Mindray BeneFusion mNP User manual

BeneFusion mNP
Enteral Feeding Pump
Operator’s Manual

I
© Copyright 2023 Shenzhen Mindray Scientific Co., Ltd. All rights reserved.
Release date: December 2023
Revision: 1.0

II
Intellectual Property Statement
SHENZHEN MINDRAY SCIENTIFIC CO., LTD. (hereinafter called Mindray Scientific) owns
the intellectual property rights to this product and this manual. This manual may refer to
information protected by copyrights or patents and does not convey any license under
the patent rights of Mindray Scientific, nor the rights of others.
Mindray Scientific intends to maintain the contents of this manual as confidential
information. Disclosure of the information in this manual in any manner whatsoever
without the written permission of Mindray Scientific is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation of this
manual in any manner whatsoever without the written permission of Mindray Scientific
is strictly forbidden.
, , , and are the registered
trademarks or trademarks owned by Mindray in China and other countries. Mindray
Scientific is authorized by Mindray to use above registered trademarks or trademarks.
Responsibility on the Manufacturer Party
Contents of this manual are subject to changes without prior notice.
All information contained in this manual is believed to be correct. Mindray Scientific
shall not be liable for errors contained herein nor for incidental or consequential
damages in connection with the furnishing, performance, or use of this manual.
Mindray Scientific is responsible for the effects on safety, reliability and performance of
this product, only if:
■all installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray Scientific authorized personnel;
■the electrical installation of the relevant room complies with the applicable
national and local requirements;
■the product is used in accordance with the instructions for use.
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED
OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE.

III
Exemptions
Mindray Scientific's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential damages
or delay resulting from the improper use or application of the product or the use of parts
or accessories not approved by Mindray Scientific or repairs by people other than
Mindray Scientific authorized personnel.
This warranty shall not extend to
■Malfunction or damage caused by improper use or man-made failure.
■Malfunction or damage caused by unstable or out-of-range power input.
■Malfunction or damage caused by force majeure such as fire and earthquake.
■Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
■Malfunction of the instrument or part whose serial number is not legible enough.
■Others not caused by instrument or part itself.
Company Contact
Manufacturer: Shenzhen Mindray Scientific Co., Ltd.
Address: 6/F, Bldg 2, 1203 Nanhuan Avenue, Yutang Block,
Guangming District, 518106 Shenzhen, P.R.China
Website: www.mindray.com
E-mail Address: [email protected]om
Tel: [phone]
Fax: [phone]
EC-Representative: Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestraβe 80, 20537 Hamburg, Germany
Tel: [phone]
Fax: [phone]

IV
Notification of Adverse Events
As a health care provider, you may report the occurrence of certain events to SHENZHEN
MINDRAY SCIENTIFIC CO., LTD., and possibly to the competent authority of the Member
state in which the user and / or patient is established.
These events, include device-related death and serious injury or illness. In addition, as
part of our Quality Assurance Program, SHENZHEN MINDRAY SCIENTIFIC CO., LTD.
requests to be notified of device failures or malfunctions. This information is required to
ensure that SHENZHEN MINDRAY SCIENTIFIC CO., LTD. provides only the highest quality
products.
Preface
Manual Purpose
This manual contains the instructions necessary to operate the product safely and in
accordance with its function and intended use. Observance of this manual is a
prerequisite for proper product performance and correct operation and ensures patient
and operator safety.
This manual is based on the maximum configuration and therefore some contents may
not apply to your product. If you have any question, please contact us.
This manual is an integral part of the product. It should always be kept close to the
equipment so that it can be obtained conveniently when needed.
Intended Audience
This manual is geared for clinical professionals who are expected to have a working
knowledge of medical procedures, practices and terminology as required for monitoring
of critically ill patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect
the setup or data displayed on your equipment.
Conventions
■Italic text is used in this manual to quote the referenced chapters or sections.
■Bold text is used to indicate the screen texts.
■→is used to indicate operational procedures.

