Fresenius Kabi Agilia VP User manual

Agilia VP
Volumetric Infusion Pump
Applicable to software version 4.1
Instructions For Use
For Use in Healthcare Facilities and
Homecare Environments

2
Symbols used in this document
Labelling symbols
Warning of a potential hazard that
could result in serious personal
injury and/or product damage if the
written instructions are not followed.
Warning
(Refer to the Instructions For Use)
Refer to the Instructions For Use
Product reference / part number
Product serial number
Input terminal - connector
Output terminal - connector
Electrical fuses
Alternating Current (AC)
Direct Current (DC)
IP22
Index of protection against solid
foreign objects (> 12.5 mm) and
dripping liquids
Part included in a recycling process
Protection against leakage current;
defibrillation-proof type CF applied
part
CE mark
Recommendations to be followed.
Name and address of the
manufacturer / Date of manufacture
Name and address of the
manufacturing facility
Protection against electric shock:
class II
Non-ionizing electromagnetic
radiation
Fragile, handle with care
This way up
Keep away from rain
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
General symbol for recyclable
material
Eco packaging symbol
Medical Device
16675-1_IFU_Agilia_VP_Eng
Unique Device Identifier
0123

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Table of Contents
1 INTRODUCTION 9
1.1 SCOPE ...................................................................................................9
1.2 PRINCIPLES OF OPERATION .....................................................................9
1.3 INTENDED PURPOSE ...............................................................................9
1.4 INTENDED USE......................................................................................10
1.4.1 Indications .......................................................................................... 10
1.4.2 Contraindications................................................................................ 11
1.4.3 Intended users.................................................................................... 11
1.4.4 Intended patients................................................................................ 11
1.4.5 Use Environment................................................................................ 12
1.4.6 Specificities for Homecare Environments........................................... 13
1.5 CLINICAL BENEFITS ...............................................................................15
1.6 SIDE-EFFECTS ......................................................................................15
1.7 RISKS FOR PATIENTS.............................................................................15
2 AGILIA CONNECT INFUSION SYSTEM 16
3 DESCRIPTION 18
3.1 FRONT VIEW.........................................................................................18
3.2 BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) .....................................18
3.3 BACK VIEW...........................................................................................19
3.4 KEYPAD................................................................................................20
3.5 DISPLAY AND SYMBOLS.........................................................................22
3.5.1 Infusion Status.................................................................................... 22
3.5.2 Screen Options................................................................................... 22
3.5.3 Navigation Buttons ............................................................................. 23
3.5.4 Alarms and Safety Features............................................................... 23
3.6 PACKAGING ..........................................................................................24
4 FUNDAMENTALS 25
4.1 PROFILES .............................................................................................25
4.2 INFUSION MODES ..................................................................................26

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5 INSTALLATION 27
5.1 TYPES OF INSTALLATIONS .....................................................................27
5.2 USING THE ROTATING POLE CLAMP.......................................................28
5.3 ATTACHING THE PUMP(S) ......................................................................29
5.3.1 Attaching to a Pole ............................................................................. 29
5.3.2 Attaching to a Rail .............................................................................. 31
5.3.3 Using on a Flat Table ......................................................................... 31
5.3.4 Attaching Two Pumps Together ......................................................... 32
6 GETTING STARTED 33
6.1 FLOWCHART .........................................................................................33
6.2 USING THE PUMP FOR THE FIRST TIME ..................................................33
6.3 POWERING ON ......................................................................................34
6.4 INSTALLING THE ADMINISTRATION SET IN THE PUMP...............................36
6.5 CONNECTING A DROP SENSOR..............................................................37
6.6 PUMP HEIGHT.......................................................................................39
7 OPERATION 40
7.1 FLOWCHART .........................................................................................40
7.2 SELECTING A PROFILE ..........................................................................41
7.3 PROGRAMMING AN INFUSION .................................................................41
7.4 STARTING AN INFUSION .........................................................................43
7.5 MONITORING AN INFUSION.....................................................................44
7.6 FUNCTIONS DURING INFUSION ...............................................................45
7.6.1 Stop .................................................................................................... 45
7.6.2 Rate Titration...................................................................................... 45
7.6.3 Administering a Direct Bolus .............................................................. 46
7.7 COMPLETING AN INFUSION ....................................................................47
7.7.1 Near End of Infusion Alert .................................................................. 47
7.7.2 End of Infusion ................................................................................... 48
7.7.3 Powering off ....................................................................................... 49
7.8 INFUSION MODES ..................................................................................49
7.8.1 Volume / Time / Rate (V/T/R) ............................................................. 49
7.8.2 Volume / Rate (V/R) ........................................................................... 49
7.8.3 Volume / Time (V/T) ........................................................................... 49
7.8.4 Simple Rate (only with Drop Sensor) ................................................. 50
7.9 OTHER FUNCTIONS ...............................................................................50

