Mindray BeneFusion SP3 Vet User manual

BeneFusion SP3 Vet
Syringe Pump
Operator’s Manual

I
© Copyright 2018-2019 Shenzhen Mindray Scientific Co., Ltd.All rights reserved.
Release date: March 2019
Revision: 4.0

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.

III
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS FORANY PARTICULAR PURPOSE.
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.skmedica.com
Tel:
[phone]
Fax:
[phone]
EC-Representative:
Shanghai International Holding Corp. GmbH (Europe)
Address:
Eiffestraße 80, 20537 Hamburg, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726

IV
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
animal 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 animals.
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.
[ ] is used to enclose screen texts.
< > is used to enclose the keys.
→is used to indicate operational procedures.

1
Contents
1 Safety.....................................................................................................................1-1
1.1 Safety Information...............................................................................................1-1
1.1.1 Warnings .................................................................................................1-2
1.1.2 Cautions ..................................................................................................1-3
1.1.3 Notes.......................................................................................................1-4
1.2 Equipment Symbols ............................................................................................1-4
2 Overview................................................................................................................2-1
2.1 Description...........................................................................................................2-1
2.1.1 Intended Use...........................................................................................2-1
2.1.2 Contraindications.....................................................................................2-1
2.1.3 Appearance, Parts and Features............................................................2-1
2.2 Host .....................................................................................................................2-2
2.2.1 Front View ...............................................................................................2-2
2.2.2 Rear View................................................................................................2-4
2.2.3 Side View.................................................................................................2-4
2.2.4 Bottom View ............................................................................................2-5
2.3 Screen Display ....................................................................................................2-6
2.4 Cursor..................................................................................................................2-6
3 Installation and Setting........................................................................................3-1
3.1 Installation ...........................................................................................................3-1
3.1.1 Out of Box Audit (OOBA) ........................................................................3-2
3.1.2 Operating Conditions ..............................................................................3-2
3.1.3 Mount the Clamp.....................................................................................3-3
3.1.3.1 Standard Pole Clamp......................................................................3-3
3.1.3.2 Advanced Pole Clamp (Optional) ...................................................3-3
3.1.4 Fix BeneFusion DS3 Infusion Supervision System (Optional)...............3-4
3.1.5 Connect theAC Power Source ...............................................................3-4
3.2 Conventional Settings .........................................................................................3-5
3.2.1 Adjust Alarm Sound Volume....................................................................3-5
3.2.2 Adjust Screen Brightness........................................................................3-5
3.2.3 Set Language..........................................................................................3-6
3.2.4 Set Date and Time...................................................................................3-6
3.3 Restore Factory Default ......................................................................................3-6
4 Basic Operation....................................................................................................4-1
4.1 Infusion Flow Chart .............................................................................................4-1
4.2 Operational Procedures ......................................................................................4-2
4.2.1 Turn on the Pump....................................................................................4-2
4.2.2 Load the Syringe.....................................................................................4-2

2
4.2.3 Change the Syringe.................................................................................4-3
4.2.4 Select Syringe Brands.............................................................................4-4
4.2.5 Parameter Memory Function...................................................................4-4
4.2.6 Select Infusion Mode...............................................................................4-4
4.2.7 Purge Air..................................................................................................4-5
4.2.8 Set Infusion Parameters..........................................................................4-5
4.2.9 Infusion....................................................................................................4-5
4.2.10 Infusion Pause.......................................................................................4-6
4.2.11 BOLUS...................................................................................................4-6
4.2.12 Change the Rate during Operation.......................................................4-6
4.2.13 Complete...............................................................................................4-7
4.2.14 Standby.................................................................................................4-7
4.2.15 Turn off the Pump..................................................................................4-7
5 Infusion Mode.......................................................................................................5-1
5.1 Rate Mode...........................................................................................................5-1
5.2 Time Mode...........................................................................................................5-2
5.3 Body Weight Mode..............................................................................................5-2
5.4 Intermittent Mode.................................................................................................5-4
6 Setting Parameters...............................................................................................6-1
6.1 KVO.....................................................................................................................6-1
6.2 Drug Library.........................................................................................................6-1
6.3 Occlusion Pressure.............................................................................................6-2
6.3.1 Set Occlusion Pressure...........................................................................6-2
6.3.2 Set Pressure Unit....................................................................................6-2
6.3.3 Dynamic Pressure Scanning (DPS)........................................................6-2
6.3.4Automatic Pressure Release Function (Anti-Bolus)................................6-3
6.4 Key Lock Function...............................................................................................6-3
6.5 Reminder Function..............................................................................................6-3
6.6 Time Near End.....................................................................................................6-3
6.7 Commonly Used Syringes...................................................................................6-4
7 Other Functions....................................................................................................7-1
7.1 History Record.....................................................................................................7-1
7.2 Power-down Save...............................................................................................7-1
7.3 Nurse Call............................................................................................................7-1
7.4 Wireless Networking (Optional)...........................................................................7-2
7.5 Data Export..........................................................................................................7-3
8 Alarms....................................................................................................................8-1
8.1 Alarm Level..........................................................................................................8-1
8.2 Alarm Types.........................................................................................................8-1
8.2.1 Multi-level Alarm Rules............................................................................8-2

