Medcaptain MP-60 User manual [gb]

Operation Manual

Infusion Pump MP-60

Please read this “Operation Manual” carefully and follow “Precautions for Use” before

using the MP-60 Infusion Pump.

MEDCAPTAIN MEDICAL TECHNOLOGYCO., LTD.

Intellectual Property and Statement

The intellectual property right of this product and its Service Manual belongs to
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. (hereinafter short as MEDCAPTAIN).
©2015-2016 All rights reserved MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

Without prior approval from MEDCAPTAIN in writing, this Service Manual shall not be
photocopied, modified or translated, fully or partially, by any individual or organization.

, MEDCAPTAIN and are registered trademarks or trademarks of

MEDCAPTAIN.

Statements

MEDCAPTAIN reserves the right for final interpretation of this Service Manual.
MEDCAPTAIN reserves the right to modify the contents of this service manual for a more
accurate and effective service quality. The modified contents should be reflected in the newly
published service manual version.
MEDCAPTAIN is responsible for safety, reliability and performance of this equipment only
in the case that:

 Use in accordance with the Operation manual.
 All disassembly, replacement, test, modification and repair are executed by qualified

persons approved by MEDCAPTAIN.

 All replacement parts, supporting accessories and consumables during the

maintenance are provided by MEDCAPTAIN.

 Maintenance records for product are reserved.

Version Information

 V1.0

 Firstly publish
 Publish date：2014.2.28

 V2.0

 Registration change and content modification
 Publish date：2014.5.30

 V2.1

 Interface Modification
 Publish date：2016.3.5

Intellectual Property and Statement

 V2.2

 Service interval modification and writing mistake correction
 Publish date：2016.7.30

After Service

Thank you for using the infusion pump of MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

 During the warranty period, we provide free after-sale services except the following causes:

 Artificially damaged.
 Inappropriate use.
 The voltage of supply network exceeds the range.
 Irresistible natural disasters.
 Replacing or using parts, accessories and consumables without approval of

MEDCAPTAIN.
 Other troubles not caused by product itself.
If the warranty period is expired, we couldcontinue to provide charged maintaining service.

If you have any question when using the infusion pump, please contact local distributor or
directly contact us at any time.

The after-sales service contact details of Medcaptain Medical Technology Co., Ltd. are as

follows:

Address: 12th Floor, Baiwang Research Building, No.5158 Shahe West Road, Xili,
Nanshan District, Shenzhen, P.R.China
Telephone:[phone]
Fax: [phone]
Postal: 518055
Website: http://www.medcaptain.com
E-mail:[email protected]

 MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. and all local dealers established

after-sales service agencies, can effectively, timely solutions to your problems.

WARNING:

 The device should be operated by clinic medical staffs or under the instruction of special

clinic medical staffs. The operator should have been trained on how to use this product.

Contents

1 OVERVIEW .................................................................................................. 1

1.1 INTENDED USE ............................................................................................... 1

1.2 CONTRAINDICATION ........................................................................................ 1

1.3 PRODUCT FEATURES ...................................................................................... 1

2 PRECAUTIONS FOR USE ........................................................................... 3

3 PRODUCT SPECIFICATIONS...................................................................... 8

4 PRODUCT DESCRIPTION ......................................................................... 10

4.1 PRINCIPLE OF OPERATION .............................................................................10

4.2 COMPOSITION OF INFUSION PUMP ..................................................................10

4.3 HANDLE .......................................................................................................13

4.4 DROP SENSOR ..............................................................................................13

4.5 POLE CLAMP ................................................................................................13

4.6 NURSE PAGER ..............................................................................................14

4.7 ACCESSORIES ACCOMPANIED .........................................................................14

4.8 OPTIONAL ACCESSORIES ...............................................................................14

5 PREPARATIONS FOR USE ....................................................................... 15

6 OPERATING INSTRUCTIONS ................................................................... 16

6.1 DISPLAY AND KEYS ........................................................................................16

6.2 START UP .....................................................................................................18

6.3 IV SET INSTALLATION .....................................................................................19

6.4 PURGE .........................................................................................................21

Contents

6.5 SETTING THE INFUSION RATE ..........................................................................21

6.6 PUNCTURE ...................................................................................................22

6.7 STARTING INFUSION ......................................................................................22

6.8 CHANGE RATE DURING INFUSION ....................................................................23

6.9 BOLUS .........................................................................................................23

6.10 STOPPING INFUSION ......................................................................................24

6.11 REPLACING OR ADJUSTING IV SET ..................................................................24

6.12 TURNING THE POWER OFF .............................................................................25

7 SETTING THE INFUSION PUMP ............................................................... 26

7.1 INFUSION SET ...............................................................................................26

7.1.1 Infusionmode ............................................................................................... 26

7.1.2 Occlusion Level ........................................................................................... 28

7.1.3 Bolus Mode .................................................................................................. 29

7.1.4 KVO Rate..................................................................................................... 29

7.1.5 Brand ............................................................................................................ 29

7.1.6 Relay set ....................................................................................................... 29

7.1.7 Drip Mode Set .............................................................................................. 29

7.1.8 NearFinished ................................................................................................ 30

7.2 SYSTEM SET .................................................................................................30

7.2.1 Volume Setting ............................................................................................ 30

7.2.2 Display SET ................................................................................................. 30

7.2.3 Internet Set ................................................................................................... 31

7.2.4 Lock screen Set ............................................................................................ 32

7.2.5 Collection Set ............................................................................................... 33

7.2.6 Linkage mode............................................................................................... 33

7.2.7 PressureUnit ................................................................................................. 34

7.2.8 Date&Time set ............................................................................................. 34

7.2.9 Maintenance ................................................................................................. 34

Contents

7.3 HISTORY ......................................................................................................35

7.4 PATIENT FILE ................................................................................................36

7.5 USE INTERNAL BATTERY ................................................................................36

7.6 CONNECTING TO THE <INFUSION CENTRAL MONITORING

SYSTEM>(OPTIONAL) ...............................................................................................38

7.7 NURSE PAGER (OPTIONAL) .............................................................................38

7.8 VOICE COMMUNICATION(OPTIONAL) ................................................................38

7.9 CONNECTING A BARCODE SCANNER (OPTIONAL) ..............................................38

7.10 USER-SPECIFIC REQUIREMENTS (OPTIONAL) ...................................................38

7.10.1 Maximum Flow rate ..................................................................................... 38

8 TROUBLESHOOTING ................................................................................ 39

8.1 ALARM .........................................................................................................39

8.2 FAULTS AND TROUBLESHOOTING ....................................................................40

8.3 TROUBLES AND TROUBLE SHOOTING ...............................................................41

9 MAINTENANCE ......................................................................................... 42

9.1 CLEANING, DISINFECTING ..............................................................................42

9.2 PERIODIC MAINTENANCE ...............................................................................42

9.2.1 Checking the Appearance ............................................................................ 42

9.2.2 Checking the Power Cable ........................................................................... 42

9.2.3 Checking the infusion rate ........................................................................... 43

9.2.4 Alarm ........................................................................................................... 43

9.2.5 Electric and mechanical safety..................................................................... 43

9.2.6 Checking the Internal Battery ...................................................................... 43

9.2.7 Replacing the Battery ................................................................................... 44

Contents

9.3 MAINTENANCE ..............................................................................................44

9.4 STORAGE .....................................................................................................45

9.5 TRANSPORTATION .........................................................................................45

9.6 ENVIRONMENTAL PROTECTION AND RECOVERY ...............................................45

10 INFUSION ACCURACY CHARACTERISTICS ............................................ 46

10.1 FLOW RATE CHARACTERISTICS ......................................................................46

10.2 OCCLUSION CHARACTERISTICS ......................................................................49

APPENDIX A ELECTRON MAGNETIC COMPATIBILITY (EMC) ........................... 50

APPENDIX B THE DEFAULT FACTORY SETTINGS ............................................ 56

APPENDIX CTOXIC AND HAZARDOUS SUBSTANCES OR ELEMENTS ............ 57

Overview

1 Overview

1.1 Intended use

This product is intended for hospitals to infuse liquid at constant-speed or liquid

medicine continuously through the veins of patients.