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7.9.1 Priming the Administration Set ........................................................... 50
7.9.2 Advancing an Air Bubble .................................................................... 51
7.9.3 Auto-restart......................................................................................... 53
7.9.4 Pre-programming the Pump ............................................................... 54
8 MENUS 55
8.1 OVERVIEW ............................................................................................55
8.2 PROFILE ...............................................................................................56
8.3 PRESSURE............................................................................................57
8.4 VOLUME TO BE INFUSED (VTBI) ...........................................................59
8.5 KEYPAD LOCK STATUS..........................................................................60
8.6 BATTERY LIFE.......................................................................................62
8.7 VOLUME INFUSED .................................................................................63
8.8 PAUSE..................................................................................................64
8.9 DAY/NIGHT MODE.................................................................................65
8.10 FLOW RATE (ML/H) ...............................................................................67
8.11 ALARM VOLUME ....................................................................................68
8.12 CALL-BACK ALERT ................................................................................69
8.13 VIEW FLOW RATE HISTORY ...................................................................71
8.14 VIEW PRESSURE HISTORY ....................................................................72
8.15 VIEW EVENT LOG..................................................................................73
8.16 DATE / TIME .........................................................................................74
8.17 MAINTENANCE ......................................................................................75
9 OPTIONS 76
9.1 COMMANDS ..........................................................................................76
9.2 OPTION DESCRIPTIONS .........................................................................76
9.3 PUMP SETTINGS ...................................................................................77
10 DATA COMMUNICATION 78
11 USER TEST 79
12 ALARMS AND SAFETY FEATURES 80
12.1 INTRODUCTION......................................................................................80

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12.2 ALARM DESCRIPTIONS ..........................................................................80
12.3 GENERAL REMARKS ..............................................................................81
12.4 LIST OF ALARMS ...................................................................................81
12.5 AUDIO ONLY INFORMATION SIGNALS......................................................90
13 VOLUMAT LINES 91
13.1 PREPARING THE ADMINISTRATION SET AND THE FLUID CONTAINER ....91
13.2 PRIMING THE ADMINISTRATION SET BEFORE USE ..................................92
13.3 OTHER USES OF ADMINISTRATION SETS ................................................94
13.4 REMOVAL AND REPLACEMENT OF ADMINISTRATION SETS .......................96
14 DEVICE STORAGE 97
14.1 PRECAUTIONS FOR STORAGE ................................................................97
14.2 STORAGE AND TRANSPORT CONDITIONS................................................97
14.3 PREPARING THE DEVICE FOR STORAGE .................................................97
14.4 USING THE DEVICE AFTER STORAGE .....................................................98
15 SPECIFICATIONS 99
15.1 ESSENTIAL FEATURES ...........................................................................99
15.2 FLOW RATE ........................................................................................100
15.3 VOLUME TO BE INFUSED (VTBI) .........................................................100
15.4 INFUSION TIME....................................................................................100
15.5 AIR DETECTION...................................................................................100
15.6 PRESSURE MANAGEMENT ...................................................................101
15.7 ACCURACY .........................................................................................102
15.8 CALCULATION RULES ..........................................................................104
16 CLEANING AND DISINFECTING 105
16.1 WHEN TO CLEAN AND DISINFECT THE PUMP ........................................105
16.2 RECOMMENDED AND PROHIBITED AGENTS...........................................106
16.3 INSTRUCTIONS FOR CLEANING AND DISINFECTING ................................106
17 POWER MANAGEMENT 109
17.1 AC POWER SUPPLY PRECAUTIONS......................................................109

