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MS004-Infusion Pump 5000 series User Manual -CE英文
MS004-Infusion Pump 5000 series User Manual -CE英文
MS004-Infusion Pump 5000 series User Manual -CE英文
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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.
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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
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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.
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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.
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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.
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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 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
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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
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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
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Chapter 2 Introduction
alarm
indicator
mains
power
indicator
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Key symbol Description
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.
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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.
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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.
Vertical direction:
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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.
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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.
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4.2 Operation workflow
parameters
Connect to patient Connect IV set tubing to patient
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4.3 Operation steps
4.3.1 Power on
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.
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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.
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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.
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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.
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Drip chamber
Drop sensor
Drip
Drip direction
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.
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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.
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.
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Note 2:The priming volume is not included in the total volume of infusion.
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. 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 unlock.
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B.Braun 20d/mL 1
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.
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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
Rate mode
Rate ---.-
---.- mL/h
VTBI ---.- mL
Accum. vol. 0.0 mL
Sel Adj
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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.
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Programmable Descriptions
parameters
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.
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5. When Bolus infusion, the “Near complete!” alarm is blocked and will not be triggered
until the bolus volume is infused completely.
Menu
Occlusion level Medium
Air detection Medium
Change rate on
Nearly empty time 3 Min
KVO 2.0 mL/h
Sel Ok Exit
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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.
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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.
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.
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Parameters Attributes
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)
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:
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Chapter 7 Alarm system
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%
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
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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
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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
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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
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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.
The casing or other please contact the after-sales service department of Medsure
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4. Please contact after-sales service department of Medsure
Medical Technology co., Ltd.
Chapter 8 Battery
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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.
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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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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.
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.
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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 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
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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:
Rechargeable battery
Type CF equipment
Date of manufacture
manufacturer
Serial Number.
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Caution! (read important information in the operating
instructions)
Temperature limitation
Numerical display upper and lower temperature limits (°C)
Humidity limitation
The numerical value shows the upper and lower humidity
limits (%)
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Keep away from sunlight
Alarm symbol
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Chapter 12 Specifications
12.1 Product
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
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
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
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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.
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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.
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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.
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
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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
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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
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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.
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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.
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
Electrical fast
2 kV , 1kV 2 kV , 1kV
transient/burst
100KHz repetition frequency 100KHz repetition frequency
IEC 61000-4-4
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Surge ±1kV line to line ±1kV line to line
IEC 61000-4-5 ±2kV line to ground ±2kV line to ground
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
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Table 3 Guidance and Manufacturer's Declaration - Electromagnetic Immunity
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.
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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
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Medsure Medical Technology Co., Ltd.
EC REP
Luxus Lebenswelt GmbH Kochstr. 1,47877, Willich, Germany
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