3
8.3 Alarm Handling Rules..........................................................................................8-2
8.4 Alarm Countermeasures......................................................................................8-3
9 Battery ...................................................................................................................9-1
9.1 Battery Performance Optimization......................................................................9-2
9.2 Check the Battery................................................................................................9-2
9.3 Battery Recycling.................................................................................................9-3
10 Preservation and Sanitation........................................................................... 10-1
10.1 Description...................................................................................................... 10-1
10.2 Cleaning ......................................................................................................... 10-1
10.3 Disinfection..................................................................................................... 10-2
11 Maintenance......................................................................................................11-1
11.1 Inspection.........................................................................................................11-1
11.2 Maintenance Plan............................................................................................11-2
11.3 View Information..............................................................................................11-2
11.4 Accuracy Calibration........................................................................................11-2
11.5 Safe Disposal and Recycling...........................................................................11-3
12 Accessories...................................................................................................... 12-1
A Product Specifications.......................................................................................A-1
A.1 Safety Specifications..........................................................................................A-1
A.1.1 Product Classification ............................................................................A-1
A.1.2 Operating Environment..........................................................................A-2
A.2 Physical Specifications ......................................................................................A-2
A.3 Hardware Specifications....................................................................................A-3
A.3.1 Display....................................................................................................A-3
A.3.2 Battery....................................................................................................A-3
A.3.3 Host LED................................................................................................A-3
A.3.4 Auditory Indicator ...................................................................................A-4
A.3.5 External Ports.........................................................................................A-4
A.3.6 Signal Output Interface..........................................................................A-4
A.4 Specifications.....................................................................................................A-5
A.5 A Reference Table Showing OcclusionAlarm Delay and Possible Dose..........A-8
A.6 Infusion Accuracy Curve....................................................................................A-9
A.7 Trumpet Curve .................................................................................................A-10
B EMC and Radio Regulatory Compliance..........................................................B-1
B.1 EMC ...................................................................................................................B-1
B.2 Radio Regulatory Compliance...........................................................................B-6
C Alarm Information...............................................................................................C-1

4
D Symbols and Terms............................................................................................D-1
D.1 List of Units........................................................................................................D-1
D.2 List of Symbols...................................................................................................D-2
D.3 List of Terms.......................................................................................................D-2
D.4 List of Unit Conversion.......................................................................................D-3
E Toxic and Hazardous Substances or Elements...............................................E-1
F Declaration of Conformity.................................................................................. F-1

1-1
1 Safety
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.

