
occlusion position and dredge; If it is still occluded, open the
infusion pump door, then reinstall the infusion tubing and
start the infusion pump again.

39 / 62
 4. Please contact 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 infusion 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 infusion
pump is running on the internal battery. The infusion pump display will display the current
battery level roughly.
If the power supply is not connected when the infusion pump is turned on, the infusion
pump will automatically trigger AC disconnected alarm after the self-test, and automatically
switch to the internal backup battery. After the infusion 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, the pump can continuously infuse for at least 7 hours at
25mL/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 (25mL/h) the battery will run out. When the battery is exhausted, the
infusion stops, the infusion pump triggers the battery empty alarm. In order to avoid over
discharge of the battery, the pump will shut down after 5 minutes automatically.

40 / 62
 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 charge

For the first time to use or if the battery is depleted, the infusion pump must be connected
to mains power supply (no less than 7 hours) to charge the battery.
When the infusion 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.
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 infusion 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.

41 / 62
 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.

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.

42 / 62
 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.

Chapter 9 Cleaning and Maintenance

9.1 Cleaning
The infusion 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 infusion
pump directly.
If you need to store the infusion 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 infusion pump.
Cleaning the infusion pump periodically by following steps:
1. Disconnect the infusion pump from the main power supply.
2. Wipe the infusion pump enclosure slightly, pay special attention to the clean of the
pressure plate, Driven box, pressure sensor, bubble sensor and other internal structure.
3. After cleaning, disinfect the infusion 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.

43 / 62
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 and accessories.
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 drop
Pressure calibration, drop sensor
Preventive rate detection abnormally,
calibration, IV set accuracy
maintenance the infusion flow is not
calibration
accurate, calibrate only by
service engineer according
to the service manual.
According to the description of
chapter 7 alarm system, check
Every two years, either
whether it can work normally or
Alarm system after repaired or upgraded,
not, during the inspection,
inspection check by biomed or service
occlusion and air alarms shall be
engineer.
triggered correctly at least. See
“Note4” for examples.
Every two years, or after
Safety inspection
the replacement of the
according to IEC
board or the infusion pump,
60601-1:2012
　 it needs to be done, check

44 / 62
 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 infusion 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 infusion 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.
Downstream While infusing, after blocking the tubing between pump and
occlusion!!! patient, the pump shall trigger “Downstream occlusion!!!” alarm
correctly. There shall be high priority audio and visual alarm
signal.
Install a IV set filled with bubbles, the pump shall trigger “ Air
Air alarm!!! alarm!!!” alarm correctly. There shall be high priority audio and
visual alarm signal.
For more details, please refer to "7.2 Failure Analysis and Troubleshooting".

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.
45 / 62
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.

Authorized representative in the European Community.

46 / 62
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.

47 / 62
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

48 / 62
Chapter 12 Specifications

12.1 Product

weight 1.8kg (including pole clamp)

290±8（length）×110±5（width）×125±5（height）(not
Size including the dimension of pump clamp and the drop sensor)，
unit: mm.

direction Horizontal

The configuration parameters in the infusion pump menu and

Data save time infusion history log of infusion pump will not be lost after
shutdown.

Working temperature +5℃～+40℃

Working relative humidity Not higher than 90%

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

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

Expected service life 5 years (excluding battery)

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

49 / 62
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

Main power AC voltage 100-240V~; power frequency 50Hz/60Hz; input
current 0.35-0.14A. (The factory setting, the user is not
adjustable.)
Fuse F2AH250V

Power cable 3×1.0mm2×3m，250V/10A

type of battery
Battery working time
Battery charging time
Operating mode
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 1
year warranty)
Continuous operation of no less than 7 hours at an infusion
rate of 25 mL/h
At least 7 hours
(A temperature below 15 ° C or above 25 ° C is not
conducive to battery charging)
continue to operate

12.4 Infusion rate

Normal Infusion rate 0.1mL/h～1200mL/h
Priming rate can be set within the range of 100.0ml /h ~ 1200mL/h
Bolus rate can be set within the range of current setting rate ~
1200mL/h

12.5 KVO rate

KVO rate 0.0～5.0mL/h (step 0.1mL/h)

12.6 Infusion accuracy

Check item Precision value Detection demand
50 / 62
 Infusion accuracy after ±5% Measured at 1mL/h and 25
calibration mL/h infusion rate while the
back pressure is no more than
+13.33 kPa and no less than -
13.33 kPa.
Bolus accuracy ±5% Measured at the supported
maximum bolus rate while the
bolus volume is 1mL or the
maximum volume.
Note:±5% of the infusion accuracy is the nominal infusion accuracy, which may affect the
infusion accuracy due to factors such as IV set differences.

