Technical - Manual - For - Agilia - SP - Range - in - v1.6 - Agilia SP MC - Eng

Agilia SP
Agilia SP MC
Agilia SP MC WiFi
Agilia SP TIVA
Syringe Infusion Pumps
Applicable to software version 1.6
TECHNICAL MANUAL
Symbol Descriptions
Warning
Name and address of the manufacturing facility
(Refer to the Instructions for Use)
Refer to the Instructions for Use Protection against electric shock: class II
Product reference / part number Non-ionizing electromagnetic radiation
Product serial number Fragile, handle with care
Input terminal - connector This way up
Output terminal - connector Keep away from rain
Electrical fuses Temperature limitation
Alternating Current (AC) Humidity limitation
Direct Current (DC) Atmospheric pressure limitation
Index of protection against ingress of water or

IP22 General symbol for recyclable material
particulate matter
Not for use in residential areas Eco packaging symbol
For CA only.
Part included in a recycling process
CCSAUS mark
For US/CA only.

Protection against leakage current; defibrillation-
Caution: Federal law restricts this device to sale by or
proof type CF applied part
on the order of a physician (See 21 CFR 801.109(b)(1))
Name and address of the manufacturer / Date of

0123
CE mark
manufacture
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.
2 10403-7_tm_agilia_sp_V1.6_eng
Table of Contents
1 INTRODUCTION 6
1.1 SCOPE ................................................................................................................................................... 6

1.2 INTENDED USE ....................................................................................................................................... 6
1.3 INTENDED USERS.................................................................................................................................... 6
1.4 CONTRAINDICATIONS ............................................................................................................................... 6
1.5 USE ENVIRONMENT ................................................................................................................................. 6
2 DESCRIPTION 7
2.1 PHYSICAL DESCRIPTION .......................................................................................................................... 7

2.1.1 Housing ...................................................................................................................................................... 7
2.1.2 Keypad ....................................................................................................................................................... 8
2.1.3 Display Board ........................................................................................................................................... 11
2.1.4 CPU Board ............................................................................................................................................... 14
2.1.5 Power Supply Board................................................................................................................................. 18
2.1.6 AC Power Board....................................................................................................................................... 21
2.1.7 Wi-Fi Board .............................................................................................................................................. 22
2.1.8 Back View................................................................................................................................................. 23
2.1.9 Mechanical Framework Assembly............................................................................................................ 23
2.1.10 Mechanical Plunger Driver Assembly....................................................................................................... 23
2.2 PRINCIPLES OF OPERATION ................................................................................................................... 24
2.3 OPERATION DIAGRAM ........................................................................................................................... 25
3 FUNDAMENTALS 26
3.1 TRAINING .............................................................................................................................................. 26

3.2 MAINTENANCE SCHEDULE ..................................................................................................................... 26
3.3 ACCESSING / EXITING THE OPERATING FUNCTIONS ................................................................................ 27
4 PROFILE MENU 28
4.1 ACCESSING THE PROFILE MENU ............................................................................................................ 28

4.2 PROFILE MENU FUNCTIONS ................................................................................................................... 28
5 BASIC PROFILE CONFIGURATION 29
5.1 ACCESSING THE BASIC PROFILE CONFIGURATION .................................................................................. 29

5.2 BASIC PROFILE CONFIGURATION FUNCTIONS ......................................................................................... 29
6 MAINTENANCE OPERATIONS 34
6.1 MAINTENANCE OPTIONS ........................................................................................................................ 34

6.2 RUNNING TESTS ................................................................................................................................... 36
6.2.1 Accessing the Tests Menu ....................................................................................................................... 36
6.2.2 Test 1: Identification ................................................................................................................................. 37
6.2.3 Test 2: Maintenance................................................................................................................................. 38
6.2.4 Test 3: Maintenance Messages ............................................................................................................... 38
6.2.5 Test 4: Events .......................................................................................................................................... 38
6.2.6 Test 5: Force ............................................................................................................................................ 39
6.2.7 Test 6: Displacement................................................................................................................................ 41
6.2.8 Test 7: Syringe Barrel Clasp .................................................................................................................... 43
6.2.9 Test 8: Battery Info ................................................................................................................................... 46
6.2.10 Test 9: Indication ...................................................................................................................................... 47
6.2.11 Test 10: Keypad ....................................................................................................................................... 47
6.2.12 Test 11: Ageing Test ................................................................................................................................ 48
3
6.2.13 Test 12: Battery Life ................................................................................................................................. 49
6.2.14 Test 13: Battery Test ................................................................................................................................ 49
6.2.15 Test 20: Pump Code ................................................................................................................................ 51
6.2.16 Test 21: Power Info .................................................................................................................................. 51
6.2.17 Test 22: LCD Voltage ............................................................................................................................... 53
6.2.18 Test 23: Temperature............................................................................................................................... 53
6.2.19 Test 24: Watchdog ................................................................................................................................... 54
6.2.20 Test 25: Wi-Fi Module Information ........................................................................................................... 55
6.2.21 Checking the Pressure Limit Alarm .......................................................................................................... 56
6.2.22 Checking the End of Infusion Alarm ......................................................................................................... 57
6.2.23 Control the plunger head detection finger and anti-siphon arms movement............................................ 58
6.2.24 Control the disengagement and plunger head alarms ............................................................................. 59
6.2.25 Checking the AC Power Supply / Battery Operation ................................................................................ 61
6.2.26 Electrical Test........................................................................................................................................... 61
6.3 QUALITY CONTROL PROCEDURE............................................................................................................ 62
6.3.1 Running a Quality Control ........................................................................................................................ 62
6.3.2 Quality Control Certificate ........................................................................................................................ 65
6.4 TESTING THE FLOW RATE ..................................................................................................................... 66
7 TROUBLESHOOTING AND MESSAGES 68
7.1 ALARM MESSAGES AND INFORMATION SIGNALS ..................................................................................... 68

7.2 TROUBLESHOOTING GUIDE .................................................................................................................... 71
7.3 ERROR CODES ..................................................................................................................................... 72
8 INTERVENTION PROCEDURES 76
8.1 PROCEDURE #1: BATTERY AND BATTERY DOOR - BOOST CAPACITOR DISCHARGE.................................. 77
8.2 PROCEDURE #2: UPPER CASE .............................................................................................................. 79
8.3 PROCEDURE #3: DISPLAY BOARD/LCD DISPLAY .................................................................................... 81
8.4 PROCEDURE #4: CPU BOARD ............................................................................................................... 83
8.5 PROCEDURE #5: POWER SUPPLY BOARD AND AC POWER BOARD ......................................................... 86
8.6 PROCEDURE #6: WI-FI BOARD .............................................................................................................. 89
8.7 PROCEDURE #7: SYRINGE BARREL CLASP............................................................................................. 92
8.8 PROCEDURE #8: SYRINGE DETECTION SYSTEM ..................................................................................... 96
8.9 PROCEDURE #9: MOTOR ..................................................................................................................... 100
8.10 PROCEDURE #10: DISENGAGEMENT FLEXIBLE CIRCUIT ........................................................................ 103
8.11 PROCEDURE #11: FORCE SENSOR + RIBBON CABLE KIT ..................................................................... 108
8.12 PROCEDURE #12: LINEAR SENSOR KIT................................................................................................ 113
8.13 PROCEDURE #13: PLUNGER COVER AND LEVER KIT ............................................................................ 117
8.14 PROCEDURE #14: PLUNGER KIT .......................................................................................................... 119
8.15 PROCEDURE #15: CARRIAGE KIT ........................................................................................................ 123
9 DEVICE STORAGE 127
10 CLEANING AND DISINFECTING 128
11 POWER MANAGEMENT 129
4
12 TECHNICAL CHARACTERISTICS 130
12.1 POWER SUPPLY .................................................................................................................................. 130

12.2 BATTERY ............................................................................................................................................ 130
12.3 POWER CONSUMPTION ....................................................................................................................... 130
12.4 COMMUNICATION PORT ....................................................................................................................... 131
12.5 INFRARED COMMUNICATION ................................................................................................................ 131
12.6 AGILIA USB CABLE ............................................................................................................................. 131
12.7 COMPLIANCE ...................................................................................................................................... 131
12.8 DIMENSIONS - WEIGHT ........................................................................................................................ 132
12.9 ELECTRONIC BOARDS ......................................................................................................................... 132
12.10 MATERIAL CHARACTERISTICS ............................................................................................................. 132
13 SPECIFICATIONS 133
14 RECYCLING 134
15 WARRANTY 135
16 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 136
17 SPARE PARTS CATALOG 137
18 ORDERING INFORMATION 138
18.1 DATA MANAGEMENT CABLES............................................................................................................... 138

18.2 ASSOCIATED SOFTWARE ..................................................................................................................... 138
18.3 DISPOSABLES ..................................................................................................................................... 138
19 GLOSSARY OF TERMS 139
INDEX 142
5
1 Introduction
1.1 Scope
This technical manual is applicable to the Agilia SP range:
 Agilia SP
 Agilia SP MC
 Agilia SP MC WiFi
 Agilia SP TIVA
The user must adhere to the instructions specified in this technical manual. Failure to adhere to these
instructions may result in damage to the equipment, injury to patients or injury to users.
Certain functions and options described in this technical manual differ from one infusion pump version to
another (Agilia SP, Agilia SP MC, Agilia SP MC WiFi, Agilia SP TIVA), and according to the destination
country.
Warning
Check that this technical manual is applicable to the current software version of the device.
 The software version of the device is displayed on the startup screen.
 The software version described in this technical manual is displayed in the Release Notes at the end
of this document.
1.2 Intended Use

The Agilia SP range is a transportable and reusable device that can be used everyday.
The Agilia SP range can be used for intermittent or continuous infusions.
The Agilia SP range is intended for use on only one patient at a time. It can be reused indefinitely on
multiple patients throughout its lifetime.
For more information, refer to the Instructions for Use of the relevant pump.
1.3 Intended Users

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.
Service and maintenance must only be performed by biomedical engineers or technicians, or by IT
specialists.
Technical maintenance tasks (including inspections and checks) are performed by trained biomedical
engineers, or by dedicated medical rental and/or service organizations who have been trained and
approved by the manufacturer.
For training, contact your Fresenius Kabi sales representative.
1.4 Contraindications
 While being serviced, the device must not be connected to a patient.
 Do not modify the pump (except in the case of operations recommended by Fresenius Kabi).
For more information, refer to the Instructions for Use of the relevant pump.
1.5 Use Environment

Pumps must be used in the operating conditions (temperature, pressure, humidity and altitude) specified
in their Instructions for Use. Refer to the Instructions for Use of the relevant pump.
6
2 Description
2.1 Physical Description

2.1.1 Housing
9 1
1
8 7
2 3
3
6
4 5
Figure 2.1: Housing
Legend
1 Cover 6 Disengagement Lever
2 Keypad 7 Syringe Guard
3 Base 8 Syringe Flange Cradle
4 Syringe Barrel Clasp 9 Angle Bracket
5 Plunger Driver
The Agilia SP range of pumps is made up of 3 main parts: a cover, a base and an angle bracket.
 The cover contains the following:
- Display board
- Keypad
 The base supports the following:
- CPU board
- Mechanical framework assembly
- Plunger driver unit
- Wi-Fi board (for Wi-Fi infusion pumps)
 The angle bracket supports the following:
- Power supply board
- AC power board
- Battery
- Fixing clamp system
7
2.1.2 Keypad
There are different keypads depending on the pump's model and country of destination.
1
2 14
3
4
13
4 5 6 7 8 9 10 11 12
Figure 2.2: Keypad for Agilia SP ROW
Legend
1 Screen 8 Infusion Indicator Lights
2 Battery Charge Status Indicator 9 Decrement
3 Power Supply Indicator 10 Fast Decrement
4 On / Off 11 Confirm Value / Move to Next Field
5 Bolus / Prime 12 Stop

Menu / Cancel Value / Move Back to Previous
6 Fast Increment 13 Field
7 Increment 14
3 Alarm Silence
8
1
2 17
3
16
4
15
14
5 6 7 8 9 10 11 12 13
Figure 2.3: Keypad for Agilia SP MC NAM
1
2 17
3
16
4
15
14
5 6 7 8 9 10 11 12 13
Figure 2.4: Keypad for Agilia SP MC ROW
Legend
1 Screen 10 Decrement
2 Battery Charge Status Indicator 11 Fast Decrement
3 Power Supply Indicator 12 Confirm Value / Move to Next Field
4 Wi-Fi Symbol (for Wi-Fi pumps only) 13 Stop / Pause
5 On / Off 14
3 Cancel Value / Move Back to Previous Field
6 Bolus / Prime 15
3 Menu
7 Fast Increment 16
3 Pressure Menu
8 Increment 17
3 Alarm Silence
9 Infusion Indicator Lights
9
1
2 16
3
15
4
SP
14
13
4 5 6 7 8 9 10 11 12
Figure 2.5: Keypad (Agilia SP TIVA, Japanese market )
Legend
1 Screen 9 Decrement
2 Battery Charge Status Indicator 10 Fast Decrement
3 Power Supply Indicator 11 Confirm Value / Move to Next Field
4 On / Off 12 Stop / Pause
5 Bolus / Prime 13 Cancel Value / Move Back to Previous Field
6 Fast Increment 14
3 Menu
7 Increment 15
3 Graph
8 Infusion Indicator Lights 16

3 Alarm Silence
10
2.1.3 Display Board
The display board is located under the front of the command panel, and contains all essential parts for
human-machine interaction:
 Keypad
 Synoptics and control indicators
 LCD screen
This board is connected to other parts with the connectors shown below.
J2
J1
J3
Figure 2.6: Display Board
Legend
J1 J1 Connector to Keypad
J2 J2 Connector to CPU Board
J3 J3 Connector to LCD Display
11
J1 Connector to Keypad
Pin n° Signal Description
1 GND Ground
2 KBD_COL_0 Column 0
5 KBD_LINE_0 Line 0
6 KBD_LINE_1 Line 1
7 KBD_LINE_2 Line 2
8 TON/OFF On/Off key
9 KBD_LINE_3 Line 3
10 GND Ground
11 GND Ground
12 GND Ground
J2 Connector to CPU Board

1 GND Ground
2 PRES_BOARD/ HMI board presence detection
3 +3V3 +3.3V power supply
5 ANA_VLCD LCD charge pump voltage
6 GND Ground
7 S_ANA_DOOR Door close detection
8 RESET/ Global reset
9 GND Ground
10 CS_LED-KBD/ LED or keypad selection
11 CS_LCD/ LCD selection
12 GND Ground
LCD type of the interface cycle:
13 LCD_CD
Control/Data (0:control, 1:data)
14 LCD_MS LCD mode selection
15 GND Ground
16 HMI_MOSI_SDA SPI data written / I²C data for HMI board
17 GND Ground
18 HMI_MISO SPI data read for HMI board
19 GND Ground
20 HMI_SCK_SCL SPI/I²C clock for HMI board
21 GND Ground
22 KON-OFF On/Off key
23 +5V +5V power supply
25 CMD_FAIL LED command failure
26 GND Ground
12
J3 Connector to Display
1 GND Ground
2 A Anode of the backlight (+5V)
3 K Cathode of the backlight
4 GND Ground
5 SCK SPI clock (HMI_SCK_SCL signal)
6 GND Ground
7 SDA SPI data (MOSI) (HMI_MOSI_SDA signal)
8 GND Ground
9 CD Control/Data (0:control, 1:data) (LCD_CD signal)
10 GND Ground
11 /RST Reset (RESET/ signal)
12 GND Ground
13 CS0 Chip select (CSLCD/ signal)
14 GND Ground
15 BM0/DB13 Mode select (LCD_MS signal)
16 GND Ground
17 VLCD Charge pump voltage (ANA_VLCD signal)
18 GND Ground
19 +3V3 +3V3 power supply
20 GND Ground
21 GND Ground
22 GND Ground
13
2.1.4 CPU Board
The CPU board consists of a main microcontroller, FLASH and RAM memories, and various analog or
power functions, such as:
 One single-step bipolar motor command
 Adjustment of and acquisition from different detectors
 Different lines of communication (synchronous and asynchronous serial links).
The CPU Board is connected to the Display Board with the J3 connector.
A ribbon cable connects it to the Power Supply Board with the J6 connector.
J1 J2
J3
J5
J4
J6 J7 J8
Figure 2.7: CPU Board (Front View)
J9
Figure 2.8: CPU Board (Back View)
Legend
J1 J1 Connector - Connection to Syringe Barrel J6 J6 Connector - Connection to Power Supply Board
Clasp (potentiometer and flange switch)
J2 J2 Connector - Connection to Linear Displacement J7 J7 Connector - Connection to Motor
Potentiometer
J3 J3 Connector - Connection to Display Board J8
J1 J8Connector - Connection to JTAG Connector
(micro programming)
J4 J4 Connector - Connection to Wi-Fi Board if one is J9 J9 Connector - Connection to Plunger Driver
present (force sensor and disengagement opto switch)
J5 J5 Connector - Connection to Opto Motor
14
J1 Connector to Syringe Barrel Clasp
1 GND Ground
2 SW_OUT Flange switch state
3 SW_IN Flange switch power supply
4 DIA+ +3.3 V power supply
5 DIA_OUT Syringe barrel clasp potentiometer value
6 DIA- Ground
J2 Connector to Displacement Linear Potentiometer

1 DISP- Ground
2 DISP_OUT Displacement potentiometer status
3 DISP+ +3.3 V power supply
J3 Connector to Display Board

1 GND Ground
2 A Anode of the backlight (+5V)
3 K Cathode of the backlight (K_BACKL signal)
4 GND Ground
5 SCK SPI clock (HMI_SCK_SCL signal)
6 GND Ground
7 SDA SPI data (MOSI) (HMI_MOSI_SDA signal)
8 GND Ground
9 CD Control/data (0:control, 1:data) (LCD_CD signal)
10 GND Ground
11 /RST Reset (RESET/ signal)
12 GND Ground
13 CS0 Chip select (CSLCD/ signal)
14 GND Ground
15 BM0/DB13 Mode select (LCD_MS signal)
16 GND Ground
17 VLCD Charge pump voltage (ANA_VLCD signal)
18 GND Ground
20 GND Ground
21 GND Ground
22 GND Ground
15
J4 Connector to Wi-Fi Board (for Wi-Fi pumps only)
1 Floating Not used on Agilia VP range. Leave floating
3 GND Ground
6 GND Ground
7 WIFI_VCC +3V3 Wi-Fi power supply
9 UART-RxD Receive data
10 UART-TxD Transmit data
11 UART-RTS Hardware flow control (request to send)
12 UART-CTS Hardware flow control (clear to send)
13 GND Ground
14 GND Ground
J5 Connector to Opto Motor

Pin n° Type Signal Description
1 Power GND Ground
2 Input OP_OPTO Analog output signal of the photomicrosensor (photo-transistor collector)
3 Power GND Ground (photo-transistor emitter)
4 Power GND Ground (photo-diode cathode)
5 Output OP_CD_OPTO Power supply signal of the photomicrosensor (photo-diode anode)
6 Power GND Ground
J6 Connector to Power Supply Board

1 GND Ground
2 PRES_BOARD/ HMI board presence detection
5 ANA_VLCD LCD charge pump voltage
6 GND Ground
7 S_ANA_DOOR Door close detection
8 RESET/ Global reset
9 GND Ground
10 CS_LED-KBD/ LED or keypad selection
11 CS_LCD/ LCD selection
12 GND Ground
13 LCD_CD LCD type of the interface cycle: Control/data (0:control, 1:data)
14 LCD_MS LCD mode selection
15 GND Ground
16 HMI_MOSI_SDA SPI data written/I²C data for HMI board
17 GND Ground
18 HMI_MISO SPI Data read for HMI board
19 GND Ground
20 HMI_SCK_SCL SPI/I²C clock for HMI board
21 GND Ground
16
26 GND Ground
J7 to Motor Connector
1 MOTP_OUT1B Output B of the coil 1
2 MOTP_OUT1A Output A of the coil 1
3 MOTP_OUT2A Output A of the coil 2
4 MOTP_OUT2B Output B of the coil 2
5 GND Ground
6 GND Ground
J8 to JTAG Connector (micro programming)

1 GND Ground
3 TRST/ Test reset
4 TDO Test data output
5 GND Ground
6 TDI Test data input
7 MR/ Manual reset
8 TMS Test mode select
9 TCK Test clock
10 GND Ground
J9 Connector to Plunger Driver

1 GND Ground
2 PLGH_OPTO/ Analog output signal of the piston photomicrosensor
3 FORCE - Negative input of the force sensor
4 FORCE + Positive input of the force sensor
5 +3V3 3V3 power supply of force sensor
6 DSG_OPTO/ Analog output signal of the release photomicrosensor
7 PLGHDSG_CD_OPTO Power supply signal of the photomicrosensors
8 DSG_SW_ON/ Analog output signal of the release switch
9 DSG_SW_OFF/ Analog output signal of the release switch
10 GND Ground
17
2.1.5 Power Supply Board
The power supply board consists of he following:
 An ATtiny26L secondary microcontroller associated with the one on the CPU board.
 Different analog or power functions, including:
- Power supply management for all boards
- Battery charger
- Infrared interface
- Separate lines of communication (internal and external) to the boards
- Speaker
- Buzzer
- Super-capacitor
The power supply board is located on the angle bracket. See figure 2.1, page 7. It supplies power to the
electronic unit from the 100 V - 240 V AC network, or from 9 V DC. It also charges a 2.2 Ah battery. This
board is connected to other parts with the connectors shown below.
J1
J2
Figure 2.9: Power Supply Board (Front View)
J5
J3
J4
Figure 2.10: Power Supply Board (Back View)
Legend
J1 Connector - Connection to CPU Board J4 Connector - Connection to Secondary
J1 J4
Microcontroller
J2 Connector - Connection to microphone, J5 Connector - Connection to AC Power Board
J2 speaker and external plug (RS232 Communication J5
Port and DC Power Input/Output)
J3 J3 Connector - Connection to Internal Battery
18
1 GND Ground
4 GND Ground
5 +VCOMM Common power supply (main or external +10V)
6 +VCOMM Common power supply (main or external +10V)
7 GND Ground
8 SO_ANA_SPEAK Speaker analog output
9 +3V3-PERM Permanent +3.3V power supply (battery backup)
10 GND Ground
11 PWR_SCL I²C clock for POWER board
12 GND Ground
13 PWR_SDA I²C data for POWER board
14 GND Ground
15 IRDA_TX Infrared data transmission
16 PWR_CD_PRI_VCOMM Primary microcontroller common power supply switch
17 IRDA_RX Infrared data received
18 SO_CD_SHDN/ Speaker shutdown command
19 SO_ANA_MIC Analog microphone input
20 GND Ground
21 EXT_TX External transmit data
22 PRES_BOARD/ HMI and UC board presence detection
23 EXT_RX External receive data
26 GND Ground
J2 Connector to External plug

1 SP- Negative connection to the speaker
2 SP+ Positive connection to the speaker
3 GND Ground - Terminal 2 of the microphone
4 MIC_TERM1 Microphone terminal 1 signal
5 GND Ground
6 VEXT_IN 10 VDC input
7 GND Ground
8 RELAY Nurse call output
9 GND Ground
10 5V0_OUT 5 VDC output
11 RXD RxD communication line
12 TXD TxD communication line
13 GND Ground
14 GND Ground
19
J3 Connector to Internal Battery
1 VBAT Positive output of the smart battery
2 BAT_DATA One-wire communication link between the SMP and the battery
3 GND Ground (negative output of the smart battery)
4 GND Ground
5 GND Ground
J4 Connector to ATtiny 26 Secondary Microcontroller

1 MISO Secondary microcontroller SPI data input
2 +3V3-PERM Secondary microcontroller power supply
3 SCK Secondary microcontroller SPI clock
4 MOSI Secondary microcontroller SPI data output
5 RST/ Secondary microcontroller reset
6 GND Ground
J5 Connector to AC Power Board

1 Neutral Neutral wire
2 Line Hot wire
3 GND Ground
20
2.1.6 AC Power Board
The AC power board contains the power cord inlet, the ECM filter, and the F1 line fuse.
It is the interface of the power supply. The AC power board is located on the angle bracket.
See figure 2.1, page 7. This allows the power supply board to be changed without the need for soldering.
This board is connected to other parts with the connectors shown below.
J1
Figure 2.11: AC Power Board (Front View)
J2
F1 1
Figure 2.12: AC Power Board (Back View)
Legend
J1 J1 Connector - Connection to Power Supply F1
J1 Line Fuse F1
Board
J2 J2 Connector - Power Cord Inlet 1
J1 Fuse Identification Label
J1 Connector to Power Supply Board

2 Line Hot wire
3 GND Ground
J2 Connector to AC Power
2 Line Hot wire
3 GND Ground
21
2.1.7 Wi-Fi Board
For Agilia Wi-Fi pumps only.
The Wi-Fi board is securely fixed to a holder above the CPU Board.
A ribbon cable connects it to the CPU Board with the J1 connector.
Figure 2.13: Wi-Fi Board (Front View)
J1
Figure 2.14: Wi-Fi Board (Back View)
Legend
J1 J1 Connector - Connection to CPU Board

3 GND Ground
6 GND Ground
9 UART-RxD Receive data
10 UART-TxD Transmit data
11 UART-RTS Hardware Flow Control (Request to send)
12 UART-CTS Hardware Flow control (Clear to send)
13 GND Ground
14 GND Ground
22
2.1.8 Back View
5
4
3
1 2
Figure 2.15: Back View
Legend
1 Release Button 4 Power Cord Inlet
21 Rotating Pole Clamp 53 Infrared Cell
3 RS232 Communication Port 63 Attachment Lock Knob
2.1.9 Mechanical Framework Assembly

The mechanical framework assembly is made up of a motor-reducer unit which drives a rack screw-nut
assembly, made up of 2 flanges and a linear sensor.
The mechanical assembly also contains a photo-electric cell dedicated to monitoring the motor’s rotation.
2.1.10 Mechanical Plunger Driver Assembly

The mechanical plunger driver assembly is located on the mechanical framework. The framework ensures
the displacement of the plunger via a screw-nut system.
The plunger driver is equipped with a disengagement control which allows it to disassociate from the
screw-nut system.
23
2.2 Principles of Operation
From an operational point of view, the Agilia SP range of pumps is made up of 3 sub-assemblies:
 Syringe test and maintenance
 Motory
 External connection
2.2.1 Syringe Test and Maintenance Sub-assembly

The syringe is positioned in its housing and held in place by the syringe barrel clasp.
Detection of the syringe size (50/60 mL, 30 mL, 20 mL, 10 mL or 5 mL) is ensured by the potentiometric
sensor positioned on the syringe barrel clasp.
The correct positioning of the syringe flanges in the groove is checked by detecting the flanges.
2.2.2 Motor Sub-assembly

The motor sub-assembly ensures the displacement of the syringe piston.
It is set in motion by a motor-reducer linked to a screw-nut system.
Rotation control is ensured by a pinion attached to a motor shaft end and connected to an opto-electric
sensor.
A linear potentiometer mounted on an aluminum profile uses a rolling ball contact to ensure plunger
displacement control.
A micro-switch allows the disengagement mechanism position to be checked.
Correct positioning of the piston against the plunger driver is tested by the anti-siphon arm.
A force sensor integrated into the plunger driver detects the force exerted on the piston, and triggers an
alarm when the limit has been reached.
2.2.3 External Connection Sub-assembly

The Agilia SP range of pumps has two plugs located at the back of the angle bracket. See figure 2.15,
page 23.
 AC power supply plug
 8-pin binder plug which, together with various specific Fresenius Kabi accessories, enables the
following:
- Continuous external power supply
- Serial link
24
2.3 Operation Diagram
Opening Optical sensor
levers (plunger driver
head)
Switch (detection) Plunger driver head
Opening
arms
Potentiometer
Force
Syringe barrel clasp
sensor
Switch
(disengagement)
Half nuts
Gear Optical sensor

box (disengagement)
Optical
sensor
Stepper Linear
motor potentionmeter
Pumping mechanism Syringe installation Position sensor Plunger head

DISPLAY BOARD
Force sensor
LEDs Optical sensor
Motor driver
Electronic Electronic Electronic
interface interface interface interface
Integrated
amplifier
Interface
Internal communication
watchdog
Flash memory
Main microprocessor
Display Keypad RAM memory
Temperature sensor
Supervisory circuit
Sound Communication
management interface
Wi-Fi BOARD communication Watchdog
CPU BOARD
(if present)
Microphone
Secondary Battery/Battery
microprocessor charger
HP
Speaker
IrDa Battery
Interface Communication
communication Internal watchdog
RS232 to USB cable
External connector
AC/DC
DC supplies converter
Different
voltages
Power supply
Safety management
POWER SUPPLY BOARD
EMC filter AC
power supply
AC POWER BOARD
25
3 Fundamentals
3.1 Training
The following three training levels outline the specifics needed to maintain and preserve the equipment.
Training level Description / Prerequisites

Training intended for users for on-site maintenance, using the technical documentation of the pump and
specific tools:
1
 Knowledge of mechanics and electronics
 Biomedical structure knowledge
Training intended for technicians specializing in maintenance performed with specific tools and
procedures:
2
 Good mechanical and electronics knowledge
 Two years experience minimum in a biomedical department
Training intended for technicians specialized in repair performed in the maintenance department using
specific procedures and tools, including instruments for measurement and adjustments. Complete check-
up using this pump manual:
3
 Good mechanical and electrical knowledge
 Good computer knowledge
 At least two years experience in a biomedical department
Information
3.2 Maintenance Schedule

3.2.1 Preventive Maintenance
Any abnormal functioning or failures must be reported to the qualified technical staff in your organization,
or to your Fresenius Kabi representative. In these instances, the pump should not be used.
Warning
In order to maintain the pump’s performance, a preventive maintenance inspection must be carried out at
least once every 3 years. This procedure, which includes changing the battery, should be carried out by
trained and qualified technical personnel in compliance with this document and procedures. Only
authorized personnel should attempt to repair the device.
If these maintenance procedures are not observed, the pump’s correct operation will be impaired.
3.2.2 Quality Control

Upon request by the healthcare facility, a quality control check can be performed on the device every
12 months.
A regular quality check (not included in the guarantee) consists of various inspection operations listed in
this document. See section 6.2, page 36.
Information
These control checks must be performed by trained technical personnel, and are not covered by any
contracts or agreements provided by Fresenius Kabi.
For more information, contact your Fresenius Kabi sales representative.
26
3.3 Accessing / Exiting the Operating Functions
The Options menu gives access to the functions for operating the pump. The Options menu allows the
operator to customize the pump, edit infusion and maintenance parameters, and run tests.
The Options menu comprises the following:
 Pump Settings
 Basic Profile Configuration
 Profile Menu
 Maintenance
3.3.1 Accessing the Options Menu

When the pump is powered off, simultaneously press both and to access the Options menu.
Options Menu Access code? Description

Pump Settings No (unless modified by Test20) Please refer to the IFU.
Profile Yes Section 4, page 28.
Basic Profile Configuration Yes Section 5, page 29.
Maintenance Yes Section 6, page 34.
Information
If the wrong access code is entered, Error is displayed.
As long as the pump remains powered on, the code does not need to be entered again.
Commands
Operation Key
Scroll options and change selected value (increasing/decreasing) Arrow keys
Confirm Value / Move to Next Field Confirmation key
Select -Deselect  Fast Increment key
Go to parent menu (if any) and cancel option Menu key
3.3.2 Exiting the Options Menu

Power the pump off and on again to exit the Options menu and return to standard operation.
All data, including newly selected and entered option, is saved to memory when the pump is powered off.
27
4 Profile Menu
4.1 Accessing the Profile Menu

1. Access the Options menu. See section 3.3, page 27.
2. Press the arrow keys to select Profile menu.
3. Press enter.
4. Enter the Profile menu access code "0080".
5. Press OK.
4.2 Profile Menu Functions

Function Choice Action
Pro 1: Default profile Basic Profile Displays the active profile name, and gives access
Profile 1 to the profile menu by the confirmation key.
Selects and loads a profile. See procedure below.
Profile 2
...
Pro 2: Select profile at power on Select  - Deselect  Activates or deactivates profile selection at startup.
- Restores the Basic Profile factory settings to the
Pro 3: Restore Basic Profile (Factory settings)
pump.
Selecting and loading a profile

1. Access the Profile menu.
2. Press the arrow keys to select Pro1: Default profile.
3. Press enter.
4. Press the arrow keys to select the profile name in the list provided.
5. Press OK.
The relevant profile information is displayed:
 Profile name
 Author
 Creation date
 Modification date
 Version
Information
In addition to Basic Profile, the default profile names are available if specified with Vigilant Drug'Lib.
Vigilant Drug'Lib may not be available in some countries. Contact your Fresenius Kabi sales
representative.
6. Press OK to confirm the loading operation, or C to change the profile.