1-2
1.1.1 Warnings
WARNING
Device, cables and accessories must be inspected before use to
guarantee their normal and safe operation.
This equipment can only be connected to the socket with ground
protection. Please adopt a rechargeable battery instead of the socket as
the power supply if the socket is not provided with a ground lead.
To prevent fire or explosion, do not operate the equipment in the
presence of anesthetic, flammable or explosive materials.
Do not open the equipment casing as there is the impending danger of
electric shock. Equipment maintenance and upgrades must be carried
out by maintenance technicians whom are trained and licensed by the
manufacturer. Moreover, the process must be done only after the AC
power supply is disconnected. Maintenance carried out by individuals
non-affiliated to the manufacturer or by non-licensed personnel may
affect the safety, performance and function of the product.
When used with electrosurgery equipment, the safety of animals should
be ensured.
The animal's clinical condition and the working condition of the syringe
pump must be monitored carefully, the alarm volume and alarm levels
need to be set according to the actual needs. Operation and
performance relying solely on the auditory alarm system alone is not
sufficient, and setting the alarm at a low volume may endanger the
animal. If the alarm volume is less than the surroundings volume, which
can further lead to operators identify alarm mistakenly.
The interconnection of other infusion systems or ACCESSORIES to the
PATIENT LINE may lead to performance degradation and failure to
achieve the expected performance, the working condition of the pump
and patient's clinical condition shall be monitored regularly.
Please carefully install the power line and cables with various
accessories to prevent the animal from choking or suffocation caused
by entanglement of the cables or by electrical disturbance.
The packaging materials must be disposed of in compliance with local
laws and regulations or the hospital policy on waste management. They
must be kept out of the reach of children.
Infusion cannula knots, filter coagulation and occlusions arising from
needle insertion can cause the pressure inside the syringe to rise during
infusion. When this occurs, removing the occlusion can cause
excessive liquid to be infused into the animal, so appropriate measures
should be taken.
This equipment has to be used with professional medical consumables,
and its accuracy cannot be guaranteed when it is used with a syringe

1-3
which is a non-standard consumable or a consumable without
calibration, please contact the company for calibration service.
Do not touch the animal when connecting the peripheral equipment via
the input/output signal ports to prevent animal leakage current from
exceeding the requirements specified by the standard.
In the process of defibrillation, do not touch animal and other
non-defibrillation equipments to prevent electric shock damage, and
defibrillation will not affect the basic performance (such as infusion
accuracy, alarm and signal transmission) of the pump.
The equipment use a mains plug as isolation means to the mains power.
Do not locate the equipment in a place difficult to operate the mains
plug.
1.1.2 Cautions
CAUTION
Use the accessories specified in this Operator’s Manual to guarantee the
animal’s safety.
When this syringe pump and its accessories exceed their service life,
they must be disposed of in accordance with local statutes or hospital
regulations. If you have any queries, please contact your distributor or
the manufacturer.
Electromagnetic fields may affect equipment performance. This makes it
necessary for other equipment used in the vicinity of the pump to meet
EMC standards. Mobile phones, X ray and MRI equipment are all
potential interference sources because of their high-intensity
electromagnetic radiation.
Before the equipment is connected to the power supply, check that the
voltage and frequency of the power supply match the specifications on
the label or in this Operator’s Manual.
Please install and carry the equipment correctly to protect the
equipment from damage from drops, impacts, violent shaking or other
external mechanical forces. The equipment should be observed to verify
normal operation after fall, otherwise it cannot be used.
Disposable accessories must be disposed of after use in accordance
with the relevant hospital regulations.
Avoid direct sunshine, high temperatures and dampness.
Check the built-in battery before use to make sure it has sufficient
power. Recharge the battery if necessary.
The syringe with the luer taper is recommended for use, which can
effectively prevent animals from under current caused by the
occurrence of the cannula to slip out when under tension.

1-4
1.1.3 Notes
NOTE
Install the equipment in a position where it can be easily accessed for
inspection, operation and maintenance.
Keep this Operator’s Manual near to the equipment for future ease of
reference.
The software was developed in compliance with IEC62304. The
possibility of hazards arising from software errors is minimized.
This Operator’s Manual describes the most complete functional
configuration of the equipment. The product you are using may not have
some of the settings or functions described herein.
Do not insert devices that are not specified by the manufacturer into the
multifunction interfaces.
During infusion, the syringe pump can accurately control the rate,
infusion volume and infusion time, and monitor the operation in
real-time, to effectively prevent over currents, under currents and
instances of backflow.
The device is not in touch with the drugs or animals directly. Thus, there
is no need to process Biocompatibility test on it.
1.2 Equipment Symbols
Some symbols may not appear on your equipment.
Refer to instruction
manual/booklet
ON/OFF
Caution
Serial number
Alternating current
Battery
Both direct and
alternating current
Direct current
Alarms
AUDIO PAUSED
Clear/Back
Start; start of action
Bolus
Confirm