1.2 Contraindication

None

1.3 Product Features

MEDCAPTAIN MP-60 is a micro-continuous infusion pump. It ensures constant infusion
speed and accurate dosing volume during longtime infusion.
This infusion pump is used for continuous and micro-volume infusion of liquid or liquid
medicine of little volume and high concentration, including, but are not limited to the
infusion of chemotherapeutic agents, cardiovascular drugs, antineoplastic, oxytocic,
anticoagulant, anesthetic agents.

 All current disposable IV sets conform to the standard are supportable.
 New IV set conform to the standard can be customized.
 Providing eleven occlusion levels and displaying pressure status of the tube.
 Maximum infusion rate can be set to 1200mL/h.
 Calibration functions for infusion accuracy is available.
 Safety design by monitoring infusion states.
 Multiple modes of infusion.
 Configure with multi-channel infusion workstation, realizing relay infusion function.
 WIFI module could be connected to the ICMS to monitor the infusion status.
 Nurse call function.
 Voice Communication function.
 Touchscreen, providing quick and convenient man-machine interface.
 Display night mode, reducing light interference to patients and environment.
 Connection to barcode scanner function.
 Three types of power supply: AC power supply, DC power supply, and internal lithium

battery are available. The lithium battery can power the infusion pump for no less
than 5 hours (at 25ml/h rate).

 Double CPU and redundancy design for key units.
 Two-way alarm for monitoring the main control circuit and motor drive circuit

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Overview

 Independent motor driving CPU and motor subdivided drive chip design.
 Setting and giving automatic prompt of maintenance interval.
 Modular installation design enables multi-channel pumps among pumps.

Note:

Handle, pole clamp, barcode scanner, WIFI communication module, voice
communication, nurse call and relay infusion function are optional, dependingon the
user’s need.

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Precautions For Use

2 Precautions for Use

In this manual, precautions are classified into warning and caution according to the
importance. The meanings are as follows:

WARNING:
The information is about safety and efficiency. Operation against the warning may cause
injuries.
CAUTION:
The information is about guiding suggestions. Operation against the caution may affect
normal use of the product. Read carefully the warnings and cautions in this manual.

WARNING

 The infusion pump must be operated by clinical professionals.
 The infusion pump cannot be used for blood transfusion.
 Prior to use, please check the status of the pump, power cord and other related

accessories to ensure the device could be used normally and safely

 Pay extra attention to kinks of the infusion line when it is used for low-infusion. The

smaller the set infusion rate becomes, the longer it takes from the occurrence of
occlusion to its detection, which may suspend the infusion for a long time.

 To avoid the risk of fire or explosion, do not use the infusion pump in a flammable or

oxygenated environment.

 The altitude difference between the pump and heart position of the patient should not

be larger than 100cm. Smaller difference of the altitude will increase the accuracy of
the pressure sensor’s result.

 In the event of tube twisting, filter condensation or intubation occlusion during infusion,

the internal pressure of the infusion tube will increase. Once the causes for occlusion
are removed, too much infusion liquid may be infused into the patient. Therefore,
proper actions should be taken. For example, clamp the infusion tube before
removing the occlusion causes.

 To guarantee the infusion safety and alarming function, it is recommended that you

use the IV sets specified by the manufacturer only..

 Only the IV set, tube, infusion needle and other medical parts complying with the local

regulations can be used on the infusion pump. Contact your local distributor for more
information.

 Operations against the requirements, procedures, warnings and cautions provided in

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Precautions For Use

this manual may cause infusion failure, inadequate, over dosing, or other potential
risks.

 It is recommended to install the drop sensor and open the drop monitoring function. A

long time extrusion without moving or replacing the tube may cause an inadequate
infusion.

 There should be a regular monitoring by clinical professionals to observe the clinical

situation and infusion pump working conditionwhen using the device,

 The power cord or other affiliated lines should be kept properly to avoid any risk of

twining on patient or electrical disturbance.

 High-frequency surgical equipment, mobile phone, wireless device and defibrillator

may have interference on the infusion pump. Keep away from such devices while
operating.

 To avoid the risk of electric shock, this equipment must only be connected to a supply

mains with protective earth.

 If the pump and its related accessories are reaching over the life time, they must be

crapped and disposed in accordance with the local laws or hospital ordinances.
Please contact your local representative for further details.

 Do not modify this equipment without authorization of the manufacturer.
 When operating the pump or checking the pump's alarm system, the operator shall

be in front of the device, no farther than 1 meter.

 There is no patient circuit in this device. The output of the equipment is not

allowed to be accessible to patient.

 The operator shall not touch MP-60 and the patient simultaneously.

CAUTION:

 The infusion set is treated as the applied part of the pump.
 Check the setting values on the prescription and infusion pump.The infusion can be

started when both values are equal.

 In order to prevent extra infusion, close the rolling clamp of the IV sets before

separating the IV sets from pump.

 Follow the tube replacement alarm on the display interface, replace the IV sets or

move the IV sets tubing more than 10cm, to keep the infusion accuracy continuously.

 Ensure that the infusion pump has been fixed tightly on the stand and the stand is

stable. Prevent the pump from collision, dropping mechanical vibration or other
impact of external forces to avoid damage on the pump.

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Precautions For Use

 Before pressing the [START] key, check if the infusion speed is correct, especially the

position of the decimal point.

 Do not operate on the display with sharp objects. Otherwise, the display may be

damaged.

 Occlusion alarm may occur when high-viscosity liquid is infused at high speed

through a thin intravenous needle. Increase the occlusion level or decrease the
infusion speed.

 The drop sensor detects drops, but not the flow rate. If the liquid in the drop chamber

keeps dripping into continuous liquid flow, the drop signal cannot be detected.

 Infusion pump should be placed without the reach of patients and other irrelevant

personnel.

 Avoid direct sunlight, high temperature and high humidity.
 Do not disinfect the infusion pump by using high-pressure steam sterilization method.
 Before using the internal battery, check the battery to ensure that sufficient power is

available. Recharge, if required.

 Ensure that the infusion pump always has a battery installed during operation.

Otherwise, the system may stop without issuing an alarm when external power is
interrupted due to power failure or a short circuit, causing an unsafe condition.

 If the infusion pump cannot work as described in this manual for unknown reasons,

stop it and report the details (including IV set, infusion flow, serial number of infusion
pump, and type of infusion liquid) to your local distributor or our customer service
department.

 Do not operate on the screen using sharp objects. It may damage the screen.
 Do not disassemble or reconstruct the infusion pump without authorization.
 Liquid intrusion into the AC power socket, USB or nurse call socket may cause

short-circuiting. While connecting the power cable, check if the connecting parts are
dry. If liquid spills on the infusion pump, clean the pump with a dry wiper. Use after
the service engineer checking.

 The maximum temperature at the applied part of the pump may reach 41.1℃, when

running continuously under the highest environment temperate at the highest infusion
rate.

 Before use, carefully check if the occlusion pressure test function of the infusion

pump is normal .The Maximum infusion pressure at the end of the infusion tube
generated by the pump may be up to 3500mmHg under the condition of

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Precautions For Use

occlusionwhen sensor failed.

 The delay time between the onset of the alarm condition and the representation of the

alarm is no longer than 150ms.

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Precautions For Use

Authorized Representative in the European Community

CE Mark: conforms to essential requirements of the Medical

Device Directive 93/42/EEC.

Date of manufacture.

Manufacturer

Specifies serial number

TYPE CF APPLIED PART

Alternating current

Direct current

DISPOSAL: Do not dispose this product as unsorted municipal

waste. Collection of such waste separately for special treatment

is necessary.

CAUTION! Read the accompanying document.

General warning sign

Refer to instruction manual / booklet

IPX2

Level of protection from liquid intrusion

Interference may occur near the devices with below sign.

Nurse pager

ON/OFF

HOME

Symbols

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Product Specifications

Product name

Infusion pump

Model

MP-60

Power supply

AC power supply:
AC 100-240V,50/60 Hz, power consumption 45 VA
External DC power supply: DC 12 V 1A
Internal battery: lithium battery 11.1 V 1500 mAh
Battery model: 154457
Time of battery continuous use: no less than 5 hours (for infusion at 25
mL/h rate with a new battery)

Fuse

T1.6AL 250VAC

Compatible IV sets

All disposable IV sets conform to the standard

Infusion mode

Rate, Time, Weight, Sequence, Relay, Drip Mode

Infusion setting
range

0.1-1200.0mL/h or（0.03-400d/min）
See the least increment in chart 6-3

VTBI setting range

0.1 - 99.99（Least increment 0.01）
100 - 999.9（Least increment 0.1）
1000 - 9999（Least increment 1）

Total volume
display

0-99999.99ml

Accuracy

±5%

Purge operation

1200.0ml/h

Bolus operation

0.1~1200.0ml/h
Automatically calculate the bolus rate by bolus amount, cannot lower
than the current rate.