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17.2 BATTERY PRECAUTIONS ......................................................................109
17.3 BATTERY OPERATING MODE ...............................................................110
18 TECHNICAL CHARACTERISTICS 111
18.1 POWER SUPPLY..................................................................................111
18.2 BATTERY ............................................................................................111
18.3 POWER CONSUMPTION........................................................................111
18.4 COMMUNICATION PORT ......................................................................112
18.5 INFRARED COMMUNICATION ................................................................112
18.6 DROP SENSOR CONNECTOR ...............................................................112
18.7 SOUND LEVELS...................................................................................112
18.8 COMPLIANCE ......................................................................................113
18.9 DIMENSIONS AND WEIGHT ...................................................................113
18.10 TRUMPET AND START-UP CURVES .......................................................114
19 TROUBLESHOOTING 117
20 RECYCLING 119
21 WARRANTY 120
21.1 GENERAL WARRANTY CONDITIONS ......................................................120
21.2 LIMITED WARRANTY ............................................................................120
21.3 WARRANTY CONDITIONS FOR ACCESSORIES ........................................120
22 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 121
22.1 ELECTROMAGNETIC COMPATIBILITY ..................................................121
22.2 ELECTROSTATIC DISCHARGE (ESD) ....................................................121
22.3 ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE .122
22.4 EMC AND ESSENTIAL PERFORMANCES ................................................124
23 SERVICING 130
23.1 INFORMATION ON DEVICE SERVICING...................................................130
23.2 MAINTENANCE REQUIREMENTS............................................................130
23.3 QUALITY CONTROL .............................................................................131

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23.4 NOTIFICATION OF SERIOUS INCIDENT....................................................131
24 CYBERSECURITY 132
24.1 CYBERSECURITY AND IT-NETWORK ENVIRONMENT ...............................132
24.2 INHERENT DESIGN ...............................................................................133
24.3 INFORMATION REGARDING CYBERSECURITY..........................................133
24.4 FIREWALL CONFIGURATION ..................................................................135
24.5 POTENTIAL VULNERABILITIES ...............................................................135
25 GLOSSARY OF TERMS 138
APPENDIX: FACTORY CONFIGURATION 142
INDEX 143

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1Introduction
1.1 Scope
1.2 Principles of Operation
1.3 Intended Purpose
These Instructions for Use (IFU) are applicable to the Agilia VP large
volume pump. This device is referred to throughout this manual as the
"Agilia VP".
The user must adhere to the instructions specified in this IFU. Failure to
adhere to these instructions may result in damage to the equipment,
injury to patients or injury to users.
Warning
Check that this IFU is applicable to the current software version of the
device.
The software version of the device is displayed on the start-up
screen.
The software version described in this IFU is displayed in the
Release Notes, page 145.
Agilia VP is a programmable electronic medical system dedicated to
administering a pre-determined volume of infusion product at a
programmed rate. This peristaltic pump ensures fluid delivery using
pumping and clamping fingers to advance the liquid to the patient
through an administration set.
Agilia VP is a transportable and reusable device that can be used
everyday.
Agilia VP can be used for intermittent or continuous infusions.
Agilia VP is intended for use on only one patient at a time. It can be
reused indefinitely on multiple patients throughout its lifetime.
Infusion pump and accessories for IV administration of fluids.