The drug library associated with the selected profile is loaded.
28
5 Basic Profile Configuration
The Basic Profile Configuration menu is available only if Basic Profile has previously been selected as the
default profile. See section 4, page 28.
5.1 Accessing the Basic Profile Configuration

2. Press the arrow keys to select Basic Profile configuration.
3. Press enter.
4. Enter the Basic Profile configuration access code "0200".

5. Press OK.
6. Press the arrow keys to select the setting category (User or Ward).
7. Press enter.
5.2 Basic Profile Configuration Functions

Function Setting Description Range of Settings
User 1: Displays the volume-dose on the Enabled / Disabled
Vol-dose information
Screen options infusion monitoring screen.
Displays the remaining infusion time Enabled / Disabled
Time information
on the infusion monitoring screen.
Displays the the battery life Enabled / Disabled
Battery life information information on the infusion
monitoring screen.
Displays a man as infusion in Enabled / Disabled
Man
progress indicator
Displays a syringe as infusion in Enabled / Disabled
Syringe
progress indicator
User 2: Profile Pro Displays or hides menu items Enabled / Disabled
Menu items available for Basic Profile.
Volume limit VL
Volume/Time V/T
or Dose/Time D/T
Pause
Patient
Programmed bolus
Alarm volume
Vol-dose history
View event log
Library information
Data Set DS
29
User 4: Pressure Mode Selects the mode. 3 levels / Variable
 Variable: One initial pressure
value that can be adjusted during
infusion.
 3 levels: 3 fixed pressure limits
that can be selected during
infusion.
DPS Activates or deactivates the DPS Yes / No
(Dynamic Pressure System) mode
while an infusion is in progress.
Unit Selects the pressure unit. mmHg / kPa (for
Japanese market only) /
PSI
Maximum pressure value If Mode = Variable, defines the 500  900 mmHg
maximum pressure allowed during
an infusion.
High pressure value If Mode = 3 levels, defines the 300  750 mmHg
maximum pressure allowed during
an infusion.
Medium pressure value If Mode = 3 levels, defines the 150  600 mmHg
medium pressure allowed during an
infusion.
Low pressure value If Mode = 3 levels, defines the low 50  300 mmHg
pressure allowed during an infusion.
Limit stored If enabled, the last pressure limit Enabled / Disabled
adjustment is automatically stored in
memory for the next startup.
If disabled, the user has to enter
pressure limit for the next startup.
Limit If Limit stored is disabled, sets the 50 mmHg  "Maximum
maximum pressure allowed during pressure value"
an infusion.
If Limit stored is enabled, the limit is
set to ’---’ and cannot be changed.
Drop threshold If DPS = Yes, sets a pressure drop ’----’ (No drop pressure
threshold. A message is generated if monitoring) or:
the pressure drops below this 100  500 mmHg
threshold.
Raise threshold If DPS = Yes, defines a pressure rise 100  200 mmHg
threshold. A message is generated if
the pressure rises above this
threshold.
DPS stored If DPS = Yes and DPS stored is Enabled / Disabled
enabled, the latest DPS adjustments
during infusion are saved
automatically at power off for the
next startup.
If DPS stored is disabled, the DPS
adjustments must be entered at the
next startup.
User 5: KVO KVO1 Sets the KVO1 flow rate. 0.1  5 mL/h
KVO2 Sets the KVO2 flow rate. 0.1  5 mL/h
Continuous Activates the Continuous function. Yes / No
After the VTBI is completed, the
infusion continues at the
programmed flow rate.
Silence duration Sets the silence duration alarm in 1 min  12 hours
KVO.
30
User 12: View flow rate history Displays or hides menu item: View Enabled / Disabled
Graph items flow rate history.
View pressure history Displays or hides menu item: View Enabled / Disabled
pressure history.
View concentration history Displays or hides menu item: View Enabled / Disabled
concentration history (For
Agilia SP TIVA)
Par 1: Key press sound Turns the key press sound on or off. Enabled / Disabled
Key press sound
Par 2: Alarm Volume Sets the volume for alarms. 7 volume levels
Alarm Volume
Par 3: Drug and parameters: Saves the drug name only, or all Enabled / Disabled
Store infusion  Store drug name only infusion parameters, or nothing.
parameters  Store param. infusion
Same infusion screen: If Displayed is enabled, enables the Enabled / Disabled
Displayed display of the same infusion screen.
Same infusion screen:Time Duration of context backup. 1  24 hours
Volume infused: Cleared If Cleared is enabled, the infused Enabled / Disabled
volume is reset to 0 at each infusion
start.
Volume infused: Stored If Stored is enabled, the infused Enabled / Disabled
volume is saved in memory.
Par 4: Maximum rate for 50 mL Sets the maximum infusion rate for 0.1  1200 mL/h
Maximum rate syringe 50 / 60 mL syringes.
Maximum rate for 30 mL Sets the maximum infusion rate for 0.1  600 mL/h
syringe 30 mL syringes.
Par 7: Infusion start: Mandatory Displays a Mandatory prime Enabled / Disabled
Infusion start prime message, an Advised prime
Infusion start: Advised message, or no message prior to Enabled / Disabled
prime starting an infusion.
Par 8: Empty syringe mode If Empty syringe mode is enabled, Enabled / Disabled
Empty syringe an "Empty syringe mode" banner
starts blinking after the
acknowledgement of a medium-
priority "End of infusion" alarm.
Par 9: 50 mL Sets the bolus rate for 50 mL 0.1  1200 mL/h
Bolus rates syringes.
30 mL Sets the bolus rate for 30 mL 0.1  600 mL/h
syringes.
syringes.
syringes.
syringes.
Par 15: Syringe name Displays the syringe or ward name in Enabled / Disabled
Syringe/ward name Ward name the Infusion monitoring screen.
displays
31
Par 18: Screen brightness low Brightens or darkens the screen at Enabled / Disabled
Day/Night mode next night mode startup.
Infusion indicators low Brightens or darkens the infusion Enabled / Disabled
indicators at next night mode startup.
Key press sound off Turns on or off the key press sound Enabled / Disabled
at next night mode startup.
Manual mode Displays or hides "Day/Night mode" Enabled / Disabled
menu item.
Auto mode Enables/disables the ability to Enabled / Disabled
automatically activate night mode.
Day/Night mode If Auto mode is enabled, press OK 00h00  23h59
to set a daily period for the automatic 00:00  23:59
activation of night mode.
Par 19: Direct bolus Activates or deactivates the Direct Enabled / Disabled
Other functions bolus function.
Loading dose or Activates or deactivates the Loading Enabled / Disabled
Induction dose dose or Induction dose function.
(Agilia SP TIVA)
Programmed bolus Activates or deactivates the Enabled / Disabled
Programmed bolus function.
Par 20: Concentration units Sets the available concentration Enabled / Disabled
Authorized units units: nanog, µg, mg, g, mmol, munit,
unit, cal, kcal, mEq, /mL, /XmL
Dose unit Sets the available dose units: Enabled / Disabled
nanog/h, nanog/kg/min, nanog/kg/h,
µg/h, µg/min, µg/kg/min, µg/kg/h,
mg/min, mg/h, mg/24h, mg/kg/min,
mg/kg/h, mg/kg/24h, mg/m2/h,
mg/m2/24h, g/h, g/kg/min, g/kg/h,
g/kg/24h, mmol/h, mmol/kg/h,
mmol/kg/24h, munit/min,
munit/kg/min, munit/kg/h, unit/min,
unit/h, unit/kg/min, unit/kg/h, kcal/h,
kcal/24h, kcal/kg/h, mEq/min,
mEq/h, mEq/kg/min, mEq/kg/h
Par 22: Dose Sets the available modes for the Enabled / Disabled
Programming modes profile.
Par 23: Min weight (kg) Sets the lower programmable limit of 0.25 kg 
Patient parameters patient weight. "Max weight (kg)"
Max weight (kg) Sets the upper programmable limit of "Min weight (kg)" 
patient weight. 350 kg
Default weight (kg) Sets the patient default weight. "Min weight (kg)" 
"Max weight (kg)"
Min surface (m²) Sets the lower programmable limit of 0.05 m² 
patient BSA. "Max surface (m²)"
Max surface (m²) Sets the upper programmable limit of "Min surface (m²)"
patient BSA.  4.5 m²
Default surface (m²) Sets the default patient BSA. "Min surface (m²)"

"Max surface (m²)"
Par 25: Same therapy screen Displays the same therapy screen Yes / No
Same therapy when changing current drug.
screen
Par 31: Time Sets the remaining time that triggers 1  30 min
Near end of infusion the Near end of infusion alert.
alert
32
Par 34: While stopped only If While stopped only is enabled, Enabled / Disabled
Rate titration allows rate modification after an
infusion stop only.
Note:
 The displayed menu may change depending on the pump configuration and destination country.
 µ = mc or micro.
33
6 Maintenance Operations
6.1 Maintenance Options

6.1.1 Accessing the Maintenance Options Menu
2. Press the arrow keys to select Maintenance.
3. Press enter.
4. Enter the Maintenance access code.

5. Press OK.
6. Press the arrow keys to select Maintenance options.

7. Press enter.
6.1.2 Maintenance Date

1. Access the Maintenance options menu. See section 6.1.1, page 34.
2. Press the arrow keys to select Svc 1: Maintenance date.
3. Press enter.
The next scheduled maintenance date is displayed.
4. Press exit to return to the Maintenance options menu.
Information
This date corresponds to the next preventive maintenance date to be carried out.
See section 3.2.1, page 26.
The date is displayed for consultation only, and cannot be changed here.
6.1.3 Initial Set up

2. Press the arrow keys to select Svc 2: Initial set up.
3. Press enter.
4. Select Yes using the arrow keys to ask for the initial configuration to be
loaded at the next pump startup. Otherwise, select No.
5. Press OK to confirm the selection.
34
6.1.4 Data Log Event
2. Press the arrow keys to select Svc 3: Data log event.
3. Press enter.
4. Use the arrow keys to select the desired clinical or technical event.
5. Press enter.
The details of the event are displayed.
6. Press exit to return to the Maintenance options menu.
6.1.5 Maintenance Information

2. Press the arrow keys to select Svc 4: Maintenance information.
3. Press enter.
4. Press to allow or disallow the display of a Maintenance info. screen at the

next pump startup.
5. Press OK to confirm the selection.
35
6.2 Running Tests
You must systematically run tests after calibrating sensors.
At the end of a full test cycle, you can obtain certificates. See section 6.3.2, page 65.
Information
Before running Tests/Controls from the pump or with Agilia Partner, it is recommended to work with a
pump configured with the Basic Profile and with Factory (default) settings. Load the Basic Profile from the
pump’s maintenance Profile menu: "Pro 3:Restore Basic Profile". See section 4.2, page 28.
Calibration Associated Tests

Force sensor  Occlusion alarm
Syringe barrel clasp  Syringe barrel clasp
Displacement  Displacement
6.2.1 Accessing the Tests Menu

2. Press the arrow keys to select Maintenance.
3. Press enter.
4. Enter the Maintenance access code.

5. Press OK.
6. Press the arrow keys to select Tests.

7. Press enter.
The Tests screen is displayed.
List of Tests
Tests Tests
Test 1 Identification. See section 6.2.2, page 37. Test 11 Ageing test. See section 6.2.12, page 48.
Test 2 Maintenance options. See section 6.2.3, page 38. Test 12 Battery life. See section 6.2.13, page 49.
Maintenance messages.
Test 3 Test 13 Battery test. See section 6.2.14, page 49.
Test 4 Events. See section 6.2.5, page 38. Test 20 Pump code. See section 6.2.15, page 51.
Test 5 Force. See section 6.2.6, page 39. Test 21 Power information. See section 6.2.16, page 51.
Test 6 Displacement. See section 6.2.7, page 41. Test 22 LCD voltage. See section 6.2.17, page 53.
Test 7 Syringe barrel clasp. See section 6.2.8, page 43. Test 23 Temperature. See section 6.2.18, page 53.
Test 8 Battery information. See section 6.2.9, page 46. Test 24 Watchdog. See section 6.2.19, page 54.
Wi-Fi module information.
Test 9 Indication. See section 6.2.10, page 47. Test 25
Test 10 Keypad. See section 6.2.11, page 47.
36
6.2.2 Test 1: Identification
Test Description
This test checks that the Identification parameters of the pump are correct. The Identification
parameters are displayed for information only. They cannot be modified here.
1. Access the Tests menu. See section 6.2.1, page 36.

2. Press the arrow keys to select Test 1: Identification.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
 Pump name
 Pump version or revision with software generation date
 Pump serial number
 CPU board serial number
 Power supply board serial number
 Power supply board software version or software revision with the
generation date
 Battery serial number
 For each language available:

- Language name
- Language file version or revision
- Language file creation date
 For each parameter zone:
- Parameter zone number + version or revision
- Parameter zone creation date
- Last manual modification date
 Boot version or revision
 Boot creation date
 Embedded software version or software revision with the generation date
5. Press exit to return to the Tests menu.
37
6.2.3 Test 2: Maintenance
Test Description
Run this test to check that the pump maintenance data is correct.

2. Press the arrow keys to select Test 2: Maintenance.
3. Press enter.
 Duration: Running time since last preventive maintenance in hours (if less
than 72 hours), in days (if less than 120 days) or in months
 Date: Last preventive maintenance date
 Total duration: Total running time in hours (if less than 72 hours), in days
(if less than 120 days) or in months.
 Total distance: Total running distance of the plunger’s driver in m.
6.2.4 Test 3: Maintenance Messages

Test Description
Run this test to check the maintenance messages entered. The maintenance message is
displayed for information only. It cannot be modified here.

2. Press the arrow keys to select Test 3: Maintenance messages.
3. Press enter.
Informational messages stored by After Sales Service are displayed.
6.2.5 Test 4: Events

Test Description
Run this test to consult the list of pump events, and the details of each recorded technical event.
The clinical events are not displayed here.

2. Press the arrow keys to select Test 4: Events.
3. Press enter.
The technical events are listed.
4. Press the arrow keys to select an event.
5. Press enter.
The selected event is displayed in detail.
6. Press the arrow keys to scroll through the event detail screen.
7. Press exit to return to the list of events.
38
6.2.6 Test 5: Force
Test Description
The syringe force sensor is used to monitor the pressure and detect occlusions in the syringe.
Run this test to validate the accuracy of the force sensor.
This test checks the pressure inside the syringe when an occlusion alarm is triggered.
Force sensor
Force sensor
Main
microprocessor Integrated
amplifier
CPU BOARD
The force sensor works properly and is correctly calibrated.

This test failed if one of these two conditions is encountered:
 The force sensor is not calibrated. Calibrate the force sensor using Agilia Partner
maintenance software.
 The force sensor is defective, or not correctly connected to the CPU board. This
problem leads to an error code 22:
- Check the cable connection to CPU board (J9 connector). See figure 2.7,
page 14.
- Replace the force sensor. See section 8.11, page 108.
Required Tools and Equipment

 1 Dynamometer
Prerequisites
 The dynamometer’s calibration certificate is valid.

2. Press the arrow keys to select Test 5: Force.
3. Press enter.
 Conversion: Sensor value in mV. The displayed voltage value depends on
the pressure applied on the sensor
 Force: Force value expressed in g
 0 sensor: Sensor offset value expressed in mV. Value saved during last
calibration
 Force = 0 kg: Calibration at 0 kg (0 PSI or 0 bar) in mV. Value saved
during last calibration
 Force = 5 kg: Calibration at 5 kg (11.6 PSI or 0.8 bar) in mV.Value saved during last calibration
 Date: Date of last calibration displayed in the following format:
Month/Day/Year (mm/dd/yyyy)
 Number: Last calibration number
5. Press the arrow keys to display the Conversion/Force screen.
6. Push the disengagement lever down and move the plunger driver to the right.
7. Apply a force to the sensor, then release it.
8. Check that the Force value is between -200 g and +200 g.
39
9. Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to
the right.
10.Place the dynamometer in the syringe cradle, with the flanges correctly inserted in the provided slot.
11.Secure the dynamometer with the syringe barrel clasp.
12.Slide the arm spacer to the left.
13.Push the disengagement lever, and move the plunger driver gently to the left until it is in contact with
the plunger head of the dynamometer.
14.Release the disengagement lever.
The arms must not be in contact with the arm spacer.
Figure 6.1: Installation of dynamometer
15.Apply a force of 0.4 bar.

16.Check that the Force value is between -2200 g and +2800 g.
17.Press exit to return to the Tests menu.
18.Open the syringe barrel clasp, push the disengagement lever down,
and move the plunger driver to the right to zero the pressure.
19.Start an infusion at 1000 mL/h.
20.Check that the pump triggers an "Occlusion" pre alarm, then an "Occlusion" alarm in less than
60 seconds when 8.0 PSI (0.55 bar) < Pressure < 10.9 PSI (0.75 bar).
21.Press to silence the alarm.
22.Press to stop the infusion.

23.Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to
the right.
24.Remove the dynamometer.
40
6.2.7 Test 6: Displacement
Test Description
The Displacement sensor is a linear potentiometer used to control the linear motion of the
plunger driver and to determine the remaining volume in the syringe.
Run this test to validate the accuracy of the displacement sensor.
Displacement Linear potentiometer
Main sensor
microprocessor
Interface
CPU BOARD
The plunger’s driver displacement is correctly calibrated.

 The displacement sensor is not calibrated. Calibrate the displacement sensor using
Agilia Partner maintenance software.
 The displacement sensor is defective or not correctly connected to the CPU board.
This problem leads to an error code 21:
- Check the cable connection to CPU board (J2 connector).
See figure 2.7, page 14.
- Replace the displacement sensor. See section 8.12, page 113.

 1 displacement verification gauge, 2.56 in (65 mm) long
Prerequisites
 The calibration certificate of the displacement verification gauge is valid.

2. Press the arrow keys to select Test 6: Displacement.
3. Press enter.
the plunger head position
 Position: Plunger head position value in mm
 Low (20 mm): Sensor value in mV when the plunger head is positioned at
20 mm (0.79 in). Value saved during last calibration
 High (115 mm): Sensor value in mV when the plunger head is positioned
at 115 mm (4.53 in). Value saved during last calibration
 Date: Date of last calibration displayed in the following format:
Month/Day/Year (mm/dd/yyyy)
 Linearization: Date of last calibration that included a linearization. This
date is displayed in the following format: Month/Day/Year (mm/dd/yyyy)
41
5. Press the arrow keys to display the Conversion/Position screen.
6. Push the disengagement lever down, and move the plunger driver gently to the right stop.
7. Check the value displayed for Position. The value must be between 4.67 in and 5.41 in
(118.5 mm and 137.5 mm).
8. Push the disengagement lever down, and move the plunger driver gently to the left stop.
9. Check the value displayed for Position. The value must be between 0.39 in and 0.60 in
(10 mm and 15.2 mm).
10.Open the syringe barrel clasp and place the 2.56 in (65 mm) gauge in the syringe cradle, with the
flanges correctly inserted in the provided slot and the 2.56 in (65 mm) part positioned to the right.
11.Secure the gauge with the syringe barrel clasp.
12.Push the disengagement lever down, and move the plunger driver gently to the left until it is in contact
with the gauge.
Figure 6.2: Installation of the 2.56 in (65 mm) displacement gauge
13.Check the value displayed for Position. The value must be between
2.5 in and 2.62 in (63.5 mm and 66.5 mm).
14.Open the syringe barrel clasp.

15.Push the disengagement lever down and move the plunger driver to the right.
16.Remove the 2.56 in (65 mm) displacement gauge.
42
6.2.8 Test 7: Syringe Barrel Clasp
Test Description
The Syringe barrel clasp sensor is used to maintain the syringe in the pump, to detect the good
positioning of the syringe and to measure the diameter of the syringe.
Run this test to check:
 correct measurement for the syringe diameter
 correct functioning of the syringe fastening system
Optical sensor - disengagement
Opening levers (plunger head)
Switch (syringe
detection) Opening arms
Syringe barrel Potentiometer

clasp
Syringe
Main installation
microprocessor
Interface
CPU BOARD
The plunger’s driver displacement is correctly calibrated.

 The syringe barrel clasp sensor is not calibrated. Calibrate the syringe barrel clasp
sensor using Agilia Partner maintenance software.
 The syringe barrel clasp sensor is defective or not correctly connected to the CPU
board. This problem leads to an error code 20:
- Check the cable connection to CPU board (J1 connector). See figure 2.7,
page 14.
- Replace the displacement sensor. See section 8.7, page 92.

 V1 diameter verification gauge, 11.5 mm (0.45 in) diameter
 V2 diameter verification gauge, 15.5 mm (0.61 in) diameter
 V4 diameter verification gauge, 28 mm (1.10 in) diameter
Prerequisites
 The calibration certificates of the diameter verification gauges are valid.

2. Press the arrow keys to select Test 7: Syringe barrel clasp.
3. Press enter.
43
the syringe diameter installed
 Diameter: Syringe diameter in mm. Value measured by the sensor.
 Low (11 mm): Sensor value in mV when the C1 calibration tool
(diameter = 11 mm) is installed. Value saved during last calibration
 Middle (22.9 mm): Sensor value in mV when the C2 calibration tool
(diameter = 22.9 mm) is installed. Value saved during last calibration
 High (33 mm): Sensor value in mV when the C3 calibration tool
(diameter = 33 mm) is installed. Value saved during last calibration
 Date: Date of last calibration
5. Press the arrow keys to display the Conversion/Diameter screen.

the right.
7. Place the V1 diameter verification gauge in the syringe cradle, with the flanges correctly inserted in
the provided slot.
8. Secure the V1 diameter verification gauge with the syringe barrel clasp, and press OK on the pump.
Figure 6.3: Installation of V1 diameter verification gauge
9. Check the value displayed for Diameter. The value must be equal to 10.5 mm ± 1.5 mm
(0.35 in to 0.47 in).
10.Open the syringe barrel clasp, and remove the V1 diameter verification gauge.
11.Place the V2 diameter verification gauge in the syringe cradle, with the flanges correctly inserted in
the provided slot.
12.Secure the V2 diameter verification gauge with the syringe barrel clasp, and press OK on the pump.
13.Check the value displayed for Diameter. The value must be equal to 15.5 mm ± 1.5 mm
(0.55 in to 0.70 in).
15.Place the V4 diameter verification gauge in the syringe cradle, with the flanges correctly inserted in
the provided slot.
16.Secure the V4 diameter verification gauge with the syringe barrel clasp, and press OK on the pump.
44
17.Check the value displayed for Diameter. The value must be equal to 28 mm ± 1.5 mm
(1.04 in to 1.16 in).
The test fails if one of these three Diameter values is outside the tolerance zone.
45
6.2.9 Test 8: Battery Info
Test Description
This test provides information about battery usage time, voltage output, current output, and
temperature.
Run this test to check that the battery data is correct.
The battery capacity is acceptable.

If this test fails:
 Connect the pump to an AC power supply to charge the battery.
 Run the test again. If the test fails, replace the battery.
See section 8.2, page 79.

 No specific tools or equipment are required

2. Press the arrow keys to select Test 8: Battery info.
3. Press enter.
 Duration: Battery operating time in hours, days and months
 Cycles: Number of charge/discharge cycles, equivalent to Duration (in
hours) divided by 7
 Since: Date of the first use on battery
 Conversion and Voltage: Voltage value at the battery terminals in V, and
conversion into mV
 Conversion and Temperature: Battery temperature in °C, and conversion
into LSB
 Conversion and Current: Battery charge/discharge current in mA, and
conversion into LSB
5. Check that the displayed values are within the limits shown in the table below.
Value Limits
Voltage 5.0 V to 8.7 V
Current - Connected to an AC power supply, battery being charged -135 mA to -165 mA
(battery charge status indicator is flashing)
Current - Connected to an AC power supply, battery fully charged -50 mA to +50 mA
(battery charge status indicator is lit permanently)
Current - Pump running on battery -50 mA to -200 mA
(battery charge status indicator is off)
Temperature +2 °C to +48 °C (+35.6 °F to +118.4 °F) for normal
room temperatures
46
6.2.10 Test 9: Indication
Test Description
Run this test to check the correct functioning of display, battery charge status indicator, power
supply indicator, infusion indicator lights, microphone and buzzer.
The pump screen, indicators, microphone and buzzer work properly.

If this test fails, replace the display board and LCD display. See section 8.3, page 81.


2. Press the arrow keys to select Test 9: Indication.
3. Press enter.
4. Check that:
 A white screen is displayed.
 The battery charge status indicator, power supply indicator, infusion
indicator lights are lit.
 OK is blinking in the bottom-right corner of the screen.
5. Press OK.
6. Check that:
 A blue Indication screen is displayed.
 The battery charge status indicator, power supply indicator, infusion
indicator lights are flashing.
 Exit is displayed in the bottom-right corner.
 The microphone and buzzer sound.
If you do not press exit in the next 10 seconds, the pump returns automatically to Tests menu.
6.2.11 Test 10: Keypad

Test Description
Run this test to check the correct functioning of all pump keys.
The keypad works properly.

If this test fails, replace the upper case that supports the keypad.


2. Press the arrow keys to select Test 10: Keypad.
3. Press enter.
4. Press all keys one by one, and check that the corresponding circle on the
screen is highlighted.
5. Press for at least 5 seconds to exit and return to the Tests menu.
47
6.2.12 Test 11: Ageing Test
Test Description
The Ageing test checks that the motor unit is functioning correctly by carrying out
displacements between the 115 mm (4.52 in) and 20 mm (0.79 in) positions.
The motor unit is functioning correctly.
If the test fails, replace the motor unit. See section 8.9, page 100.