KVO rate

0.1-5.0mL/h

Air-bubble sensor

Sensitivity: detect air-bubble ≥







Occlusion level

300mmHg~900mmHg，3 levels are available

Alarm

Near Finished, Finished, OCCL, Low Battery, Battery Empty, No
Battery, No Power Supply, The Pump Door Open, Air Bubble , No Drip
Sensor, No Drips, Drips Abnormal, Reminder Alarm , Relay Index
Duplicate, Infusion Start Fail , Standby Time Expired

Special function

Repeat alarming:If there is still alarm after mute alarm sound, it will

3 Product Specifications

8 / 57

Product Specifications

alarm again in 2 minutes
Event recording: Can store and playback 2000 events maximum
Sound volume: 11 levels are available
Power supply switching: When AC/DC power supply is cut off ,the
infusion automatically switch to internal battery supply
Barcode scanning: Input the patient information by barcode canning

WIFI function

Connect infusion workstation, nurse pager, voice communication
and infusion pump information network

Operating
conditions

Temperature: 5℃ to 40℃ Humidity:15% to 95% RH
Pressure altitude: 70.0kPa-106.0kPa

Storage conditions

Temperature: -20℃ to +55℃ Humidity: 10% to 93% RH
Pressure altitude:22.0kPa-107.4kPa

Operation Mode

Continuous operation

Classification

1. Class I / Internally powered equipment;

2. Type CF applied part;

3. IPX2;

4. No sterilization requirement for pump

5. Not category AP / APG equipment;

6. Mode of operation: continuous

Dimensions

202(W) ×74(H) ×133(D)mm

Weight

About 1.6 kg (including battery)

Service Life

10 years

Main safety
standards

IEC60601-1 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
IEC60601-2-24 Medical electrical equipment –Part 2-24: Particular
requirements for the safety of infusion pumps and controllers
IEC60601-1-8 Medical electrical equipment -- Part 1-8: General
requirements for basic safety and essential performance -- Collateral
standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
IEC60601-1-2 Medical electrical equipment - Part 1-2: General
requirements for basic safety - Collateral standard: Electromagnetic
compatibility requirements and tests

9 / 57

Product Description

1 –Touchscreen

2 – [HOME]key

3 – [ON/OFF]key

4 –[OPEN]key

5 –pump door

6 –Shell

7 –Alarm indicator

4 Product Description

4.1 Principle of Operation

The MP-60 infusion pump mainly consists of pump shell, display screenand operating
system, monitoring system, alarm system, motor drive system, tubing peristaltic module,
power supply system, drop sensor, WIFI communication module (optional), handle
(optional) and pole clamp (optional).

The infusion pump adopts the dual processor structure, controls the motor precisely,
drives the peristaltic sheet to infuse through the mechanical drive device, monitors the
sensors and infusion process, and provides sound and light alarms.

4.2 Composition of Infusion Pump

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Product Description

1 –Lighting lamp

2 – Depressor

3 – Anti-free-flow clamp

4–Anti-free-flow clamp button

5 – Peristaltic pump plate

6 – Air bubble sensor

7 –Pressure sensor

8 –Infusion tube slit

9 – Catch

 Lighting lamp. To provide lighting in a dim environment, so as to install and check the

infusion tube

 Depressor and peristaltic plate. Driven by the step motor, press and move the tube to

realize liquid flow

 Anti-free-flow clamp. Stop liquid flow and infusion backwards after the pump door

opens

 Anti-free-flow clamp button. Press the button and the clamp will automatically open or

close.

 Pressure sensor and bubble sensor. Sensors monitor occlusion pressure and air

bubble inside the infusion tube.

 Infusion tube slit. At sides of pump to guide the infusion tube in a line behind the

pump door.

 Catch. The two catches are used to close the pump door.

11 / 57

Product Description

1 –Battery cover

2 –Threaded hole

3 –Auxiliary alarm

4 – AC power inlet

5 –Combination clamp

6 –External inlet 1

7 –External inlet 2

8 –External inlet 3

9 –Buzzer

10 – Shell

 Battery chamber. Replaceable battery inside the chamber.
 Threaded hole. To fix the pole clamp, then fix the pump to the IV pole via the pole

clamp.

 Auxiliary alarm. Audible alarm sounds when product functions abnormally.
 Buzzer. To alarm in high, medium or low level during infusion and enable voice

conversation.

 AC power inlet. To connect the external AC power source.
 External inlets 1, 2 and 3. The three inlets share the same signal and can be

connected to 3 external devices at the same time. The external devices include drop

sensor, barcode scanner, external DC power cord. The external inlet 1 and 2 could

be used as the interface for the local WLAN.

CAUTION:

 Only the accessories or devices specified by the manufacturer allowed to be

connected to the Pump. Otherwise may cause electrical shock. See Table4-1.

 The person who connects the devices and accessories to each other or who uses the

devices and accessories is responsible and liable for installation and operation that

complies with IEC/EN 60601-1-1 or clause 16 of IEC 60601-1.

 The plug is used as disconnect to the mains supply, do not position the pump so that

12 / 57

Product Description

1

3

2

1 –Handle

2 –Slide rail

3 –Tubing management bracket

3

2

1

4

1 –Button

2 –Drop hole

3 –Cable

4 –Socket

1

2

1 – Mounting screw

2 – Mounting knob of infusion stand

it is difficult to operate the disconnection device.

4.3 Handle

4.4 Drop sensor

4.5 Pole Clamp

13 / 57

Product Description

1 –Button

2 –Cable

3 –Socket

1 –AC power cord 1

2 – Pole clamp 1

3 – Handle 1

4 – Operation manual 1

5 –Packing list1

6 -– Quick-operation instruction 1

Options

Description

Parts code

Power cable

Standard configuration by factory

7000000005

Lithium battery pack

11.1V@1500mAh

7404000006

Handle

MP-1

9113000002

Nurse pager

MP-2

9113001002

Drop sensor

MP-3

9114002521

Barcode scanner

MP-4

9005000008

Pole clamp

——

9114002501

4.6 Nurse Pager

4.7 Accessories accompanied

4.8 Optional Accessories

Table 4-1 List of Optional Accessories

14 / 57

Preparations For Use

5 Preparations for Use

 Before using the infusion pump, read carefully the Operation Manual and precautions

in this manual.

 When using the infusion pump for the first time, set up the date and time to ensure

that history can be recorded correctly.

 Before using the infusion pump for the first time, set the brand of infusion pump.
 Before using the infusion pump for the first time, recharge the internal battery fully. If

the infusion pump is off, the battery can be charged fully at least 10 hours after being

connected to an external power supply.

 Place the infusion pump on a stable platform.
 Or use the provided pole clamp to mount the infusion pump on an infusion stand.

 Put the infusion pump on the pole clamp while aligning the retaining knob with

the threaded hole, and rotate the handle to fix the infusion pump on the pole
clamp.

 Clamp the pole clamp on the infusion stand, adjust the infusion pump to an

appropriate position, and tighten the retaining knob for infusion stand on the pole
clamp.

 Connect external power supply.

 Insert the supplied AC power cord into the AC inlet on the right side of the

infusion pump. Plug the cord into an AC power outlet with grounding terminal.

 To power the infusion pump with external DC power supply, contact your local

distributor for help.

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Operating Instructions

1 –Alarm indicator

2 –TFT Touchscreen

3 –Home key

4 –ON/OFF key

5-OPEN key

6 Operating Instructions

6.1 Display and keys

 Display

The alarm indicator indicates alarms with three colors: red, yellow and green represent
three levels of high, medium and low, depending on the importance of infusion
information.
TFT Touchscreen, resolution: 320X240

The display is divided into three areas: information area, work data area and function key
area. See below for further description.

Information area: to display the IV set brand and
specification, occlusion level, real- time pressure,
external power source, battery capacity and WIFI signal.
Touch the brand and specifications zone to enter a page
of IV set brand adjustment. Touch the occlusion
pressure level to enter a page of occlusion level
selection. See below for further description.