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1.4 Intended Use
1.4.1 Indications
Warning
In homecare environment, the pump must only be used to infuse
noncritical drugs. Otherwise, there is a risk of interruptions in the therapy
which could have critical consequences for the patient. The following
fluids can only be infused under the permanent supervision of a trained
healthcare professional:
Catecholamines
Morphine
Chemotherapy
Other critical drugs
The pump is indicated to administer products through clinically
accepted routes. These products include:
Intended Products
Parenteral Fluids
Standard solutions
Colloids
Parenteral nutrition
Medication
Diluted drugs
Antibiotics
Chemotherapy
Catecholamines
Short acting drugs
Anesthesia drugs
Blood and blood
derivatives
Blood
Red blood cells
Platelets
Plasma
Albumin
Warning
Infusion of bolus or small volume of chemotherapy vesicants through
peripheraI route should be administered according to the good clinical
practice of the healthcare facility. If infusion pump is used, the patient
should still be continually assessed for any signs of potential
extravasation.
Warning
When using Agilia VP to infuse critical medications, ensure that
adequate monitoring is provided.

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1.4.2 Contraindications
1.4.3 Intended users
1.4.4 Intended patients
When using Agilia VP to infuse critical medications in healthcare
facilities, ensure that backup pumps and administration sets are
available for immediate use.
Only use Agilia VP for the infusion of fluids that are intended for infusion
pumps.
Do not use the pump for epidural use.
Do not use the pump for enteral nutrition.
Administration Routes
The system allows infusion via the following access routes:
IV access with any device that administers a medical fluid to a
vein and is equipped with a female Luer lock,
Subcutaneous access.
There are no known contraindications to the use of the device when
used according to this document.
In healthcare facilities, the pump must only be used by qualified and
trained healthcare professionals.
In homecare environments, the pump must only be used by
appropriately trained users including homecare professionals, patients
or their relatives (in case of patient's inability to correctly react to pump
alarms) under the responsibility of healthcare professionals. In
homecare environments, the IFU must be provided to the homecare
nurse.
Two Quick Reference Guides are available (one for homecare
professionals, one for the patient) in order to describe the typical
operations performed at home. We recommend using them and keeping
the Quick Reference Guide for the patient near the pump.
Typical initial training duration: 1 hour.
It is recommended that users attend a refresher training session of about
20 minutes every year.
For training, contact your Fresenius Kabi sales representative.
Agilia VP is intended to be used according to healthcare facilities
protocols on patients with the following characteristics:

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1.4.5 Use Environment
Patient Characteristics
Sex Male
Female
Age
Neonates (except in homecare environment)
Pediatrics
Adults
Elderly
Weight 0.25 kg to 350 kg
Body Surface Area 0.05 m² to 4.5 m²
When using the pump with a very sensitive population such as the
neonates, make sure to:
Switch to night mode
Set the alarm volume to the minimum level
Agilia VP is intended for use in the following environments:
Healthcare facilities and in pre-hospital medical ground
transportation, under the supervision of trained healthcare
professionals.
Homecare environment under the responsibility of trained
healthcare professionals, by following specific precautions: See
Section 1.4.6, page 13.
The pump must be used in the following operational conditions to ensure
proper performance:
Operating temperature range:
5 °C to 40 °C
Operating pressure range:
700 hPa (525 mmHg / 10.15 PSI) to 1060 hPa (795 mmHg /
15.37 PSI)
Operating humidity range:
20 % to 90 % with no condensation
Altitude:
Up to 3000 m above sea-level

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1.4.6 Specificities for Homecare Environments
Warning
Do not use the pump in the following environments:
Explosive or flammable environments
High humidity environments (shower, bath, etc.)
Ultrasonic environments not to damage the pump or its components
Magnetic Resonance Imaging (MRI) not to deteriorate the MRI
images
Hyperbaric chamber
Warning
The functionality of the pump can be affected by pressure variations,
mechanical shocks, heat ignition sources, and so on.
Warning
Device which may create pressure decrease downstream the pump (i.e.
ECMO, dialyser) should be used carefully with the pump and
appropriate measures should be taken to avoid influence on the pump
performances.
Information
The pump can be used in ambulances exclusively with the Agilia
Holder Ambulance accessory. Due to use in road ambulances,
performances of the device can be modified. For more
information, refer to Agilia Holder Ambulance IFU.
For more information on using the device in specific conditions,
contact your Fresenius Kabi representative.
Warning
Product version
Only pumps with software version 2.2 or above can be used in
homecare environments. In early versions, all homecare functionalities
are unavailable.
If your software version is not compatible with homecare environments,
contact your Fresenius Kabi representative.