1-5
Stop
Menu
Move up/Increase
Move down/Decrease
Move left
Move right
Configured wireless
module and connected
successfully
Non-ionizing
electromagnetic radiation
Night mode
DEFIBRILLATION-PROOF
TYPE CF APPLIED PART
Date of manufacture
Manufacturer
THIS WAY UP
Keep dry
Fragile, handle with
care
STACKING LIMIT BY
NUMBER
Comply with the
requirements of
Directive 2012/19/EU
Waste Electrical &
Electronic Equipment
IP34
Protected against solid
foreign objects with a
diameter no less than
2.5mm and protected
against spraying liquid
water
Authorized
representative in the
European Community
CE mark, comply with the
requirements of the Council
Directive 93/42/EEC
(Medical Device Directive).
Recovery/recyclable
Input/output
Environmentally-friendly
use periods of
electronic products
(20 years)
Temperature limitations
Atmospheric pressure
limitations
Humidity limitations

2-1
2 Overview
2.1 Description
2.1.1 Intended Use
The syringe pump is used in conjunction with the syringe to control the dose of liquid
infused into the animal’s body.
The syringe pump is expected to be used in institutes or units with healthcare
capabilities. This includes but is not limited to hospitals.
WARNING
The syringe pump is for clinical use. It must only be used under
appropriate conditions by professional clinicians, medical device
technicians, or by suitably trained nurses. Personnel using this product
must receive sufficient training. This product must not be operated by
anyone who has not been authorized to do so or has not received
suitable training.
2.1.2 Contraindications
None
2.1.3 Appearance, Parts and Features
The syringe pump primarily consists of a housing, pole clamp and BeneFusion DS3
Infusion Supervision System. By precisely controlling the rotational speed of the
stepping motor, the screw rod is driven to run at the set speed, the dose of liquid
infused into the animal’s body by syringe can be controlled, the syringe pump can be
used for precise and continuous infusion of liquids, and all components are suitable
for use in animal environment. Wireless modules are optional. Functions of the
software comprise Rate Mode, Time Mode, Body Weight Mode, Intermittent Mode,
Drug Library, History Record, and Anti-bolus function.
The syringe pump also includes syringes as applied parts. Since some parts and
functions are optional, the syringe pump you purchased may not contain these
additional parts and their relevant functions.

2-2
2.2 Host
2.2.1 Front View
1. Alarm light
The alarm light indicates different alarm levels in different colors and flash
frequencies, please refer to Chapter 8 Alarms for details.
2. Display
Used for displaying infusion parameters and relevant content.
3. <DIRECTION>
Used for adjusting value, change lines and pages.
4. <CLEAR/BACK>
Under the setting status, press this key to set the value to "0".
Edited value is "0", press this key to return the value to the previous value.
Under non-setting status, press this key to return to the previous menu.
5. <OK>
Used for entering setting status, confirming input operation and saving value.
6. <START>
After the syringe is loaded correctly and the infusion parameters are set, press
this key to start the infusion.
In the [Bolus] settings screen, after bolus parameters are set, press this key to
auto bolus.
7. <STOP>
During infusion, press this key to stop infusion. Infusion stops caused by alarms
(such as Occlusion), press this key to cancel the alarm.
8. <BOLUS>
During infusion, press this key to enter the [Bolus] settings screen.
Under non-running status, press this key to to enter the [Purge] prompt screen.

2-3
9. <AUDIO PAUSED>
Pauses alarm sound.
10. <POWER>
Used for turning power on, entering in standby state and turning off operations.
11. <MENU>
Used for entering [Main Menu] interface.
Under operation status, press and hold this key to lock; in locked state, press
and hold this key to unlock.
12. AC/DC indicator light
On: The pump is connected to an AC/DC power supply (including shutdown).
Off: The pump is not connected to anAC/DC power supply.
13. Extension cannula clamp
Fixes the extension cannula.
14. Syringe fixation clamp
15. Battery indicator light
Steady green indicates that the battery is charging (including shutdown).
Flashing green indicates that the battery is providing power.
Light off indicates that the pump is turned off and not connected to anAC power
supply.
16. Slider
Secures syringe and drives plunger assembly.
17. Handle

2-4
2.2.2 Rear View
1. Product label
2. Pole clamp mounting holes (two)
3. AC power supply port
Connection for the AC power cord.
4. Multifunction interface with the following functions:
DC power supply port
RS232 interface
Nurse call interface
2.2.3 Side View
1. Handle
2. Extension cannula clamp

2-5
1. Clip
2. Syringe fixation clamp
3. Slot
4. Spindle clamp
5. Slider
6. Handle
2.2.4 Bottom View
1. Speaker hole