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Operating Instructions

Occlusion pressure level: 2

Occlusion pressure real-time: a full set of 5 bars. The more bars displayed, the larger
pressure it is.

External power source. Displays when external AC/DC power source is connected.

Screenlock symbol, consists of lock and unlock.

Battery volume and charging states: a full set of 4 bars, the more bars displayed, the

larger battery volume.

WIFI signal

Display when connecting to workstation

Work data area: Displays infusion rate, infusion volume
or different infusion work data according to different
infusion mode. The work data could be adjusted by
touching the specific zone in difference working mode.

Function key area: Touchscreen includes keys of [Start],
[Purge], [Clear], [Stop]. Setting keys such as numbers
and letters appear on corresponding interfaces.

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Operating Instructions

 Keys

Except touchscreen keys, there are also 3 keys on the key panel: [HOME],[ON/OFF] and
[OPEN].

 [HOME]:Main menu key. Before infusion, press [HOME]once to enter a setting

menu, such as Infusion set, Local set, History and Interconnect set. To return to
the infusion preparing interface, press[HOME]once again in any setting interface.
During infusion, press[HOME]to switch to infusion interface, enlarge and display
the infusion rate.

 [ON/OFF]: Switch on/off key. When the pump is off, press [ON/OFF] to turn on

the pump. When the pump is on, press [ON/OFF], and shutdown interface pops
up, select [Power Off]]or long press [ON/OFF]for 3 seconds to shutdown.

 [OPEN]: Door open key. Press[OPEN]and the pump door open automatically, no

matter the power is on or off. Push the door forward slightly till you feel the

resistance, the door closes automatically.

6.2 Start up

CAUTION:

 Start up and then install the IV set.

 Press[ON/OFF]to start up.

 The self-test starts and start up interface appears.

 After self-test finishes, it enters infusion preparing interface.

 The screen displays patient information, infusion brand and occlusion level

stored last time the device powered off.

 If the self-test is abnormal, corresponding information will appear on information

area.

Infusion preparation interface:

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Operating Instructions

WARNING:

 After the power switch is turned on, confirm the loudspeaker, warning indicator is

working all right, and check if the self-test is finished and no error messages appear.

(Refer to Chapter 8 Troubleshooting.)

 Ensure the displayed IV set brand corresponds with the using IV set brand.
 If the IV set brand set is different from the using IV set brand, the infusion accuracy

and alarm function cannot be guaranteed.

 Previous patient information will be cleared if [Yes] is selected on the New Patient

screen.

6.3 IV set installation

 Insert the needle into IV bottle vertically, and the liquid infuses into the drop chamber.
 When the liquid level is at 1/3 of the drop chamber, open the roller clamp.
 Infuse liquid into the tube to purge the air, and then close the roller clamp.
 Press [OPEN] to open the pump door.
 Press [Anti-Free-Flow Clamp] to open the anti-free-flow clamp, place the tube inside

the clamp, and press the key again to clamp the tube.

 Place the tube inside the air bubble sensor and pressure sensor in sequence, then

stretch the tube. Make sure the tube is inside both ends of the tube slit, and then push
the pump door to close it.

CAUTION:

 The height range of the liquidcontainer above the PATIENT and/or pumpshould be

20-80cm.

 Too loose or too tight tube may cause inaccurate infusion.
 The tube must be fixed into the air bubble sensor completely.

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Operating Instructions

 Install the drop sensor

CAUTION:

 To ensure the accuracy of drop detection, the drop sensor should be installed as far

as possible close to the down liquid level. The liquid level is approprite to be in the 1/3

of the drop champer.

 The liquid level must be lower than the drop sensor.
 Prevent the drop sensor from being tilt and always stay out of the sun during infusion.
 Avoid the drip bottle is clipped too tight by drop sensor.
 Drop sensor detects the drop but not Measures fluids flow. Drop signal are

undetectable if the continuous fluids flow is formed in the drip bottle.

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Operating Instructions

IV set specification（d/mL）

Purge rate（mL/h）

20

1200.0

6.4 Purge

WARNING:

 Before purging the IV line, ensure that the IV line is not connected to patients.
 Priming can be done only in non-infusion process.
 Ensure liquid has run out from the needle before stopping purging.
 Air bubble detection and alarm function wiil be closed during purge.
 Click [PURGE], then click [yes] on the pop-up interface, the infusion pump would

purge quickly. Click [stop], the purge stops.

 The green indicator flashes when purging.
 Relationship between IV set specifications and purge rate, refer to the Table 6-1.

Table 6-1 Relationship between IV set specifications and purge rate

CAUTION:

 When high viscosity IV fluids are infused through thin vein needle by bolus operation,

occlusion alarm may occur. In such conditions, reduce the infusion speed to purge.

 Total volume cannot be cleared after infusion starts.
 The volume under the purge function will not be calculated into the total volume.

6.5 Setting the infusion rate

 Click the rate area on the Touchscreen to enter the setting interface.

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Operating Instructions

IV set specification (d/mL)

Setting range (mL/h)

20

0.1-1200.0

Rate range（ml/h）

Minimum increment（ml/h）

0.10 - 99.99

0.01

100 - 999.9

0.1

1000 - 1200

1

 Click [CLEAR] to clear the total volume.
 Relationship between IV set specifications and range, see Table 6-2. The minimum

increment see Table 6-3.

Table 6-2 Relationship between IV set specifications and range

Table 6-3 Relationship between rate range and the minimum increment

CAUTION:

 If the flow rate is changed in the infusion process, the infusion will be done at the new

flow rate.

6.6 Puncture

Insert the vein infusion needle into the patient’s vein.

6.7 Starting Infusion

Click [START], start infusion at the setting rate and green indicator flashes.

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Operating Instructions

CAUTION:

 Infusion can only start when the recipe value equals to the set value.
 If no operation is performed after IV set installation for more than 2 minutes,

START-REMINDER alarm sounds.

6.8 Change rate during infusion

 Click the rate display area on the screen, enter and change the rate on the pop-up

interface.

 After entering the rate, if click [Cancel], it will return to original infusion interface

without change; Click [Confirm], it will return to original infusion interface and operates
at the new rate.

CAUTION:

 If no operation is performed in reference and setting rate interfaces for more than 10

seconds, it will return to infusion interface automatically.

6.9 Bolus

 During infusion; click [Bolus] to enter the bolus setting interface. Set any two of Bolus

VTBI, Bolus rate and Bolus Time, click [Bolus Start] to enter the bolus interface, click
[Bolus Stop] to stop the bolus.

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Operating Instructions

IV set specification

(d/ml)

Bolus rate（ml/h）

The minimum bolus

volume(ml)

The maximum

bolus volume(ml)

20

0.1-1200.0

0.1

50.0

Bolus rates are different depending on the IV set specification as follows.

Table 6-4Relationship between IV set specification and flow rate

CAUTION:

 Current bolus volume is displayed when bolus is running.
 Bolus volume will be accumulated into the total volume.

6.10 Stopping Infusion

In the infusion process or after infusion, press the [STOP] key to stop the operation
and green indicator will be off.

6.11 Replacing or adjusting IV set

An extrusion damage of tube in continuous infusion of the IV set would affect the
infusion precision. After about 8-hour or regulated hour continuous infusion of the IV set,
the infusion should be stopped, open the pump door, and move the IV tube about 10 cm
from the original position, so that the IV tube functions better. Changing the whole IV set is
better solution.

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Operating Instructions

6.12 Turning the Power Off

 Press the [ON/OFF] key, choose Power Off, Standby or Cancel.

 Click [Power Off] to shutdown.
 Click [Standby] to enter standby interface, the standby time can be modify.

 Click [Cancel] to return to previous interface.

.

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Setting the Infusion Pump

7 Setting the InfusionPump

CAUTION:

 After the pump is shutdown, all parameter settings will be automatically saved.
 Parts of parameters will not be saved in force shutdown.

7.1 Infusion set

Press [HOME] key to enter the setting interface, click [Infusion Set] to enter the
detailed infusion setting interface. Infusion set, occlusion level, bolus mode, KVO rate,
brand, relay set,near finished could be set and adjusted here.

7.1.1 Infusionmode

 5infusion modes: Rate, Time, Weight, Sequence, Dripare aer available

 Rate mode

Under the Rate Mode, set the rate and VTBI, click [Confirm] to operate.

 Time mode
Under theTimeMode, set the VTBI and Time, the rate will be calculated automatically,
click [Confirm] to operate.