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Environment Considerations
Consider the following operational conditions to ensure proper
device performance:
- Do not expose to sun light, keep in dry place, at room
temperature, normal pressure.
- Keep in clean environment.
- Keep away from objects which can potentially damage the
device.
- Keep away from any noise disturbance which could prevent
patient or relatives from hearing the pump alarms.
- Keep away from heat source, dust, fluff, direct and prolonged
light exposure.
- Keep away from animals, pests or children.
Do not share an outlet with another electrical device.
General Considerations
Healthcare professionals should not divulge to the patient or
relatives the pump's lock system or any information that may
allow an access to all programming and operating functions.
The responsibility of using the pump is shared between the
healthcare professional and the patient.
Homecare providers or healthcare facilities are responsible for
disposal of administration sets and bags used at home according
to current standards in order to limit the risk of harm and
infection.
The use of the Drop Sensor is not recommended for homecare
environments.
Warning
It is the healthcare professional’s responsibility to ensure that the
patient or his/her relatives have the required capacity (physical,
cognitive or perceptive) to use the pump in homecare
environments. Otherwise, there is a risk of usage errors and
incorrect therapy which could have critical consequences for the
patient.
Homecare providers must ensure that they can provide backup
sets and a backup pump within a short time period to avoid
interruptions of administration which could have critical
consequences in case of pump failure in the patient’s home.
Give particular attention to the risk of strangulation with cables
and sets, and with the small parts that could be swallowed or
inhaled.

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1.5 Clinical benefits
1.6 Side-effects
1.7 Risks for patients
Maintenance Requirements
Homecare providers are responsible for periodic maintenance and
calibration of pumps used in homecare environments.
Homecare providers must be informed if the device is dropped or if any
malfunctions occur. In this case, do not use the device and contact your
homecare providers.
Clinical benefits are achieved through the functions provided to the
intended users, which has a positive impact on patient management.
Clinical benefits of Agilia VP infusion system are the following:
Provide a controlled and accurate system for the infusion of large
volume of drugs, fluids and blood products (volume delivery
accuracy of the system is ±5%, flow rate adjustable from 0.1 to
1200 mL/h, compatible with a wide range of dedicated
administration sets).
Provide features and infusion functions adapted to the needs of
patients and healthcare professionals (continuous infusion and
bolus infusion, different flow rate modes, pause function, keep
vein open function, view infusion history, night mode, infusion
monitoring screen, wide range of drugs and fluids compatible).
Provide safety features and relevant alarms that improve infusion
safety and prevent unexpected infusion discontinuation
(Dynamic Pressure System, pressure monitoring, adjustable air
parameters, keypad lock options, alarm system compliant with
EN/IEC 60601-1-8).
There is no side-effect directly associated to the use of Agilia VP.
Failure to follow all instructions described in this document or loss or
degradation of essential performance (Section 15.1, page 99.) may
result in: overdose, underdose, delay of therapy, incorrect therapy,
exsanguination, toxicity, infection, air embolism, trauma or electric
shock.

