Fresenius Kabi Agilia SP TIVA User manual

Agilia SP TIVA
Agilia SP TIVA WiFi
Syringe Infusion Pumps
Applicable to software version 2.2
Instructions For Use
For Use in Healthcare Facilities

15634-1_Master_IFU_Agilia_SP_TIVA_Eng
Symbol Descriptions
Warning
(Refer to the Instructions for Use)
Name and address of the
manufacturer / Date of manufacture
Refer to the Instructions for Use Name and address of the
manufacturing facility
Product reference / part number Protection against electric shock:
class II
Product serial number Non-ionizing electromagnetic
radiation
Input terminal - connector Fragile, handle with care
Output terminal - connector This way up
Electrical fuses Keep away from rain
Alternating Current (AC) Temperature limitation
Direct Current (DC) Humidity limitation
IP22
Index of protection against solid
foreign objects (> 12.5 mm) and
dripping liquids
Atmospheric pressure limitation
Not for use in residential areas General symbol for recyclable
material
Part included in a recycling process Eco packaging symbol
Protection against leakage current;
defibrillation-proof type CF applied
part
CE mark
Warning of a potential hazard that
could result in serious personal
injury and/or product damage if the
written instructions are not followed.
Recommendations to be followed.
0123
2

3
Table of Contents
1 INTRODUCTION 9
1.1 SCOPE ...................................................................................................9
1.2 INTENDED USE........................................................................................9
1.3 PRINCIPLES OF OPERATION .....................................................................9
1.4 INTENDED PRODUCTS TO BE INFUSED....................................................10
1.5 INTENDED USERS..................................................................................10
1.6 INTENDED PATIENTS .............................................................................11
1.7 CONTRAINDICATIONS.............................................................................12
1.8 USE ENVIRONMENT...............................................................................12
2 AGILIA CONNECT INFUSION SYSTEM 13
3 DESCRIPTION 15
3.1 FRONT VIEW.........................................................................................15
3.2 BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) .....................................15
3.3 BACK VIEW...........................................................................................16
3.4 KEYPAD................................................................................................17
3.5 DISPLAY AND SYMBOLS.........................................................................19
3.5.1 Infusion Status.................................................................................... 19
3.5.2 Screen Options................................................................................... 19
3.5.3 Navigation Buttons ............................................................................. 20
3.5.4 Alarms and Safety Features............................................................... 20
3.5.5 Infusion Features................................................................................ 20
3.5.6 Data Communication.......................................................................... 21
3.6 PACKAGING ..........................................................................................21
4 FUNDAMENTALS 22
4.1 PROFILES .............................................................................................22
4.2 DRUG LIBRARIES...................................................................................23
4.3 DRUGS .................................................................................................24
4.3.1 Infusion Rates .................................................................................... 24
4.3.2 Drug X (mL/h)..................................................................................... 24
4.3.3 Hard Limits and Soft Limits ................................................................ 24
4.3.4 Infusion Modes ................................................................................... 25
4.4 DATA SET.............................................................................................25
4.5 TARGET CONTROLLED INFUSION (TCI)...................................................26
4.5.1 Introduction to Pharmacokinetic Models ............................................ 26

4
4.5.2 Target Concentration.......................................................................... 27
4.5.3 Pharmacokinetic Models in the Agilia SP TIVA................................. 28
4.5.4 TCI Modes in the Agilia SP TIVA ..................................................... 28
4.5.5 Populations ....................................................................................... 29
5 INSTALLATION 31
5.1 TYPES OF INSTALLATIONS .....................................................................31
5.2 USING THE ROTATING POLE CLAMP.......................................................32
5.3 ATTACHING THE PUMP(S) ......................................................................33
5.3.1 Attaching to a Pole ............................................................................. 33
5.3.2 Attaching to a Rail .............................................................................. 34
5.3.3 Using on a Flat Table ......................................................................... 34
5.3.4 Attaching Two Pumps Together ......................................................... 35
6 GETTING STARTED 36
6.1 FLOWCHART .........................................................................................36
6.2 USING THE PUMP FOR THE FIRST TIME ..................................................37
6.3 POWERING ON ......................................................................................37
6.4 INSTALLING A SYRINGE..........................................................................39
6.5 PUMP HEIGHT.......................................................................................39
7 OPERATION 40
7.1 FLOWCHART .........................................................................................40
7.2 SELECTING A PROFILE ..........................................................................41
7.3 SELECTING THE PROGRAMMING MODE ..................................................41
7.4 SELECTING A SYRINGE ..........................................................................43
7.5 SELECTING A DRUG ..............................................................................44
7.6 PROGRAMMING AN INFUSION .................................................................45
7.6.1 Programming an Infusion by Flow Rate ............................................. 45
7.6.2 Programming an Infusion by Dose ..................................................... 45
7.6.3 Programming Beyond Soft Limits ...................................................... 50
7.6.4 Programming an Infusion (TCI Programming Mode) ......................... 52
7.7 STARTING AN INFUSION .........................................................................54
7.8 MONITORING AN INFUSION.....................................................................55
7.9 FUNCTIONS DURING INFUSION ...............................................................59
7.9.1 Stop .................................................................................................... 59
7.9.2 Adjusting Infusion parameters: Rate Titration / Target Modification .. 59
7.9.3 Administering a Bolus......................................................................... 60
7.10 COMPLETING AN INFUSION ....................................................................63