2. Press the arrow keys to select Test 11: Ageing test.
3. Press enter.
4. Press the arrow keys to enter the flow rate to be applied in mL/h.
Available range: 0.1 to 1500 mL/h.
5. Press OK.
6. Press the arrow keys to enter the motor command mode (Current).
Available options: Low, High, Maximum or Auto.
7. Press OK.
8. Press the arrow keys to select the displacement type Advance or Go/return.
9. Press OK to start the test.
If a battery alarm is present, the test cannot be launched (the OK button is not
available).
The pump starts moving the plunger forward.
While an ageing test is in progress, the pump displays the following information:
 Flow rate in mL/h
 Motor command mode (Current = Low, High, Maximum or Auto)
 Animation representing the plunger displacement
The test ends when:
 The plunger reaches the 20 mm (0.79 in) position (Displacement = Advance).
 The plunger reaches the 115 mm (4.52 in) position (Displacement = Go/return). The plunger
starts moving backwards when it reaches the 20 mm position.
 The user presses the exit key.
Information
During the test, the motor rotation is tested and the pump triggers an error if a problem is detected.
At end of test, the pump displays the following information:

 Flow rate in mL/h
 Motor command mode (Low, High, Maximum or Auto)
 The test status (Finish)
10.Press exit at end of test to return to the Test screen.
48
6.2.13 Test 12: Battery Life
Test Description
This test provides information on the current battery charge percentage, and displays results of
the last battery discharge test (last run of "Test 13: Battery test").

If the charge is low, connect the pump to an AC power supply to charge the battery.
If the displayed "Alarm" is less than 01h30 (01:30), replace the battery.

Prerequisites
 Run test 13: "Battery test" on the pump before launching this test.

2. Press the arrow keys to select Test 12: Battery life.
3. Press enter.
 Charge: Battery charge current rate (in %)
 Auto Off: Date of last automatic cut off (value saved during last battery
test)
 Pre alarm: Duration between transition to battery and pre alarm (value
saved during last battery test)
 Alarm: Duration between transition to battery and alarm (value saved
during last battery test)
 Cut off: Duration from alarm to automatic pump power off (value saved
during last battery test)
6.2.14 Test 13: Battery Test

Test Description
During this test, a battery discharge is performed. Pre alarm, alarm and cut off times are
determined and registered so that it is possible to evaluate if the battery works correctly.
At the end of a battery test, the results are recorded and can be checked by running
"Test 12: Battery life". Then the pump powers off.

Replace the battery.

Prerequisites
 The pump is disconnected from the AC power supply.
49
2. Press the arrow keys to select Test 13: Battery test.
3. Press enter.
Information
If the pump is connected to an AC power supply, the test does not start and the
following screen is displayed.
Disconnect the pump from the AC power supply. The test is automatically initiated.
While a battery test is in progress, the pump displays the following information:
 Pre alarm: Duration from transition to battery until pre alarm in hours and
minutes (hh:mm).
This duration increases up to the pre alarm triggering time, then stops.
 Alarm: Duration from transition to battery until alarm in hours and minutes
(hh:mm).
This duration:
- is equal to ’--:--’ as long as the pre alarm is not triggered,
- starts from the pre alarm triggering time, then increases up to the alarm
triggering time, and finally stops.
 Cut off: Duration from alarm to automatic pump power off.
This duration:
- is equal to ’--:--’ as long as the alarm is not triggered,
- is reset to ’00:00’ when the alarm is triggered,
- increases up to the pump cut off.
Information
If the pump is connected to an AC power supply while a battery test is running,
the test stops and the following screen is displayed.
Press exit to return to the Tests menu.
4. At end of test, display the "Pre alarm", "Alarm" and "Cut off" stored in memory:
 Connect the pump to an AC power supply
 Power on the pump
 Run test 12 (Battery life)
 Check that the displayed "Alarm" is equal to or greater than 01h30 (01:30).
If not, replace the battery. See section 8.1, page 77.
50
6.2.15 Test 20: Pump Code
Test Description
Run this test to display and modify the code which gives access to the Pump Settings from the
Options menu. See section 3.3, page 27.

2. Press the arrow keys to select Test 20: Pump code.
3. Press enter.
The current Pump Settings access code is displayed.
4. Enter the code.
5. Press OK to confirm.
Information
If you do not want to protect access to the Pump settings by a code, enter "0000".
6.2.16 Test 21: Power Info

Test Description
Run this test to display power source information on the following parts:
 DC voltage
 Battery DC voltage charging value
 Backup capacitor voltage and temperature
 5 V booster voltage.
Information
The backup capacitor voltage and temperature must be systematically checked during the maintenance
protocol.
The AC power board and power supply boards work properly.

DC voltage out of limits:
 Check the connections between power supply board (J5 connector) and AC power
board.
 Check the fuse on AC power board.
 Replace the power supply board.
 Replace the angle bracket supporting the AC power board.
Backup capacitor voltage and/or 5 V booster voltage out of limits:
 Connect the pump to an AC power supply and wait for 30 minutes.
 Check the backup capacitor voltage.
 Replace the power supply board if the voltage is outside the limits.
A too high voltage may result in damage to the equipment.
51
2. Press the arrow keys to select Test 21: Power info.
3. Press enter.
The DC voltage is displayed:
 Conversion: DC voltage conversion value (in mV)
 DC voltage: DC voltage charging value (in V)
4. Connect and disconnect the pump from the power source, and check that the DC voltage value
changes:
 With a pump connected to an AC power supply:
 With a pump running on battery:
5. Press the arrow keys to scroll through the other information screens:
 Conversion: Backup capacitor conversion value in mV
 Backup capacitor: Backup capacitor voltage in V
 Conversion: Backup capacitor temperature conversion value in mV

 Backup temperature: Backup capacitor temperature in °C
 Conversion: 5 V booster conversion value in mV

 5 V booster: 5 V booster voltage in V
6. Check that the displayed values are within the limits shown in the table below.
Value Limits
DC Voltage - Pump connected to an AC power supply 9.5 V to 10.5 V
DC Voltage - Pump running on battery -0.5 V to 0.5 V
Backup capacitor 2.3 V to 2.7 V
Backup temperature -20 °C to +110 °C (-4 °F to +230 °F)
5 V booster 4600 mV to 5920 mV
52
6.2.17 Test 22: LCD Voltage
Test Description
Run this test to display the charge voltage of the pump’s LCD screen (for information only).

2. Press the arrow keys to select Test 22: Lcd Voltage.
3. Press enter.
 Conversion: This conversion voltage value is the LCD charge pump
voltage measured at the CPU board input terminals.
 Voltage: This voltage value is the measured LCD charge pump voltage.
6.2.18 Test 23: Temperature

Test Description
Run this test to display the temperature measured by the NTC thermistor (for information only).
The CPU board works properly.

If this test fails, replace the CPU board. See section 8.4, page 83.
If the problem persists, contact the Fresenius Kabi Technical Service.

2. Press the arrow keys to select Test 23: Temperature.
3. Press enter.
 Conversion: The temperature conversion value measured in mV by the
NTC thermistor on the CPU board.
 Temperature: The temperature measured in °C by the NTC thermistor on
the CPU board.
4. Check that the displayed value is within the limits shown in the table below.
Values Limit
Temperature -20 °C to +80 °C (-4 °F to +176 °F)
53
6.2.19 Test 24: Watchdog
Test Description
This test checks the status of the pump’s microprocessor (free or busy) every 2 seconds.
The pump’s microprocessor is not too busy to carry out infusions correctly.
If the test fails, it means that the pump’s microprocessor is too busy.
An infusion is likely not to be carried out correctly.

Prerequisites
 The pump must be used on battery with the AC power cord disconnected.

2. Press the arrow keys to select Test 24: Watchdog.
3. Press enter.
If the pump is connected to the AC power supply:
 Disconnect the AC power cable.

The OK button becomes available.
 Press OK.
The pump starts checking the fault mode.
5. Check that all red LEDs light up and that the buzzer sounds between 1.0 seconds and 2.25 seconds.
If the test fails, a message "Watchdog not functional return to After Sales Service" is displayed.
6. Press key for 5 seconds to stop the alarm and return to Tests screen.
Information
The Watchdog test must be systematically carried out after each maintenance procedure.
54
6.2.20 Test 25: Wi-Fi Module Information
Test Description
This test displays for information the Wi-Fi parameters saved on the pump. Run this test to
check that all parameters are correct.
If they are not, upload the Wi-Fi configuration to the pump using Agilia Partner maintenance
software.
Prerequisites
 The pump must be equipped with Wi-Fi.
Information
When powering on a pump, it may take a few minutes for the Wi-Fi module information to refresh.
If some data are not displayed when performing this test, wait a few minutes for the pump to refresh Wi-Fi
module information (without powering off the pump), then run the test again.
If after a prolonged period where no information is displayed, contact your Biomed or IT service
department.

2. Press the arrow keys to select Test 25: Wi-Fi module information.
3. Press enter.
The following data is displayed for information:
 Network SSID (Service Set IDentifier)
 MAC address
 IP address
 Subnet mask address
 Gateway address
 RSSI: value in dBm
 SNR: value in dBm
 Data rate: value in Mbps.

 Date and time of last connection to server
 Version of Wi-Fi module application firmware
 Version of Wi-Fi module Bootloader firmware
 Version of Wi-Fi module Radio firmware
4. Press exit to return to the Tests screen.
55
6.2.21 Checking the Pressure Limit Alarm
Test Description
Run this test to check the triggering of an occlusion alarm when the pressure downstream the
pump exceeds the pressure limit stated in the Pressure management menu.

 1 Dynamometer
Prerequisites
 The dynamometer’s calibration certificate is valid.
1. Access the Basic Profile configuration. See section 5.1, page 29.
2. Press the arrow keys to select User.
3. Press enter.
4. Press the arrow keys to select User 4: Pressure.
5. Press enter.
6. Select:
 Mode = 3 levels
 High = 900 mmHg (17.4 PSI or 1.20 bar)
 Medium = 500 mmHg (9.67 PSI or 0.67 bar)
 Low = 200 mmHg (3.87 PSI or 0.27 bar)
7. Power the pump off and on again to exit the Options menu and return to standard operation.
the right.
9. Place the dynamometer in the syringe cradle, with the flanges correctly inserted in the provided slot.
10.Secure the dynamometer with the syringe barrel clasp.
11.Slide the arm spacer to the left.
12.Push the disengagement lever, and move the plunger driver gently to the left until it is in contact with
the plunger head of the dynamometer.
13.Release the disengagement lever.
The arms must not be in contact with the arm spacer.
Figure 6.6: Installation of dynamometer
56
14.Press C to change the syringe.
15.Press the arrow keys to select "BD Precise 50 mL".

16.Press OK.
17.Press or .
18.Press the arrow keys to select .

19.Select a Medium limit of 500 mmHg. (9.67 PSI or 0.67 bar).
20.Select a flow rate of 120 mL/h.

21.Start the infusion at 120 mL/h.
22.Check for the absence of an occlusion alarm.
23.Check that the infusion LEDs are flashing.
24.Check that the occlusion alarm is triggered at an "x" pressure value of:
430 mmHg (8.31 PSI or 0.6 bar) < x < 570 mmHg (11.02 PSI or 0.8 bar).
25.Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to
the right.
26.Remove the dynamometer.
6.2.22 Checking the End of Infusion Alarm

1. Power the pump off and on again to exit the Options menu and return to standard operation.
2. Push the disengagement lever down and move the plunger to the right.
3. Install a "BD Plastipak" 50 mL syringe.
4. Secure the syringe with the syringe barrel clasp.
5. Position the syringe piston at a remaining VTBI value of at least 10 mL.
6. Push the disengagement lever down, and move the plunger driver gently to the left until it is in contact
with the syringe, with the antisiphon arm positioned on the syringe piston.
7. Release the disengagement lever.
8. Select a flow rate of 200 mL/h.
9. Start the infusion and check that the end of infusion pre alarm is triggered.
10.Wait for the End of infusion alarm.
11.Run Test 6 Displacement.

12.Note the Position value and check that Position = 17.7 mm ± 0.5 mm
(0.7 in ±0.02 in).
57
6.2.23 Control the plunger head detection finger and anti-siphon arms movement
1. Press the disengagement lever.
2. Check that the anti-siphon arms move towards

the syringe.
3. Release the disengagement lever.

4. Check that the anti-siphon arms move partially
back.
5. Check that the arms are symmetrical and in
contact.
6. Press the plunger head detection finger.

A "click" is to be heard.
7. Check that the anti-siphon arms move back

towards the plunger driver (the finger detects the
presence of the syringe and the arms lock it against
the plunger driver).
CONFORM
8. If the anti-siphon arms do not move back or if the
plunger head detection finger remains depressed,
the control is not conform.
NOT CONFORM
58
9. If this test is not conform, either:
 replace the plunger kit for Agilia SP (see section 8.14, page 124.),
or
 disassemble the plunger driver and remove the upper and lower anti-siphon arms,
 clean and grease their axes with "Polylub GLI151" ref. Z171423,
 grease the inside of the left helico lever with "Polylub GLI151" ref. Z171423,
 reassemble the parts paying attention to the correct positioning of the (white) left helico gear,
(black) right helico gear and left helico lever.
10.Perform the following calibrations using Agilia Partner maintenance software.

 Force sensor
 Displacement
11.Perform the regular servicing tests. See Quality Control Procedure, section 6.3, page 62.
6.2.24 Control the disengagement and plunger head alarms

1. If needed, exit the Maintenance mode
pressing "OFF" .
2. Install a 50mL syringe and secure it with
the syringe barrel clasp.
3. Move the plunger driver and position it in
contact with the syringe plunger head.
4. Close the anti-siphon arms on the
syringe plunger.
5. Press "ON" .
6. Select a profile.
7. Check that a "50mL" syringe is
displayed with no alarm being triggered.
8. Confirm selection of syringe.
9. Program an infusion (refer to the IFU for
detailed procedure according to profile).
10.Start the infusion.
59
11.Press the disengagement lever.
12.Check that the "Disengagement
mechanism !!!" message is displayed.
13.Move back the plunger driver and

release the disengagement lever.
14.Check that the "Plunger head alarm !!!"
message is displayed.
15.Press "Alarm silence" key.

16.Press and hold the plunger head
detection finger.
message disappears and is replaced by
the "Disengagement mechanism !!!"
message.
18.Release the plunger head detection
finger.
message reappears.
20.If this test is not conform, either:

 replace the plunger kit for Agilia SP (see section 8.14, page 124.),
or
 disassemble the plunger driver and remove the upper and lower anti-siphon arms,
 clean and grease their axes with "Polylub GLI151" ref. Z171423,
 grease the inside of the left helico lever with "Polylub GLI151" ref. Z171423,
 reassemble the parts paying attention to the correct positioning of the (white) left helico gear,
(black) right helico gear and left helico lever.
21.Perform the following calibrations using Agilia Partner maintenance software.

 Force sensor
 Displacement
22.Perform the regular servicing tests. See Quality Control Procedure, section 6.3, page 62.
60
6.2.25 Checking the AC Power Supply / Battery Operation
Test Description
Run this test to check the power supply indicator state while switching from AC power supply
to battery.
The power supply indicator works properly.

If this test fails, replace the upper case that supports the keypad.
1. Disconnect the pump’s AC power cord.

2. Check that the plug-shaped power supply indicator is off.
3. Connect the pump to an AC power supply.
4. Check that the plug-shaped power supply indicator lights up green.
6.2.26 Electrical Test

Test Description
This test checks the electrical safety of the pump according to the IEC 60601-1 medical
electrical equipment standard.
The pump is compliant with the IEC 60601-1 medical electrical equipment standard.
Contact your biomedical department or your Fresenius Kabi sales representative.

Run the electrical safety test according to the IEC 60601-1 medical electrical equipment standard.
61
6.3 Quality Control Procedure
6.3.1 Running a Quality Control
Print the form provided. See section 6.3.2, page 65.
Run Test 2: Maintenance. See section 6.2.3, page 38.
 Enter the following maintenance data in the form:
- Running time in hours since last preventive maintenance date
- Last preventive maintenance date
 Fix the next preventive maintenance date. Add a maximum of 3 years to the date of last preventive
maintenance.
 Fill the Next maintenance date in the form.
1. Run Test 1: Identification. Identification and general appearance check. See section 6.2.2, page 37.
 Check housing.
 Check AC power cord.
 Check the product code REF and serial number SN on the pump
identification label.
 Fill the pump identification data in the form:
- Pump type
- Product code
- Serial number
2. Check the attachment lock knob and rotating pole clamp (locking system test).
62
3. Check the LCD contrast and adjust if necessary:
 Access the Pump Settings menu in the Options menu.
 Select User 3: Contrast.
4. Run Test 9: Indication. See section 6.2.10, page 47.
Check backlight, all pump LEDs, power supply indicator, battery charge indicator. Check that the
speaker and buzzer are functioning correctly.
5. Run Test 10: Keypad. See section 6.2.11, page 47.
Check the keypad.
6. Run Test 24: Watchdog. See section 6.2.19, page 54.
 Check that all red LEDs light up and that the buzzer sounds between 1.0 seconds and
2.25 seconds.
 Press for 5 seconds to stop the alarm and power off the pump.
7. Run Test 7: Syringe Barrel Clasp. Check the syringe barrel clasp sensor.
 Position the V1 diameter verification gauge.
 Check the value displayed for Diameter. The value must be equal to 10.5 mm ± 1.5 mm
(0.35 in to 0.47 in).
(0.55 in to 0.70 in).
(1.04 in to 1.16 in).
 If one of these values is outside the tolerance zone, run a calibration of the syringe barrel clasp
sensor using Agilia Partner maintenance software.
8. Run Test 5: Force (occlusion alarm test). See section 6.2.6, page 39.
 Install a dynamometer.
 Start an infusion at 1000 mL/h.
 Check that the pump triggers an "Occlusion" pre alarm, then an "Occlusion" alarm in less than
60 seconds when 8.0 PSI (0.55 bar) < Pressure < 10.9 PSI (0.75 bar).
If not, calibrate the force sensor using Agilia Partner maintenance software.
 Press to silence the alarm.
 Press to stop the infusion.
9. Run Test 6: Displacement. Check the displacement sensor. See section 6.2.7, page 41.
 Move the plunger driver to the right stop.
 Check the value displayed for Position. The value must be between 118.5 mm and 137.5 mm
(4.67 in and 5.41 in).
 Install the 65 mm (2.56 in) displacement gauge.
 Check the value displayed for Position. The value must be equal to 65 mm ± 1.5 mm
(2.56 in ± 0.06 in).
 Move the plunger driver to the left stop.
 Check the value displayed for Position. The value must be between 10 mm and 15.2 mm (0.39 in
and 0.60 in).
 If one of these values is outside the tolerance zone, run a calibration of the displacement sensor
using Agilia Partner maintenance software.
10.Control the plunger head detection finger and anti-siphon arms movement (see section 6.2.23,
page 58.)
11.Control the disengagement and plunger head alarms (see section 6.2.24, page 59.)
63
12. Check the AC power disconnection:
 Disconnect the pump’s AC power cord.
 Check that the plug-shaped power supply indicator is off.
 Connect the pump to an AC power supply.
 Check that the plug-shaped power supply indicator lights up green.
13. Check the battery life:
 Connect the pump to an AC power supply.
 Recharge the battery for 8 hours (pump switched off).
 Run Test 13: Battery test. See section 6.2.14, page 49.
 At end of test:
- Connect the pump to an AC power supply
- Power on the pump
- Run Test 12: Battery life. See section 6.2.13, page 49.
- Check that the displayed "Alarm" is equal to or greater than 01h30 (01:30).
If not, replace the battery. See section 8.1, page 77.
14. Run the electrical test according to EN/IEC 60601-1 standard. See section 6.2.26, page 61.
15. Enter the following identification data in the form:
 Result (Pass/Fail) for each test
 Global result for Quality control (Pass/Fail)
 Biomedical name
 Ward name
 Name
 Technical department
 Date and signature
64
6.3.2 Quality Control Certificate
Pump type: Product code: Serial number:
Hospital name: Running time since last Date of last preventive maintenance:
preventive maintenance date:
Ward name: Date of next preventive maintenance:
No. Procedure Pass Fail

1 Test 1: Identification and general appearance check.
Pump housing, AC power cord, product code, serial number.
2 Locking system test. Check the attachment lock knob and rotating pole clamp.
3 LCD display test. Check/adjust the LCD contrast (Pump settings > User 3).
4 Test 9: Indication. Backlight, LEDs, indicators and buzzer test.
5 Test 10: Keypad. Keypad test.
6 Test 24: Watchdog.Watchdog.
Default mode triggered in seconds (between 1.0 second and 2.25 seconds).
7 Test 7: Syringe Barrel Clasp. Check the syringe barrel clasp sensor.
Tool V1 - Diameter: mm (between 9.0 mm and 12.0 mm (0.35 in and 0.47 in)).
Tool V2 - Diameter: mm (between 14 0 mm and 17.0 mm (0.55 in and 0.70 in)).
Tool V4 - Diameter: mm (between 26.5 mm and 29.5 mm (1.04 in and 1.16 in)).
8 Test 5: Force. Occlusion alarm test
Triggering of an occlusion alarm in less than 60 seconds at PSI
(between 8.0 PSI (0.55 bar) and 10.9 PSI (0.75 bar)).
9 Test 6: Displacement calibration test. Checking the displacement sensor
Right stop - Position: mm (between 4.67 in and 5.41 in (118.5 mm and 137.5 mm)).
65 mm gauge - Position: mm (between 2.50 in and 2.62 in (63.5 mm and 66.5 mm)).
Left stop - Position: mm (between 0.39 in and 0.60 in (10.0 mm and 15.2 mm)).
10 Check the plunger head detection finger and anti-siphon arms movement.
11 Check the disengagement and plunger head alarms.
12 Power indicator test. AC power disconnection.
13 Electrical tests
Pass
Fail
Name: Date: Signature:
Technical department:
Observations:
65
6.4 Testing the Flow Rate
Test Description
During this flow rate test an infusion is carried out at a certain flow rate, and the delivered
volume is reported.
The volume reported is compared to the theoretical volume, and the flow rate test is stated as
passed if the calculated flow rate error is between -3 % and +3 %.
The flow rate is correctly calibrated.
If the test fails, calibrate the displacement using Agilia Partner maintenance software.

 1 Scale with a sensitivity of 0.01 g and a beaker
 1 Catheter extension with a Luer lock end: length 40 in (100 cm), interior diameter 0.1 in (2.5 mm)
 1 Needle: type G18 or G21 (flow rate > 30 mL/h), or G26 (flow rate < 30 mL/h)
 1 Luer Lock syringe (brand new)
 1 Chronometer
 Distilled water, oil.
Prerequisites
 The scale’s calibration certificate is valid.
Recommended temperatures for flow rate accuracy:

 Room temperature: 10 °C to 30 °C (50 °F to 86 °F)
 Temperature of the water in the syringe: 10 °C to 30 °C (50 °F to 86 °F)
Information
 Do not recycle distilled water.
 The test procedure below can be performed with all syringe sizes (50/60 mL, 30 mL, 20 mL, 10 mL,
5 mL).
1. Setup the equipment:

 Fill the syringe with distilled water at the maximum of its volume.
 Prime the syringe to eliminate air bubbles.
 Connect the catheter extension to the syringe.
 Connect the cannula to the other end of the catheter extension.
 Install the syringe on the pump.
 Place the beaker at the center of the scale platform.
 Place the cannula inside the beaker.
 Fill the beaker with some water, making sure the cannula is dipped in the water (> 1 cm (0.4 in)).
 Add several drops of oil to create a greasy film on the surface of the water. This way the user will
avoid any measurement error due to evaporation of the water.
 Power on the pump.
66
1
ml
10
20
30
40
50
60
0.4 in
(1 cm)
2
3
Figure 6.7: Flow rate test using a scale
Legend
1 Catheter extension bracket support 3 Anti-vibration measuring table
2 Scale
Information
Check that the installation surface is level.
2. Prime the syringe and the extension set using the key.
Refer to the Instructions for Use of the relevant pump.
3. Check for the absence of air bubbles.
4. On the pump, select a flow rate and start a first infusion to stabilize it.
For a flow rate of less than 5 mL/h, wait at least one hour.
For higher rates, wait between 10 and 30 minutes.
5. Stop the infusion when the stabilization time is elapsed.
6. Zero the scale or write down the initial weight.
7. Simultaneously re-start the infusion with the same flow rate and start the chronometer.
8. After the infusion time (e.g. 10 minutes, 15 minutes, 1 hour), stop the infusion.
9. At the end of infusion, weigh the beaker with water and write down this new value.
If the scale was not zeroed at start of infusion, calculate the difference with the initial weight.
10.Divide the infused volume in mL (for water: 1 mL for 1 g) by the infusion time in hours: this gives the
measured value for the flow rate in mL/h.
11.Calculate the difference between the theoretical value and the measured value according to the
following formula:
(Measured value - Theoretical value)

x100 = Error percentage
Theoretical value
The flow rate test is stated as passed if the calculated flow rate error is between -3 % and +3 %.
67
7 Troubleshooting and Messages
7.1 Alarm Messages and Information Signals

Displayed Message Priority Problem / Resolution
ERxx(yyyy) !!! High (!!!) Technical alarm. See section 7.3, page 72.
Battery alarm !!! The battery is discharged.
High (!!!) The pump will power OFF automatically within 5 minutes.
 Connect the pump to a power supply immediately.
Very low battery !!! Very low battery.
High (!!!)  Connect the pump to a power supply and allow time to
charge.
End of infusion !!! High (!!!) The infusion is completed (simple rate).
Occlusion alarm !!! The pressure in the infusion line has reached the threshold
level.
High (!!!)
 Check whether the infusion line is occluded. If necessary,
readjust the pressure threshold.
Syringe installation !!! The syringe is not installed correctly (plunger driver, syringe
High (!!!) barrel clasp or flange detection).
 Check the syringe installation.
End of volume limit !!! High (!!!) The volume limit is reached.
End of volume/time !!! High (!!!)
The VTBI is completed.
End of dose/time !!! High (!!!)
Plunger head alarm !!! The plunger head is missing or incorrectly inserted.
High (!!!)
Disengagement mechanism !!! The Disengagement mechanism is open after selection of a
High (!!!) syringe.
Battery pre-alarm !! Low battery.
Medium (!!)
 Connect the pump to a power supply.
Occlusion pre-alarm !! In-line pressure has reached the following value:
 25 mmHg / 2.5 kPa / 0.5 PSI below the programmed
threshold (from 50 to 250 mmHg).
Medium (!!)  50 mmHg / 5 kPa / 1 PSI below the programmed threshold
(over 250 mmHg).
 Check the infusion line.
 Set the correct pressure threshold.
Near end of infusion !! The time remaining is less than the defined time duration
(adjustable between 1 and 30 minutes), and the remaining
Medium (!!)
volume of fluid in the syringe has dropped to less than 10% of
the syringe capacity.
Near end of volume limit !! The time remaining is less than the defined time duration
(adjustable between 1 minute and 30 minutes), and the
Medium (!!)
remaining VTBI until the volume limit has dropped to less than
10% of the syringe capacity.
Near end of volume/time !! Medium (!!) The time remaining is less than the defined time duration
Near end of dose/time !! (adjustable between 1 and 30 minutes), and the remaining
Medium (!!) VTBI has dropped to less than 10% of the syringe capacity.
Check settings !! The flow rate (or dose) has been modified using the keys, but
Medium (!!) has not been confirmed.
 Check the flow rate (or dose) and press OK to confirm.
Waiting settings !! A value must be entered.
Medium (!!)
 Enter a value and press OK to confirm.
Waiting start !! The infusion settings have been entered, but have not been
confirmed with start.
Medium (!!)
 Check the infusion settings, and press start to start the
infusion.
68
Displayed Message Priority Problem / Resolution
End of volume limit ! The volume limit is reached and the end of infusion setting is
Low (!)
set as "KVO" or "continuous".
End of volume/time ! Low (!) The VTBI is completed and the end of infusion setting is set as
End of dose/time ! Low (!) "KVO" or "continuous".
Pressure increase ! The pressure is increasing in the infusion line.
Low (!)
 Check for occlusions in the infusion line.
Drop in pressure ! The pressure is decreasing in the infusion line.
Low (!)  Check the downstream Luer lock connection and the
integrity of the entire line.
High internal temperature ! Temperature increase.
Low (!)  Check device environment.
 Send the pump for maintenance.
AC power failure ! The power supply is inconsistent.
Low (!)
 Contact your Technical Service.
If the pump is not used during an extended period, connect to a
Low (!)
power supply and wait until the battery is charged.
Alarm reporting not available The pump is mounted on a Link+ Agilia rack that has not been
on the Link ! upgraded.
Low (!)
 Contact your qualified technician or your Fresenius Kabi
Technical Service.
Remove completely syringe ! Preventive auto-test on potential failure of plunger head.
Low (!)
 Remove and reinstall syringe.
Upper soft max The upper soft limit is exceeded, according to the drug settings
Information signal
defined in the drug library.
Lower soft min The lower soft limit is exceeded, according to the drug settings
Information signal
defined in the drug library.
Reached hard limit Information signal The upper or lower hard limit is reached.
Power disconnection The pump is disconnected from the AC power. A single beep is
emitted.
 Press to acknowledge.
Information signal  Check that the battery life is sufficient for the expected
infusion duration.
 If the disconnection was unintentional, check the power
connection.
Keypad lock status The keypad is locked.
Information signal
 Unlock the keypad.
Keypad locked The keypad is locked and the syringe barrel clasp was opened
Unlock keypad to continue Information signal and closed.
 Unlock the keypad.
Insufficient Dose In TCI mode, the remaining volume/dose in the syringe is
Information signal
insufficient to reach the target (for Agilia SP TIVA).
69
In the case of a system malfunction, the alarm sounds and an error message Erxx(yyyy) !!! is
displayed.
1. Record the error message Erxx(yyyy) !!!.
2. Disconnect the pump from the power supply.
3. Reset the device by pressing the key for 10-15 seconds, and release it when the device powers
off.
Warning
If the alarms persist when the pump is powered on again, do not use the device on a patient, and contact
qualified biomedical engineering staff in your healthcare facility, or your Fresenius Kabi sales
representative.
Alarm Priority Required Operator Response Description