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Contents
1 Safety ..........................................................................................................................................1 - 1
1.1 Safety Information .......................................................................................................................................1 - 1
1.2 Equipment Symbols ....................................................................................................................................1 - 3
2 Equipment Introduction ............................................................................................................2 - 1
2.1 Intended Purpose .........................................................................................................................................2 - 1
2.2 Indirect Benefit ..............................................................................................................................................2 - 2
2.3 Applied Part ....................................................................................................................................................2 - 2
2.4 Main Unit .........................................................................................................................................................2 - 2
2.5 Screen Display ...............................................................................................................................................2 - 4
3 Equipment Preparation .............................................................................................................3 - 1
3.1 Equipment Preparation Safety Information .......................................................................................3 - 1
3.2 Installation ......................................................................................................................................................3 - 2
3.3 Setting Up the Equipment ........................................................................................................................3 - 2
4 Getting Started ...........................................................................................................................4 - 1
4.1 Turning on the Pump ..................................................................................................................................4 - 1
4.2 Preparing the IV Container ........................................................................................................................4 - 1
4.3 Loading the Infusion Set ............................................................................................................................4 - 1
4.4 Purge .................................................................................................................................................................4 - 3
4.5 Starting Infusion ............................................................................................................................................4 - 3
4.6 Bolus Infusion .................................................................................................................................................4 - 4
4.7 Changing the Infusion Parameters ........................................................................................................4 - 4
4.8 Pausing the Infusion ....................................................................................................................................4 - 5
4.9 Setting Keep Tube Open (KTO) Rate ......................................................................................................4 - 5
4.10 Replacing the IV Container .....................................................................................................................4 - 5
4.11 Unloading the Infusion Set .....................................................................................................................4 - 6
4.12 Viewing the Infused Volume ..................................................................................................................4 - 6
4.13 Entering the Standby Mode ...................................................................................................................4 - 7
4.14 Turning Off the Pump ...............................................................................................................................4 - 7
5 Alarms .........................................................................................................................................5 - 1
5.1 Alarm Safety Information ..........................................................................................................................5 - 1
5.2 Understanding the Alarms ........................................................................................................................5 - 1
5.3 Alarm Screen ..................................................................................................................................................5 - 2
5.4 Resetting Alarms ...........................................................................................................................................5 - 2
5.5 Pausing Alarm Sound ..................................................................................................................................5 - 3
5.6 Alarm Solutions .............................................................................................................................................5 - 3

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5.7 Occlusion Alarm ............................................................................................................................................5 - 6
6 Menu Options .............................................................................................................................6 - 1
6.1 General Option ..............................................................................................................................................6 - 1
6.2 Department Management ........................................................................................................................6 - 2
6.3 System Options .............................................................................................................................................6 - 2
6.4 User Maintenance ........................................................................................................................................6 - 2
7 Infusion Modes ...........................................................................................................................7 - 1
7.1 Continuous Feeding/Time Feeding/Nourishing Feeding .............................................................7 - 1
7.2 Intermittent Feeding ...................................................................................................................................7 - 1
8 Feeding Library ..........................................................................................................................8 - 1
9 Networked Communication ......................................................................................................9 - 1
9.1 Network Safety Information .....................................................................................................................9 - 1
9.2 Connecting the Equipment to the CMS ...............................................................................................9 - 1
9.3 Connecting the Equipment to the eGateway ....................................................................................9 - 2
10 Maintenance ...........................................................................................................................10 - 1
10.1 Maintenance Safety Information ....................................................................................................... 10 - 1
10.2 Maintenance and Testing Schedule ................................................................................................. 10 - 2
10.3 Maintaining the Battery ........................................................................................................................ 10 - 3
10.4 Checking the History Record .............................................................................................................. 10 - 4
10.5 Disposing of the Equipment ............................................................................................................... 10 - 4
11 Care and Cleaning ..................................................................................................................11 - 1
11.1 Care and Cleaning Safety Information ............................................................................................ 11 - 1
11.2 Cleaning the Equipment ...................................................................................................................... 11 - 2
11.3 Disinfecting the Equipment ................................................................................................................ 11 - 2
11.4 Cleaning the Pole Clamp and DC Adapter ..................................................................................... 11 - 5
11.5 Disinfecting the Pole Clamp and DC Adapter .............................................................................. 11 - 5
11.6 Sterilization ............................................................................................................................................... 11 - 6
12 Accessories ..............................................................................................................................12 - 1
A Product Specifications .............................................................................................................. A - 1
A.1 Specifications ............................................................................................................................................... A - 1
A.2 Wireless Network ........................................................................................................................................ A - 2
A.3 Infusion Specifications .............................................................................................................................. A - 3
A.4 Recommended Infusion Sets .................................................................................................................. A - 4
A.5 Occlusion Alarm Delay and Bolus Volume ......................................................................................... A - 5
A.6 Infusion Accuracy Graphs ........................................................................................................................ A - 6