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7.10.1 Near End of Infusion Alert .................................................................. 63
7.10.2 End of Infusion .................................................................................. 64
7.10.3 Powering off ....................................................................................... 64
7.11 INFUSION MODES ..................................................................................64
7.11.1 Simple Rate........................................................................................ 64
7.11.2 Volume/Time & Dose/Time ................................................................ 65
7.11.3 Volume Limit....................................................................................... 66
7.12 OTHER FUNCTIONS ...............................................................................67
7.12.1 Priming the Syringe and the Extension Set........................................ 67
7.12.2 Pre-programming the Pump ............................................................... 69
8 MENUS 70
8.1 OVERVIEW ............................................................................................70
8.2 PROFILE ...............................................................................................72
8.3 PRESSURE ......................................................................................73
8.4 KEYPAD LOCK STATUS..........................................................................75
8.5 BATTERY LIFE.......................................................................................77
8.6 VOLUME INFUSED / DOSE INFUSED ........................................................78
8.7 PAUSE..................................................................................................79
8.8 PROGRAMMED BOLUS ...........................................................................80
8.9 PATIENT ...............................................................................................80
8.10 DAY/NIGHT MODE.................................................................................81
8.11 VOLUME/TIME & DOSE/TIME..................................................................83
8.12 VOLUME LIMIT.......................................................................................83
8.13 ALARM VOLUME ....................................................................................84
8.14 VOLUME-DOSE HISTORY .......................................................................85
8.15 FLOW RATE HISTORY............................................................................86
8.16 PRESSURE HISTORY .............................................................................87
8.17 CONCENTRATION HISTORY ....................................................................88
8.18 SYRINGE...............................................................................................89
8.19 VIEW EVENT LOG..................................................................................90
8.20 DATE / TIME .........................................................................................91
8.21 MAINTENANCE ......................................................................................92
8.22 LIBRARY INFORMATION ..........................................................................93
8.23 CLINICAL INFORMATION .........................................................................94
8.24 DATA SET.............................................................................................95
8.25 WAKE UP CONCENTRATION ...................................................................96

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8.26 TCI SETUP ..........................................................................................97
9 OPTIONS 98
9.1 COMMANDS ..........................................................................................98
9.2 OPTION DESCRIPTIONS .........................................................................98
9.3 PUMP SETTINGS ...................................................................................99
10 DATA COMMUNICATION 100
10.1 OVERVIEW .........................................................................................100
10.2 COMMUNICATION VIA AGILIA CABLES ...................................................100
10.3 COMMUNICATION VIA WI-FI ................................................................101
10.4 DATA SET UPLOAD ............................................................................101
11 USER TEST 102
12 ALARMS AND SAFETY FEATURES 103
12.1 INTRODUCTION....................................................................................103
12.2 ALARM DESCRIPTIONS ........................................................................103
12.3 GENERAL REMARKS ............................................................................104
12.4 LIST OF ALARMS .................................................................................104
13 SYRINGES 112
13.1 SYRINGE LIST .....................................................................................112
13.2 PREPARING A SYRINGE .......................................................................112
13.3 OPERATIONS FOR SYRINGES ...............................................................114
13.4 GRAVITY INFUSION IN PARALLEL WITH A PUMP.....................................115
14 DEVICE STORAGE 116
14.1 PRECAUTIONS FOR STORAGE ..............................................................116
14.2 STORAGE AND TRANSPORT CONDITIONS..............................................116
14.3 PREPARING THE DEVICE FOR STORAGE ...............................................116
14.4 USING THE DEVICE AFTER STORAGE ...................................................117
15 SPECIFICATIONS 118
15.1 ESSENTIAL FEATURES .........................................................................118
15.2 FLOW RATE ........................................................................................118
15.3 VOLUME TO BE INFUSED (VTBI) .........................................................119
15.4 DOSE TO BE INFUSED (DTBI) .............................................................119

