Mindray BeneFusion uVP User manual

BeneFusion uVP
BeneFusion uVP ex
Infusion Pump
Instruction for Use

I
© Copyright 2021-2023 Shenzhen Mindray Scientific Co., Ltd. All rights reserved.
Release date: 2023-01
Revision: 4.0

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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]
Summary of Safety
and Clinical
Performance
(SSIP):
https://www.mindray.com/content/dam/xpace/en/
site/mdr-sscp/ivp-and-uvp/kf-h-046-024481-00-uvp-
instruction-for-use.pdf

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
2 Equipment Introduction ............................................................................................................2 - 1
2.1 Intended Purpose .........................................................................................................................................2 - 1
2.2 Indirect Benefit ..............................................................................................................................................2 - 2
2.3 Applied Part ....................................................................................................................................................2 - 2
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 Loading the Infusion Set ............................................................................................................................4 - 1
4.3 Purge .................................................................................................................................................................4 - 2
4.4 Starting Infusion ............................................................................................................................................4 - 2
4.5 Bolus Infusion .................................................................................................................................................4 - 3
4.6 Setting Keep Vein Open (KVO) Rate .......................................................................................................4 - 3
4.7 Replacing the IV Container .......................................................................................................................4 - 3
4.8 Unloading the Infusion Set .......................................................................................................................4 - 4
4.9 Turning Off the Pump .................................................................................................................................4 - 4
5 Alarms .........................................................................................................................................5 - 1
5.1 Alarm Safety Information ..........................................................................................................................5 - 1
5.2 Understanding the Alarms ........................................................................................................................5 - 1
5.3 Alarm Solutions .............................................................................................................................................5 - 2
5.4 Occlusion Alarm ............................................................................................................................................5 - 2
6 Menu Options .............................................................................................................................6 - 1
7 Infusion Modes ...........................................................................................................................7 - 1
7.1 Rate Mode/Time Mode/Drip Mode/Micro-infusion Mode ............................................................7 - 1
7.2 Dose Mode ......................................................................................................................................................7 - 1
7.3 Loading Dose Mode ....................................................................................................................................7 - 1
7.4 Intermittent Mode ........................................................................................................................................7 - 2
7.5 Ramp Mode ....................................................................................................................................................7 - 2
7.6 Dose Time Mode ...........................................................................................................................................7 - 2

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7.7 Rhythm Dose ..................................................................................................................................................7 - 2
8 Drug Library/Drug Info Library .................................................................................................8 - 1
9 Networked Communication ......................................................................................................9 - 1
10 Maintenance ...........................................................................................................................10 - 1
10.1 Maintenance Safety Information ....................................................................................................... 10 - 1
10.2 Maintaining the Battery ........................................................................................................................ 10 - 1
10.3 Checking the History Record .............................................................................................................. 10 - 3
10.4 Disposing of the Equipment ............................................................................................................... 10 - 3
11 Care and Cleaning ..................................................................................................................11 - 1
12 Accessories ..............................................................................................................................12 - 1
A Product Specifications .............................................................................................................. A - 1
A.1 Specifications ............................................................................................................................................... A - 1
A.2 Wireless Network ........................................................................................................................................ A - 3
A.3 Infusion Specifications .............................................................................................................................. A - 3
A.4 Recommended Infusion Sets .................................................................................................................. A - 5
A.5 Occlusion Alarm Delay and Bolus Volume ......................................................................................... A - 6
A.6 Infusion Accuracy Graphs ........................................................................................................................ A - 6
A.7 Operating Environment ..........................................................................................................................A - 10
B EMC and Radio Regulatory Compliance ...................................................................................B - 1
B.1 EMC ....................................................................................................................................................................B - 1
B.2 Radio Regulatory Compliance .................................................................................................................B - 9

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.
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.
•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.
•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.

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•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.

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2 - 1
2Equipment Introduction
2.1 Intended Purpose
The infusion pump is intended for use for the delivery of medications, solutions,
nutrition, lipids, blood and blood components indicated for infusion therapy.
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
Infusion pumps are for patients who need receive various types of medications,
solutions, nutrition, lipids, blood and blood components in controlled amounts through
an intravenous (IV) route or enteral route.
2.1.2 Intended Users
The infusion pump is intended to be used by trained healthcare professionals.
2.1.3 Intended Patient Population
The Infusion pump is intended for use on adult, pediatric and neonate.
2.1.4 Intended Medical Conditions
The infusion pump is intended to be used in professional healthcare facilities.
2.1.5 Contra-indications
None.

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2.1.6 Side-effects
None.
2.2 Indirect Benefit
Through SOTA analysis, since the infusion 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 infusion set.