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A.7 Operating Environment ............................................................................................................................ A - 9
B EMC and Radio Regulatory Compliance ...................................................................................B - 1
B.1 EMC ....................................................................................................................................................................B - 1
B.2 Radio Regulatory Compliance .................................................................................................................B - 9
C Abbreviations .............................................................................................................................C - 1

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1 - 1
1Safety
1.1 Safety Information
WARNING
•Indicates a potential hazard or unsafe practice that, if not avoided, could
result in death, serious injury or damage to product/property.
CAUTION
•Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury, product malfunction or damage to product/
property.
NOTE
•Provides application tips or other useful information to ensure that you get
the most out of the product.
1.1.1 Warnings
WARNING
•To avoid risk of electric shock, the equipment must only be connected to
mains power with protective earth. If a protective earth conductor is not
provided, operate it on battery power, if possible.
•To avoid explosion hazard, do not use the equipment in the presence of
oxygen-rich atmospheres, flammable anesthetics, or other flammable
agents.
•The equipment is not intended to be used within the Magnetic Resonance
(MR) environment.
•Do not use the multiple portable socket outlets (MPSO) or AC mains
extension cords. Ensure that the sum of the individual ground leakage
currents does not exceed the allowable limits.

1 - 2
•Do not open the equipment housings. All servicing and future upgrades must
be carried out by trained and authorized personnel. Moreover, the servicing
must be done only after the AC power supply is disconnected.
•Do not place the equipment or accessories in any position that might cause it
to fall on the patient.
•Do not start an infusion unless the setup was verified to be correct.
•To avoid inadvertent disconnection, route all cables in a way to prevent a
stumbling hazard. Wrap and secure excess cabling to reduce risk of
entanglement by patients or personnel.
•Clearing the occlusion result from line kinks, filter coagulation, etc. may
cause extra bolus to patients. Appropriate measures should be taken.
•Do not touch the patient and device connectors simultaneously. Otherwise
leakage current may result in patient injury.
•To avoid electric shock, do not touch patient and other non-defibrillation
proof equipments during defibrillation. Defibrillation will not affect the
performance of the equipment.
•Keep a distance of at least 20 cm away from the patient when operating the
pump.
•Ensure that the pumps are being operated correctly according to the
warnings in the manual. If not, the devices should be observed that they are
working normally.
1.1.2 Cautions
CAUTION
•When several infusion lines are connected to the same vascular access, there
may be back flow or prolonged response time of occlusion alarm. Therefore,
use check valve at the line end or follow local hospitals’ instructions while in
connection with other infusion system.
•When using this equipment for enteral nutrition, do not use enteral fluids for
intravenous infusion to avoid patient injury, and use only dedicated
disposable enteral feeding sets for enteral nutrition.
•Ensure that the equipment is supplied with continuous electric power during
work. Sudden power failure may cause data loss. If it is not sure whether the
power supply is stable, it is recommended to prepare another equipment in
case of power failure.
•Electromagnetic fields may affect equipment performance. This makes it
necessary for other equipment used in the vicinity of this equipment to meet
EMC standards. Mobile phones, X ray and MRI equipment are all potential
interference sources because of their high-intensity electromagnetic
radiation.

1 - 3
•Always install or carry the equipment properly to avoid damage caused by
drop, impact, strong vibration or other mechanical force. The equipment
should be observed to verify normal operation after fall, otherwise it cannot
be used.
•Dry the equipment immediately in case of rain or water spray.
•Some settings are password protected and can only be changed by
authorized personnel. Contact your department manager or biomedical
engineering department for the passwords used at your facility.
1.1.3 Notes
NOTE
•The software was developed in compliance with IEC62304.
•The equipment provides power-down storage. Alarms limit setting and
history record are saved and will be maintained if the equipment is powered
down suddenly. The storage time is equals to the equipment’s service life.
The alarm limit settings before power-down are reloaded when the
equipment is restarted.
•This manual describes all features and options. Your equipment may not
have all of them.
1.2 Equipment Symbols
Some symbols may not appear on your equipment.
Refer to instruction manual/
booklet
Caution
Alternating current Input/output
Both direct and alternating
current
Direct current
Battery USB connector
Stand-by Stop