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15.5 INFUSION TIME....................................................................................119
15.6 CONCENTRATION ................................................................................120
15.7 PATIENT DATA ....................................................................................120
15.8 PRESSURE MANAGEMENT ...................................................................120
15.9 ACCURACY .........................................................................................121
15.10 UNITS AND CONVERSION RULES..........................................................123
16 CLEANING AND DISINFECTING 125
16.1 WHEN TO CLEAN AND DISINFECT THE PUMP ........................................125
16.2 RECOMMENDED AND PROHIBITED AGENTS...........................................125
16.3 INSTRUCTIONS FOR CLEANING AND DISINFECTING ................................126
17 POWER MANAGEMENT 129
17.1 AC POWER SUPPLY PRECAUTIONS......................................................129
17.2 BATTERY PRECAUTIONS ......................................................................129
17.3 BATTERY OPERATING MODE ...............................................................130
18 TECHNICAL CHARACTERISTICS 131
18.1 POWER SUPPLY..................................................................................131
18.2 BATTERY ............................................................................................131
18.3 POWER CONSUMPTION........................................................................131
18.4 COMMUNICATION PORT .......................................................................132
18.5 INFRARED COMMUNICATION.................................................................132
18.6 SOUND LEVELS...................................................................................132
18.7 COMPLIANCE ......................................................................................133
18.8 DIMENSIONS AND WEIGHT ...................................................................133
18.9 TRUMPET AND START-UP CURVES .......................................................134
19 WI-FI 136
19.1 GENERAL INFORMATION ......................................................................136
19.2 SPECIFICATIONS .................................................................................137
20 TROUBLESHOOTING 139
21 RECYCLING 141
22 WARRANTY 142
22.1 GENERAL WARRANTY CONDITIONS ......................................................142

8
22.2 LIMITED WARRANTY ............................................................................142
22.3 WARRANTY CONDITIONS FOR ACCESSORIES ........................................142
23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 143
23.1 ELECTROMAGNETIC COMPATIBILITY ..................................................143
23.2 ELECTROSTATIC DISCHARGE (ESD) ....................................................143
23.3 ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE .144
23.4 EMC AND ESSENTIAL PERFORMANCES ................................................146
24 SERVICING 152
24.1 INFORMATION ON DEVICE SERVICING...................................................152
24.2 MAINTENANCE REQUIREMENTS............................................................152
24.3 QUALITY CONTROL .............................................................................153
25 GLOSSARY OF TERMS 154
APPENDIX 1: FACTORY CONFIGURATION 157
APPENDIX 2: PHARMACOKINETIC MODELS 158
INDEX 161

9
1Introduction
1.1 Scope
1.2 Intended Use
1.3 Principles of Operation
These Instructions for Use (IFU) are applicable to the Agilia SP TIVA
and Agilia SP TIVA WiFi pumps. These devices are referred to
throughout this manual as "Agilia SP TIVA".
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 164.
The Agilia SP TIVA Syringe Pump is intended for use on adults,
pediatrics, and neonatal patients for the intermittent or continuous
delivery of parenteral fluids (such as solutions, colloids, parenteral
nutrition), medications (such as diluted drugs, chemotherapy,
anesthesia drugs), blood and blood derivatives, and medications
through clinically accepted routes of administration. It is intended for use
by trained healthcare professionals in clinical healthcare facilities and in
pre-hospital medical ground transportation.
Agilia SP TIVA is a programmable electronic medical system dedicated
to administering a pre-determined volume of a syringe at a programmed
rate. This syringe pump ensures a fluid delivery, by pushing the syringe
plunger and advancing the liquid to the patient through an extension set
(applied part).
Agilia SP TIVA focuses on anesthesia infusions.
Agilia SP TIVA is a transportable and reusable device that can be used
everyday.
The size of a syringe can be 5, 10, 20, 30 or 50-60 mL.
Agilia SP TIVA can be used for intermittent or continuous infusions.
Agilia SP TIVA is intended for use on only one patient at a time. It can
be reused indefinitely on multiple patients throughout its lifetime.