 The infusion stops.
High (!!!) Immediate response  An alarm description is displayed on the
pump screen.
Medium (!!) Prompt response
 The infusion continues.
Low (!) Awareness
Information
Awareness  An information message is displayed on the
Signals pump screen.
70
7.2 Troubleshooting Guide
Description Cause Recommended Action
End of infusion detected too early (at The installed syringe doesn't  Replace or confirm the right syringe brand.
approximately 10 mL). correspond to the selected  Calibrate the displacement sensor using
No end of infusion pre-alarm and alarm syringe. Agilia Partner maintenance software.
Flow rate or displacement drift. The installed syringe doesn't  Replace or confirm the right syringe brand.
correspond with the selected  Check the displacement calibration.
syringe.  If necessary, recalibrate the displacement
The position sensor calibration sensor using Agilia Partner maintenance
values have drifted. software.
 Replace the displacement sensor.
Occlusion alarm after the pump has been Wrong calibration of the force  Recalibrate the force sensor using
turned on. sensor. Agilia Partner maintenance software.
Force sensor is out of order.  Replace the force sensor and ribbon cable kit.
Flexible circuit is cut. See section 8.11, page 108.
Occlusion alarm during the infusion. The pressure limit selected is too  Select a higher pressure limit (Pressure
low. management menu ).
Wrong calibration of the force  Recalibrate the force sensor using
sensor. Agilia Partner maintenance software.
Flexible circuit is cut.  Replace the force sensor and ribbon cable kit.
Disengagement alarm after the pump has The disengagement micro-switch  Replace the disengagement flexible circuit.
been turned on or during the infusion. is defective. See section 8.10, page 103.
Carriage flexible circuit is cut.
Unjustified alarm involving plunger head Optical switch and/or anti-siphon  Check the anti-siphon system.
position. arm finger detection are defective.  Check the plunger driver internal mechanism.
Flexible circuit is cut.  Replace the force sensor.
Unjustified alarm involving syringe barrel Defective syringe barrel clasp  Check the syringe barrel clasp.
clasp and/or syringe body. potentiometer. Run test 7. See section 6.2.8, page 43.
Flat ribbon cable is defective.  If the error remains, replace the syringe barrel
Switch or flat ribbon cable flange clasp.
detection is defective.  Calibrate the syringe barrel clasp using
Agilia Partner maintenance software and
check the pump functionality.
Display defect: LED, LCD display. Control transistors, LED and/or  Check the display board.
connections are defective.  Check the connectIons between CPU board
and display board.
 Replace the display board/LCD display.
See Section 8.3, page 81.
The power supply indicator doesn't light Battery is totally discharged.  Connect the pump to the AC power supply.
up.  Replace the battery.
Power supply board is defective. See section 8.1, page 77.
 Check the power cord and AC power supply.
 Replace the power supply board.
Battery alarm even though it has been The power supply board is  Replace the power supply board.
completely charged. damaged. See section 8.5, page 86.
The pump turns ON or OFF by itself. Defective keypad.  Replace the upper case. See section 8.2,
Power supply board is damaged. page 79.
 Check the keypad by running test 10.
 Replace the power supply board if necessary.
Some keys of the keypad do not work. Defective keypad.  Replace the upper case.
 Check the keypad by running test 10.
Mechanical elements are damaged. After a fall.  Check the status of the casings and the
mechanical system.
71
7.3 Error Codes
Error Code Description Recommended Actions
01 Motor rotation  Check correct functioning of the motor.
 Check the ribbon cable connection between the optical switch
and the CPU board (J5 connector). See figure 2.7, page 14.
 Check the correct functioning of the motor rotation optical switch.
 Replace the CPU board. See section 8.4, page 83.
 Carry out a complete configuration/calibration/control cycle using
02 Displacement  Check the displacement sensor calibration.
Run test 6 Displacement. See section 6.2.7, page 41.
 Check the displacement sensor connection to CPU board
(J2 connector). See figure 2.7, page 14.
10 RAM  Replace the CPU board.
11 Flash memory (deleting or  Replace the CPU board. See section 8.4, page 83.
programming problem)  Carry out a complete configuration/calibration/control cycle using
12 Resources  Carry out a complete configuration for the pump using the
If the problem cannot be resolved:
13 Secondary Crc16  Carry out a complete configuration/calibration/control cycle using
microcontroller - version is Agilia Partner maintenance software.
incorrect
14 Secondary microcontroller  Replace the Power supply board. See section 8.5, page 86.
restarting - Watchdog
problem
15 Secondary microcontroller  Check the ribbon cable connection between Power supply board
communication (J1 connector) and CPU board (J6 connector).
 Replace the Power supply board. See section 8.5, page 86.
16 Disconnected battery  Check the battery connection to power supply board
(J3 connector). See section 2.1.5, page 18.
 Check the battery charging voltage. Run test 12.
 Replace the battery. See section 8.1, page 77.
17 Battery charge  Check the battery charging voltage. Run test 12.
18 AC power presence  Remove the battery door. See section 8.1, page 77.
 Check the status of the AC power fuse.
 Replace the Power supply board. See section 8.5, page 86.
19 Battery temperature  Check the battery status. Run test 8.
72
20 Syringe barrel clasp  Check the syringe barrel clasp calibration. Run test 7.
potentiometer See section 6.2.8, page 43.
 Calibrate the syringe barrel clasp using Agilia Partner
 If the error remains, check the cable connection to CPU board
 If the error remains, replace the syringe barrel clasp.
 Calibrate the syringe barrel clasp using Agilia Partner
maintenance software and check the pump functionality.
21 Displacement linear  Check the displacement calibration. Run test 6.
potentiometer See section 6.2.7, page 41.
 Calibrate the displacement using Agilia Partner maintenance
software.
 If the error remains, replace the displacement sensor.
 Calibrate the displacement using Agilia Partner maintenance
software and check the pump functionality.
22 Force sensor  Check the force sensor calibration. Run test 5.
 Calibrate the force sensor using Agilia Partner maintenance
software.
 If the error remains, replace the force sensor and ribbon cable kit.
 Calibrate the force sensor using Agilia Partner maintenance
software and check the pump functionality.
23 Syringe flanges switch  Check the syringe flanges switch is functioning correctly by
running test 7. See section 6.2.8, page 43.
 Check the cable connection to CPU board (J1 connector).
 Replace the syringe barrel clasp flexible circuit.
24 Disengagement switch  Check the functionality of the disengagement switch.
 Replace the disengagement flexible circuit.
25 Syringe head detection  Check the functionality of the syringe head optical switch by
optical switch running test 7. See section 6.2.8, page 43.
 Replace the plunger kit.See section 8.14, page 119.
26 Board missing  Check the connection between Display board and CPU board.
 Check the connection between Power supply board and CPU
board.
 Replace the faulty part(s).
27 LCD backlight missing  Check the connection between Display board (J3 connector) and
LCD display. See section 2.1.3, page 11.
 Replace the LCD display. See section 8.3, page 81.
 If the problem cannot be resolved, replace the Display board.
73
28 Keypad  Run test 10 to check the keypad. See section 6.2.11, page 47.
 Replace the upper case. See section 8.2, page 79.
 Run test 10 to check the keypad.
 If the problem cannot be resolved, replace the Display board.
29 Analog/digital converter  Replace the CPU board. See section 8.4, page 83.
30 Time keeper  Replace the Power supply board supporting the secondary
microcontroller. See section 8.5, page 86.
31 Syringe parameters  Carry out a complete configuration using Agilia Partner
33 Disengagement optical  Check the functionality of the disengagement switch.
switch  Check the cable connection to CPU board (J9 connector).
 Replace the disengagement flexible circuit.
34 Infusion flow rate  Carry out a complete configuration using Agilia Partner
35 Motor period  Carry out a complete configuration using Agilia Partner
36 Motor rotation direction  Carry out a complete configuration using Agilia Partner
37 OFF key.  Check that you have not pressed the OFF key too repeatedly.
Reading status problem or  Replace the Power supply board to check the functionality of the
key pressed too repeatedly secondary microcontroller. See section 8.5, page 86.
 Replace the Display board. See Section 8.3, page 81.
 Replace the CPU board to check the functionality of the main
microcontroller.See section 8.4, page 83.
38 Locked OFF key  Run test 10 to check the functionality of the keypad, and
especially the OFF key. See section 6.2.11, page 47.
 Replace the upper case. See section 8.2, page 79.
 Replace the Power supply board to check the secondary
microcontroller functionality. See section 8.5, page 86.
39 Impossible to power off  Replace the Power supply board. See section 8.5, page 86.
40 TCI calculation error  Restart the pump.

(for Agilia SP TIVA)  Program and start an infusion with a TCI profile.
Please refer to the Agilia SP TIVA Instructions for Use.
43 LCD communication failure  Replace the Display board. See Section 8.3, page 81.
44 LCD driver failure  Replace the Display board. See Section 8.3, page 81.
45 Defective LCD voltage  Replace the Display board. See Section 8.3, page 81.
46 Backup capacitor  Contact the Fresenius Kabi Technical Service.

temperature too high
47 Backup capacitor  Contact the Fresenius Kabi Technical Service.
temperature out of range
48 Pump temperature out of  Place the pump in normal operating temperature.
range Please refer to the Instructions for Use of the relevant pump.
49 Backup capacitor and safety  Replace the Power supply board. See section 8.5, page 86.
5 V booster charging circuit
defective
50 Power supply board voltage  Replace the Power supply board. See section 8.5, page 86.
out of range
74
51 Defective speaker  Check the connection to Power supply board (J2 connector).
 Replace the speaker and flexible circuit.
52 Defective buzzer Buzzer sound level too low or defective speaker (see error code 51).
 Replace the Power supply board supporting the buzzer.
53 Battery parameter in  Contact the Fresenius Kabi Technical Service.
coulometer EPROM
54 Secondary microcontroller /  Contact the Fresenius Kabi Technical Service.
coulometer power supply
board communication
55 Defective profile  Carry out a complete configuration check using Agilia Partner
56 CMDFAIL  Replace the Power supply board. See section 8.5, page 86.
Autotest failure on starting  Replace the Display board. See section 8.3, page 81.
up the pump.  Replace the CPU board. See section 8.4, page 83.
97 Defective oscillator  Replace the CPU board. See section 8.4, page 83.
98 Defective reset circuit  Replace the CPU board. See section 8.4, page 83.
99 Activation of the watchdog  Replace the Power supply board to check the functionality of the
secondary microcontroller. See section 8.5, page 86.
 Replace the CPU board to check the functionality of the main
microcontroller.
75
8 Intervention Procedures
This section details all dismantling and re-assembling procedures.
Warning
 ONLY use the recommended accessories and spare parts delivered with the pump. NO PART IS
REPAIRABLE. When replacing components, only use Fresenius Kabi spare parts. Refer to the
"Spare Parts Catalog" for ordering information.
 Any instruments or devices used for maintenance must be regularly checked or re-calibrated
according to their specifications and local regulations.
 Disconnect the battery, and discharge the boost capacitor before opening the pump (see
procedure no.1). A risk of electric shock exists when touching a charged boost capacitor.
 For safety reasons, the technician should not intervene when the pump is connected to an AC power
supply:
- Unplug the power supply cord from the AC power supply.
- Power off the pump.
 When working with electronic components, we recommend wearing an anti-static bracelet
connected to earth and working on an anti-static mat.
 Do not touch the electronic boards with your hands.
76
8.1 Procedure #1: Battery and Battery Door - Boost Capacitor Discharge
 1 Torx T-10 screwdriver
 1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
The battery must be only replaced by a qualified person.
Dismantling
1. Unscrew the 2 screws [1] that hold the battery door in place.
2. Remove the battery door [2].
3. Power on the pump.
1 1
77
5. Disconnect the [J3] connector and remove the battery [3].
The boost capacitor starts to discharge.
The buzzer sounds and red LEDs light during this discharge (approximately 20 minutes).
J3
Information
If the identification labels of the fuse [5] and the battery [4] are damaged, they must be replaced.
Contact Fresenius Kabi to get new labels.
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Insert the battery in the correct direction.
3. Perform a charge/discharge cycle.
4. Perform the regular servicing tests. See Quality Control Procedure, page 62.
78
8.2 Procedure #2: Upper Case
Maintenance level
Prerequisites
 The battery is disconnected and the boost capacitor discharged.
Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 3 screws [1].
1 1
3. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [5].
4. Disconnect CPU board flat cable [5] at [J1].
5. Unscrew the 2 screws [3] that hold the upper case [4] to the base.
6. Remove the upper case [4], being careful not to pull out the display board flat cable.
5
J1
3 3
79
7. Disconnect the display board flat cable at [J2].
8. Disconnect the display board / keypad cable (connection at [J1]).
9. Remove the 4 screws [6] that fasten the board unit to the upper case.
6 6
J1
6 J2 6
10.Remove the display board unit from the upper case [7].
Re-assembling
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the regular servicing tests. See Quality Control Certificate, page 65.
80
8.3 Procedure #3: Display Board/LCD Display
Maintenance level
Prerequisites
Dismantling
1 1
5
J1
3 3
81
8. Disconnect the display board / keypad cable (connection at [J1]).
9. Remove the 4 screws [6] that fasten the board unit to the upper case.
10.Remove the display board unit from the upper case.
6 6
J1
6 J2 J3 6
11.Disconnect the display board / LCD display connection at [J3].

12.Unclip and separate the LCD display [8] from the display board [7].
J3
Re-assembling
2. Perform the following calibration using Agilia Partner maintenance software:
 LCD contrast
3. Perform the regular servicing tests. See
82
8.4 Procedure #4: CPU Board
Maintenance level
Prerequisites
Dismantling
If a Wi-Fi pump is used, remove the Wi-Fi board, then dislodge the CPU board as described
later in this procedure.
To remove the Wi-Fi board: See section 8.6, page 89.
1 1
5
J1
3 3
83
J1
J2
8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7].
J1 J2
J3
J1
J5
J6 J7
84
9. Remove the CPU board [7].
While doing this, take care not to pull out the flat cable on the inside.
10.Disconnect the flat cable [J9].
J9
Re-assembling
2. Perform the following calibrations using Agilia Partner maintenance software:
 Force sensor
 Syringe barrel clasp
 Displacement
 Date
 LCD contrast
Information
When replacing the CPU board, carry out a complete configuration of the pump (calibrations and tests).
Each pump has its own CPU board model. Be careful not to mix up the different pump references.
85
8.5 Procedure #5: Power Supply Board and AC Power Board
Maintenance level
Prerequisites
Dismantling
1 1
5
J1
3 3
86
J1
J2
8. Disconnect flat cable [J2].

9. Unscrew and remove screw [4].
10.Remove the power supply board:
 Pull the board out by its corner edge to dislodge it from securing clip [5].
 Dislodge the board from slot [6].
J2
5 6
87
Re-assembling
1. Place the black insulator part [7] on the AC supply board.
2. Insert the power supply board in slot [6].
3. Locate securing clip [5] then press the power supply board down, locking the board into
position with the securing clip.
6
5
88
8.6 Procedure #6: Wi-Fi Board
Maintenance level
Prerequisites
 This procedure is only applicable to pumps equipped with a Wi-Fi module.
Dismantling
1 1
5
J1
3 3
89
J1
J2
8. Disconnect the flat cable connected to the CPU board at [J4] (Wi-Fi board connection).
9. Unscrew and remove the screw [7] that holds the Wi-Fi board holder [8] to the CPU board.
10.Dislodge the Wi-Fi board holder from the right flange slot [9].
J4
90
11.Dislodge the Wi-Fi board [10] from the holder [8].
12.Disconnect flat cable [11] from Wi-Fi board [10] (connection at [J1]).
10 10 J1
8
11
Re-assembling
91
8.7 Procedure #7: Syringe Barrel Clasp
Maintenance level
Prerequisites
Dismantling
1 1
5
J1
3 3
92
J1
J2
8. Unscrew and remove the 2 screws [6] that hold the syringe guard.
9. Remove the syringe guard [7].
6 7
10.Disconnect the cable that connects the CPU board to displacement linear potentiometer at
[J2].
J2
93
11.Push the disengagement lever [8] down and move the plunger driver to its maximum.
12.Remove the 2 plastic caps [9] using a flat screwdriver.
13.Unscrew and remove the 2 screws.
14.Unclip and remove the syringe flange cradle [10].
15.Unscrew and remove the 2 screws [11] that hold the base.
16.Remove the base [12].
While removing the base [12], pay attention to the position of angle bracket clip kit [13]
between the base and the aluminum profile. When re-assembling the base, make sure to
position this part as it was originally.
8 13
9 11 13 11
12
12
17.Unscrew and remove the 2 screws [14].

18.Remove the syringe barrel clasp bridle [15].
14 14
15
15
94
19.Unclip and remove clip [18].
20.Pull syringe barrel clasp kit [16] out of its base location.
21.Disconnect the syringe detector [17] from the syringe barrel clasp kit [16].
22.Remove syringe barrel clasp kit [16]
16 18 17 16 18
Re-assembling
Do not forget to clip part [18] into the groove of syinge barrel clasp before attaching bridle
[15].
95
8.8 Procedure #8: Syringe Detection System
Maintenance level
Prerequisites
Dismantling
1 1
5
J1
3 3
96
J1
J2
6 7
97
10.Disconnect the cable that connects the CPU board to displacement linear potentiometer at
[J2].
J2
11.Push the disengagement lever [8] down and move the plunger driver to its maximum.
8 13
9 11 13 11
12
12

18.Remove the syringe barrel clasp bridle [15].
98
16 14 14
15
16 15
20.Unclip and remove clip [18].

21.Pull syringe barrel clasp kit [17] out of its base location.
22.Disconnect the syringe detector [19] from the syringe barrel clasp kit [17].
23.Remove the syringe detector [19].
24.Remove membrane [20].
The syringe detection system [21] comprises syringe detector [19] and membrane [20].
19 20
17
20
18
18 19 21
Re-assembling
Do not forget to clip part [18] into the groove of syinge barrel clasp before attaching bridle
[15]. Pay attention to the direction of the flat cable connections when assembling.
99
8.9 Procedure #9: Motor
Maintenance level
Prerequisites
Dismantling
1 1
5
J1
3 3
100
7. Disconnect the cable that connects the motor to the CPU board at [J7].
8. Unscrew and remove the 4 screws [7] that hold the motor [8] to the mechanical framework.
J7
7 7
7 7
9. Remove the motor [8].
101
Re-assembling
1. Place the motor in position being careful not to damage the gear wheel teeth. While doing
this, pay attention to reconnect the opto motor ground loop [9] on the inside at screw [7b]
level (see the sketch below).
2. Engage the 2 gear wheels together without forcing, and turn them slightly.
3. Tighten the 4 motor fixing screws, following the order [7a], [7b], [7c], [7d] given in the
sketch below.
7d
7b
7c
7a 7b 7a
7c
7d 9

 Displacement
6. Perform the regular servicing tests. See section 6.3, page 62.
102
8.10 Procedure #10: Disengagement Flexible Circuit
Maintenance level
Prerequisites
Dismantling
1 1
5
J1
3 3
103
J1
J2
9. Unscrew and remove the screw [6] that holds the CPU board [7] to the flange.
J1 7 J2
J3
J1
J5
J6 J7
104
10.Remove the CPU board.
While doing this, be careful not to pull out the flat cable on the inside.
J9
12.Unscrew the upper screw [9] that holds the board disengagement flexible circuit to the
carriage kit [10].
10
105
13.Removeself-locking ring [11] using a flat screwdriver. Thisself-locking ring holds the board
disengagement flexible circuit to the carriage kit.
11 11 11
14.Disconnect the plunger driver flat cable [12] from the board [13].
15.Unscrew and remove the screw [14] that holds the upper 1/2 band to the lower 1/2 band.
14 13
14
12
16.Dislodge the disengagement flexible circuit [15].
15
106
Re-assembling
Insert aperture [16] in spur [17].
Replaceself-locking ring [11] with a new one when assembling the board disengagement
flexible circuit to the carriage kit.
17 16

 Displacement
107
8.11 Procedure #11: Force Sensor + Ribbon Cable Kit
Maintenance level
Prerequisites
Dismantling
1 1
5
J1
3 3
108
J1
J2
J1 7 J2
J3
J1
J5
J6 J7
109
J9
12.Push the disengagement lever down [9] and move the plunger driver to its maximum.
18.Unscrew and remove the 3 screws [15] that hold the right flange assembly to the aluminum
profile.
19.Take the unit apart.
9 14
15
11
10 12 14 12
10
13
13
15 15
110
20.Remove theself-locking ring [16].
21.Unscrew and remove the linking band that holds screw [17].
22.Disconnect the flat cable [18].
23.Remove the carriage kit [19].
25.Unscrew then remove the 2 screws that hold the plunger cover in place.
26.Remove the plunger cover and lever kit [21].
21
20 21
20
17
19
16
18
27.Unscrew and remove the 2 screws [22] that hold the pressure sensor support [23].
28.Remove the pressure sensor support [23].
While removing the pressure sensor support [23], pay attention to the position of
spring [24]. Do not forget to position this spring as it was before re-fixng the support.
29.Rotate part [25] in the direction shown in the sketch.
26 27
22
23
22
24 25
30.At the same time, dislodge boards [26] and [27] and pull out the force sensor and ribbon
cable kit [28].
While pulling out the force sensor and ribbon cable kit, pay attention to the position of the
boards [26] and [27]. Also pay attention to the springs that maintain part [25]. Do not forget
to position all these elements as they were before re-assembling the unit.
111
26
28
27
Re-assembling
 Force sensor
112
8.12 Procedure #12: Linear Sensor Kit
Maintenance level
Prerequisites
Dismantling
1 1
5
J1
3 3
113
J1
J2
J1 7 J2
J3
J1
J5
J6 J7
114
J9
profile.
9 14
15
11
10 12 14 12
10
13
13
15 15
115
21.Remove gear wheel [17].
16
16 17
22.Unscrew and remove the 3 screws [18] that hold the linearity sensor kit in place.
23.Remove the linearity sensor kit [20] being careful not to pull out the flat cable [19].
18
19
18 18
20
Re-assembling
Pay attention to the direction of the flat cable connections and to reconnect the opto motor
ground loop when assembling.
 Displacement
116
8.13 Procedure #13: Plunger Cover and Lever Kit
 1 flat screwdriver
Maintenance level
Prerequisites
Dismantling
1 2
4. Remove the 2 plastic caps [3] using a flat screwdriver.

5. Unscrew then remove the 2 screws that hold the plunger cover in place.
6. Remove the plunger cover [4] and lever kit [5].
3 5
117
Re-assembling
 Force sensor
 Displacement
118
8.14 Procedure #14: Plunger Kit
Maintenance level
Prerequisites
Dismantling
1 1
5
J1
3 3
119
J1
J2
J1 7 J2
J3
J1
J5
J6 J7
120
J9
profile.
9 14
15
11
10 12 14 12
10
13
13
15 15
121
24.Take apart the plunger kit [20] using a rotating movement to remove the pin from the
plunger cover.
17
19
16
18
20
Re-assembling
 Force sensor
 Displacement
122
8.15 Procedure #15: Carriage Kit
Maintenance level
Prerequisites
Dismantling
1 1
5
J1
3 3
123
J1
J2
J1 7 J2
J3
J1
J5
J6 J7
124
J9
profile.
9 14
15
11
10 12 14 12
10
13
13
15 15
125
20.Remove the self-locking ring [16].
17
19
16
18
19
Re-assembling
 Force sensor
 Displacement
126
9 Device Storage
Refer to the Instructions for Use of the relevant pump for the following information:
 Precautions for storage
 Storage and transport conditions
 Preparing the device for storage
 Using the device after storage
127
10 Cleaning and Disinfecting
 When to clean and disinfect the pump
 Recommended and prohibited agents
 Instructions for cleaning and disinfecting
Warning
 The disinfecting procedure must be done immediately after cleaning. Disinfecting the pump without
prior cleaning is not effective.
 The pump is not intended to be sterilized; sterilization may result in damage to the pump.
128
11 Power Management
 AC power supply precautions
 Battery precautions
 Battery operating mode
129
12 Technical Characteristics
12.1 Power Supply

Use the power supply cord supplied with the pump.
For use in the US, it is mandatory to use an Agilia power cord compliant with USA standards and with the
IEC 60227 standard.
Maximum admissible apparent electrical cable network impedance: 50 Ω.
The power cord conductor must have a cross section of at least 0.75 mm2.
Power supply
100 V - 240 V ~ / 50 / 60 Hz with functional earth
AC Power Maximum consumption 10-15 VA

1 X T1.6AH 250V accessible in the battery
Protective fuse
compartment
External
Power Supply
9 VDC / Power > 15 W
(Available in a
Future Release)
Length: 3.00 m
Maximum length: 3.00 m
Cord Type: SJT3x18AWG
Technical data: 3x18AWG (Green, black, white), dielectric strength: 2 kVac, 1 min
Standard: UL62 CSA 22.2 No. 49
Type: HG/TR
Plug Technical data: 15A - 12.5V AC.
Standard: NEMA 5-15 Hospital Grade
Type: C13
Connector Technical data: 10A - 250V UL CSA
Standard: EN 60320-1 C22.2 N°21 UL 817
12.2 Battery
Disconnect the battery before opening the device. Avoid short circuits and extreme temperatures.
If the device is not used for more than 3 months, the date is erased (all other settings are stored
permanently). When you power on the pump, you must set the date again.
Characteristics 7.2 V 2.2 Ah - Li-ion Smart battery
Weight Approximately 100 g

Flow Rate Wi-Fi Battery Life
Battery Life 5 mL/h  >6h
5 mL/h  > 11 h
Battery Recharge Pump OFF: < 6 h / Pump ON: < 20 h
 = Wi-Fi enabled
 = Wi-Fi disabled or not used
12.3 Power Consumption

The infusion pump typically consumes about 3.5 W in standard operating conditions.
130
12.4 Communication Port
The connector located at the back of the device allows data communication with a PC.
Serial Cable TTL output
Power Input 10 V / 15 W to power supply the product
Power Output 5 VDC / 150 mA to power Agilia USB cable
12.5 Infrared Communication

The pump is equipped with an infrared cell located at the back of the device.
Mode Wireless optical communication using infrared light
Compatibility Asynchronous Serial Infrared (SIR) physical layer irPHY 1.0, baseband no carrier
Transport
Proprietary
Protocol
Speed 115.2 kb/s max
Wavelength 880 nm to 900 nm infrared band with 45 nm spectral bandwidth
Eye Safety Class 0 of IEC 62471
12.6 Agilia USB Cable

Function Allows communication between a pump and a computer on the USB port
Connector 8-pin proprietary connector / Male A USB connector
Input / Output
250 mW
power (pump)
Input / Output
100 mW
Power (PC)
Compatibility USB 2.0 compliant.
Insulation 1500 V, compliant with UL standard
Speed 19.2 kb/s max
Length 85 in (2.15 m)
Maximum Length 110 in (2.8 m)
12.7 Compliance
Compliant with the following standards:
ElectroMedical Index of protection against ingress of water or
 IEC 60601-1 IP22
Equipment Safety particulate matter
 IEC 60601-1-8
EMC
Compliant with the following standards: Protection against leakage current: Defibrillation-proof
(ElectroMagnetic
 IEC 60601-1-2 type CF applied part*
Compatibility)
Particular  IEC 60601-2-24 Protection against electric shocks: class II

Standards  ANSI/AAMI ID26 Functional earth**
* After a defibrillation, the pump recovery time is around 2 seconds.