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Setting the Infusion Pump

 Weight mode
Under the WeightMode, set the Conc, DoseRate, Weight and VTBI, the device will

calculate the rate automatically. Click [Confirm] to operate.

 Sequence Mode
Under the Sequence Mode, set the 5 sequence rate and time, click [Confirm] to

operate in sequence.

 Drip Mode

Under the Drip Mode, set the rate and VTBI, and then click [Confirm] to operate.

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Setting the Infusion Pump

Occlusion

level

Display

Pressure

（mmHg）

Pressure

（Kpa）

Pressure

（bar）

Pressure

（psi）

1

P 1

300

40

0.4

5.8

2

P 2

550

73

0.7

10.6 3 P 3

900

120

1.2

17.4

CAUTION:

 The pump will calculate the corresponding rate according to the current drip rate

(dots/min) and current IV set’s spec.

 The pump control the flow by using corresponding flow rate (ml/h) but not by

detecting the drip rate (dots/ml).

7.1.2 Occlusion Level

 3 levels of occlusion are available (Factory setting is level 2).

Table 7-1 Relations between occlusion level and pressure

CAUTION:

 To preventthe unblocked alarm to cause patients with extra amount of pills after input,

Anti - Bolus alarm, electric opportunity back automatically release line pressure.

 When you infuse viscous solution with the Occlusion Level setting on level1 and the

tubing is clear, occlusion alarm tends to be issued. Carefully watch the on the

upper information area, and change the occlusion level if above 2 bars appear.

 When you operate the pump with the Occlusion Level setting on level 3, the in-line

pressure builds up substantially until Occlusion alarm is issued. Always make sure

that the IV line is securely connected to the pump.

 Occlusion alarm may occur when high-viscosity liquid is infused at high speed

through a thin intravenous needle. Increase the occlusion level or decrease the

infusion speed.

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Setting the Infusion Pump

7.1.3 Bolus Mode

 There are three modes: Manual Bolus, Rapid quantitative Bolus and Automatic Bolus.

Please refer to the chapter 6.9 for further instructions.

7.1.4 KVO Rate

 KVO-rate could be adjusted from 0.1ml/h to 5ml/h (Step by 0.01ml/h), Default rate:

1ml/h.

7.1.5 Brand

 You can choose the consumable brand by: [Home] -> [Infusion Set] -> [Brand].
 Several brands of 20d/mL IV set have been preset and customized. Select the

infusion accordingly for clinical uses.

CAUTION:

 Users must use the consumable brand which is specified by the manufacturer.
 To add in infusion of other brand, users are strongly recommended to contact the

manufacturer or manufacturer’s representative to set and test, so as to ensure the

infusion accuracy.

7.1.6 Relay set

 Open relay mode, set the relay number under the mode.

CAUTION:

 The relay number must be set in sequence from number 1 when there are several

infusion pumps or infusion pumps.

7.1.7 Drip Mode Set

 Open the drip mode, detect the drop sensor and count the drops during infusion.

CAUTION:

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Setting the Infusion Pump

 If disconnected the drop sensor but the drip mode is open, the pump produces no

drop sensor alarm.

7.1.8 NearFinished

 Near Finished Alarm: Alarm-time could be adjusted from 1min to 30min before

Finished (Step by1min), Default time: 3min before Finished.

7.2 System Set

7.2.1 Volume Setting

 11 volume levels are available (The factory setting is level 5).

CAUTION:

 Do not set an alarm volume that is lower than the environment noise, or it may cause

the alarm system to be out of work or the alarm cannot be correctly recognized timely.

 If setting alarm to extreme values that can render the alarm system useless. Check

the alarm limited according to clinical condition.

 If the pump is inserted to a working station, once the volume setting on the pump is

changed, the setting on the station will be synchronized at the same time.

7.2.2 Display SET

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Setting the Infusion Pump

 There are seven different color options for UI type.
 The brightness could be adjusted in [Normal Bright].
 All the parameters of the night mode could be adjusted here.

CAUTION:

 Under the night mode, setting range of start time is 17:00-09:00, finish time range is

the same as start time range. By default, the start is 00:00; finish time is 00:00.

 If the pump is inserted to a working station, once the display setting on the pump is

changed, the setting on the station will be synchronized at the same time.

7.2.3 Internet Set

 [Info Channel], [Local WLAN], and [Workstation WLAN] (not available if the pump is

not connected to a workstation) could be chose and set.

 Click [Info Channel] to choose the channel type.

 Choose [Local WLAN] to use local WLAN channel to connect to the network, and

the local WLAN parameters could be set.

 Choose [Station WLAN] to use station WLAN channel to connect to the network,

and the station WLAN parameters could be set.

 Choose [Local RS485] to use local RS485 cable to connect to the network.

 Choose [Station RS485] to use station RS485 cable to connect to the network.

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Setting the Infusion Pump

CAUTION:

 The pump could communicate with working station, and the working station could

manage the alarm and implement relay function between pumps.

 The setting of [Local RS485] and [Station RS485] must be done by the

manufacturer’s representatives. Please contact manufacturer or local dealer for

further information.

 Only the accessory or devices supplied or specified by manufacturer allowed to be

connected with the pump. Otherwise it may cause the pump not work normally or

other unpredictable hazards.

 Click [Local WLAN]/[Station WLAN] to set up WLAN parameters.
 [WIFI Disable] option should be cancelled, the AP name, Password of the network

should be inputted, and the TCP/IP’s information should be set.

7.2.4 Lock screen Set

 Click [ScreenLock Password] to enable/disable the screen lock password function.

When the function is enable, a password is required to unlock the screen. When the

function is disable, there will be no require on password to unlock the screen.

 Click [Auto Lock] to set up the screen auto lock function. This function could be set as:

OFF, 15s, 30s, 1min, 2min, 5min, 10min, 30min. The default value is OFF, which

means the screen auto lock function is disable.

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Setting the Infusion Pump

7.2.5 Collection Set

 [Mode Collection]: Choose the frequently used infusion mode from the [Infusion mode]

option. Once the frequently used infusion modes are chosen, the unnecessary modes

will not appear in the list of 7.1.1 [Infusion mode] option. The default setting is “all the

four infusion modes are chosen”.

 [Brand Collection]: Choose the frequently used infusion set’s brand from the [Brand]

option. Once the frequently used brands are chosen, the unnecessary brands will not

appear in the list of 7.1.5 [Brand] option. The default setting is “all the preloaded

brands are chosen”.

7.2.6 Linkage mode

 If the linkage mode is turned on, press the anti-free flow clamp button to open the

clamp, and release the button to clamp the tube.

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Setting the Infusion Pump

7.2.7 PressureUnit

 Choose the measurement unit for the pressure. The optional units are: mmHg, kPa,

bar and PSI. The default setting is mmHg.

7.2.8 Date&Time set

 Set the date, time, and their format.

7.2.9 Maintenance

 Click [Maintenance] option to do the [Language Select], [Touch Adjust], [Factory Data

Reset], and check the version information.

 To check the version information, follow the route of: [Home] -> [System Set] ->

[Maintenance] -> [Version Info].

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Setting the Infusion Pump

Event

Record Parameters

Start up

Occurred time

Shutdown

Occurred time

Standby

Occurred time, standby set time

Start

Occurred time, rate, VTBI

Bolus

Occurred time, Bolus rate, Bolus way

Bolus stop

Occurred time, Bolus rate, Bolus accumulated volume

Stop

Occurred time, rate, accumulated volume

KVO

Occurredtime, accumulated volume, KVO rate

KVO stop

Occurredtime, KVO rate,KVO accumulated volume

Flow rate change

Occurredtime, Flow rate before and after change

Alarm

Occurredtime, alarm event, system trouble with trouble code

Purge

Occurredtime, purge rate, accumulated volume

Purge stop

Occurredtime, purge rate, purge accumulated volume

7.3 History

The history records are as Table 7-2.
Table 7-2 History records

CAUTION:

 2000 history records are available to be stored at maximum. If the amount reaches

storage limit, the earliest record would be removed.

 Alarm system can’t be poweredoff separately by operator unless the pump is

powered off.The time of powering off is captured in the history records.

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Setting the Infusion Pump

7.4 Patient File

 Click [Patient File] to enter the patient file page. The [Department], [Room No.], [Bed

No.] and [Patient Data] could be set up.