1 - 4
Non-ionizing electromagnetic
radiation
General warning sign
Unique device identification Medical Device
Date of manufacture Manufacturer
Serial number Authorized representative
in the European Community
Protected against solid
foreign objects with a
diameter no less than 1.0 mm
in diameter. Protected against
splashing water.
DEFIBRILLATION-PROOF
TYPE CF APPLIED PART
Dispose of in accordance to
your country’s requirements
Temperature limitations
Atmospheric pressure
limitations
Humidity limitations
THIS WAY UP Keep dry
Fragile, handle with care STACKING LIMIT BY NUMBER
CLASS II equipment
The product bears CE mark indicating its conformity with the provisions of the
REGULATION (EU) 2017/745 on medical devices and fulfills the general safety
and performance requirements of Annex I of this regulation.
Note: The product complies with the Council Directive 2011/65/EU.

1 - 5
The general meaning assigned to geometric shapes, safety colors and contrast colors for
safety signs are as follows:
Geometric
shape
Meaning Safety color Contrast
color
Graphical
symbol color
Mandatory
action
Blue White White
Warning Yellow Black Black

1 - 6
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2Equipment Introduction
2.1 Intended Purpose
The enteral feeding pump is intended for use for the delivery of enteral nutrition for
enteral therapy with feeding set.
WARNING
•This pump is intended for use only by clinical professionals or under their
guidance. It must only be used by persons who have received adequate
training in its use. Anyone unauthorized or untrained must not perform any
operation on it.
NOTE
•According to the conclusion of clinical evaluation and residual risk
evaluation, for the intended patients, there is no known side effects that can
occur during or after the use of the medical device. And there is no need for
the operator to make extra preparations. Thus, no residual risk associated
with using the medical device should be disclosed.
2.1.1 Indication for Use
The enteral feeding pump is intended for use for the delivery of enteral nutrition for
enteral therapy with feeding set.
2.1.2 Intended Users
The enteral feeding pump is intended to be used by trained healthcare professionals.
2.1.3 Intended Patient Population
The enteral feeding pump can be used for adults and pediatrics. Not for use with
neonates.
2.1.4 Intended Medical Conditions
The enteral feeding pump is expected to be used in institutes or units with healthcare
capabilities.

2 - 2
2.1.5 Contra-indications
The enteral feeding pump can not be used for arterial or intravenous route.
2.1.6 Side-effects
None.
2.2 Indirect Benefit
Through SOTA analysis, since the enteral feeding pump is not directly used to treat
diseases, it will not produce the direct clinical benefits, and its clinical benefits are mainly
indirect clinical benefits (a positive impact on patient management): precise infusion.
2.3 Applied Part
The applied part of the equipment is the feeding set.
2.4 Main Unit
2.4.1 Front View
23(1
(1)
(3)
(4)
(2)
(5)
(6)
(7)
(8)
(9)
(1) Alarm light (2) Handle
(3) Infusion status indicator (4) Door opening key
(5) Stop key (6) Battery LED
(7) External power LED (8) Power switch
(9) Display

2 - 3
2.4.2 Rear View
(1)
(3)
(5)
(2)
(3)
(4)
(1)
(1) Tubing channel notches (2) Air in line sensor
(3) Pumping mechanism (with
waterproof membrane)
(4) Pressure sensor
(5) Anti free-flow clamp
(1)
(2)
(3)
(4)
(5)
(6)
(1) Pole clamp
(2) Pole clamp handle
(3) Product label

2 - 4
2.5 Screen Display
The screen may look slightly different in different infusion modes. The infusion screen
includes alarm information and system status information area, infusion status area,
pressure status area and key area.
The pressure status area on the screen indicates the condition of the current pressure:
■Green: Pressure is normal.
■Yellow: Pressure is near the threshold for the infusion.
■Red: Pressure is beyond the threshold for the infusion.
2.5.1 On-screen Symbols
The following table lists the on-screen symbols:
(4) Multifunctional connector (optional)
• Uses as a DC power input connector.
• Uses as a RS232 connector.
• Connects to the hospital’s nurse call system.
(5) USB connector
Connects USB devices, for example the USB drive.
(6) AC power input connector
Symbol Description Symbol Description
Audible alarm tones are
paused.
Alarms are acknowledged
and the alarm is reset.
Alarms are acknowledged
and the reminder sound is
given.
Night mode
Wireless network is
connected. The solid part
indicates network signal
strength.
Wireless network is not
connected.
The battery works correctly.
The solid portion represents
the remaining charge.
The battery is being charged.