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2Agilia Connect Infusion System
Agilia Range Description
Pump
Agilia VP range
Volumetric Infusion Pump
Pumps designed to deliver the contents of parenteral
infusion container (bag or bottle) through a line connected
to a patient.
Agilia SP range
Syringe Infusion Pump
Pumps designed to deliver the contents of a syringe through
a line connected to a patient.
Agilia SP PCA
Patient-Controlled Analgesia (PCA) syringe infusion
pump
Pumps intended for PCA therapy and for the administration
of analgesic drugs under the patient’s or the clinician’s
control.
Agilia ProNeo
Enteral Nutrition Syringe Pump for Neonates
Pumps designed to deliver enteral nutrition to neonates,
preterm babies and children via clinically accepted routes of
administration.
Vigilant
Software
Suite
Vigilant Centerium
Server Software
Software intended to report status of compatible Fresenius
Kabi infusion devices according to the identified installed
base for fleet management, to store and distribute datasets
to connected infusion devices and to report distribution
status, besides supporting system maintenance operations.
Vigilant Bridge
EMR Auto-documentation
Software intended to establish connection between
compatible Fresenius Kabi infusion pumps and the
Electronic Medical Records (EMR) system. Infusion data is
then automatically transmitted to the EMR.
Vigilant Insight
Infusion Data Reporting Software
Software intended to collect and report infusion information
received from compatible Fresenius Kabi connected
infusion devices to analyze and improve clinical settings
included into a dataset.
Vigilant Master Med
Drug Library Software
Software intended to create, customize, and manage drug
library data and device configurations to be uploaded to
compatible Fresenius Kabi infusion devices.Vigilant Master
Med is part of a Dose Error Reduction System (DERS).
Vigilant Sentinel
Infusion visualization system
Software designed to provide qualified healthcare
personnel with a centrally aggregated view of infusion
pumps' status within a hospital or hospital-type setting.

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Software Agilia Partner
Maintenance Software
Software designed to maintain, configure, test and calibrate
compatible Agilia infusion devices and accessories.
Accessories
Link Agilia
Agilia Link
Link+ Agilia
Stacking Rack Systems
Rack systems designed to stack 4, 6 or 8 Agilia infusion
pumps.
Link Agilia / Agilia Link are designed to centralize the power
supply.
Link+ Agilia is designed to centralize the power supply and
to centrally replicate infusion pump signalling.
Agilia MRI Guard
MRI-Shielding System
Agilia MRI Guard is intended to accommodate and power
up to four Agilia infusion pumps so that these pumps can be
operated in a Magnetic Resonance Imaging unit.
Agilia Duo
Two-channel accessory
The Agilia Duo is intended to centralize mains power for two
attached Agilia pumps.
Agilia Holder
Ambulance
Accessory intended to be used in road ambulances
equipped with AC power source and a horizontal rail in
order to fix an infusion pump.
Drop Sensor
Accessory intended to detect drops in the administration set
drip chamber when connected to a compatible volumetric
pump.
Disposables Volumat Lines
Administration Sets
Administration sets can be in contact with the patient
(applied part).
Information
For a list of compatible accessories, disposables and software, and for
ordering information, refer to the System Components booklet.
Agilia Range Description

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3Description
3.1 Front View
Figure 3.1: Front View
3.2 Bottom View (Device Identification Label)
Legend
Handle Door Lever
Pump Door
On the device identification label, the UDI (Unique Device Identifier) is
presented in machine-readable form (AIDC - Automatic Identification
and Data Capture - technology) and as text:
■ (01) Product Identifier GTIN
■ (21) Product Serial Number
■ (11) Date of Manufacture
■ (240) Product Reference
For more information on device identification label symbols, see
Symbols used in this document, page 2.
3
2
1
1
3
1
2

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3.3 Back View
Figure 3.2: Back View
Legend
Release Button Power Cord Inlet
Drop Sensor Connection Socket Infrared Cell
Rotating Pole Clamp Attachment Lock Knob
RS232 Communication Port
Symbol Location Description
Near Power Cord Inlet
Warning
See section 18, page 111.
Near RS232
Communication Port
Warning
See section 10, page 78.
5
1
3
6
7
4
2
1
3
5
1
2
3
6
3
3
7
4

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3.4 Keypad
3.4.1 Keypad Description
Figure 3.3: Keypad
Legend
Screen Decrement
Battery Charge Status Indicator Fast Decrement
Power Supply Indicator Confirm Value / Move to Next Field
On / Off Stop
Bolus / Prime / Advance Air Menu / Cancel Value / Move Back to
Previous Field
Fast Increment
Increment Alarm Silence
Infusion Indicator Lights
8
14
1211107 9654
1
2
3
4
13
1
3
79
1
2
3
710
3
3
11
4
3
12
5
3
13
3
6
3
7
3
14
3
8