 Click [Patient Data] option to enter patient data setting page. Choose [New] to build a

new patient data and the previous patient data will be cleared automatically. Choose

[Modify] to modify the current patient data.

CAUTION:

 If the pump is inserted to a working station, once the patient file on the pump is

changed, the data on the station will be synchronized at the same time.

7.5 Use Internal battery

 If there is not any AC/DC power supply, the internal battery operates.
 When external battery stops working, the internal battery starts and the yellow

indicator lights with a short alarm sound.

 Before first use or reuse before a long time, please charge at least 10 hours.
 The approx. remaining power in the built-in battery is displayed by [battery] indicators.

During battery operation, battery discharged is shown by a decreasing number of
active indicators. For details, see Table 7-3.

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Setting the Infusion Pump

[Battery capacity]state

The remaining capacity*1)

Four bars light

Operation will be possible for 300 minutes.

Three bars light

Operation will be possible for 210 minutes.

Two bars light

Operation will be possible for 140 minutes.

One bars light(green)

Operation will be possible for 70 minutes.

One bars light(red)

Operation will be possible for 30 minutes.

Table 7-3when battery works, the [Battery capacity] diagram state

*1) Working conditions:

 New battery (within one year of manufacture).
 Operating at 25mL/h using a 20d/ mL infusion. Close WIFI function.
 Room temperature of 25°C.

 When the infusion pump is connected to any external AC or DC power supply, the

charge of the built-in battery starts. When battery is charging, a lightning symbol will

be displayed at the left side of the battery symbol on the screen.

CAUTION:

 If AC or DC power is connected, the battery will be recharged.
 Use AC power to charge the battery. If recharged by an external 12 VDC power

supply, the battery cannot be fully charged (50% at most).

 During infusion and the pump powered by battery, if a low-battery alarm occurs, press

[SILENCE] to silence the alarm will repeat in two minutes, connect the pump to

AC/DC power supply immediately. If battery empty alarm occurs, the silence does not

function and infusion pump will stop.

 3 minutes before the battery empty, the pump will auto power off.
 New battery fully charged at 1200 ml/h rate of infusion, the battery of continuous use

time is 2h42min.

 The actual battery duration may be different and affected bythe ambient temperature,

flow rate, external communication, etc.

 If the battery is aging，the actual battery duration may be shorter. Periodically check

the battery.

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Setting the Infusion Pump

7.6 Connecting to the <Infusion Central Monitoring

System>(optional)

Infusion pumps can be connected to the < Infusion Central Monitoring System >,
which can obtain working states of pumps remotely.

CAUTION：

 Infusion pump cannot be operated through the < Infusion Central Monitoring

System >.

7.7 Nurse pager (optional)

After infusion pump is connected to the central station, patient can press nurse pager
in bed, and then the central station in nurse station would gives out sound tip and display
patient’s information in screen, so that the nurse can take care of the patient in time.

7.8 Voice communication(optional)

After infusion pump is connected to the central station, patient can press nurse pager
in bed, and then the central station in nurse station would gives out sound tip. Nurse can
press the talk-listen button and communicate with patient in real time to know the
information.

7.9 Connecting a barcode scanner (optional)

After a barcode scanner is connected to the pump, the patient information, such as
record No. and hospital No., can be scanned, and the patient information in the pump will
update automatically by pump prompts.

The barcode scanner can scan maximum 18 figures.

7.10 User-specific Requirements (optional)

7.10.1 Maximum Flow rate

Parameters the maximum flow rate is already set with the infusion pump. For any
modification, contact your local distributor.

38 / 57

Troubleshooting

Alarm

Sound

Light

Low-level alarm

Give out three beeps at intervals
of 25 seconds.

The yellow indicator keeps on.

Mid-level alarm

Give out three beeps at intervals
of 15 seconds.

The yellow indicator flashing.

High-level alarm

Give out a series of beeps at
intervals of 15 seconds.

The red indicator flashing.

8 Troubleshooting

8.1 Alarm

The infusion pump provides users with a variety of status information about itself and
its injection process. If any abnormality is detected, the infusion pump sounds an alarm
and notes users in the form of sound, light, and character.

All the alarms on this pump are the technical type alarm.

Considering the importance of abnormal information, alarm information is classified
into three levels from the viewpoint of security: low-level, mid-level, and high-level alarms.
For audio and visual expressions of alarms at three levels, see Table 8-1. The alarm
volume ranges from 45 dB to 85 dB.

Table 8-1 Alarm severity and the audio and visual expressions of each level

When an alarm occurs, press [SILENCE] to silence the alarm. But the buzzer beeps
again if you do not eliminate the mid/high-level alarm within 2 minutes.

CAUTION:

 The setting of the alarm will be saved permanentlywhen the power is cut. When the

pump restarts from a power failure situation, the alarm setting will be reloaded to the

system and remains the same as it was before the power failure.

WARNING:

 Potential hazard can exist if differentALARM PRE-SETS are used for the same or

similarequipment in any single area.

39 / 57

Troubleshooting

Alarm Symptoms

Alarm level

Causes

Troubleshooting

No Power Supply

Low-level

No external AC/DC power
supply is connected.

Immediately connect the AC
power supply or the external
DC power supply.

No Battery

Mid-level

The infusion pump has no
internal battery or the
internal battery operates
abnormally.

Replace the internal battery.
Low Battery

Low-level

The internal battery is
running critically low.

Immediately connect an AC
power supply or an external
DC power supply.

Battery Empty

High-level

The battery is out.

Immediately connect an AC
power supply or an external
DC power supply.

Near End

Low-level

The infusion is end within
the Near Finished Alarm
setting period.

Wait until the infusion
finishes.

Occlusion Alarm

High-level

1.The infusion IV line is
occluded；

2. The OCCL level is too
low for high viscosity drug’s
infusion.

Press [STOP] to stop the
injection. Check and
remove the cause,
continuous to inject.

Air-bubble

High-level

1. Air bubble in the infusion
line.

2. The flatten tube is fixed
inside the air bubble
detector.

Click [Stop] to remove the
alarm, check if the tube
installed in air-bubble probe
is roll flattening. Press
[PURGE] to release air
bubble quickly.

Finished

High-level

The limit amount or the
infusion time is complete

Press [STOP] to remove the
alarm.

Reminder Alarm

Low-level

Forget to operate the alarm
(no key operation is made
two minutes after the IV
sets is installed).

Press any key to clear the
alarm.

8.2 Faults and Troubleshooting

Table 8-2 Alarm symptom, alarm level,fault cause, and troubleshooting

40 / 57

Troubleshooting

Alarm Symptoms

Alarm level

Causes

Troubleshooting

Drop Error

Low-level

The drip rate is detected to
be incorrect at the drip
kettle during the infusion.

Press [Cancel] to remove
alarm. And check the
installation of the drop
sensor.

No drop sensor

Mid-level

The drop sensor detection
function is turned on, but
drop sensor is not installed.

Install the drop sensor, or
turn the drop sensor
detection function.

No drop

High-level

No drop is detected by the
drop sensor.

Press [Stop] to remove
alarm, check the installation
of the drop sensor and the
IV set.

Standby Time
Expired

Mid-level

Standby mode is end

Press cancel to exit
Standby mode.

Relay Index
Duplicate

High-level

Relay Index Duplicate

Reset Relay Index

Infusion Start Fail

High-level

Infusion pump cannot be
started under the relay
mode.

Check the infusion pump,
remove the problem that
causes the failure of start.

Trouble code

Alarm level

Troubleshooting

Sensor Error

High-level

Record the troublecode and turn off, contact manufacturer

or manufacturer’s representatives.

Motor Error

High-level

Circuitry Error

High-level

Diver COM Error

High-level

Pump finger error

High-level

Pump door error

High-level

Bubble sensor error

High-level

System Error

High-level

8.3 Troubles and trouble shooting

When the device goes wrong, a corresponding trouble code appears in the interface
and gives out high-level alarm.
Table 8-3 troubles and troubleshooting

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Maintenance

9 Maintenance

9.1 Cleaning, Disinfecting

 Before cleaning the pump，be sure to turn off the power and disconnect the AC or DC

power cables.

 If there is dirt on the pump，wipe it with wet soft cloth dampened with cold or

lukewarm water.

 Use a piece of dry soft cloth to clean the AC power supply socket, USB socket or the

nurse call socket，ensure that the socket is dry before using it.