** The functional earth is directly connected to the power suply cord. It reduces residual current that may disturb ECG or EEG devices.
131
12.8 Dimensions - Weight
H/W/D 135 x 345 x 170 mm (5.3 x 13.6 x 6.7 in)
Weight Approximately 2.1 kg (4.6 lbs)
Screen Size 70 x 35 mm (2.7 x 1.4 in)
12.9 Electronic Boards

The Agilia SP MC, Agilia SP MC WiFi, Agilia SP TIVA pumps are equipped with 4 electronic boards:
 Power supply board
 AC Power board
 CPU board
 Display board
For the Agilia SP WiFi pump, an additional electronic board is present:
 Wi-Fi board
12.10 Material Characteristics

Component Material
1 Screw cap (2) Polyamide
2 Nut bolt button Polyamide
3 M8 molded screws Polyamide
4 Angle bracket ABS
5 Battery door ABS
6 Light guide Polycarbonate
7 Window Polycarbonate
8 Molded base ABS
9 Cover hook Polyamide 6
10 Infrared window Polycarbonate
11 Eccentric bolt POM
12 Bolt front case POM
13 Bolt rear case POM
14 Bolt button POM
15 Bolt button pen POM
16 Molded lever + hooks Polyarylamide
17 Motor silent blocks Elastomere
18 Back foot LSR
19 Front foot LSR
20 Syringe barrel clasp stop Polyamide
21 Connector stopper TPE EPTR
22 Right and left flange Polycarbonate
23 Wi-Fi board support Polycarbonate
24 Plunger driver body Polycarbonate
25 Plunger driver flange Polycarbonate
26 Plunger driver flange stop Polycarbonate
27 Wing switch support Polycarbonate
28 Syringe barrel clasp bridle Polycarbonate
29 Molded syringe barrel clasp Polycarbonate
30 Dual syringe wings holder Polycarbonate
132
13 Specifications
 Infusion Rate
 Volume To Be Infused (VTBI)
 Infusion Tme
 Flow Rate Accuracy
 Occlusion Alarm Response Time
 Occlusion Alarm Threshold
 Pressure Management
 Trumpet and Start-up Curves
Essential Features
Feature Refer to
Flow rate accuracy IFU
Time to Detect Occlusion IFU
Bolus Volume After Occlusion Release IFU
Management of High-priority Alarms IFU
133
14 Recycling
Before disposal, remove the battery from the device. Batteries and devices with this label must
not be disposed of with the general waste. They must be collected separately and disposed of
according to local regulations.
Information
 For more information on waste processing regulations, contact your local Fresenius Kabi
organization or the local distributor.
 For more information on dismantling the device, refer to the chapter "Intervention Procedures" in this
document.
 Follow healthcare facility policy regarding proper disposal after use.
134
15 Warranty
 General conditions of warranty
 Limited warranty
 Warranty conditions for accessories
135
16 Guidance and Manufacturer's Declaration on EMC
 Electromagnetic compatibility
 Electrostatic discharge (ESD) information
 ESD precautions to be taken
 Electromagnetic compatibility and interference guidance
 Table 1 - Guidance and manufacturer's declaration - Electromagnetic Emissions
 Table 2 - Guidance and manufacturer's declaration - Electromagnetic Immunity
 Table 4 - Guidance and manufacturer's declaration - Electromagnetic Immunity
 Table 6 - Recommended separation distances between portable and mobile RF communication
equipment and Agilia infusion pumps.
Wi-Fi compatibility
The Agilia infusion pumps include RF transmitters whose effective radiated power (EIRP power) is defined
below:
 Frequency band 2.4 GHz: 20 dBm.
 Frequency band 5 GHz: 17 dBm.
136
17 Spare Parts Catalog
Refer to the spare parts catalog of the relevant pump.
137
18 Ordering Information
For more information, contact your Fresenius Kabi sales representative.
18.1 Data Management Cables

Refer to the Instructions for Use of the relevant pump
18.2 Associated Software

18.3 Disposables
138
19 Glossary of Terms
Term Description
A Amperes
AC Alternating Current
Ah Ampere-hours
AM Amplitude Modulation
BSA Body Surface Area
CCU Critical Care Unit
CDC Centers for Disease Control
CIS Clinical Information System
CISPR Special International Committee on Radio Interference
CT Scan Computed Tomography
dBA Decibels
DC Direct Current
DECT Digital Enhanced Cordless Telecommunications
DEHP Di(2-ethylhexyl) phthalate
DERS Dose Error Reduction Software
DI Dose Infused
DPS Dynamic Pressure System
DUR Duration
ECG Electrocardiogram
ECMO ExtraCorporeal Membrane Oxygenation
ED Emergency Department
EEG Electroencephalogram
EMC ElectroMagnetic compatibility
ErXX Error message
ESD ElectroStatic Discharge
FM Frequency Modulation
ft Feet
GPL General Public License
H/W/D Height / Width / Depth
HF High Frequency
hPa Hectopascals
Hz Hertz
IEC International Electrotechnical Commission
IFU Instructions for Use
in Inches
IT Information Technology
139
Term Description
IV Intravenous
kg Kilograms
KVO Keep Vein Open
lb Pounds
LED Light Emitting Diode
LSB Least Significant Bit
mA Milliamperes
mEq Milliequivalents
mL/h Milliliters per hour
mmHg Millimeters of Mercury
MOS Metal Oxyde Semiconductor
MRI Magnetic Resonance Imaging
mW/sr Milliwatts per steradian
NAM North America
NICU, PICU Neonatal and Pediatric Intensive Care Units
NMR Nuclear Magnetic Resonance
OCS Occlusivity Check System
OR Operating Room
PACU Post-Anesthesia Care Unit
PC Personal Computer
PE Protective Earth
PSI Pounds per Square Inch
RAM Random Access Memory
REF Product reference / part number
RF Radio Frequency
RFID Radio Frequency IDentification
ROW Rest Of the World (Other countries than US and Canada)
RS232 Serial interface connector
S/N Serial Number
SELV Safety Extra Low Voltage
SIR Asynchronous Serial Infrared
UPS Uninterruptable Power Supply
USB Universal Serial Bus
USB 2.0 OTG USB On-The-Go
Ut Test specification level
V Volt
VA Volt-Amperes
VDC Volts Direct Current
VI Volume Infused
140
Term Description
VTBI Volume to Be Infused
W Watts
141
Index
A M
AC Power Board Maintenance
Description 21 Date 34
Dismantle/Re-assemble 86 Display Startup Screen 35
Ageing Test 48 Schedule 26
Alarms 68 Maintenance Options Menu 34
Maintenance Test 38
B Material Characteristics 132
Basic Profile Configuration 29 Motor 100
Battery
Dismantle/Re-assemble 77 O
Test 46, 49 Operation Diagram 25
Options Menu 28
C
Carriage Kit 123 P
CPU Board Plunger Cover 117
Description 14 Plunger Kit 119
Dismantle/Re-assemble 83 Power Information 51
Power Supply Board
D Description 18
Dismantle/Re-assemble 86
Disengagement Flexible Circuit 103
Pressure Limit Alarm Test 56
Displacement Sensor Test 41
Pump Code 51
Display Board
Pump Identification 37
Description 11
Q
E Quality Control
Error Codes 72 Certificate 65
Maintenance 26
Events
Data Log 35
Test 38 R
Release Notes 144
F Ribbon Cable Kit 108
Force Sensor
Dismantle/Re-assemble 108 S
Test 39 Symbol Descriptions 2
Syringe Barrel Clasp
I Dismantle/Re-assemble 92
Indication Test 47 Test 43
Syringe Detection System 96
K
T
Keypad
Table of Contents 3
Description 8
Technical Characteristics 130
Test 47
Temperature Test 53
Tests
L Access Menu 36
LCD Display List 36
Dismantle/Re-assemble 81 Training 26
Voltage 53 Troubleshooting 71
Lever Kit 117
Linear Sensor Kit 113 U
Upper Case 79
142
W
Watchdog 54
Wi-Fi Board
Description 22
Wi-Fi Module Information 55
143
Release Notes
Date Software Version Revision Description

December 2015 1.5 1 Creation
February 2016 2 Software improvements (no user impact)
New IFU version
September 2016 3 (description of quick start feature is added)
No user impact
New IFU version
October 2016 4
Agilia SP model is launched
Update of intervention procedures No 4, 6, 7, 8, 9,
10, 11, 12, 14 and 15 to remove the motor ground
April 2017 5 wire.
This spare part has been removed in devices
whose serial number is from 23407157.
November 2017 6 Batty life values are updated.
1.6  Section 6.2 - Running tests: An information is added to
ask the user to work with a pump configured with Basic
Profile and Factory settings.
 Section 6.2.22 - Checking the End of Infusion Alarm: BD
Plastipak syringe replaces BD Precise for this test.
 Section 6.3.1 - Quality control procedure and Section
6.3.2 - Quality Control Certificate: Control of the plunger
March 2018 7
head detection finger and anti-siphon arms movement as
well as control of the disengagement and plunger head
alarms are added. Battery life test is removed since it is
not requested by a Quality Control.
 Intervention procedure no 9 - Motor: The reassembling
procedure is improved to avoid damages to the opto
motor ground loop.
This document may contain inaccuracies or typographical errors.

Modifications may thus be made, and included in later editions.
Due to the evolution of standards, and of legal texts and materials, the characteristics indicated in the text and images of this document are
applicable only to the device with which it is included.
The screenshots in this document are for illustrative purposes only. Screen contents may vary based on individual configurations and minor
software modifications; therefore, some screenshots may appear slightly different from what you see on the product.
This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. Vigilant® and Agilia® are registered
trademarks in the name of Fresenius Kabi in selected countries.
Made in France
Revision date: March 2018
Fresenius Vial S.A.S

Fresenius Kabi AG
Le Grand Chemin
61346 Bad Homburg
38590 Brézins
Germany
France
www.fresenius-kabi.com 0123
First CE Mark: December 2015
144
Local Contacts for Servicing
Write your contacts here:

10403-7_tm_agilia_sp_V1.6_eng
Agilia SP MC
Agilia SP MC WiFi
Syringe Infusion Pumps
Applicable to software version 1.6
INSTRUCTIONS FOR USE

Symbol Descriptions
Warning Name and address of the

(Refer to the Instructions for Use) manufacturer / Date of manufacture
Name and address of the

Refer to the Instructions for Use
manufacturing facility
Protection against electric shock:

Product reference / part number
class II
Non-ionizing electromagnetic
Product serial number
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
Index of protection against ingress of

IP22 Atmospheric pressure limitation
water or particulate matter
General symbol for recyclable

Not for use in residential areas
material
Part included in a recycling process Eco packaging symbol
Protection against leakage current;

defibrillation-proof type CF applied 0123
CE mark
part
Warning of a potential hazard that

could result in serious personal
Recommendations to be followed.
injury and/or product damage if the
written instructions are not followed.
2 9462-6_master_ifu_agilia_sp_mc_eng
Table of Contents
1 INTRODUCTION 9
1.1 SCOPE ...................................................................................................9

1.2 INTENDED USE ........................................................................................9
1.3 INTENDED USERS ..................................................................................11
1.4 INTENDED PATIENTS .............................................................................11
1.5 CONTRAINDICATIONS .............................................................................12
1.6 USE ENVIRONMENT ...............................................................................13
2 AGILIA CONNECT INFUSION SYSTEM 14
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.......................................................................... 20
3.6 PACKAGING ..........................................................................................21
4 FUNDAMENTALS 22
4.1 PROFILES .............................................................................................22

4.2 DRUG LIBRARIES...................................................................................23
4.3 DRUG LISTS..........................................................................................24
4.4 DRUGS .................................................................................................24
4.4.1 Infusion Rates .................................................................................... 24
4.4.2 Drug X (mL/h)..................................................................................... 24
4.4.3 Hard Limits and Soft Limits ................................................................ 24
4.4.4 Infusion Modes ................................................................................... 25
4.5 DATA SET .............................................................................................25
3
5 INSTALLATION 26
5.1 TYPES OF INSTALLATIONS .....................................................................26

5.2 USING THE ROTATING POLE CLAMP.......................................................27
5.3 ATTACHING THE PUMP(S) ......................................................................29
5.3.1 Attaching to a Pole ............................................................................. 29
5.3.2 Attaching to a Rail .............................................................................. 29
5.3.3 Installing on the Link Agilia Rack........................................................ 30
5.3.4 Using on a Flat Table ......................................................................... 31
5.3.5 Attaching Two Pumps Together ......................................................... 31
6 GETTING STARTED 32
6.1 FLOWCHART .........................................................................................32

6.2 USING THE PUMP FOR THE FIRST TIME ..................................................33
6.3 POWERING ON ......................................................................................33
6.4 INSTALLING A SYRINGE..........................................................................35
6.5 PUMP HEIGHT .......................................................................................35
7 OPERATION 36
7.1 FLOWCHART .........................................................................................36

7.2 SELECTING A PROFILE ..........................................................................37
7.3 SELECTING THE INFUSION RATE (FLOW RATE OR DOSE) ........................38
7.4 SELECTING A SYRINGE ..........................................................................39
7.5 SELECTING A DRUG ..............................................................................40
7.6 PROGRAMMING AN INFUSION .................................................................41
7.6.1 Programming an Infusion by Flow Rate ............................................. 41
7.6.2 Programming an Infusion by Dose ..................................................... 41
7.6.3 Programming Beyond Soft Limits....................................................... 47
7.7 STARTING AN INFUSION .........................................................................49
7.8 MONITORING AN INFUSION .....................................................................50
7.9 FUNCTIONS DURING INFUSION ...............................................................52
7.9.1 Stop .................................................................................................... 52
7.9.2 Rate Titration...................................................................................... 52
7.9.3 Administering a Bolus......................................................................... 53
7.10 COMPLETING AN INFUSION ....................................................................57
7.10.1 Near End of Infusion Alert .................................................................. 57
7.10.2 End of Infusion ................................................................................... 58
7.10.3 Powering off ....................................................................................... 58
4
7.11 INFUSION MODES ..................................................................................59
7.11.1 Simple Rate........................................................................................ 59
7.11.2 Volume/Time & Dose/Time ................................................................ 59
7.11.3 Volume Limit....................................................................................... 60
7.12 OTHER FUNCTIONS ...............................................................................62
7.12.1 Priming the Syringe and the Extension Set........................................ 62
7.12.2 Pre-programming the Pump ............................................................... 64
8 MENUS 65
8.1 OVERVIEW ............................................................................................65

8.2 PROFILE ...............................................................................................67
8.3 PRESSURE ............................................................................................68
8.4 KEYPAD LOCK STATUS ..........................................................................70
8.5 BATTERY LIFE .......................................................................................72
8.6 VOLUME INFUSED / DOSE INFUSED ........................................................73
8.7 PAUSE ..................................................................................................74
8.8 PROGRAMMED BOLUS ...........................................................................75
8.9 PATIENT ...............................................................................................76
8.10 DAY/NIGHT MODE .................................................................................77
8.11 VOLUME/TIME & DOSE/TIME ..................................................................79
8.12 VOLUME LIMIT.......................................................................................80
8.13 ALARM VOLUME ....................................................................................81
8.14 VOLUME-DOSE HISTORY .......................................................................82
8.15 VIEW FLOW RATE HISTORY ...................................................................83
8.16 VIEW PRESSURE HISTORY ....................................................................84
8.17 SYRINGE...............................................................................................85
8.18 VIEW EVENT LOG..................................................................................86
8.19 DATE / TIME .........................................................................................87
8.20 MAINTENANCE ......................................................................................88
8.21 LIBRARY INFORMATION ..........................................................................89
8.22 DATA SET .............................................................................................90
9 OPTIONS 91
9.1 COMMANDS ..........................................................................................91

9.2 OPTION DESCRIPTIONS .........................................................................91
9.3 PUMP SETTINGS ...................................................................................92
5
10 DATA COMMUNICATION 93
10.1 OVERVIEW ............................................................................................93

10.2 COMMUNICATION VIA AGILIA CABLES .....................................................93
10.3 COMMUNICATION VIA WI-FI ...................................................................94
10.4 DATA SET UPLOAD ...............................................................................95
11 USER TEST 96
12 ALARMS AND SAFETY FEATURES 97
12.1 INTRODUCTION ......................................................................................97

12.2 ALARM DESCRIPTIONS ..........................................................................97
12.3 GENERAL REMARKS ..............................................................................98
12.4 LIST OF ALARMS ...................................................................................98
13 SYRINGES 104
13.1 SYRINGE LIST .....................................................................................104

13.2 PREPARING A SYRINGE .......................................................................104
13.3 OPERATIONS FOR SYRINGES ...............................................................106
13.4 GRAVITY INFUSION IN PARALLEL WITH A PUMP .....................................107
14 DEVICE STORAGE 108
14.1 PRECAUTIONS FOR STORAGE ..............................................................108

14.2 STORAGE AND TRANSPORT CONDITIONS..............................................108
14.3 PREPARING THE DEVICE FOR STORAGE ...............................................109
14.4 USING THE DEVICE AFTER STORAGE ...................................................109
15 SPECIFICATIONS 110
15.1 ESSENTIAL FEATURES .........................................................................110

15.2 FLOW RATE ........................................................................................111
15.3 VOLUME TO BE INFUSED (VTBI) .........................................................111
15.4 DOSE TO BE INFUSED (DTBI) .............................................................112
15.5 INFUSION TIME ....................................................................................112
15.6 CONCENTRATION ................................................................................112
15.7 PATIENT DATA ....................................................................................113
6
15.8 PRESSURE MANAGEMENT ...................................................................113
15.9 ACCURACY .........................................................................................114
15.10 UNITS AND CONVERSION RULES ..........................................................116
16 CLEANING AND DISINFECTING 118
16.1 WHEN TO CLEAN AND DISINFECT THE PUMP ........................................118

16.2 RECOMMENDED AND PROHIBITED AGENTS ...........................................119
16.3 INSTRUCTIONS FOR CLEANING AND DISINFECTING ................................119
17 POWER MANAGEMENT 122
17.1 AC POWER SUPPLY PRECAUTIONS......................................................122

17.2 BATTERY PRECAUTIONS ......................................................................122
17.3 BATTERY OPERATING MODE ...............................................................123
18 TECHNICAL CHARACTERISTICS 124
18.1 POWER SUPPLY ..................................................................................124

18.2 BATTERY ............................................................................................124
18.3 POWER CONSUMPTION........................................................................124
18.4 COMMUNICATION PORT .......................................................................125
18.5 INFRARED COMMUNICATION.................................................................125
18.6 SOUND LEVELS ...................................................................................126
18.7 COMPLIANCE ......................................................................................126
18.8 DIMENSIONS AND WEIGHT ...................................................................127
18.9 TRUMPET AND START-UP CURVES .......................................................127
19 WI-FI 130
19.1 GENERAL INFORMATION ......................................................................130

19.2 SPECIFICATIONS .................................................................................131
7
20 TROUBLESHOOTING 133
21 RECYCLING 134
22 WARRANTY 135
22.1 GENERAL WARRANTY CONDITIONS ......................................................135

22.2 LIMITED WARRANTY ............................................................................135
22.3 WARRANTY CONDITIONS FOR ACCESSORIES ........................................135
23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 136
23.1 ELECTROMAGNETIC COMPATIBILITY .....................................................136

23.2 ELECTROSTATIC DISCHARGE (ESD) ....................................................136
24 SERVICING 145
24.1 INFORMATION ON DEVICE SERVICING ...................................................145

24.2 MAINTENANCE REQUIREMENTS ............................................................145
24.3 QUALITY CONTROL .............................................................................146
25 GLOSSARY OF TERMS 147
APPENDIX: FACTORY CONFIGURATION 151
INDEX 152
8
1 Introduction
1.1 Scope
These Instructions for Use (IFU) are applicable to the Agilia SP MC and
Agilia SP MC WiFi pumps. These devices are referred to throughout this
manual as the "Agilia SP MC".
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 154.
1.2 Intended Use

Agilia SP MC 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 MC 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 MC can be used for intermittent or continuous infusions.
Agilia SP MC is intended for use on only one patient at a time. It can be
reused indefinitely on multiple patients throughout its lifetime.
9
1.2.1 Intended Products to be Infused
The pump administers products through clinically accepted routes.
These products include but are not limited to the following:
Intended Products
 Standard solutions
Parenteral Fluids  Colloids
 Parenteral nutrition
 Diluted drugs
 Antibiotics
 Chemotherapy
Medication
 Catecholamines
 Short acting drugs
 Anesthesia drugs
 Blood
 Red blood cells
Transfusion  Platelets
 Plasma
 Albumin
When using Agilia SP MC 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 MC for the infusion of fluids that are intended for
infusion pumps.
1.2.2 Administration Routes

The system allows infusion via the following IV access routes:
 IV access with peripheral catheter
 IV access with central venous catheter
 IV access with implantable chamber
 IV access with any other device that administers a medical fluid
to a vein and is equipped with a female Luer lock
10
1.3 Intended Users
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.
1.4 Intended Patients

Agilia SP MC is intended to be used according to healthcare facilities
protocols on patients with the following characteristics:
Patient Characteristics
Male
Sex
Female
Neonates
Pediatrics
Age
Adults
Elderly
Weight 0.25 kg to 350 kg
Body Surface Area 0.05 m² to 4.5 m²
When using the pump with neonates, we recommend applying the

following instructions:
 Switch to night mode
 Set the alarm volume to the minimum level
11
1.5 Contraindications
 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 and ionizing radiation (e.g. X-Ray) 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.
12
1.6 Use Environment
Agilia SP MC 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 (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
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.
13
2 Agilia Connect Infusion System
Agilia Range Description

Volumetric Infusion Pump
Pumps designed to deliver the contents of parenteral
Agilia VP
infusion container (bag or bottle) through an intravenous
Pump line connected to a patient.
Syringe Infusion Pump
Agilia SP Pumps designed to deliver the contents of a syringe through
an intravenous line connected to a patient.
Medication Safety Software
Agilia Software designed to create, customize and manage data
Vigilant Drug’Lib sets to be uploaded to the Agilia VP and SP infusion
pumps.
Maintenance Software
Agilia Partner Software designed to maintain, configure, test and calibrate
the Agilia VP and SP infusion pumps.
Software Distribution Server
Software intended to distribute data sets to Agilia infusion
Centerium
pumps and centralize information coming from infusion
pumps for post analysis and reporting.
Infusion Data Reporting Software
Software designed to improve the accuracy of clinical
Vigilant Insight
settings included into a data set. It provides reports about
the use of infusion pumps.
Stacking Rack Systems
Rack systems designed to stack 4, 6 or 8 Agilia infusion
Link Agilia
Rack pumps. Link Agilia is designed to centralize the power
Link+ Agilia
supply. Link+ Agilia is designed to centralize the power
supply and to centrally replicate infusion pump signalling.
Syringes
Disposables See section 13, page 104.
(applied part)
Information
For a list of compatible accessories, disposables and software, and for
ordering information, refer to the System Components booklet.
14
3 Description
3.1 Front View
2 3 4 5
Figure 3.1: Front View

Legend
1 Handle 41 Plunger Driver
21 Syringe Barrel Clasp 53 Disengagement Lever
3 Syringe Flange Cradle 63 Syringe Guard
3.2 Bottom View (Device Identification Label)
For more information on device identification label symbols, see Symbol

Descriptions, page 2.
15
3.3 Back View
5
4
3
1 2
Figure 3.2: Back View

Legend
1 Release Button 41 Power Cord Inlet
21 Rotating Pole Clamp 53 Infrared Cell
3 RS232 Communication Port 63 Attachment Lock Knob
Symbol Location Description

Warning
Near Power Cord Inlet See section 18, page 124.
Warning
Near RS232 See section 10, page 93.
Communication Port
16
3.4 Keypad
3.4.1 Keypad Description
1
2 17
3
16
4
15
14
5 6 7 8 9 10 11 12 13
Figure 3.3: Keypad

Legend
1 Screen 10
73 Decrement
21 Battery Charge Status Indicator 11

3 Fast Decrement
3 Power Supply Indicator 12

3 Confirm Value / Move to Next Field
4 Wi-Fi Symbol 13
3 Stop / Pause
5 On / Off
Cancel Value / Move Back to Previous
14
3 Field
63 Bolus / Prime
73 Fast Increment 15
3 Menu
83 Increment 16
3 Pressure Menu
93
7 Infusion Indicator Lights 17
3 Alarm Silence
17
3.4.2 Keypad Details
3.4.2.1 Selection Keys

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.
3.4.2.2 Infusion Indicator Lights

Indicator Description
Infusion in Progress (flashing green)
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.
3.4.2.3 Status Indicators

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.
18
3.5 Display and Symbols
3.5.1 Infusion Status
Symbol Description
Infusion in Progress (Basic Profile + 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.
3.5.2 Screen Options

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.
Note: For more information on screen options, see section 9, page 91.
19
3.5.3 Navigation Buttons
Symbol Description
start Start
OK Confirm
enter Access Function
New ? Access Function and Clear Settings
exit Exit Function
C Change Selection
prog Program Function
Select / Unselect
See More Information
/ Zoom in / Zoom out
/ Move the Event Marker to the Left / Right
3.5.4 Alarms and Safety Features

Symbol Description
Power Disconnection
Alarm Silenced
Pressure Increase
Drop in Pressure
Note: For more information on alarms, see section 12, page 97.
3.5.5 Infusion Features

Symbol Description
Loading Dose
This symbol is displayed when programming a loading dose.
3.5.6 Data Communication

Symbol Description
Data Set Loaded
A new data set has been loaded to the pump.
20
3.6 Packaging
The Agilia SP MC packaging contains the following:
 1 Agilia SP MC pump
 1 Instructions for Use manual
(this document + System Components booklet)
 1 Power cord
Packaging weight: Approximately 530 g.
Packaging consists of: Recycled cardboard, expanded foam.
Information
 It is the healthcare facility’s responsibility to check the pump
integrity upon reception.
 If the packaging contents are incomplete or damaged, contact
your Fresenius Kabi sales representative.
21
4 Fundamentals
4.1 Profiles
A profile defines the device configuration and drug library used for a
group of patients in a given health care environment.
By default, factory settings include only 1 profile (Basic Profile).
Custom profiles can be created and loaded to the pump with Agilia
Vigilant Drug’Lib software. Custom profiles feature a specific pump
configuration and a drug library.
A pump can manage up to 20 profiles:
 1 Basic Profile
 Up to 19 custom profiles
Information
For pumps used on only one group of patients, we recommend disabling
the ability to select the profile, thus locking the pumps to the selected
profile.
4.1.1 Basic Profile

Basic Profile allows programming of an infusion whose settings have not
been pre-defined with Agilia Vigilant Drug’Lib software.
To program an infusion with Basic Profile, choose "Basic Profile" when
selecting a profile.
In Basic Profile, the Agilia Vigilant Drug’Lib software's safeguards are
unavailable:
 The infusion is programmed without drug names.
 Limits on drug infusion rates are not included.
Configurations and settings accessible in Basic Profile may not be
suitable for all patient groups and protocols.
22
4.1.2 Custom Profiles
Custom profiles can be configured and loaded to the pump with Agilia
Vigilant Drug’Lib software.
A custom profile contains the following:
 a specific device configuration (pump settings that control the
mechanical functions of the pump such as alarm volume, and so
on)
 a comprehensive list of medications and fluids to be infused
(optional):
- a drug library: a list with limits on drug infusion rates,
see section 4.2, page 23.
- a drug list: a list without limits on drug infusion rates.
Depending on the way it is pre-configured with Agilia Vigilant Drug’Lib
software, a custom profile may or may not include all of the
functionalities described in this IFU.
Information
 We recommend using a custom profile when infusing critical
drugs.
 We recommend that you create and upload profiles in order to
limit usage errors, and to better adapt the use of the pump to the
local practices of the different care units. For example, make sure
to limit flow rates for sensitive populations.
 We recommend creating a specific profile per patient population
and/or care unit, therapy, protocol, and so on.
4.2 Drug Libraries

A drug library is a comprehensive list of drugs that includes limits on drug
infusion rates.
Information
 Each drug library can support up to 150 drug entries that are
defined and validated by healthcare professionals according to
the drug protocols used at the healthcare facility and/or ward
level.
 Drug settings may be adjusted on the pump according to pre-
defined programming limits, such as dose limits.
 Infusion modes are not adjustable on the pump for drugs pre-
configured with Agilia Vigilant Drug’Lib software.
23
4.3 Drug Lists
A drug list is a list of drugs that does not include limits on drug infusion
rates.
4.4 Drugs
4.4.1 Infusion Rates
A drug can be pre-configured with Agilia Vigilant Drug’Lib software
according to one of the following rates:
 Flow rate: Infusion of a volume over a period of time
 Dose: Infusion of a specific amount of a drug corresponding to a
dose rate
4.4.2 Drug X (mL/h)

Drug X (mL/h) is an open entry that can be selected if the intended drug
is not found in the drug library. It has the following characteristics:
 Fewer limits than the other drugs in the library.
 A full compliment of the Agilia Vigilant Drug’Lib software’s
safeguards are unavailable.
It is strongly recommended to use Drug X (mL/h) in a limited number of
clinical cases and under close patient monitoring by the clinical staff.
For each custom profile, the healthcare facility can enable or disable
Drug X (mL/h) using the Agilia Vigilant Drug’Lib software.
4.4.3 Hard Limits and Soft Limits

Programming limits can be set for each drug with Agilia Vigilant Drug’Lib
software. Two types of limits can be set:
 Hard limits: limits that cannot be overridden when programming
an infusion.
 Soft limits: limits that can be overridden within an authorized
range when programming an infusion. An additional confirmation
will be required.
24
4.4.4 Infusion Modes
An infusion can be started according to the following modes:
Infusion Rate
Infusion Mode Description
Flow Rate Dose
Simple Rate Infusion with a programmed rate  

Volume/Time Infusion of a programmed volume or dose over a
 
Dose/Time programmed period of time
Infusion with a limitation on the volume or dose to
Volume Limit  
be infused
4.5 Data Set

A data set is a combination of custom profiles (up to a maximum of 19)
that can be uploaded to Agilia pumps with Agilia Vigilant Drug’Lib
software.
Device Device Device Device Device

Configuration Configuration Configuration Configuration Configuration
(factory) 2 3 4 20
Drug Library Drug List Drug Library Drug Library