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1.4 Intended Products to be Infused
1.5 Intended Users
The pump administers products through clinically accepted routes.
These products include but are not limited to the following:
Intended Products
Parenteral Fluids
Standard solutions
Colloids
Parenteral nutrition
Medication
Diluted drugs
Antibiotics
Chemotherapy
Catecholamines
Short acting drugs
Anesthesia drugs
Transfusion
Blood
Red blood cells
Platelets
Plasma
Albumin
When using Agilia SP TIVA to infuse critical medications, ensure that
adequate monitoring is provided, and that backup pumps and syringes
are available for immediate use.
Only use Agilia SP TIVA for the infusion of fluids that are intended for
infusion pumps.
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.
The pump must only be used by qualified and trained healthcare
professionals including but not limited to: nurses (primary users),
physicians, nurse practitioners and physician assistants.
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.

11
1.6 Intended Patients
Note: For more information on patient characteristics with TCI infusion, see section 4.5.5, page 29.
Agilia SP TIVA is intended to be used according to healthcare facilities
protocols on patients with the following characteristics:
Patient Characteristics
Sex Male
Female
Age Regular infusion: Neonates, pediatrics, adults, elderly
TCI infusion: 1 to 100 years old patients
Weight Regular infusion: 0.25 kg to 350 kg
TCI infusion: 5 kg to 200 kg
Body Surface Area 0.05 m² to 4.5 m²
Height 20 cm to 250 cm
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
Warning
Specific attention for infusing high risk and life sustaining medication
therapies : use the smallest compatible syringe size necessary to deliver
the fluid or medication; this is especially important when infusing high
risk or life-sustaining medications at low infusion rates (e.g., less than 5
mL per hour, and especially flow rates less than 0.5 mL per hour). Using
a larger syringe when infusing at low rates can lead to inadequate
syringe pump performance including delivery inaccuracies, delay of
therapy, and delayed generation of occlusion alarms. This is due to the
increased friction and compliance of the syringe plunger head with larger
syringes.

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1.7 Contraindications
1.8 Use Environment
Do not modify the pump (except in the case of operations
recommended by Fresenius Kabi).
Do not use the pump with the following fluids:
- Flammable liquids
- Fluids not suitable for infusion
Do not use the pump in the following environments:
- Explosive or flammable environments
- High humidity environments (shower, bath, etc.)
- Ultrasonic environments
- Magnetic Resonance Imaging (MRI)
- Hyperbaric chamber
Do not use the pump for the following purposes:
- Infusion in association with a dialyser or ECMO
- Enteral nutrition
- Epidural use
Do not allow the pump to come in direct contact with the patient's
body.
While the pump is infusing a patient, do not connect a computer
installed with Agilia Partner software to perform technical
operations.
Agilia SP TIVA is intended for use in healthcare facilities, under the
supervision of trained healthcare personnel.
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 to 1060 hPa
Operating humidity range: 20 % to 90 % with no condensation
Altitude: Up to 3000 m above sea-level
Warning
The functionality of the pump can be affected by pressure variations,
mechanical shocks, heat ignition sources, and so on.
Information
For more information on using the device in specific conditions,
contact your Fresenius Kabi representative.
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.

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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 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.
Software
Vigilant Master Med
Medication Safety Solution
DERS (Dose Error Reduction Software) designed to create,
customise and manage data sets to be uploaded to the
Agilia VP and SP infusion pumps.
Agilia Vigilant
Drug’Lib
Medication Safety Software
Software designed to create, customize and manage data
sets to be uploaded to the Agilia VP and SP infusion pumps.
Agilia Partner
Maintenance Software
Software designed to maintain, configure, test and calibrate
the Agilia VP and SP infusion pumps.
Centerium
Distribution Server
Software intended to distribute data sets to Agilia infusion
pumps and centralize information coming from infusion
pumps for post analysis and reporting.
Vigilant Insight
Infusion Data Reporting Software
Software designed to improve the accuracy of clinical
settings included into a data set. It provides reports about
the use of infusion pumps.
Rack Link Agilia
Link+ Agilia
Stacking Rack Systems
Rack systems designed to stack 4, 6 or 8 Agilia infusion
pumps. Link Agilia is designed to centralize the power
supply. Link+ Agilia is designed to centralize the power
supply and to centrally replicate infusion pump signalling.
Accessories Agilia Holder
Ambulance
Medical device intended to be used in road ambulances
equipped with AC power source and a horizontal rail in
order to fix an infusion pump.
Disposables Syringes
(applied part) See section 13, page 112.

14
Information
For a list of compatible accessories, disposables and software, and for
ordering information, refer to the System Components booklet.