 Do not use organic solvent such as alcohol or thinner.
 If disinfection is necessary，using the common disinfectors such as Chlorhexidine

gluconate and Benzalkonium chloride. After using the agent with a soft cloth，wipe off

it with a soft cloth dampened with water or warm water. When using the disinfecting

agent，follow the caution of each agent.

 The infusion pump cannot be autoclaved.
 Never use a dryer or similar device to dry the infusion pump.
 If liquid spills onto the pump, check whether the pump still functions normally. Test

the insulation and leakage current when necessary.

 Do not soak the infusion pump into water.

WARNING:

 Do not clean or sterilize the pump when it is running.

9.2 Periodic Maintenance

Perform a periodic maintenance inspection to ensure safe operation and the longest
possible life of the infusion pump，and check the infusion pump once every 2 years.
Contact manufacturer or manufacturer’s representatives for any doubt.

9.2.1 Checking the Appearance

 Appearance checking: There are no cracks and damages.
 Key operations: If the keys are pressed smoothly, they are available.

9.2.2 Checking the Power Cable

 Check the appearance of the power cable. If the appearance is damaged and the

plug and the socket are in poor contact, contact manufacturer or manufacturer’s

42 / 57

Maintenance

IV set

Infusion rate

Infusion time

Volume in graduate

MC/B.Braun20d/mL

120mL/h

6min

11.4-12.6mL

IV set

Infusion rate

Occlusion level

Alarm time

MC/B.Braun
20d/mL

120mL/h

P2

Within 1 minute

representatives for replacement in time.

 If you connect the infusion pump to the AC/DC power and there is no indication of

powering on, contact manufacturer or manufacturer’s representative for maintenance

in time.

9.2.3 Checking the infusion rate

 Check the infusion flow once every 2 years by the graduate and timer.

Checking condition:

9.2.4 Alarm

 Occlusion alarm

Checking condition:

 Air bubble alarm

Add in 3-5mm air in the upper infusion tube then start the infusion. When the air
bubble reaches to air bubble sensor, check the displayed alarm information and sound.

9.2.5 Electric and mechanical safety

To ensure safety, test the insulation voltage, leakage current, and earthling
resistance according to the IEC 60601-1.

9.2.6 Checking the Internal Battery

Perform the following inspections on the battery every 2 years:

 Connect to the AC power supply to recharge the battery for over 10 hours.
 Turn on the power.
 Set the infusion rate to 25 mL/h and start the infusion. Record the start time.
 Operate the system until it stops infusing due to low battery alarm. Record the finish

time.

 If the time from the start of the infusing to end of operation is 4 hours or more, the

battery condition is good.

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Maintenance

 If the time from the start of the infusing to end of operation is 1 to 1.5 hours, the

battery condition is reaching its service life.

 If the time from the start of the infusing to end of operation is less than 1 hour, the

battery has reached its service life. Replace the battery. You are advised
tocontact manufacturer or manufacturer’s representative to replace the battery.

 When the battery lever check is complete, recharge the battery for next use.

9.2.7 Replacing the Battery

 Remove the internal battery.

 Turn the power off and disconnect the power cord.

 Use a screwdriver to loosen the battery cover fixing screws at the bottom of the

pump.

 Remove the battery cover.

 Disconnect the battery cable connector.

 Remove the battery.

 Install the internal battery.

 Insert the connector of the battery cable into the battery.

 Insert the new battery into the battery compartment.

 Attach the battery cover.

 Use a screwdriver to tighten the screws securing the battery cover.

CAUTION:

 Remove the battery if the infusion pump is not likely to be used for some time.

WARNING:

 The battery’s replacement must be done by specialist who has been trained to finish

such operation. Otherwise there will be a risk of danger.

 Please strictly follow the instruction to replace the battery, and the battery should be

provided by the manufacturer. Otherwise there will be a risk of danger.

 Do not disassemble or short circuit the battery, do not through the battery into the fire.

Otherwise there will be a risk of danger caused by the battery linkage or explosion.

 Please follow the local low to dispose the old battery.

9.3 Maintenance

 If any trouble，explain the situation to your localthe manufacturer or manufacturer’s

representative and request for a repair.

44 / 57

Maintenance

 Never disassemble or try to repair the infusion pump or it may cause a serious failure.

The manufacturer and the distributor shall not be responsible for any infusion pump

that has been disassembled，modified or used for any purpose other than that for

which it is intended.

 If the infusion pump is dropped or subjected to impact，remove it from service even if

it doesn’t appear damaged externally. Request the manufacturer or manufacturer’s

representative to inspect it for a possible internal problem.

CAUTION:

 Serviceman could request for the related service manual from the manufacturer if

needed.

 Parts of the Pump are not serviced or maintained while in use with the patient.

WARNING：

 The accessories’ replacement must be done by specialist who has been trained to

finish such operation. Otherwise there will be a risk of danger.

9.4 Storage

 Avoid water spills.
 Never store in a hot and humid place.
 Store the pump out of excessive vibration，dust，and corrosive gas.
 Store the pump out of direct sunlight and ultraviolet ray as discoloration may result.

9.5 Transportation

You can deliver the infusion pump by using a common vehicle, but you must protect
the infusion pump from being clashed, shook, or wetted by the rain and snow during the
transportation. You must deliver the infusion pump in accordance with the method
specified in the order contract.

9.6 Environmental Protection and Recovery

At the end of life，please contact the manufacturer or manufacturer’s representative
for dispose advise, or dispose by a suitable method according to the applicable
environmental laws and regulations.

45 / 57

Infusion Accuracy Characteristics

10 Infusion Accuracy Characteristics

The following test is performed in accordance with the IEC60601-2-24:2012 standard.
It is used to observe the infusion accuracy and the occlusion response. (For detailed test
conditions, see the IEC60601-2-24:2012 standard.)

CAUTION:

 The infusion accuracy and the occlusion response may be affected by the use

conditions including the pressure, temperature, humidity, IV set, and infusion tube.

 The infusion accuracy does not reflect the clinical standards, for example, patients'

age and weight and medicine taken.

 The experiment data only represents the measurement data in the lab.
 To ensure the infusion precision, it is recommended that the infusion tube be

changed or moved every 8hours.

 Under the single fault condition, the maximum infusion precision error maybeup to

±40%

10.1 Flow Rate Characteristics

Start-up and Trumpet curves show the characteristics of the infusion pump after the
injection begins and the injection changing status after the infusion pump reaches a
normal flow rate.

The following test method is accordance with the method mentioned in chapter

201.12.1.102 of the standard IEC 60601-2-24:2012 (Please check above chapter for
further details.).

 Accuracy test conditions:

 Temperature: 21℃;

 Relative humidity: 65%;

 Infusion type:MC（20d/mL）、（B.Braun 20d/mL）: 5sets each.

 Infusion pump: 1 set

 Sampling interval: 0.5min

 Test Period: 120min

46 / 57

Infusion Accuracy Characteristics

Administration set (IV
set) Brand

Accuracy(%)

Remaks

B.Braun
20d/mL

+4.79

Minimum rate 1ml/h,normal condition

-0.71

Intermediate rate 25ml/h,normal condition

+0.91

Intermediate rate 25ml/h,with
+13.3kpabackpressure

+0.79

Intermediate rate 25ml/h, with

-13.3kpabackpressure

-6.61

Intermediate rate 25ml/h, when the
supplycontainer below the pump
mechanismat a distance of 0.5m

Medcaptain(MC)
20d/mL

+2.57

Minimum rate 1ml/h, normal condition

+2.28

Intermediate rate 25ml/h,normal condition

-1.10

Intermediate rate 25ml/h,with
+13.3kpabackpressure

+1.00

Intermediate rate 25ml/h, with

-13.3kpabackpressure

-11.62

Intermediate rate 25ml/h,when the
supplycontainer below the pump
mechanismat a distance of 0.5m

 Test Liquid: ISO 3696:1987 Class III water

Table 10-1 Accuracy test result

CAUTION:

 The accuracy maybe up to -11.62% when the supplycontainer below the

pump mechanismat a distance of0.5m.

 To ensure the infusion accuracy, strongly recommend that the supplycontainer is

higher than thepump mechanism.