A B C S
Profile 1
(Basic)
Profile 2
(Custom)
Profile 3
(Custom)
Profile 4
(Custom) ... Profile 20
(Custom)
Data Set configured with Agilia Vigilant Drug’Lib software
If there is no data set uploaded to the pump, the pump can be used with
the Basic Profile, without the protections of the Agilia Vigilant Drug’Lib
software.
25
5 Installation
5.1 Types of Installations

A pump can be installed on any of the following:
Location Comments
 See section 5.3.1, page 29.
On a Pole Pole specifications:

 Diameter: from 15 to 40 mm
On a Rail Rail specifications:

 Height: from 25 to 35 mm
 Depth: from 8 to 10 mm
On the
Link Agilia
Rack
On a Table Only install a pump on a table if it is not

possible to attach it to a pole, a rail or
recommended Agilia accessory.
On Another
Pump
Do not use accessories that appear to be damaged. For more

information on accessories, refer to their respective IFU.
26
Warning
 The pump must be used in a horizontal and stable position to
function properly.
 Use recommended Agilia accessories to ensure stability and
prevent the pump from falling. Do not stack the pump with
equipment other than those recommended.
5.2 Using the Rotating Pole Clamp

The rotating pole clamp is located at the back of the pump.
When installing the pump on a pole or a rail, fasten the rotating pole
clamp firmly to avoid any movement of the pump.
5.2.1 Rotating Pole Clamp Description
1 3
2
Figure 5.1: Rotating Pole Clamp System
Legend
1 Screw Clamp
21 Release Button
3 Rotating Pole Clamp
27
5.2.2 Using the Rotating Pole Clamp
You can secure the rotating pole clamp vertically or horizontally by
folding it outward until the release button clicks into the locked position.
5.2.2.1 Folding the Clamp Down (outward)

You can fold the clamp down as follows:
1. Push the release button.
2. Fold the clamp outward.
5.2.2.2 Folding the Clamp Up (inward toward the pump)

You can fold the clamp up as follows:
1. Push the release button.
2. Fold the pole clamp inward toward the
pump.
5.2.2.3 Rotating the Clamp

You can rotate the clamp as follows:
1. Fold the clamp up (see above).
2. Rotate the clamp to a vertical position.
3. If necessary, fold the clamp outward
(see above).
28
5.3 Attaching the pump(s)
5.3.1 Attaching to a Pole
1. Fold the pole clamp down to the horizontal position:
see section 5.2.2.1, page 28.
2. Unscrew the clamp, attach to the
pole, and screw the clamp until the
pump is fully secured to the pole.
3. Make sure that the pump is securely
attached.
For more information on installing the pump on a pole, consult the pole’s
Instructions for Use.
5.3.2 Attaching to a Rail

Only single pumps can be attached to a bed rail or gurney rail.
1. Rotate the pole clamp to the vertical position: see section 5.2.2.3,
page 28.
2. Unscrew the clamp, attach to the rail,
and screw the clamp until pump is
fully secured to the rail.
3. Make sure that the pump is securely

attached.
29
5.3.3 Installing on the Link Agilia Rack
1. Fold the pole clamp up: see section 5.2.2.2, page 28.
2. Position the pump in front of the rack,
and slide it carefully onto the slot in
the pump shelf.
3. Firmly push the pump so that the

locking mechanism secures the pump
(be sure you hear the "click"), as
indicated on the automatic locking
mechanism.
4. When the rack is powered by AC,
check the pump display to confirm
that the power display light is ON,
and listen for the pump’s audio signal.
ml
10
20
30
40
50
60
5. For more information on how to use
the Link Agilia and how to attach
pumps on it, refer to the Link Agilia
Instructions for Use.
Information
 Do not force the pump during installation. If you have to use
excessive force, do not use the rack. Contact your
Fresenius Kabi sales representative.
 Make sure that no Volumat Lines are kinked or damaged when
mounting the pump.
 To avoid confusing the Volumat Lines of different pumps, it is
recommended to install the Volumat Line before mounting
another pump on the rack.
30
5.3.4 Using on a Flat Table
1. Fold the pole clamp up: see section 5.2.2.2, page 28.
2. Place the pump far enough from the
table's edges to prevent it from
accidentally being pushed off.
5.3.5 Attaching Two Pumps Together

You can attach two pumps together either for transport, or before fixing
them to a pole.
1. Fold both pumps’ pole clamps up: see

section 5.2.2.2, page 28.
2. Slide the slot on the bottom of the
upper pump onto the handle of the
lower pump.
3. Turn the attachment lock knob on the
lower pump handle clockwise until the
locked symbol lines up with the
marker.
4. Make sure the two pumps are

securely attached together.
5. If needed, fold the two pole clamps
down and secure them tightly to the
pole.
Symbol Location Description
Attachment Lock Knob Locked Position
Attachment Lock Knob Unlocked Position
31
6 Getting Started
6.1 Flowchart
Once the pump is installed at the bedside, you must follow the steps
below in order to install a syringe and power on the pump.
Preparing and priming the syringe and the extension set

Section 13.2, page 104.
Powering on
Installing the syringe

Programming an infusion
Section 7, page 36.
Information
In order to ensure that all the safety features of the device are activated,
make sure that the following instructions are applied:
 The pump is powered on prior to being connected to the patient.
 The pump is not connected to the patient during the set-up.
32
6.2 Using the Pump for the First Time
1. Make sure the pump is correctly installed at the bedside.
See section 5, page 26.
2. Plug the pump into the AC power supply.
3. Before starting the pump for the first time, you must charge the
battery for approximately 8 hours.
Wait until the pump is fully charged.
Do not use the pump during the first charge.
5. Install a syringe into the pump.
6.3 Powering on
Information
 The pump can operate using the battery; however, we
recommend that the pump be connected to a power supply as
often as possible during use in order to ensure that the battery
remains charged.
 When the pump is connected to the power supply, check that the
power supply indicator lights up green, and that the power
cord and the wall plug are accessible.
1. Press .
An auto-test checks the functionality of the pump.
2. Immediately after powering on the pump, make sure that all LED
lights blink.
3. Acknowledge the different screens listed in the table below.
33
Screen After Powering on Description
 The pump is operating on battery.
The symbol shows three different charge
levels:
< 30 % battery charge
30 % - 70 % battery charge
> 70 % battery charge
 No syringe is installed on the pump.

 Syringe installation !!! is displayed on
top of the screen.
 Install a syringe.
 Maintenance reminder message (optional).
 Same infusion screen (optional).

Press Yes to keep previous infusion settings.
34
6.4 Installing a Syringe
Warning
This must only be done when the patient is not connected.
1. Open the syringe barrel clasp [A].

2. Push the disengagement lever [B]
down and move the plunger driver to
the right.
A B
3. Place the syringe in its cradle, with

the flanges correctly inserted in the
provided slot.
4. Secure the syringe with the syringe
barrel clasp [A].
5. Push the disengagement lever [B]

and move the plunger driver gently to
the left until it is in contact with the
plunger head.
6. Check the general installation.
6.5 Pump Height

Warning
 Do not place the pump more than 1.3 meter above or below the
patient.
 Do not raise or lower the pump height while a patient is connected
to it. This may lead to false alarms and will alter flow rate
accuracy.
35
7 Operation
7.1 Flowchart
Selecting a Profile
Basic Profile Custom Profile Custom Profile

Section 4.1.1, page 22. (with a Drug List) (with a Drug Library)
Section 4.1.2, page 23. Section 4.1.2, page 23.
Selecting the Selecting the

Infusion Rate Infusion Rate
Section 7.3, page 38. Section 7.3, page 38.
Selecting a Syringe
Selecting a Drug
Programming an Infusion
Starting the Infusion

Monitoring the Infusion

Functions during Infusion

Completing the Infusion

36
7.2 Selecting a Profile
You can only select a profile if more than one profile is loaded in the
pump.
1. Press to power on the pump.
2. Press the arrow keys to select a profile that corresponds to the

target group of patients.
The (lighthouse) symbol refers to custom profiles that contain
drug libraries and have been configured with Agilia Vigilant Drug’Lib
software.
The selected profile information is displayed.
4. Press OK to confirm the drug library version, or C to change the

profile.
The drug library is loaded for the profile selected.
37
7.3 Selecting the Infusion Rate (Flow Rate or Dose)
The programming mode step allows you to select the infusion rate. This
step occurs just after selecting Basic Profile, or a custom profile with a
drug list.
Note: The infusion rates for each drug of a drug library are pre-defined
with Agilia Vigilant Drug’Lib software.
Flow rate Dose
The infusion rate that was last used is displayed.

1. Press OK to confirm the infusion rate or press C to change it.
Flow rate Dose
2. Press the arrow keys to select a new infusion rate.

38
7.4 Selecting a Syringe
The pump automatically detects the size of the installed syringe.
1. Press OK to confirm the displayed syringe, or C to change it.
2. If you have chosen to select another syringe, press the arrow keys
to select a new syringe.
3. Press OK to confirm the new syringe.
A clinical advisory message may appear, if one is configured for the
selected syringe.
4. Press OK to acknowledge the clinical advisory message, or C to

return to the syringe selection screen.
39
7.5 Selecting a Drug
Note: The drug selection step is not applicable with Basic Profile.
Drugs are sorted alphabetically by the first letter of their names:
 A  C  J  L  S  U
 D  F  M  O  V  Z
 G  I  P  R  Drug X (mL/h)
1. Press the arrow keys to scroll to the drug’s first letter, and press OK.
2. Press the arrow keys to scroll to the drug’s name, and press OK.
A clinical advisory message may appear, if one is configured for the
selected drug.
3. Press OK to acknowledge the clinical advisory message and
continue programming, or C to change the drug.
40
7.6 Programming an Infusion
 This section describes the programming of an infusion with the
Simple Rate infusion mode.
 You can also program an infusion with the following modes:
- Volume/Time (or Dose/Time), see section 7.11.2, page 59.
- Volume Limit, see section 7.11.3, page 60.
7.6.1 Programming an Infusion by Flow Rate
1. Press the arrow keys to program the flow rate.
7.6.2 Programming an Infusion by Dose
7.6.2.1 Selecting the Drug Concentration

Profile Drug Concentration Selection Procedure
Basic Profile
Custom Profile A- Basic Profile and Custom Profiles (with a Drug List), page 41.
(with a drug list)
Custom Profile
B- Custom Profiles, page 42.
(with a drug library)
A- Basic Profile and Custom Profiles (with a Drug List)
1. Press the arrow keys to select the drug concentration unit, and
press OK.
41
2. Press the arrow keys to select a mass value, and press OK.
3. Press the arrow keys to select a volume value, and press OK.
The concentration is automatically calculated and displayed in the
unit selected above.
B- Custom Profiles
The selected drug is configured in Agilia Vigilant Drug’Lib software to
allow adjustments to its concentration in one of the following ways:
 Within an authorized range
 At authorized finite values (up to 5)
If no adjustment of the concentration is allowed, see section 7.6.2.2,
page 44.
42
Authorized Concentration Range
Authorized Finite Concentrations
Legend
Unauthorized Range Hard Limits
Authorized Range Default Value
Finite Values
Selecting the Drug Concentration
Range Finite values
1. Press the arrow keys to select the concentration.

43
7.6.2.2 Selecting the Patient’s Characteristics
Note: This step is only applicable with custom profiles that contain a drug
library.
Weight Body Surface Area
1. Press the arrow keys to enter the patient's weight or body surface
area.
Information
 The weight entry screen only appears if the selected drug uses
weight for dose rate calculations.
 The body surface area entry screen only appears if the selected
drug uses body surface area for dose rate calculations.
 A pre-populated default weight or body surface area will be
configured with the Agilia Vigilant Drug’Lib software.
7.6.2.3 Selecting the Infusion Unit

Note: This step is only applicable with Basic Profile and custom profiles
that contain a drug list. The infusion units for each drug of a drug library
are pre-defined with Agilia Vigilant Drug’Lib software.
1. Press the arrow keys to select the infusion unit.

44
7.6.2.4 Programming the Infusion
1. Press the arrow keys to program the dose rate value.

7.6.2.5 Programming a Loading Dose

Note: This feature can be activated or deactivated in Agilia
Vigilant Drug’Lib software (custom profiles).
Information
The loading dose is only available with the first start of an infusion. If no
is pressed inadvertently, power the pump off and then on to access the
loading dose again.
If enabled for the selected drug, you can program a loading dose after
programming an infusion defined by dose.
The screens below will appear prior to starting the infusion.
Selecting a Loading Dose
On the loading dose screen:

 Press no to return to the programming screen.
 Press Yes to program a loading dose prior to starting the
infusion.
45
Programming a Loading Dose
1. Press the arrow keys to enter a value for the dose, and press OK to
confirm.
2. Press the arrow keys to program the loading dose duration
(__ h __ min __), and press OK to confirm each time segment.
The VTBI and the flow rate are automatically calculated based on
dose and duration settings.
3. Press OK to confirm the loading dose settings.
If needed, press C or to change the loading dose settings before
starting.
4. Press start to initiate the loading dose.

Once the loading dose is finished, the pump automatically starts the
programmed infusion.
46
Interrupting a Loading Dose
1. To pause the loading dose, press .

The screen displays Continue?
2. Choose one of the following options:
 Press no or to stop the loading dose and proceed to the

programmed infusion.
 Press start to continue with the loading dose.
7.6.3 Programming Beyond Soft Limits

Note: This step is only available with custom profiles that contain a drug
library.
You can override soft limits, and adjust flow rate and dose within the
authorized ranges. You cannot override a hard limit.
Legend
Unauthorized Range Hard Limits
Programmable Range
Soft Limits
(warning and confirmation)
Authorized Range Default Value
47
Overriding a Soft Limit
1. If you reach a soft limit when programming an infusion, the pump
displays a message at the top of the screen:
 Upper soft max = the upper soft limit is exceeded
 Lower soft min = the lower soft limit is exceeded
Flow rate Dose
2. If the displayed settings correspond to the intended flow rate or

dose, press OK.
Flow rate Dose
3. Carefully review the program settings.

The original infusion settings continue until you confirm the new
settings.
4. Press OK or start to confirm the soft limit override.
Flow rate Dose
During infusion, the upper or lower soft limit message will alternate with
the drug name and concentration at the top of the screen.
48
7.7 Starting an Infusion
Flow rate Dose
1. Check the delivery path integrity, (syringe and IV access device).

2. Check that there is no air in the syringe or in the extension set.
3. Confirm that the syringe is correctly installed in the pump.
4. Connect the syringe’s extension set to the patient's IV access
device.
5. Check the infusion settings prior to starting the infusion.
6. Press start to start the infusion.
Warning
When connecting the syringe’s extension set to the patient's IV access
device, always use aseptic technique according to your healthcare
facility policy.
Information
If the syringe is not correctly positionned in the pump, we recommend
clamping, closing or disconnecting the extension set from the patient’s
IV access device.
49
7.8 Monitoring an Infusion
7.8.1 Monitoring an Infusion when Programmed by
Flow Rate
1 2
5
4 3
Legend
1 Drug Name (Custom profiles only)
Infusion Flow Rate (mL/h)

21
To change the flow rate during an infusion, see section 7.9.2, page 52.
The flow rate is displayed with the largest font size.
Infusion Duration
3
At the current rate, the remaining infusion time in hours and minutes.
Infusion duration may or may not be displayed depending on the configuration preset with
Agilia Vigilant Drug’Lib software for this drug.
4 Syringe Name / Ward Name (configurable)
Custom Profile Sign

5
When infusing a drug selected from the Agilia Vigilant Drug’Lib software library,
this lighthouse sign is displayed on the screen continuously.
50
7.8.2 Monitoring an Infusion when Programmed by Dose
1 2 3
6 5 4
Legend
1 Drug Name (Custom profiles only)
Dose
21
To change the dose during an infusion, see section 7.9.2, page 52.
Dose is displayed with the largest font size.
3 Drug Concentration
4 Infusion Flow Rate
5 Syringe Name / Ward Name (configurable)
6 Patient Characteristics
Custom Profile Sign

7
When infusing a drug selected from the Agilia Vigilant Drug’Lib software library,
this lighthouse sign is displayed on the screen continuously.
51
7.9 Functions During Infusion
7.9.1 Stop
Flow rate Dose
To stop the infusion, press .

After 2 minutes, an alarm is generated as a reminder that the infusion is
stopped.
To restart the infusion, first confirm or modify the programming settings,

then start the infusion. See section 7.6, page 41.
7.9.2 Rate Titration

You can adjust the infusion rate (flow rate or dose) during the infusion.
Depending on your pump configuration, stopping the infusion may be
required before modifying the infusion rate.
1. If required, stop the infusion, see section 7.9.1, page 52.
2. Press the arrow keys to modify the flow rate or dose.
Flow rate Dose
52
7.9.3 Administering a Bolus
A bolus is an extra dose that a pump can deliver during an infusion.
There are two ways to deliver a bolus dose during an infusion:
 Direct bolus
 Programmed bolus
Direct Bolus Programmed Bolus
Access Key
or
Occlusion Set to its maximum value: 900 mmHg / 120 kPa / 17.4 PSI
Pressure Level
Information
 The bolus volume is added to the Volume Infused (VI).
 The key is not active when the menu screen is displayed.
53
7.9.3.1 Direct Bolus
Vigilant Drug’Lib software (custom profiles) or in the pump options
(Basic profile).
1. During the infusion, press .

2. Press bolus to confirm access to bolus function.
3. To administer a direct bolus, press and hold .

4. Monitor the volume infused on the main display until the desired
bolus is reached.
5. To stop the bolus, release the key.

The infusion resumes its previous rate after the bolus is delivered.
54
7.9.3.2 Programmed Bolus
Vigilant Drug’Lib software (custom profiles) or in the pump options
(Basic profile).
During the infusion, you can program a bolus in one of the following two
ways:
 Press , then prog.
 Press , and select in the menu. Press enter to confirm.
Programming a Bolus
1. Press the arrow keys to program the bolus volume or dose, and
press OK.
2. Press the arrow keys to program the bolus duration
(__ h __ min __), and press OK.
The flow rate is calculated automatically.
Flow rate Dose
3. Press start to start the bolus.
Flow rate Dose
55
The infusion resumes its previous rate after the bolus is delivered.
Press exit or to exit the bolus function and save the programmed
bolus settings.
If you press again, this screen appears immediately and displays the
settings of the last bolus.
Interrupting a Programmed Bolus

1. Press to interrupt the bolus.
Flow rate Dose
2. Answer the question: Continue?

 Press no to return to the infusion.
 Press start to continue the bolus.
56
7.10 Completing an Infusion
7.10.1 Near End of Infusion Alert
Prior to the end of an infusion, a near end of infusion alert is
automatically triggered. The following happens:
 An audible alarm is triggered.
 An alarm message appears on the pump screen.
 The infusion indicator lights flash yellow.
Near end of infusion alert is triggered when the two criteria below are
reached simultaneously.
Default Pump
Setting Range of Values
Setting
Time Before the End of the Infusion From 1 to 30 minutes 5 minutes
The remaining volume of fluid in the

N/A N/A
syringe < 10 % of the syringe capacity
Near end of infusion alert settings are configurable with Agilia

Vigilant Drug’Lib software (custom profiles), or in the pump options
(Basic Profile). For more information, refer to the technical manual.
Silencing Near End of Infusion Alert
1. Press to silence the alarm.

2. If required, press OK to confirm the empty syringe mode.
Depending on the pump configuration, the following happens:
 The infusion continues at the programmed rate until the plunger
reaches the tip of the syringe. The syringe is not completely
emptied (regular end of infusion).
 The infusion continues until the syringe is completely emptied.
The flow rate decreases when the plunger reaches the tip of the
syringe (empty syringe - only in Simple Rate mode).
57
7.10.2 End of Infusion
When the infusion is complete, the following happens:
 An audible alarm is triggered.
 An alarm message appears on the pump screen.
 The infusion indicator lights flash red.
End of infusion settings are configurable with Agilia Vigilant Drug’Lib

software (custom profiles), or in the pump options (Basic Profile). For
more information, refer to the technical manual.
Silencing the Alarm
1. Press to silence the alarm.

2. Prepare a new syringe, and adjust the settings for a new infusion.
7.10.3 Powering off
You can power off the pump as follows:

1. Press to stop the infusion.
2. Press and hold until the pump powers off.
58
7.11 Infusion Modes
You can program an infusion with the different infusion modes available,
depending on the pump configuration, and on the selected drug.
7.11.1 Simple Rate

1. Press the arrow keys to select the infusion rate.
2. Press OK.
For more information, see section 7.6, page 41.
7.11.2 Volume/Time & Dose/Time

You can use this infusion mode to program a volume to be infused
(VTBI) over a programmed period of time.
When the VTBI is reached, an alarm is triggered.
1. For information on how to access the Volume/Time or Dose/Time

menu, see section 8.11, page 79.
Volume/Time Dose/Time
2. Press the arrow keys to set the volume or dose to be infused (VTBI /
DTBI), and press OK.
The infusion rate is automatically calculated.
Information
If you program a volume to be infused that is greater than the actual
volume in the syringe, make sure to replace the syringe when it is empty,
see section 13.3.2, page 106.
59
3. Press the arrow keys to set the infusion time, and press OK.
The infusion rate is automatically readjusted.
4. Press the arrow keys to configure the end of infusion settings and
press OK to confirm.
 Stop: The infusion stops when the VTBI is completed.
 Keep Vein Open (KVO): After the VTBI is completed, the infusion
continues at a preset flow rate to keep the IV access device
open.
 Continuous: After the VTBI is completed, the infusion continues
at the programmed flow rate.
7.11.3 Volume Limit

You can use this infusion mode to set a limit to the volume infused.
When the limit is reached, an alarm is triggered.
1. Access the Volume Limit menu, see section 8.12, page 80.
Flow rate Dose
2. Press the arrow keys to set the volume limit, and press OK.
60
Information
 If you program a volume limit that exceeds the actual volume in
the syringe, make sure to replace the syringe when it is empty,
 The volume already infused (VI) before accessing the volume limit
mode is taken into account.
3. Press the arrow keys to configure the end of infusion settings and
press OK to confirm.
 Stop: The infusion stops when the volume limit is reached.
 Keep Vein Open (KVO): After the volume limit is reached, the
infusion continues at a preset flow rate to keep the IV access
device open.
 Continuous: After the volume limit is reached, the infusion
continues at the programmed flow rate.
Flow rate Dose
61
7.12 Other Functions
7.12.1 Priming the Syringe and the Extension Set
Note: The prime function can be configured with Agilia Vigilant Drug’Lib
(custom profiles) or in the pump options (Basic profile):
 Mandatory: A message is displayed and the user is required to
prime the line before infusion.
 Advised: A message is displayed to encourage the user to to
prime the line before infusion.
 Not displayed: The pump does not remind the user to prime the
line before infusion.
Information
We strongly recommend to always use the prime function, especially for
life-sustaining drugs. Priming the syringe and the extension set
removes all the mechanical gaps and ensures that the programmed flow
rate is reached within the smallest delay once the start button is pressed.
2. Press .
3. Make sure the extension set is not connected to the patient, as
indicated on the screen.
4. Press OK to proceed.
62
5. Press and hold the key to prime, or press C to cancel
6. To end priming, release the key.

7. Make sure there is no air in the extension set.
Information
 Priming is only accessible prior to starting the infusion.
 The key is not active when the menu screen is displayed.
 During priming, the occlusion pressure level is set to its maximum
value 900 mmHg / 120 kPa / 17.4 PSI.
 Priming is limited to 3 mL maximum. Above 3 mL, you must
release and press the key again to restart priming.
Quick-Start
Quick-start is designed to decrease the delay of therapy when the
pump’s prime function is not used.
When quick-start is triggered, the infusion starts at a high flow rate
(120 mL/h) until the pump’s plunger driver starts pushing the syringe
plunger head. The flow rate then automatically switches to the
programmed value.
At the beginning of an infusion, quick-start is triggered or not triggered in
the following situations:
Prime Function
Quick-start Trigger Rule
Configuration
Mandatory  Not triggered
Advised  Not triggered
 Triggered if flow rate is equal or inferior to 50 mL/h and the
Not displayed automatic priming is not done.
 Not triggered if the automatic priming is done by the user.
Information
Priming the line automatically ensures better pump performances than
using quick-start.
Warning
If the prime function is set as "Not displayed", and if the quick-start is
triggered, an undesired bolus may occur in some cases. Always prefer
the automatic prime function for life-sustaining drugs.
63
7.12.2 Pre-programming the Pump
You can program the pump before installing the syringe.

Syringe installation !!! is displayed on top of the pump
screen.
2. Make sure the syringe barrel clasp is folded up against the pump.
The prog symbol is displayed.
3. Press prog.
4. Program the infusion.
5. Press exit to confirm.

6. When ready, install the syringe.
64
8 Menus
8.1 Overview
8.1.1 Commands
Operation Key
Access menu or exit menu
Select
Confirm (corresponds to enter on the screen)
Select  / Deselect 
8.1.2 Menu Description

Stop
Menu Symbol Infusion Associated Procedure
Required
Profile Pro NO  Displaying active profile information, page 67.
Pressure NO  Modifying the pressure limit, page 68.
Keypad lock status NO  Locking / Unlocking the keypad, page 70.
Battery life NO  Viewing the battery life, page 72.
Volume Infused  Viewing and clearing the volume or dose infused,

Dose Infused
mL? NO
page 73.
Pause YES  Programming a pause, page 74.
Programmed bolus NO  Programming a bolus, page 75.
Patient NO
 Changing a patient’s weight or body surface area,
page 76.
Day/Night mode NO
 Switching between day mode and night mode,
page 77.
Volume/Time V/T YES

 Programming a Volume/Time or Dose/Time infusion,
page 79.
Dose/Time D/T YES
Volume limit VL YES  Programming a Volume Limit infusion, page 80.
Alarm volume NO  Adjusting the alarm volume, page 81.
Volume-Dose history YES  Viewing the infusion history, page 82.
65
Stop
Menu Symbol Infusion Associated Procedure
Required
View flow rate history NO  Viewing flow rate history, page 83.
View pressure history NO  Viewing pressure history, page 84.
Syringe NO  Displaying on-pump syringe information, page 85.
View event log NO  Viewing the event log, page 86.
Date / Time NO  Setting the date and time, page 87.
Maintenance NO  Displaying maintenance information, page 88.
Library information NO  Displaying drug library information, page 89.
Data Set DS NO  Displaying active data set information, page 90.
Note: The displayed menu may change depending on the pump configuration.
For more information on factory configuration, refer to Appendix: Factory Configuration, page 151.
66
8.2 Profile
Symbol Pro
Procedure Displaying active profile information
You can display the active profile name as follows:

1. Press .
2. Press the arrow keys to select Pro .

3. Press enter.
The active profile information is displayed.
67
8.3 Pressure
Symbol
Procedure Modifying the pressure limit
The pump pressure limit is pre-defined in the pump options in one of the
following modes:
 3 levels (low , medium , high ).

The pressure limit is adjustable according to 3 pre-set values.
 Variable
The pressure limit is adjustable within a pre-defined range.
When the pressure limit is reached, an occlusion alarm is triggered.
You must silence the alarm and start the infusion again.
To consult the pressure settings, see section 15.8, page 113.
You can modify the pressure limit as follows:

1. Open the pressure menu in one of the two following ways:
 Press .
 Through the Menu:
- Press .
- Press the arrow keys to select .
2. Press enter to access the pressure limit screen.
68
3. Press the arrow keys to increase or decrease the pressure limit.
4. Press OK to validate.
5. Press to enable or disable the DPS function (optional).

Information
 The Dynamic Pressure System (DPS) informs the user of any
sudden rise or drop in pressure before the pressure limit is
reached.
 If variable pressure mode is enabled, a pre alarm is triggered
when the pressure reaches 50 mmHg below maximum pressure
(25 mmHg when maximum pressure is 50 mmHg).
 If other pumps are used in parallel, it is recommended that their
pressure limits be adjusted to the same level.
69
8.4 Keypad Lock Status
Symbol
Procedure Locking / Unlocking the keypad
You can use this feature to avoid inadvertent key presses.
Locking the Keypad
You can lock the keypad as follows:

1. Press .
2. Press the arrow keys to select .

3. Press enter.
4. Press to lock the keypad.

The screen displays .
Information
 If a key is pressed, the screen will display a keypad lock symbol.
 The and keys remain functional when the keypad is
locked.
70
Unlocking the Keypad
You can unlock the keypad as follows:

1. Press .

3. Press enter.
4. Press to unlock the keypad.

71
8.5 Battery Life
Symbol
Procedure Viewing the battery life
You can view the battery life as follows:

1. Press .
2. Use the arrow keys to select .
The time remaining under current flow rate conditions is displayed.
The bar graph shows a visual representation of battery life.
The symbol displayed shows the following:
 : The pump is plugged into the AC power supply.
 : The pump is operating on battery.
72
8.6 Volume Infused / Dose Infused
Symbol mL?
Procedure Viewing and clearing the volume or dose infused
Flow rate Dose
You can view and clear the volume or dose infused as follows:
1. Press .
2. Press the arrow keys to select mL? .