12.7 Occlusion – Occlusion level

Occlusion alarm level Pressure range
Low 200±150 mmHg (26.06±20.00 kPa)
Medium 600±220 mmHg (80.00±29.33 kPa)
High 1050±250 mmHg (140.00±33.33 kPa)

12.8 Maximum infusion pressure

Maximum infusion pressure description
This value is determined according to the pressure
No more than 180kPa requirements of in ISO 8536-4:2010 and ISO 8536-8:2004
and the upper limit of pressure under high occlusion level.

12.9 Occlusion - Occlusion time

Infusion rate Occlusion level Longest occlusion time
Low 11 minutes
1mL/h
High 50minutes
Low 30 seconds
25mL/h
High 1 minute and 45 seconds
Low 5 seconds
The maximum rate
High 6.5 seconds

51 / 62
Note 1: The above results were determined by the 20 drop /mL IV sets and the values are
approximate. The infusion rate is higher, the occlusion time is shorter.
Note 2: 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 IV set 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 infusion pump is reversed by the motor, reducing the
pressure in the tube to reduce the potential occlusion Dose. The drive error alarm, Air alarm
and drop rate deviation will be suppressed during the block release process. The tube must be
clamped before checking for the cause of the occlusion (see Warning 25).
After the occlusion, the Dose of the Bolus is determined by the method (IEC 60601-2-
24:2012): For intermediate rate, in low occlusion level case it is no more than 0.15mL, and in
high occlusion level case it is no more than 0.35mL.
Note: the above results are measured by B.Braun IV set.

12.11 Air detection sensitivity

Air bubble sensitive level Air bubble sensitivity range
Low ≥ 200µL
Medium ≥100µL
High ≥ 25µL

12.12 Supported IV sets

The IV sets required to be used is the IV sets that have been registered with the FDA and
obtained a registration certificate, and the IV sets supported by the three infusion modes are
identical. Among them, the IV set of B.Braun has 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 ".
Coding Infusion set brand 20drops/mL
01 B.Braun √
02 Lifeline √
03 Romsons √

52 / 62
 04 Polymed √
Note 1: This product is recommended to use B.Braun IV set.
Note 2: While replacing IV set, please make sure to select the IV set whose brand and
specification is same as on the actual installed one, otherwise forbid to use it.

12.13 Normal infusion set

This product supports up to eight channels at the same time. The first four channels are
only used for the recommended brand infusion sets and the other four channels are used for
customized brand infusion sets. If user use customized brand infusion set, the user shall ensure
they are applicable for using, and shall be calibrated by the professional personnel according to
the calibration method specified in technical service manuals and verified to consistent with
related requirements before use.

12.14 Curve drawing

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: 25.0mL/h
IV set brand: B.Braun
Sampling equipment: 3 sets Sampling IV sets: 3 pcs
Sampling interval: △t = 0.5 min Experimental period: 120min

53 / 62
Rate: 1.0mL/h
IV set brand: B.Braun
Sampling equipment: 3 sets Sampling IV sets: 3 pcs
Sampling interval: △t = 0.5 min Experimental period: 120min

Trumpet curve
Rate 25.0mL/h (Overall percentage error is 0.22%)
IV set brand: B.Braun
Sampling equipment: 3 sets
Sampling IV sets: 3 pcs
Sampling interval: △t = 0.5 min
Duration of observation window: p△t = 2, 5, 11, 19, 31 min
54 / 62
Rate 1.0mL/h (Overall percentage error is 0.80%)
IV set brand: B.Braun
Sampling equipment: 3 sets
Sampling IV sets: 3 pcs
Sampling interval: △t = 0.5 min
Duration of observation window: p△t = 2, 5, 11, 19, 31 min

55 / 62
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:
1. Adjust the direction or position that affects the device;
2. Increase the distance between the device and the device that affects it;
3. Use other power sources instead of powering the device to supply power to the device;
4. 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
compatibility) means that a device is not affected by electromagnetic interference generated by

56 / 62
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.
Prototype cable information: drop-rate sensor cable, cable length (m) 0.32+/-0.03.
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).
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 t——Professional healthcare facility environment.

13.3 Electromagnetic environment requirements

Table 1 Guidance and Manufacturer's Declaration - Electromagnetic Emissions
57 / 62
 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.
Electromagnetic environment –
Emission test Compliance
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
CISPR 11
are not directly connected to the home and to the
Harmonic Not applicable
public low-voltage power supply network of the
emissions
home.
IEC 61000-3-2
Voltage Not applicable
fluctuations/
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

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

58 / 62
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.

59 / 62
 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

60 / 62
710 704- LTE Band Pulse 0,2 0,3 9
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

61 / 62
 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: 2017- 03
© 2017 all rights belong to Medsure Medical Technology Co., Ltd.
All rights reserved.
Part number：7000014
File number：MS-TCF-02_8
Revise date: 2020-03
Version: A

62 / 62