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3Equipment Preparation
3.1 Equipment Preparation Safety Information
WARNING
•Use only installation accessories specified by Mindray Scientific.
•The equipment software copyright is solely owned by Mindray Scientific. No
organization or individual shall resort to modifying, copying, or exchanging
it or to any other infringement on it in any form or by any means without due
permission.
•Connect only approved devices to this equipment. Devices connected to the
equipment must meet the requirements of the applicable IEC standards (e.g.
IEC 60950 safety standards for information technology equipment and IEC
60601-1 safety standards for medical electrical equipment). The system
configuration must meet the requirements of the IEC 60601-1 medical
electrical systems standard. Any personnel who connect devices to the
equipment’s signal input/output port are responsible for providing evidence
that the safety certification of the devices has been performed in accordance
to the IEC 60601-1. If you have any questions, please contact Mindray
Scientific.
•If it is not evident from the equipment specifications whether a particular
combination with other devices is hazardous, for example, due to summation
of leakage currents, please consult the manufacturer or an expert in the field.
A determination must be made that the proposed combination will not
negatively affect the devices themselves or the patient's safety.
•Ensure that the equipment is properly secured and positioned. Position
change and severe shock may lead to changes to the delivery accuracy.
CAUTION
•The equipment should be installed by the authorized personnel.
•Before use, verify whether the packages are intact. In case of any damage, do
not apply it to patient.

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NOTE
•Save the packing case and packaging material as they can be used if the
equipment must be reshipped.
•This equipment is in accordance with the EN1789:2020 standard, and can be
used to transport patient through road ambulance.
3.2 Installation
CAUTION
•To ensure that the pump operates properly, the drop sensor should be
properly installed when d/min is switched on.
•To avoid mistakenly triggering the Empty alarm, adjust the rate to lower than
400ml/h when using the infusion set of 60 drops/ml.
•After long time infusion, small drops may hang inside the drip chamber.
These small drops should be eliminated, Otherwise, they may affect the drop
detection accuracy and cause the Empty alarm.
NOTE
•The liquid surface in the drip chamber should be lower than the lower edge
of the drop sensor, and lies between the one third and a half of the drip
chamber.
•The positioning block of the drip chamber must be vertically inserted
through the positioning groove of the drop sensor.
•Do not excessively tilt the drop sensor, or expose it to direct sunlight during
infusion. Otherwise, accuracy of the drop sensor may be influenced.
•It is suggested that the signal line of drop sensor should be replaced every six
months.
3.3 Setting Up the Equipment
WARNING
•Always use the accompanying power cord delivered with the pump.
•Before connecting the equipment to the AC mains, check that the voltage
and frequency ratings of the power line are the same as those indicated on
the equipment.

3 - 3
•Do not touch the power connector with wet hand. Eliminate the liquid or any
residue inside of or at the surroundings of the AC power input connector and
power cord connectors.
•Use the battery if the integrity of the protective earth conductor or the
protective earthing system in the installation is in doubt.
CAUTION
•When connected with the adapter, it is specified as a part of the equipment.
Use only the specified adapter.

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4 - 1
4Getting Started
4.1 Turning on the Pump
WARNING
•Before putting the system into operation, the operator must verify that the
equipment, connecting cables and accessories are in correct working order
and operating condition.
•Check that visual and auditory alarm signals are presented correctly when
the equipment is powered on. Do not use the equipment if you suspect it is
not working properly, or if it is mechanically damaged. Contact your service
personnel or us.
NOTE
•Stay within 1 meter (39 inches) of the pump while setting it up and operating
it, making sure that you have a clear view of the pump interface.
•The equipment uses a mains plug as isolation means to the mains power. Do
not locate the equipment in a place difficult to operate the mains plug.
4.2 Loading the Infusion Set
WARNING
•To ensure the accuracy of air bubble detection, check and remove the
remained fluid in the infusion set slot before loading the infusion set.
•While loading the infusion set, do not touch the free-flow clamp to avoid
being hurt.
•This pump uses standard, single use infusion set with Luer lock connections.
•The pump must be mounted to the same level as the patient’s heart. The most
accurate pressure monitoring in the infusion set is achieved when the pump
is positioned close to the patients heart level.
•We recommend you to use an infusion set stated in this manual. If a non-
recommended infusion set must be used or a different set needs to be
changed, perform the calibration and performance test before use.

4 - 2
Otherwise, the accuracy of the infusion and the performance of the pump
may be adversely affected.
•To ensure the accuracy of rate and alarm detection, the infusion set should be
calibrated in this pump before first use.
•When using the pump for blood transfusion, only use disposables dedicated
and labelled for transfusion.
•Single use accessories are not designed to be reused. Reuse may cause a risk
of contamination and affect the measurement accuracy.
NOTE
•Take care that your hands are not squeezed when you close the pump door.
•Make sure that the infusion set is located in both sides of the tubing channel
notches after loading the infusion set.
4.3 Purge
NOTE
•If required, set the purge rate after the purge is started. The initial purge rate
is 1200 ml/h.
•The Air in Line or Accumulated Air alarm will not given during purging.
•The volume used for purging is not added to the infused volume.
4.4 Starting Infusion
WARNING
•Do not connect patient until disposables have been purged and loaded into
the pump. Connecting to patient before disposables are loaded and purged
can cause serious injury or death.
•Check that no drops are falling in the drip chamber before infusion starts or
stops. If drips are falling, close the roller clamp or the Robert clamp, do not
use the equipment, and contact your service personnel.
NOTE
•Always discharge the previous patient before starting a new infusion for new
patient. Failure to do so can lead to data being attributed to the wrong
patient.