The total volume, or total dose, infused includes the programmed
infusion, loading doses and boluses. The length of time over which
they were infused is also displayed.
3. To clear the volume or dose infused, press enter.
Information
When the pump is powered off or a new drug is selected, the volume or
dose infused is cleared.
73
8.7 Pause
Symbol
Procedure Programming a pause
You can program a pause as follows:

2. Press .

4. Press enter.
5. Press the arrow keys to program the pause duration in hours and
minutes, and press OK.
6. Press the button to activate the "Start infusion at pause end"
feature. (optional)
7. Press OK to begin the programmed pause.
8. To restart the infusion before the end of the pause period, press
then start.
Information
If you do not activate the "Start infusion at pause end" option, an audible
alarm is generated at the end of the pause. The infusion must be started
manually to continue the infusion.
74
8.8 Programmed Bolus
Symbol
Procedure Programming a bolus
To program a bolus, see section 7.9.3.2, page 55.
75
8.9 Patient
Symbol
Procedure Changing a patient’s weight or body surface area
Information
 If the selected dose rate unit is weight-based (kg), the screen
displays the patient’s weight.
 If the selected dose rate unit is body surface area-based (m²), the
screen displays the patient’s body surface area.
Weight Body Surface Area
You can change the patient’s weight or body surface area as follows:
1. Press .

3. Press enter.
4. Press OK to change the patient’s weight or body surface area.
5. Press OK to confirm the infusion settings.
76
8.10 Day/Night Mode
Symbol
Procedure Switching between day mode and night mode
This function switches between day mode and night mode .

The default night mode settings are as follows:
 The key-press beep is silenced.
 Infusion indicators and screen brightness are dimmed.
Depending on your pump configuration, the switch between day and
night mode may be managed either through this menu (manual mode),
or according to pre-defined settings (auto mode). For more information,
refer to the technical manual.
Switching from Day Mode to Night Mode
You can switch to night mode as follows:

1. Press .

3. Press enter.
4. Press to activate night mode.

77
Switching from Night Mode to Day Mode
You can switch to day mode as follows:

1. Press .

3. Press enter.
4. Press to activate day mode.

78
8.11 Volume/Time & Dose/Time
V/T
Symbols
D/T
Procedure Programming a Volume/Time or Dose/Time infusion
1. Press .
2. Press the arrow keys to select V/T (or D/T ).

3. Press enter.
For more information on how to program a Volume/Time or Dose/Time
infusion, see section 7.11.2, page 59.
79
8.12 Volume Limit
Symbol VL
Procedure Programming a Volume Limit infusion
Flow rate Dose
1. Press .
2. Press the arrow keys to select VL .

3. Press enter.
For more information on how to program a Volume Limit infusion, see
section 7.11.3, page 60.
80
8.13 Alarm Volume
Symbol
Procedure Adjusting the alarm volume
You can adjust the alarm volume as follows:

1. Press .

3. Press enter.
4. Press the arrow keys to select the alarm volume.
The pump emits an alarm at the selected volume level.
5. Press OK.
81
8.14 Volume-Dose History
Symbol
Procedure Viewing the infusion history
This function allows the user to view the infusion history on the pump.
You can view the infusion history as follows:

1. Press .

3. Press enter.
4. Press the arrow keys to select the desired infusion.

The selected infusion’s details are displayed:
- Drug name
- Drug concentration
- Volume or dose infused
- Infusion total duration
- Infusion date & time
5. Press exit to return to the menu.
82
8.15 View Flow Rate History
Symbol
Procedure Viewing flow rate history
This function allows the user to check the current infusion’s history
information in order to verify the dose administered.
You can view flow rate history as follows:

1. Press .

3. Press enter.
The following information is displayed:
- An event marker (cursor)
- The event details (time and flow rate)
- The measured flow rate (solid line)
4. Press the and buttons to browse the events.
5. Press to view information about the selected event.
Information
 The history is not refreshed while the history screen is displayed.
To refresh the history data, exit and select the history again.
 Flow rate history is not stored after powering off.
83
8.16 View Pressure History
Symbol
Procedure Viewing pressure history
This function allows the user to check the current infusion’s history
information in order to verify changes in pressure.
You can view pressure history as follows:

1. Press .

3. Press enter.
- An event marker (cursor)
- The event details (time and pressure limit)
- The pressure limit (dotted line)
- The measured pressure (solid line)
4. Press the and buttons to browse the events.
5. Press to view information about the selected event.
Information
 The history is not refreshed while the history screen is displayed.
To refresh the history data, exit and select the history again.
 Pressure history is not stored after powering off.
84
8.17 Syringe
Symbol
Procedure Displaying on-pump syringe information
You can display on-pump syringe information as follows:

1. Press .
2. Use the arrow keys to select .

3. Press enter.
- Syringe capacity
- Syringe brand / name
85
8.18 View Event Log
Symbol
Procedure Viewing the event log
The event log displays details of the last events that occurred on the
pump. Events are stored in the log even after the pump is powered off
and on again. The log can store up to 1500 events. Older events are
overwritten.
Note: When the AC Power is disconnected for a period of time, or when
the batteries are not operating, the log file is kept in a non-volatile
memory for approximately 10 years.
You can view the event log as follows:

1. Press .

3. Press enter.
4. Press the arrow keys to select the desired event.

5. Press enter.
The details of the event are displayed.
86
6. Press exit to return to the previous screen.
8.19 Date / Time

Symbol
Procedure Setting the date and time
You can set the date and time as follows:

1. Press .

3. Press enter.
4. Press the arrow keys to set the following:
 Day
 Month
 Year
 Hours
 Minutes
87
8.20 Maintenance
Symbol
Procedure Displaying maintenance information
You can display maintenance information as follows:

1. Press .

3. Press enter.
4. Press the arrow keys to scroll through the maintenance information.
 Pump serial number
 Next maintenance date (dd/mm/yyyy)
 Pump model
 Software version
 Total operating time since last maintenance
88
8.21 Library Information
Symbol
Procedure Displaying drug library information
You can display drug library information as follows:

1. Press .

The number of drugs contained in the drug library is displayed.
3. Press enter.
All the drugs contained in the drug library are displayed.
4. Use the arrow keys to select a drug.
5. Press to view information on the selected drug.
89
8.22 Data Set
Symbol DS
Procedure Displaying active data set information
You can display active data set information as follows:

1. Press .
2. Press the arrow keys to select DS .

3. Press enter.
The active data set information is displayed.
90
9 Options
9.1 Commands
Operation Key
Options access +
Option selection
Confirm (corresponds to enter on the screen)
Select  / Deselect 
Selected current values are stored when the device is powered off after programming.
To return to the normal menus, power off then power on again.
9.2 Option Descriptions

Four different option groups are available on the pump. This IFU only
describes the "Pump Settings" options.
Option Access Code? Description Location
Pump Settings No Section 9.3, page 92.
Basic Profile Configuration Yes Technical Manual
Profile Yes Technical Manual
Maintenance Yes Technical Manual
Information
If the wrong access code is entered, error is displayed.
91
9.3 Pump Settings
The following options have different functions that you can select or
deselect to customize your Agilia SP MC.
Default
Function Choice
Pump Setting
 Battery logo: display or hide battery logo Disabled
[User 1]:
Screen option  Pressure logo: display or hide pressure Disabled
pictogram
[User 2]:
 Maintenance: display or hide maintenance Disabled
Menu items
 Date / Time: display or hide date/time menu Disabled
[User 3]:  Adjustment of screen contrast using the fast Medium level
Contrast increment and decrement keys
[User 7]:  Date selection: dd/mm/yyyy Production plant date

Date/Time  Time selection: __ h __ and time
[User 8]: Official language of the

 A scrolling list with all available languages
Language target country
[User 14]:
 Enable/Disable the Wi-Fi module Enabled
Wi-Fi module
[Par 5]:  Enable/Disable selected syringe confirmation Enabled
Syringe selection screen
[Par 6]:  Checkbox list with the names of available Section 13.1, page 104.
Syringes syringes, and other syringes sizes
[Par 13]:  Enable/Disable "AC power disconnection"
AC power message and "Device operating on battery" Enabled
disconnection alert message at power on
Remove trailing 0 /
[Par 35]:  Enable/Disable display of the decimal "0" after Remove trailing 0
Dose display format a dose value
during programming
[Par 37]:  Enable/Disable preventive silence for alarm Enabled
Alarm system system
92
10 Data Communication
10.1 Overview
Cable Communication Wi-Fi Communication
Connection of 1 pump to a PC for the following Communication between an hospital information
purposes: system server and a number of identified pumps
 Data set upload (via Agilia Vigilant Drug’Lib for the following purposes:
software)  Data set upload
 Maintenance (via Agilia Partner software)  Pump history retrieval
Information
 Ensure that all hospital information systems have been approved
by Fresenius Kabi. For more information, contact your technical
services representative.
 Before connecting the pump to a hospital information system, ask
your IT or biomedical department to configure the device.
10.2 Communication via Agilia Cables

10.2.1 Data Communication Cables
Information
 Only use recommended Agilia cables.
 All connections and disconnections must be performed by
qualified and appropriately trained staff.
 All IT devices (including computers, hubs and switches) inside the
patient area (< 1.5 m) must comply with IEC/EN 60601-1
(leakage current).
 IT devices connected outside the patient area (> 1.5 m) must be
at least IEC/EN 60950 compliant.
93
10.2.2 Using the Communication Port
1. Remove the protective cap from the
pump’s RS232 communication port.
2. Connect the cable to the RS232

communication port by turning the
cable wheel.
Information
Do not disconnect communication cables while data is being transferred.
10.3 Communication via Wi-Fi

The Wi-Fi option allows the pump to connect to a hospital information
system without cables.
To know if your pump is equipped with a Wi-Fi module, check for the
presence of the Wi-Fi logo on the pump’s keypad.
Wi-Fi pump Non Wi-Fi pump
To activate or deactivate the Wi-Fi module, see section 9.3, page 92.
For more information on the Wi-Fi module, refer to the technical manual.
Information
Wi-Fi pumps can be configured with Wi-Fi module enabled or disabled.
94
10.4 Data Set Upload
A new data set may be uploaded to the pump while it is infusing. The
new data set will be installed at the next pump start-up.
When a new data set has been uploaded since the last start-up of the
pump, the symbol is displayed on the screen.
2. Press OK to acknowledge.
The data set information is displayed.
3. Press OK to acknowledge this information, or C to return to the

previous screen.
The data set is installed in the pump.
Information
It is the hospital's responsibility to define a data set and upload it to the
Centerium Server for distribution to the device.
95
11 User Test
The following protocol provides the user with a quick integrity check
guide to ensure that the pump system is functional. Perform this user
test before each use of the pump.
1. Check the external appearance of the pump for the absence of

cracks or other visible damage.
2. Check for the absence of visible damage on the power cord inlet
and the power cord.
3. When used on a pole or a rail, check that the pump is securely
attached.
4. Connect the pump to the AC power supply, and check that the
power indicator lights up and a beep is emitted.
5. Power on the pump, and wait for the auto-test to complete. Check
the display and light indicators.
6. Press any key and listen for a key beep (if key beep is activated).
96
12 Alarms and Safety Features
12.1 Introduction
Agilia SP MC has a continuous monitoring system that begins when the
pump is started.
For better visibility of the alarm display, we recommend that the user be
positioned in front of the pump.
Warning
Audible alarm signals from medical devices may be masked by
environmental noise. Make sure to set the alarm volume high enough so
that you can hear the alarm signal above environmental noise.
12.2 Alarm Descriptions

There are several different levels of alarm priorities:
 High-priority alarms
 Medium-priority alarms
 Low-priority alarms
 Information signals
Required
Alarm Priority Operator Description
Response
 The infusion stops.
 The infusion indicator lights flash red.
Immediate
High (!!!)
response
 The pump emits audible alarm signals.
 An alarm description is displayed on the pump screen.
 The key silences the alarm (for two minutes).
Prompt  The infusion continues.
Medium (!!)
response  The infusion indicator lights flash yellow.
 The pump emits audible alarm signals.
Low (!) Awareness  The key silences the alarm (for no time limit).
Information Signals Awareness  An information message is displayed on the pump
screen.
97
12.3 General Remarks
 When two alarms occur at the same time, the higher priority
alarm is displayed.
 When two alarms with the same priority level are triggered at the
same time, the pump software assigns them a priority.
 When the cause of a high-priority alarm has been fixed, the red
indicators switch off. However, the message remains displayed
at the top of the screen as a reminder of the cause of the alarm.
 The device guarantees the triggering of high-level priority alarms
in every use condition.
 A maximum of 1 mL may be infused due to a single fault
condition.
 For all alarms (except occlusion alarms), the amount of time
between the alarm condition and the alarm generation is less
than 5 seconds.
 If the AC power is disconnected and if the battery is discharged,
the alarms settings are not modified and are stored indefinitely.
12.4 List of Alarms

12.4.1 Syringe Alarms
Stops
Message Priority Problem / Resolution
Infusion?
The syringe is not installed correctly (plunger
Syringe driver, syringe barrel clasp or flange
installation !!!
High (!!!) Yes detection).
The plunger head is missing or incorrectly
Plunger head
High (!!!) Yes inserted.
alarm !!!
Disengagement Disengaged mechanism.
High (!!!) Yes
mechanism !!!  Check the syringe installation.
Preventive auto-test on potential failure of
Remove completely
Low (!) No plunger head.
syringe !
 Remove and reinstall the syringe.
98
12.4.2 Volume Limit Alarms
Stops
Infusion?
End of volume
limit !!!
High (!!!) Yes The volume limit is reached.
The time remaining is less than the defined

time duration (adjustable between 1 and
Near end of volume
limit !!
Medium (!!) No 30 minutes), and the remaining VTBI until the
volume limit has dropped to less than 10% of
the syringe capacity.
The volume limit is reached and the end of
End of volume
limit !
Low (!) No infusion setting is set as "KVO" or
"continuous".
12.4.3 Volume/Time & Dose/Time Alarms

Stops
Infusion?
End of
volume/time !!! High (!!!) Yes The VTBI is completed.
End of dose/time !!!
Near end of The time remaining is less than the defined
volume/time !! time duration (adjustable between 1 and
Medium (!!) No 30 minutes), and the remaining VTBI has
Near end of
dose/time !!
dropped to less than 10 % of the syringe
capacity.
End of volume/time ! The VTBI is completed and the end of infusion
Low (!) No
End of dose/time ! setting is set as "KVO" or "continuous".
12.4.4 Infusion Alarms

Stops
Infusion?
End of infusion !!! High (!!!) Yes The infusion is completed (simple rate).
The time remaining is less than the defined
time duration (adjustable between 1 and
Near end of
infusion !!
Medium (!!) No 30 minutes), and the remaining volume of fluid
in the syringe has dropped to less than 10 %
of the syringe capacity.
The flow rate (or dose) has been modified
using the keys, but has not been confirmed.
Check settings !! Medium (!!) No
 Check the flow rate (or dose) and press OK
to confirm.
A value must be entered.
Waiting settings !! Medium (!!) No
 Enter a value and press OK to confirm.
99
Stops
Infusion?
The infusion settings have been entered, but
have not been confirmed with start.
Waiting start !! Medium (!!) No
 Check the infusion settings, and
press start to start the infusion.
Information The upper soft limit is exceeded, according to
Upper soft max No
signal the drug settings defined in the drug library.
Information The lower soft limit is exceeded, according to
Lower soft min No
signal the drug settings defined in the drug library.
Information
Reached hard limit No The upper or lower hard limit is reached.
signal
12.4.5 Pressure Alarms

Stops
Infusion?
The pressure in the infusion line has reached
the threshold level.
Occlusion alarm !!! High (!!!) Yes  Check whether the infusion line is
occluded. If necessary, readjust the
pressure threshold.
In-line pressure has reached the following
value:
 25 mmHg / 2.5 kPa / 0.5 PSI below the
programmed threshold (from 50 to
Occlusion
Medium (!!) No 250 mmHg).
pre alarm !!  50 mmHg / 5 kPa / 1 PSI below the
programmed threshold (over 250 mmHg).
 Check the infusion line.
 Set the correct pressure threshold.
The pressure is increasing in the infusion line.
Pressure increase ! Low (!) No
 Check for occlusions in the infusion line.
The pressure is decreasing in the infusion line.
Drop in pressure ! Low (!) No  Check the downstream Luer lock

connection and the integrity of the entire
line.
100
12.4.6 Battery Alarms
Stops
Infusion?
The battery is discharged.
 The pump will power OFF automatically
Battery alarm !!! High (!!!) Yes within 5 minutes.
 Connect the pump to a power supply
immediately.
Very low battery.
Very low battery !!! High (!!!) Yes  Connect the pump to a power supply and
allow time to charge.
Low battery.
Battery pre alarm !! Medium (!!) No
 Connect the pump to a power supply.
If the pump is not used during an extended
Low (!) No period, connect to a power supply and wait
until the battery is charged.
12.4.7 Power Alarms

Stops
Infusion?
The power supply is inconsistent.
AC power failure ! Low (!) No
 Contact your technical support.
The pump is disconnected from the AC power.
A single beep is emitted.
 Press to acknowledge.
Information
Power disconnection
signal
No  Check that the battery life is sufficient for
the expected infusion duration.
 If the disconnection was unintentional,
check the power connection.
12.4.8 Keypad Alarms

Stops
Infusion?
Information The keypad is locked.
Keypad lock status No
signal  Unlock the keypad.
Keypad locked The keypad is locked and the syringe barrel
Information clasp was opened and closed.
Unlock keypad to No
signal
continue  Unlock the keypad.
101
12.4.9 Technical Error Alarms
Stops
Infusion?
Technical alarm.
Erxx(yyyy) !!! High (!!!) Yes  Contact your qualified technician or your
High internal Temperature increase.
Low (!) No
temperature !  Check device environment.
The pump is mounted on a Link+ Agilia rack
Alarm reporting not that has not been upgraded.
available on the Low (!) No
Link !  Contact your qualified technician or your
In the case of a system malfunction, the alarm sounds and an error

message Erxx(yyyy) !!! is displayed.
1. Record the error message Erxx(yyyy) !!!.
2. Disconnect the pump from the power supply.
3. Reset the device by pressing the key for 10-15 seconds, and
release it when the device powers off.
Warning
If the alarms persist when the pump is powered on again, do not use the
device on a patient, and contact qualified biomedical engineering staff in
your healthcare facility, or your Fresenius Kabi sales representative.
102
12.4.10 Audio-only Information Signals
Stops
Type Comment Activation
Infusion?
Beep until key is
Switch mode No Beep starts when action is not allowed
released
End of loading dose 3 beeps No At the end of the loading dose
End of programmed
3 beeps No At the end of a programmed bolus
bolus
Start infusion at the end At the end of a pause, when the infusion
3 beeps N/A
of pause automatically starts
AC power connection 1 beep No When power is connected
Forbidden key 1 beep No Repeated until key is released
Key beep 1 beep No For each key pressed
Other non validation
1 beep No For each key pressed
beep
Manual bolus 1 beep No Repeated for each mL infused
Syringe prime 1 beep N/A Repeated every 5 seconds
End of pause 4 beeps N/A At the end of pause - repeated
103
13 Syringes
13.1 Syringe List

Information
 Agilia SP MC offers a maximum 100 syringes of different types,
brands and sizes. For a list of compatible syringes, and for
ordering information, refer to the System Components booklet.
 The list of available syringes on your pump is accessible from the
pump options.
 For general information on syringes (expiration date, storage,
sterility, and so on), refer to the syringe manufacturer’s
instructions.
 Only use compatible syringes. Use of any other syringe may
affect the accuracy of the infusion, and result in injury to the
patient and damage to the pump.
Warning
Fresenius Kabi cannot accept responsibility for any flow rate errors that
are due to changes to syringe specifications introduced by the
manufacturer.
13.2 Preparing a Syringe

1. Prepare the fluid to be infused
according to your healthcare facility’s
protocol.
2. Select a syringe.
3. Check the syringe and IV access
device integrity.
4. Connect the extension set to the
syringe according to local practices.
5. If necessary, fill the syringe and check
that it is watertight.
6. Prime the extension set according to
your healthcare facility’s protocol.
7. Confirm that there is no air in the syringe or in the extension set.
104
Information
 The fluid in the syringe and the syringe must be within normal
operating temperature conditions: +18 °/+30 °C.
 It is recommended to prime the set immediately before starting
the infusion.
 Do not use in conjunction with positive pressure infusion devices
that could generate back pressure higher than 2000 hPa
(1500 mmHg): doing so will damage the administration set and
the pump.
 Some extension sets may have components such as a filter that
require special instructions.
 Certain drugs may require specific extension sets.
 Connect the infusion line in accordance with procedures in your
healthcare facility using good medical practices. It is
recommended to use a Luer lock system to reduce the risk of
disconnection, leakage, air-in-line, or contamination.
105
13.3 Operations for Syringes
13.3.1 Removing a Syringe
2. Disconnect the patient.
3. Open the syringe barrel clasp.
4. Press to silence the audible signal for 2 minutes.

5. Push the disengagement lever down and remove the syringe from
its cradle.
6. Disconnect the syringe from its extension set.
7. Disconnect the extension set from the IV access device in
accordance with healthcare facility protocol.
13.3.2 Changing a Syringe

1. Remove the syringe,
2. Install another syringe, and follow the steps described in the
flowchart.
Information
Properly dispose of used syringes.
13.3.3 Syringe Replacement Interval

Replace the syringe according to your healthcare facility’s protocol or
CDC guidelines.
106
13.4 Gravity Infusion in Parallel with a Pump
You can infuse the contents of a fluid container via gravity, in parallel
with the pump.
ml
10
20
30
40
50
60
Figure 13.1: Gravity Infusion (in parallel with a pump)

Information
 Fresenius Kabi recommends the use of a back check valve or
positive pressure infusion devices when an infusion on the pump
is connected to a gravity line. This will prevent the back-up of IV
fluid or medication into the gravity line.
 If there is no back check valve on a gravity infusion line during a
multi-line infusion, it will be impossible to detect patient-side
occlusions. Such an occlusion could cause the pumped drug to
back up into the gravity line, and later be infused in an
uncontrolled manner when the occlusion is released.
 Be careful about drugs interactions and incompatibilites during a
multi-line infusion. Fresenius Kabi recommends infusing the
critical drugs first.
107
14 Device Storage
14.1 Precautions for Storage

 Handle the device with care during storage.
 Store the device in a cool, dry place. The storage area must be
clean and organized.
 Clean and disinfect the device prior to storage.
Warning
If the device is not used for an extended period (longer than 2 months),
it is recommended that the battery be removed from the device and put
in storage by authorized personnel. If the battery cannot be removed, or
the device will be used in less than 2 months, charge the battery at least
once a month by connecting the device to the AC power supply for at
least 8 hours.
14.2 Storage and Transport Conditions

Observe the following conditions for storage and transport:
 Temperature:
-10 °C to +60 °C
 Pressure:
500 hPa (375 mmHg / 7.25 PSI) to 1060 hPa (795 mmHg /
15.37 PSI)
 Relative humidity:
10 % to 90 % without condensation
 Altitude:
Up to 3000 m
108
14.3 Preparing the Device for Storage
Prepare the device for storage as follows:
1. Power the pump OFF and remove the syringe.
2. If necessary (long-term storage), disconnect the pump’s power cord
and all data communication cables.
3. Remove the pump from its mounting point.
4. Clean the pump.
5. Handle the pump with care, and store it in a compliant area.
For detailed instructions, refer to the related chapters in this document.
14.4 Using the Device After Storage

If the battery has been removed for long-term storage, contact your
biomedical department in order to reinstall the battery prior to use.
We recommend charging the battery for at least 8 hours.
We recommend that the "User test" is performed when the device is
installed after storage, and before being used on a patient, see section
11, page 96.
109
15 Specifications
Information
The range of settings and default values described in this section
correspond to the factory configuration. Range of settings and default
values may be adjusted in the pump options (Basic Profile) or in Agilia
Vigilant Drug’Lib software (custom profiles). Increment rules may be
modified by Agilia Vigilant Drug’Lib software (custom profiles).
15.1 Essential Features

The pump’s essential features are defined in standard operating
conditions:
Feature Refer to
Section 15.9.1, page 114.
Flow Rate Accuracy
Time to Detect Occlusion Section 15.9.3, page 114.
Bolus Volume After Occlusion Release Section 15.9.4, page 115.
Management of High-priority Alarms Section 12, page 97.
110
15.2 Flow Rate
Syringe
Minimum
Format 50 mL
/ 30 mL 20 mL 10 mL 5 mL
Increment
60 mL
0.1 0.1 0.1 0.1 0.1 0.01 (0.10  9.99)

Infusion Rate mL/h      0.1 (10.0  99.9)
1200 600 600 350 250 1 (100  1200)
50 50 50 50 50
Direct Bolus* mL/h      50
1200 600 600 350 250
Priming mL/h 1200 600 600 350 250 N/A
0.1 0.1 0.1 0.1 0.1 0.01 (0.10  9.99)

Programmed Bolus mL/h      0.1 (10.0  99.9)
1200 600 600 350 250 1 (100  1200)
0.1 0.1 0.1 0.1 0.1
KVO** mL/h      0.1
5 5 5 5 5
0.1 0.1 0.1 0.1 0.1 0.01 (0.10  9.99)
Loading Dose mL/h      0.1 (10.0  99.9)
1200 600 600 350 250 1 (100  1200)
* Direct bolus default value = Upper flow rate value for each syringe size.
** KVO defaut value = 1 mL/h.
15.3 Volume To Be Infused (VTBI)

Default Minimum
Format Range of Settings
Value Increment
0.1 (0.1  99.9)
Volume Limit mL 0.1  999 0.1 1 (100  999)
Volume/Time mL 0.1  99.9 0.1 0.1
Direct Bolus mL 0.1  50 N/A 0.1
Programmed Bolus mL 0.1  99.9 0.1 0.1
Applicable for all syringe sizes (50/60 mL, 30 mL, 20 mL, 10 mL, 5 mL)
111
15.4 Dose To Be Infused (DTBI)
Default Minimum
Value Increment
0.001 (0.010  4.999)
0.01 (5.00  9.99)
Dose Unit 0.01  9999 N/A 0.1 (10.0  99.9)
1 (100  9999)
0.01 (0.01  9.99)
Programmed Bolus Unit 0.01  9999 N/A 0.1 (10  99.9)
1 (100  9999)
0.01 (0.01  9.99)
Loading Dose Unit 0.01  9999 N/A 0.1 (10.0  99.9)
1 (100  9999)
15.5 Infusion Time

Default Minimum
Value Increment
00h00min01
__ h __
Infusion Rate  N/A 00h00min01
min __
96h00min00
00h00min01
__ h __
Programmed Bolus  00h02min00 00h00min01
min __
24h00min00
00h00min01
__ h __
Loading Dose  00h02min00 00h00min01
min __
24h00min00
KVO Silence Alarm
__ h __ 00h01  12h00 00h01 00h01
Duration
Pause __ h __ 00h01  24h00 00h01 00h01
15.6 Concentration
Default Minimum
Value Increment
0.01 (0.01  9.99)
Concentration Unit 0.01  70000 0.01 0.1 (10.0  99.9)
1 (100  70000)
Volume of Diluent mL 1  2000 1 1
112
15.7 Patient Data
Default Minimum
Value Increment
0.01 (0.25  4.99)
Patient Weight kg 0.25  350 70 0.1 (5.0  19.9)
1 (20  350)
Patient Body
m² 0.05  4.5 2 0.01
Surface Area
15.8 Pressure Management

Setting Description Setting Format Default Value
Mode Infusion pressure mode. 3 levels / Variable Variable

Allows DPS option activation
DPS Yes / No Yes
on the pump pressure menu.
Unit Pressure unit selection. mmHg / kPa / PSI mmHg
The last pressure limit
adjustment is automatically
Limit Stored Enabled / Disabled Disabled
stored in memory for the next
startup.
The last DPS adjustment is
DPS Stored automatically stored in Enabled / Disabled Disabled
memory for the next startup.
Default Minimum
Value Increment
Low mmHg 50  300 100 50
3 Levels
Medium mmHg 150  600 250 50
High mmHg 250  900 500 50
25 (50  250)
Full Range mmHg 50  900 500
Variable
50 (250  900)
Maximum
mmHg 500  900 900 50
Limit
Raise
mmHg 50  400 100 50
Threshold
DPS
Drop
mmHg 100  400 100 50
Threshold
Note: 1 bar = 750 mmHg = 100 kPa = 14.5 PSI.
113
15.9 Accuracy
Warning
Accuracy (flow rate, time, volume infused, pressure) can be influenced
by syringe model, syringe configuration, extension set configuration,
fluid viscosity, and fluid temperature.
Note: All tests below are in accordance with the IEC 60601-2-24
standard and ANSI/AAMI ID26.
Values are representative of syringes used during internal tests and are
provided as indicators only.
15.9.1 Flow Rate Accuracy

Accuracy
Flow Rate ± 3%
15.9.2 Effects of Pressure Variations on Accuracy

Accuracy
Back Pressure
(From Mean Values)
+ 39.9 kPa ~ - 3%
+ 13.33 kPa ~ - 1.5%
- 13.33 kPa ~ + 1.5%
15.9.3 Occlusion Alarm Accuracy