15
3Description
3.1 Front View
Figure 3.1: Front View
3.2 Bottom View (Device Identification Label)
Legend
Handle Plunger Driver
Syringe Barrel Clasp Disengagement Lever
Syringe Flange Cradle Syringe Guard
For more information on device identification label symbols, see Symbol
Descriptions, page 2.
3 5
6
2
1
4
1
1
4
1
2
3
5
3
3
6

16
3.3 Back View
Figure 3.2: Back View
Legend
Release Button Power Cord Inlet
Rotating Pole Clamp Infrared Cell
RS232 Communication Port Attachment Lock Knob
Symbol Location Description
Near Power Cord Inlet
Warning
See section 18, page 131.
Near RS232
Communication Port
Warning
See section 10, page 100.
6
4
3
5
2
1
1
1
4
1
2
3
5
3
3
6

17
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
Wi-Fi Symbol Stop
On / Off Cancel Value / Move Back to Previous
Field
Bolus / Prime
Fast Increment Menu
Increment Graph
Infusion Indicator Lights Alarm Silence
SP
4
9
15
14
17
16
1312118 10765
1
2
3
1
3
710
1
2
3
11
3
3
12
4
3
13
5
3
14
3
6
3
7
3
15
3
8
3
16
3
79
3
17

18
3.4.2 Keypad Details
3.4.2.1 Selection Keys
3.4.2.2 Infusion Indicator Lights
3.4.2.3 Status Indicators
Key Description
Arrow Keys
Keys for selecting volume, time, flow rate and other values.
+Fast Access to Maximum Value or Top of a List
+Fast Access to Minimum Value or Bottom of a List
Note:
Pressing and holding any of the arrow keys results in faster increment or decrement.
Indicator Description
Infusion in Progress (flashing green)
TCI therapy in progress with no flow rate delivery (1 constant green light)
Low-Priority Alarm (constant yellow)
Medium-Priority Alarm (flashing yellow)
High-Priority Alarm (flashing red)
Note:
Infusion indicator lights provide information about the infusion: in progress, or with a low, medium
or high-priority alarm.
Green indicator lights will continuously flash from right to left while the infusion is running.
The frequency of flashing varies according to flow rate.
Indicator Description
Power Supply Indicator
When the device is attached to an active power supply, the indicator light is
a constant green. If the pump is not connected to the AC power, it does not
light up.
Battery Charge Status Indicator
When the device is attached to an active power supply, the indicator light
provides information about battery charge status:
If the indicator is blinking, the battery is being charged.
If the indicator is lit permanently, the battery is fully charged.
If the pump is not connected to the AC power, it does not light up.

19
3.5 Display and Symbols
3.5.1 Infusion Status
3.5.2 Screen Options
Symbol Description
Infusion in Progress (Basic & TCI + Custom Profiles with a drug list)
Symbols for infusion in progress.
Infusion in Progress (Custom Profiles with a drug library)
This symbol is displayed when the pump is infusing a drug customized with
Agilia Vigilant Drug’Lib software.
Infusion Stopped
STOP remains in the center of the screen until the user starts the infusion
again.
Symbol Description
Battery Logo
This symbol shows three different charge levels.
< 30 % battery charge
30 % - 70 % battery charge
> 70 % battery charge
If the ‘Battery logo’ option is enabled, this symbol is displayed constantly.
If the ‘Battery logo’ option is disabled, this symbol is only displayed when
the pump is operating on battery.
Pressure Logo
This symbol gives information about pump pressure settings and measured
pressure levels.
Keypad locked symbol
This symbol informs the user that the keypad is locked.
Wi-Fi module status
 The Wi-Fi signal strength is high.
 The Wi-Fi signal strength is medium.
 The Wi-Fi signal strength is low.
 No Wi-Fi signal (the Wi-Fi module is activated).
 The Wi-Fi module is not activated.

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3.5.3 Navigation Buttons
3.5.4 Alarms and Safety Features
3.5.5 Infusion Features
Symbol Description
Start
Confirm
Access Function
Access Function and Clear Settings
Exit Function
Change Selection
Program Function
Select / Unselect
See More Information
/Zoom in / Zoom out
/Move the Event Marker to the Left / Right
Symbol Description
Power Disconnection
Alarm Silenced
Pressure Increase
Drop in Pressure
Note: For more information on alarms, see section 12, page 103.
Symbol Description
Induction Dose
This symbol is displayed when programming an induction dose.
Plasma Control Mode
See section 4.5.4, page 28.
Effect-site Control Mode
See section 4.5.4, page 28.
start
OK
enter
New ?
exit
C
prog