47 / 57

Infusion Accuracy Characteristics

Start-up curves of MC 25mL/h

Start-up curves ofMC 1mL/h

Trumpet curve of MC 25mL/h

Trumpet curve of MC 1mL/h

Start-up curves of B.Braun 25mL/h

Start-up curves ofB.Braun 1mL/h

Trumpet curve of B.Braun 25mL/h

Trumpet curve of B.Braun 1mL/h

Table 10-2 Accuracy test result

48 / 57

Infusion Accuracy Characteristics

Infusion
rate

Occlusion
pressure level

Occlusion pressure
（mmHg）

Occlusion alarm time
（hh:mm:ss）

Bolus
(ml)

25mL/h

I

300±100

00:01:17

0.12

III

900±200

00:04:06

0.39

Infusion
rate

Occlusion
pressure level

Occlusion pressure
（mmHg）

Occlusion alarm time
（hh:mm:ss）

1mL/h
I

300±100

00:16:00

III

900±200

00:42:00

Infusion
rate

Occlusion
pressure level

Occlusion pressure
（mmHg）

Occlusion alarm time
（hh:mm:ss）

0.1mL/h
I

300±100

01:07:00

III

900±200

10:26:00

Description

Unit

Unit conversion

Pressure
kPa

1kPa=7.5mmHg

psi

1psi=51.724mmHg

bar

1bar=750mmHg

10.2 Occlusion Characteristics

The occlusion characteristics are reflected by the longest delay time to start an alarm.

The following test method is accordance with the method mentioned in chapter

201.12.4.4.104 of the standard IEC 60601-2-24:2012 (Please check above chapter for
further details.).

Occlusion test conditions:

Temperature: 21℃;

Relative humidity: 65%;

Length of the infusion tube: 1m

Table 10-3The occlusion level, alarm delay time and pill amount under the rate of 25mL/h

Table 10-4The occlusion level and alarm delay time under the rate of 1mL/h

Table 10-5The occlusion level and alarm delay time under the rate of 0.1mL/h

CAUTION:

Unit conversion list

49 / 57

Appendix A

Guidance and manufacturer’s declaration – electromagnetic emissions

The [MP-60] is intended for use in the electromagnetic environment specified below.
The customer or the user of the [MP-60] should assure that it is used in such an
environment.

Emission test

Emission test

Emission test

RF emission
CISPR 11

Group 1

MP-60 infusion pump only use
radio-frequency power while
operating its internal functions,
therefore, the radio-frequency
emission is much low and has little
interference to the electronic devices
nearby.

Radio-frequency
emission
CISPR 11

Class A

The MP-60 infusion pump can be used in
any building including civil residence.

Harmonic emission
IEC61000-3-2

Class A

Voltage fluctuation
and flashing
IEC 61000-3-3

Complies

Appendix A Electron Magnetic Compatibility (EMC)

The MP-60 Infusion Pump conforms to EMC standard EN 60601-1-2.

50 / 57

Appendix A

Guidance and manufacturer’s declaration – electromagnetic immunity

The [MP-60] is intended for use in the electromagnetic environment specified below. The customer
or the user of the [MP-60] should assure that it is used in such an environment.

IMMUNITYtest

IEC60601test level

Compliance level

Electromagnetic environment
–guidance

Electrostatic
discharge
（ESD）
IEC 61000-4-2

±8 kV contact
discharge
±15 kV air discharge

±8 kV contact
discharge
±15 kV air
discharge

Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30 %.

Electrical fast
transient
（EFT）
IEC61000-4-4

±2 kV power cable
±1 kV I/O cable

±2 kV power cable

Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5

±1 kV difference mode
±2 kV common mode

±1 kV difference
mode
±2 kV common
mode

The voltage
dropping, short
interruption and
voltage change
IEC 61000-4-11

＜5% UT（dropping＞
95% UT）0.5 period

40% UT（ dropping
60% UT）5 period

70% UT（dropping 30%
UT）25 period

＜5% UT（dropping＞
95% UT）5seconds

＜5% UT（dropping
＞95% UT）0.5

period

40% UT（ dropping
60% UT）5 period

70% UT（dropping
30% UT）25 period

＜5% UT（dropping
＞95% U

T

）

5seconds

Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of the
[MP-60] requires
continued operation during
power mains interruptions, it
is recommended that the
[MP-60] be powered from an
uninterruptible power supply
or a battery..

Power

3 A/m

3 A/m

Power frequency magnetic

51 / 57

Appendix A

frequency
magnetic fields
（50/60Hz）
IEC 61000-4-8

fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment

NOTE UTis the a.c mains voltage prior to application of the test level.

52 / 57

Appendix A

Guidance and manufacturer’s declaration – electromagnetic immunity

The [MP-60] is intended for use in the electromagnetic environment specified below. The
customer or the user of the [MP-60] should assure that it is used in such an environment.

Immunity

Test

IEC 60601

test level

Compliance

level

Electromagnetic environment –guidance

Conducted
RF
IEC61000-4-6

3 Vrms
150k～
80MHz

3 Vrms

Portable and mobile RF communications
equipment should be used no closer to any part
of the [MP-60], including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:

Pd

2.1

Pd

2.1

80M～800MHz

Pd

3.2

800M～2.5GHz
where Pis the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and dis the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a,
should be less than the compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of equipment marked
with the following symbol:

Radiated RF
IEC61000-4-3

3V/m
80M～

2.5GHz

3 V/m

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

53 / 57

Appendix A

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
dueto fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the [MP-60] is used exceeds the applicable RF
compliance level above, the [MP-60] should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or
relocating the [MP-60].

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

54 / 57

Appendix A

Recommended separation distances between portable and mobile RF communications equipment
and the [MP-60]

The [MP-60] is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the [MP-60] can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the [MP-60] as recommended below, according to
the maximum output power of the communications equipment.

Rated maximum
output power of
transmitter （W）

Separation distance according to frequency of transmitter(m).

150k～80MHz

Pd 2.1

80M～800MHz

Pd 2.1

800M～2.5GHz

Pd 3.2

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation
distance din metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where Pis the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply inall situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

55 / 57

Appendix B

Parameters setting

The default factory setting

KVO flow rate

1ml/h

Pressure unit

mmHg

Occlusion pressure

P2（middle level）

Near end

3min

Built-in consumable brand

MC(20d/ml)、B.Braun(20d/ml)

System time and date

The default factory setting

Time

00:00

Date

2014-1-1

Time form

24 hours

Date form

Year-month-day

Appendix B The Default Factory Settings

This chapter lists some default factory settings of infusion pump. Users can not
modify the default factory settings, but if necessary, they can recover the infusion pump to
the default factory settings state.
Parameters

System time

56 / 57

Appendix C

Description

Plumbum
Pb

Mercury
Hg

Cadmium
Cd

Chromium
VI Cr(VI)

Polybromi
nated
biphenyls
PBB

polybrominat
ed diphenyl
ethers
PBDE

pump shell

○ ○ ○ ○ ○

○

key and
cover

○ ○ ○ ○ ○

○

label

○ ○ ○ ○ ○

○

display

× × × × × × hardware

○ ○ ○ × ○

○

connection
wire

○ ○ ○ ○ ○

○

PCBA

× ○ ○ ○ ○

○

packing
material

○ ○ ○ ○ ×

×
battery

× × × × × × accessory

× ○ ○ ○ ○

○

remark:

“○” shows that the content of this toxic and harmful substance in all homogeneous

materials are under the regulated limitation requirement of SJ/T11363-2006.

“×”shows that he content of this toxic and harmful substance in one homogeneous

materials is over the regulated limitation requirement of SJ/T11363-2006.

Appendix CToxic and Hazardous Substances or Elements

57 / 57

Precautions for Use

MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

Registration address: 12th Floor, Baiwang Research Building, No.5158 Shahe West Road,

Xili, Nanshan District, Shenzhen, P.R.China

Production address: 1-4 Floor,11th Building,Nangang Industrial Park, Songbai Road, Xili,

Nanshan District, Shenzhen, P.R.China

After-sales service address: 12th Floor, Baiwang Research Building, No.5158 Shahe
West Road, Xili, Nanshan District, Shenzhen, P.R.China

EU- Representative name: WellKang Ltd

EU- Representative address: Suite B, 29 Harley Street LONDONW1G 9QR, England,

United Kingdom

Telephone: [phone] 0123

Fax: [phone]

Postal code: 518055

Website: http://www.medcaptain.com

E-mail: [email protected]

Copyright of 2016 Medcaptain Medical Technology Co., Ltd. (V2.2)