Accuracy
Occlusion Alarm Threshold

Syringe** Rate
50 mmHg 900 mmHg
Occlusion Alarm Response 0.1 mL/h < 5 hours < 28 hours
Time* 50 mL 1 mL/h < 30 minutes < 3 hours
5 mL/h < 7 minutes < 30 minutes
0.1 mL/h < 4 hours < 14 hours
20 mL 1 mL/h < 20 minutes < 75 minutes
5 mL/h < 5 minutes < 15 minutes
* Test condition: Temperature: 20 °C, Extension set length: 150 cm
** Syringe: BD Precise
114
15.9.4 Volume Accuracy
Warning
Accuracy may be reduced when the infusion flow rate is below 1 mL/h.
Accuracy
Direct Bolus*
≤ 10 mL: ± 0.2 mL
> 10 mL: ± 3%
Programmed Bolus*
Bolus Volume at Occlusion Release

Syringe** Rate
Bolus Volume at Occlusion
50 mmHg 900 mmHg
Release*
50 mL 5 mL/h -0.05 ≤ X ≤ 0.35 mL -0.05 ≤ X ≤ 0.35 mL
* Test condition: Back pressure: 0 mmHg

** Syringe: BD Precise
 A back flow pumping is provided to reduce the bolus volume at occlusion release.
 During pump movement from 0 to 1 m above the patient, a bolus (-0.05 ≤ X ≤ 0.35 mL) may occur.
15.9.5 Pressure Accuracy

Accuracy
< 500 mmHg: ± 75 mmHg
Pressure
> 500 mmHg: ± 15 %
115
15.10 Units and Conversion Rules
15.10.1 Concentration Units
Units Suffix
nanog, microg, mg, g
mmol
Concentration
mUnit, Unit /mL, /--mL
Units
cal, kcal
mEq
15.10.2 Dose Units

Units
nanog/h,
nanog/kg/min, nanog/kg/h
microg/min, microg/h,
microg/kg/min, microg/kg/h
mg/min, mg/h, mg/24h,
mg/kg/min, mg/kg/h, mg/kg/24h,
mg/m²/h, mg/m²/24h
g/h, g/kg/min, g/kg/h, g/kg/24h

Dose Units
mmol/h, mmol/kg/h, mmol/kg/24h
mUnit/min, mUnit/kg/min, mUnit/kg/h
Unit/min, Unit/h, Unit/kg/min, Unit/kg/h
kcal/h, kcal/24h, kcal/kg/h
mEq/min, mEq/h, mEq/kg/min, mEq/kg/h
116
15.10.3 Conversion Rules
1 micro unit = 1000 nano unit
1 m unit = 1000 micro unit
1 k unit = 1000 unit
1 unit/h = 24 unit/24 h
1 unit/min = 60 unit/h
unit/kg/h (dose) × kg (weight) Conversion of a dose

mL/h = including the unit/kg into
unit/mL (concentration) volume flow rate (mL/h)
unit/m2/h (dose) × m2 (body surface area) Conversion of a dose

mL/h = including the unit/m2 into
unit/mL (concentration) volume flow rate (mL/h)
Conversion Rules
unit/h (dose) Expression of a

mL/h =
unit/mL (concentration) volumetric flow rate
unit/kg (dose) × kg (weight) Conversion of a dose

mL = including the unit/kg into
unit/mL (concentration) volume (mL)
unit/m2 (dose) × m2 (body surface area) Conversion of a dose

mL = including the unit/m2 into
unit/mL (concentration) volume (mL)
unit (dose) Expression of a volume

mL =
unit/mL (concentration) (mL)
117
16 Cleaning and Disinfecting
To avoid the risks of infection and microbial transmission, make sure to

adequately clean and disinfect the equipment.
Warning
 The disinfecting procedure must be done immediately after
cleaning. Disinfecting the pump without prior cleaning is not
effective.
 The pump is not intended to be sterilized; sterilization may result
in damage to the pump.
 In case of contamination by blood or bodily fluids when the pump
is in use, and if allowed by your local practices and healthcare
facility policies, immediately perform the quick cleaning described
below. Always follow your local protection rules.
Quick Cleaning Only

Note: This quick cleaning does not replace the need for a complete
cleaning.
1. Check that the keypad is locked in order to avoid unintended
modification of the infusion parameters. Do not move the pump.
2. Use ready-to-use wipes to wipe down all exposed surfaces of the
pump.
3. At the end of the infusion, perform the complete cleaning protocol,
16.1 When to Clean and Disinfect the Pump

Thoroughly clean and disinfect the pump in the following cases:
 After each patient use
 Before any maintenance
 On a routine basis when the pump is not in use
 Before storage
118
16.2 Recommended and Prohibited Agents
We recommend the following cleaning and disinfecting agents:
16.2.1 Recommended Agents

Recommended Agent
Didecyldimethylammonium chloride
Cleaning
(example: Wip’Anios Excel by Anios)
Didecyldimethylammonium chloride
Disinfecting
(example: Wip’Anios Excel by Anios)
16.2.2 Prohibited Agents

The following cleaning and disinfecting agents are prohibited:
 Trichloroethylene
 Abrasive detergents
 Undiluted alcohol
These aggressive agents may damage the plastic parts of the pump and
cause it to malfunction.
16.3 Instructions for Cleaning and Disinfecting

Follow the instructions provided to ensure effective cleaning and
disinfecting of the equipment.
 Use the agents according to the manufacturer's instructions. This
may include wearing personal protective equipment (gloves, lab
coat, glasses, and so on), or diluting the agent according to the
manufacturer's guidelines.
 For disinfectants, respect the contact time required for the
antimicrobial agents to act (the time the agent must be left on the
pump for disinfection to be effective).
The following warning is provided to protect staff against electric shock,

and to protect the pump from damage that can cause it to malfunction.
Warning
 Only trained staff can clean and disinfect the pump.
 Do not place the pump in an autoclave or immerse it in liquid.
 Do not spray liquids directly on connectors. Instead, use a
cleaning cloth or disposable wipes.
119
16.3.1 Cleaning Instructions
Prerequisites
 The pump is powered off.
 The power cord and all other cables are unplugged.
 The air is at room temperature (20 to 25 °C).
 The operator is wearing suitable protective equipment.
Protocol
1. Place the pump on a clean surface or disposable underlay.
2. Use a ready-to-use wipe to remove any major grime.
3. Thoroughly wipe down all exposed surfaces (housing, keyboard,
syringe barrel area, syringe guard, plunger driver, disengagement
lever, syringe barrel clasp, etc.) of the pump, from top to bottom.
You can use the silver handle to lift and move the pump.
 When wiping down the sides, avoid wetting the connector
sockets.
 Do not allow liquids to run, leak, or drip into the pump housing.
4. Make sure the pump remains damp for at least 1 minute.
5. Set down the pump, and wipe down the silver handle, the
attachment lock knob, the screw clamp and the release button.
6. Use a fresh ready-to-use wipe to gently wipe down the back side of
the syringe barrel clasp and all exposed surfaces in the syringe
barrel area.
7. Make sure the pump remains damp for at least 1 minute to dissolve
all organic matter.
8. Use a swab to gently scrub the exposed surfaces of the pump. Be
sure to scrub along the seams and edges of the control panel, and
the narrow or hard-to-reach areas.
9. Wipe down the power cord and any pump accessories.
10.Allow the pump to dry completely at room temperature.
120
16.3.2 Disinfecting Instructions
Prerequisites
 The cleaning protocol has been performed.
 The pump is powered off.
 The power cord and all other cables are unplugged.
 The air is at room temperature (20 to 25 °C).
 The operator is wearing suitable protective equipment.
Protocol
1. Place the previously cleaned pump on a clean surface or disposable
underlay.
2. Use a ready-to-use wipe to wipe down all exposed surfaces of the
pump, making sure to cover all cracks, crevices, and hard-to-reach
areas. You can use the silver handle to lift and move the pump.
 When wiping down the sides, avoid wetting the connector
sockets.
 Do not allow liquids to run, leak, or drip into the pump housing.
3. Set down the pump, and wipe down the silver handle, the
attachment lock knob, the screw clamp and the release button.
4. Use a fresh ready-to-use wipe to gently wipe down the back side of
the syringe barrel clasp and all exposed surfaces in the syringe
barrel area.
5. Using a fresh ready-to-use wipe, repeat steps 2 to 4.
6. Leave the disinfecting agent on the pump for at least 3 minutes.
7. Wipe down the power cord and any pump accessories.
8. Allow the pump to dry completely at room temperature.
121
17 Power Management
17.1 AC Power Supply Precautions

Check that the AC power supply voltage corresponds to the value
indicated on the label on the bottom of the device. Do not exceed the
permitted voltage.
The power outlet must remain accessible at all times to allow emergency
power supply disconnection.
Warning
 The pump and its accessories can only be connected to the AC
power supply with the power cord supplied by Fresenius Kabi, or
with a power supply accessory from the Agilia product range.
 Do not use an extension cord when connecting the pump to the
AC power supply.
 Pumps must be plugged into a medical grade power strip if one is
used.
17.2 Battery Precautions

The device uses a Lithium-ion rechargeable battery.
The following actions may cause leakage, overheating, smoke,
explosion or fire; which could result in deterioration of performance,
failure, damage to the equipment or injury to the user:
 Incorrect handling of a Lithium-ion battery.
 Replacement of the battery by inadequately trained personnel.
122
Information
 Do not replace with a battery other than the one provided by
Fresenius Kabi.
 Do not use the pump without the battery connected.
 Do not disconnect the battery when the device is operating on AC
or battery power. Disconnect the power cord and power off the
device before disconnecting the battery.
 Do not incinerate or place near a flame.
 Do not drop, crush, puncture, modify or disassemble the battery.
 Do not use a battery that is severely scratched or damaged.
 Do not short the terminals.
 Do not expose to high temperatures or very low temperatures:
refer to the operating conditions for use, and the storage
instructions.
 Do not try to charge or discharge the battery outside of the device.
 For more information on replacing the battery, refer to the
technical manual.
17.3 Battery Operating Mode

The device is provided with an internal battery that automatically
provides power to the device in case of power failure or disconnection
from the AC power supply. The battery charges when the pump is
connected to AC power supply.
Before starting for the first time, charge the battery for approximately
8 hours by plugging in the power supply cord with the pump powered off.
Information
During operation, leave the device connected to the power supply in
order to maintain the battery's charge and maximum capacity, and to
maximize battery lifetime and performance.
123
18 Technical Characteristics
18.1 Power Supply

It is mandatory to use an Agilia power cord compliant with USA
standards and with the IEC 60227 standard.
The power cord conductor must have a cross section of at least
0.75 mm2.
100 V - 240 V ~ / 50 / 60 Hz with functional

Power supply
earth
AC Power Maximum consumption 10-15 VA
1 X T1.6AH 250V accessible in the battery
Protective fuse
compartment
18.2 Battery
Disconnect the battery before opening the device. Avoid short circuits
and extreme temperatures.
If the device is not used for more than 3 months, the date is erased (all
other settings are stored permanently). When you power on the pump,
you must set the date again.
Characteristics 7.2 V 2.2 Ah - Li-ion Smart battery
Weight Approximately 100 g
Flow Rate Wi-Fi Battery Life

Battery Life 5 mL/h  >6h
5 mL/h  > 11 h
Battery Recharge Pump OFF: < 6 h / Pump ON: < 20 h
 = Wi-Fi enabled
 = Wi-Fi disabled or not used
18.3 Power Consumption

The pump typically consumes about 3.5 W in standard operating
conditions.
124
18.4 Communication Port
The connector located at the back of the device allows data
communication with a PC.
Serial Cable TTL output
Power Input 10 V / 15 W to power supply the product
Power Output 5 VDC / 150 mA to power Agilia USB cable
18.5 Infrared Communication

The pump is equipped with an infrared cell located at the back of the
device.
Mode Wireless optical communication using infrared light
Asynchronous Serial Infrared (SIR) physical layer irPHY 1.0, baseband no

Compatibility
carrier
Transport Protocol Proprietary
Speed 115.2 kb/s max
Wavelength 880 nm to 900 nm infrared band with 45 nm spectral bandwidth
Eye Safety Class 0 of IEC 62471
125
18.6 Sound Levels
18.6.1 Operating Pump Sound Levels (without alarms)
Flow Rate (mL/h) Sound Level (dBA)
0 21
1 23
20 27
100 30
400 49
1200 32
Note: These values are provided for information purposes only.
18.6.2 Alarms Sound Levels

Sound Level (dBA)
Alarm Priority
min Max
High-priority 55 63
Medium-priority 50 57
Low-priority 45 52
18.7 Compliance
Compliant with the following
Index of protection against
ElectroMedical standards:
IP22 ingress of water or particulate
Equipment Safety  IEC 60601-1
matter
 IEC 60601-1-8
EMC Compliant with the following Protection against leakage
(ElectroMagnetic standard: current: Defibrillation-proof
Compatibility)  IEC 60601-1-2 type CF applied part*
Protection against electric

Particular  IEC 60601-2-24 shocks: class II
Standards  ANSI/AAMI ID26
Functional earth**
* After a defibrillation, the pump recovery time is around 2 seconds.

** The functional earth is directly connected to the power supply cord. It reduces residual current that
may disturb ECG or EEG devices.
126
18.8 Dimensions and Weight
H/W/D 135 x 345 x 170 mm
Weight Approximately 2.1 kg
Screen Size 70 x 35 mm
18.9 Trumpet and Start-up Curves

The trumpet curve shows the variation of the mean flow rate accuracy
over specific observation periods. The variations are presented only as
maximum and minimum deviations from the overall mean flow within the
observation window.
Trumpet curves are presented below for a number of representative flow
rates.
The test protocol used to obtain these results is described in ANSI/AAMI
ID26.
The curves can be helpful in determining the suitability of infusion
parameters for specific drugs and concentrations.
Syringe used: BD Precise 50 mL
Fluid used: distilled water
Recommendations to improve performances and safety when the pump
is commonly used at low flow rates (≤ 20 mL/h):
 Limit the range of available flow rates in accordance with the
maximum flow rate to be used.
 Lower the pressure limit in order to gain in time to detect
occlusion.
127
18.9.1 Flow rate: 1 mL/h
Legend
2
Instantaneous
flow rate
Set flow rate
Flow rate (mL/h)
Sampling time: 10 s
0
0 10 20 30 40 50 60 70 80 90 100 110 120
Time (minutes)
Figure 18.1: Start-up and instantaneous flow rate

(1 mL/h over first 2 hours on 96 hours)
Legend
10
Measured
variance from
flow rate
6,0
3,9 Error
5
Flow rate
Flow rate (mL/h)
1,0
1,1
0 Sampling time: 10 s
-1,6
-1,9
-5
-4,4
-6,5
-8,6
-10
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Time (minutes)
Figure 18.2: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
128
18.9.2 Flow rate: 5 mL/h
Legend
10
Instantaneous
flow rate
9
Set flow rate
8
7
Flow rate (mL/h)
Sampling time: 10 s
6
0
0 10 20 30 40 50 60 70 80 90 100 110 120
Time (minutes)
Figure 18.3: Start-up and instantaneous flow rate

Legend
10
Measured
variance from
flow rate
Error
5
Flow rate
1,7
Flow rate (mL/h)
0,7 0,2
1,0 0,4
0 Sampling time: 10 s
-0,3
-0,7 -0,5
-1,0
-1,9
-5
-10
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Time (minutes)
Figure 18.4: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
129
19 Wi-Fi
19.1 General Information

The Agilia Connect Infusion System includes an IEEE 802.11 radio-
frequency transmitter incorporated in the Agilia Wi-Fi pumps. It operates
using the following standards and frequencies:
 IEEE 802.11a: 5 GHz Frequency Band
 IEEE 802.11b: 2.4 GHz Frequency Band
 IEEE 802.11g: 2.4 GHz Frequency Band
 IEEE 802.11n: 2.4 and 5 GHz Frequency Band
Information
For more information on differentiation between Wi-Fi and non Wi-Fi
pumps, see section 10.3, page 94.
The Wi-Fi module incorporated in the Agilia Wi-Fi pumps is intended to

perform the following, via periodic communication cycles:
 Transfer data sets (from Centerium server to pump)
 Transfer pump history (from pump to a server)
 Communicate general information on the operating status of the
pump
Agilia infusion pumps contain transmitter with the following IDs:
 FCC ID: XF6-RSWC301
 IC ID: 8407A-RSWC301.
Agilia Wi-Fi pumps must be installed to provide a separation distance of
at least 8 in (20 cm) from all persons and must not be co-located or
operating in conjunction with any other antenna or transmitter.
Warning
Agilia Wi-Fi pumps must be configured by qualified and appropriately
trained staff.
Information
If communication with the wireless network is interrupted, the pump can
be used as intended. For more information, contact your
Fresenius Kabi sales representative
130
19.2 Specifications
19.2.1 Technical Specifications
Description
Technology IEEE 802.11 a/b/g/n
 2.400  2.500 GHz (2.4 GHz is ISM band)

Frequency Band
 4.900  5.850 GHz (High Band)
OFDM with BPSK, QPSK, 16-QAM, and 64-QAM 802.11b with CCK and
Modulation
DSSS
Wireless Security WPA/WPA2-Entreprise, WPA/WPA2-PSK
Network Protocols TCP, IPv4, DHCP, HTTP
 17 dBm for 802.11b DSSS

Typical Transmit  17 dBm for 802.11b CCK
Power (± 2 dBm)  15 dBm for 802.11g/n OFDM
 12 dBm in 802.11a mode
19.2.2 Electromagnetic Compatibility

For information on electromagnetic compatibilty, see section 23.2.3,
page 139.
19.2.2.1 USA - FCC Notice

The users manual or instruction manual for an intentional or
unintentional radiator shall caution the user that changes or
modifications not expressely approved by the party responsible for
compliance could void the user's authority to operate the equipment.
19.2.2.2 Europe - R&TTE Directive

This product is designated as a radio device that utilizes harmonized
frequencies and power levels for Europe.
131
19.2.3 Protocols and Standards
This wireless functionality references and uses the following protocols
and standards:
 IEEE 802.11a/b/g/n standard
 WPA/WPA2-Entreprise, WPA/WPA2-PSK (Wi-Fi protected
access) is a long-term security solution for wireless networks.
For more information, refer to the IEEE 802.11.
 TCP (Transmission Control Protocol / Internet Protocol), IPv4
(Internet Protocol Version 4), DHCP (Dynamic Host
Configuration Protocol) and HTTP (Hypertext Transfer Protocol)
are standard data transport protocol used for the internet and
other similar networks.
Agilia infusion pumps do not require an active wireless communication
to function as intended (infuse). All wireless transactions are initiated by
the device and are periodic in nature. The absence of connection (for
example, out of range) does not affect the device ability to infuse. Data
that is pending is stored and re-transmitted when the connection
becomes available. Data integrity and quality of service are inherent in
the design. The system should be ensured and maintained by a qualified
and trained technical user, or a Fresenius Kabi representative.
132
20 Troubleshooting
Issue Recommended Actions

The pump is unstable when mounted.  Check that the rotating pole clamp is fastened.
The pump is damaged, or you notice  Remove the power cord.
something abnormal (unusual noise,  Contact your biomedical department or your
abnormal heat or smoke). Fresenius Kabi sales representative immediately.
The pump has been dropped or was  Do not use the pump.
subjected to a force that may have  Contact your biomedical department or your
produced internal damage. Fresenius Kabi sales representative.
 Check the rotating pole clamp position.
The pump cannot be installed or
 Contact your biomedical department or your
removed from the Link Agilia.
 Connect the pump to the AC power supply to see if the
The pump does not start after battery is fully discharged.
pressing .  Contact your biomedical department or your
 Check the cable connector.
Data communication cables cannot be  Check the pump connector.
connected or removed from the pump.  Contact your biomedical department or your
 Check the infusion line configuration.
 Check the fluid viscosity.
Flow rate variance is higher than flow  Check that the fluid temperature is within the
rate accuracy. recommended range.
 Check the general condition of the keypad.
 Check the contrast.
Keypad problem (keys, LEDs).
 Connect the pump to the AC power supply.
The power supply indicator does
not light up.
 Connect the pump to the AC power supply.
The pump powers off on its own.  Contact your biomedical department or your
 Check the AC power voltage.
The battery alarm is ON even though
the pump has been correctly charged.
The pump powers off when it is  The battery is completely discharged: charge the battery.
disconnected from the AC power  Contact your biomedical department or your
supply. Fresenius Kabi sales representative.
 Contact your IT or biomedical department, or your
Wi-Fi communication error.
133
21 Recycling
Before disposal, remove the battery from the device. Batteries

and devices with this label must not be disposed of with the
general waste. They must be collected separately and
disposed of according to local regulations.
Information
 For more information on waste processing regulations, contact
your Fresenius Kabi sales representative or the local distributor.
 For more information on dismantling the device, refer to the
technical manual.
 Follow healthcare facility policy regarding proper disposal after
use.
134
22 Warranty
22.1 General Warranty Conditions

Fresenius Kabi guarantees that this product is free from defects in
material and workmanship during the period defined by the accepted
sales conditions, except for the batteries and the accessories.
22.2 Limited Warranty

To benefit from the materials and workmanship guarantee from our
Fresenius Kabi sales representative or authorized agent, make sure to
observe the following conditions:
 The device must have been used according to the instructions
described in this document and in other accompanying
documents.
 The device must not have been damaged while being stored or
repaired, and must not show signs of improper handling.
 The device must not have been altered or repaired by unqualified
personnel.
 The internal battery of the device must not have been replaced
by a battery other than that specified by the manufacturer.
 The serial number (SN) must not have been altered, changed or
erased.
Information
 If one or more of these conditions have been violated,
Fresenius Kabi will prepare a repair estimate covering all
required parts and labor.
 To repair or return a device, contact your Fresenius Kabi sales
representative.
22.3 Warranty Conditions for Accessories

Batteries and accessories may have specific warranty conditions.
Contact your Fresenius Kabi sales representative for more information.
135
23 Guidance and Manufacturer's
Declaration on EMC
23.1 Electromagnetic Compatibility

Warning
 Agilia SP MC and its accessories are intended to be used in the
electromagnetic environments specified below.
 The customer or the user of Agilia SP MC should assure that it is
used in such environments.
 Agilia SP MC must not be used in the presence of intense
electromagnetic fields, such as those generated by certain
electrically powered medical devices. Do not use the pump in
MRI, CT Scan or X-Ray environments.
When mounted on the Link+ Agilia, the pump is intended to be used in

the electromagnetic environment specified in the Link+ Agilia IFU.
Excluding the cases described in this manual, pump operation must be
systematically checked by a qualified operator, if the pump is installed in
the vicinity of other electrical devices.
Points (e.g. screws) and surfaces that are only accessible for
maintenance also require precautions. Points (e.g. battery contacts for
battery replacement) and surfaces that are accessible only by
maintenance staff also require precautions.
23.2 Electrostatic Discharge (ESD)

Information
 Electronic components and semiconductors can be destroyed by
electrostatic discharge (ESD). In particular, components made
with metal oxide semiconductor (MOS) can be damaged from
direct or indirect discharges. Damage caused by ESD may not be
immediately identifiable, and malfunctions can even occur after a
longer period of operation.
 Exceeding and / or repeating the test level attained in guidance &
manufacturer's declaration on EMC may permanently damage
the device and / or cause serious malfunctions (for example, loss
of communication and system failures).
136
23.2.1 ESD Precautions to be Taken
The following environmental conditions related to electrostatic sensitive
components (ESD standards) must be observed:
 Floors coated with wood, tiles or concrete
 Relative humidity of at least 30%
If it is not possible to guarantee this environment, the following additional
precautions must be taken:
 Use of anti-static equipment
 Preliminary user discharge (explained below)
 Anti-static clothing
The best precaution is preliminary user discharge on a grounded metal
object such as a rail, a pole or a metal part located at the rear of
Agilia SP MC.
For maintenance operation performed on Agilia SP MC, place the
device on a conductive working surface, and wear a special ESD
conductive wristband.
23.2.2 Electromagnetic Compatibility and Interference

Guidance
Agilia SP MC has been tested in accordance with the electromagnetic
compatibility standards applicable to medical devices. Its immunity is
designed to ensure correct operation. Limitation of the emitted radiation
avoids undesirable interference with other equipment.
Agilia SP MC is classified as a Class B device according to CISPR 11
emitted radiation and should not be used outside the healthcare facility
environment. The user might be required to take mitigation measures,
such as relocating or reorienting the equipment.
Warning
Use of accessories and cables other than those recommended by
Fresenius Kabi, could result in increased emissions and / or decreased
immunity of the Agilia SP MC system.
If Agilia SP MC is placed near devices such as HF surgical equipment,

X-Ray equipment, NMR, cell phones, DECT phones or wireless access
points, portable RFID reader, large scale RFID reader and RFID tags, it
is essential to observe a minimum distance between Agilia SP MC and
this equipment.
137
If Agilia SP MC causes harmful interference, or if it is disrupted by
external interference, try the following:
 Reorient or relocate Agilia SP MC, the patient or disruptive
equipment.
 Change the routing of cables.
 Separate power cords from the communication cables / signals.
 Connect the Agilia SP MC AC Power plug to a protected /
backed-up / filtered supply or directly to the UPS circuit
(uninterruptible power supply).
 Take care with ground / earth loops formed by communication
cables and / or power circuits: use class II powered systems or
insulated bridges to break loops.
 Maintain earth potential at the same level between Agilia SP MC
circuit and the circuit of the remote equipment.
 Increase the separation between Agilia SP MC and the patient or
disruptive equipment.
 Plug Agilia SP MC into an outlet on a different circuit from the
one to which the patient or disruptive equipment is connected.
 In any case, whatever the context, the user should conduct
interoperability testing in a real situation to find the correct setup
and location.
138
23.2.3 Table 1 - Guidance and Manufacturer's Declaration -
Electromagnetic Emissions
Warning
Compliance
Emission Test Obtained by Electromagnetic Environment - Guidance
the Device
Agilia SP MC only uses RF energy for its internal
RF emissions operation. Its RF emissions are therefore very low and are
Group 1
CISPR 11 not likely to cause any interference in nearby electronic
equipment.
RF emissions
Class B
CISPR 11
Agilia SP MC is suitable for use in all establishments other
Harmonic emissions
Class A than domestic and those directly connected to the public
IEC61000-3-2
low-voltage power supply network that supplies buildings
Voltage fluctuations used for domestic purposes.
Flicker emissions Comply
IEC 61000-3-3
Conducted
emissions 150 kHz - Class 5
108 Mhz CISPR25 Agilia SP MC is suitable for use in automotive
Radiated emissions environments.
150 kHz - 2.5 Ghz Class 3
CISPR25
139
Electromagnetic Immunity
Warning
IEC 60601-1-2
--------------
Compliance
IEC 60601-2-24 Level Electromagnetic Environment -
Immunity Test
and ANSI/AAMI Obtained by Guidance
ID26 the Device
Test Level
Electrostatic ± 6 kV contact ± 8 kV contact Floor coverings made from wood, tiles and
Discharge (ESD) ± 8 kV air ± 15 kV air concrete, with relative humidity level at
IEC 61000-4-2 -------------- least 30 %, make it possible to guarantee
± 8 kV contact the necessary level of conformity. If it is not
± 15 kV air possible to guarantee this environment,
additional precautions must be taken, such
as: use of anti-static equipment,
preliminary user discharge and the
wearing of antistatic clothing.
± 2 kV for power ± 2 kV for power
Electrical fast AC power quality should be that of a
supply lines supply lines
Transient / burst typical commercial or healthcare facility
± 1 kV for input ± 1 kV for input
IEC 61000-4-4 environment.
output lines output lines
± 1 kV ± 1 kV
AC power quality should be that of a
Surge differential mode differential mode
typical commercial or healthcare facility
IEC 61000-4-5 ± 2 kV ± 2 kV
environment.
common mode common mode
< 5% Ut < 5% Ut
(> 95% dip in Ut) (> 95% dip in Ut)
for 0.5 cycles for 0.5 cycles
Voltage dips,
40% Ut 40% Ut AC power quality should be that of a
short
(60% dip in Ut) (60% dip in Ut) typical commercial or healthcare facility
interruptions and
for 5 cycles for 5 cycles environment.
voltage
variations on 70% Ut 70% Ut For short and long interruptions (< than
power supply (30% dip in Ut) (30% dip in Ut) battery life) of AC power, the internal
input lines for 25 cycles for 25 cycles battery provides continuity of service.
IEC 61000-4-11
< 5% Ut < 5% Ut
(> 95% dip in Ut) (> 95% dip in Ut)
for 5 s for 5 s
140
IEC 60601-1-2
--------------
Compliance
Immunity Test
ID26 the Device
Test Level
Power frequency 3 A/m 400 A/m If necessary, the power of the magnetic
(50/60 Hz) -------------- field should be measured in the intended
magnetic field 400 A/m installation location to ensure that it is
IEC 61000-4-8 lower than compliance level.
If the measured field in the location where
Agilia SP MC is used exceeds the
applicable magnetic field compliance level
above, observe Agilia SP MC to verify that
it is operating normally. If you notice
abnormal performance, additional
measures may be necessary, such as
reorienting or relocating Agilia SP MC, or
installing magnetic shielding.
Note: "Ut" is the AC Power voltage prior to applying the test level.
141
Electromagnetic Immunity
Warning
IEC 60601-1-2
--------------
Compliance
Immunity Test
ID26 the Device
Test Level
Portable and mobile RF communication
equipment should be used no closer to
any part of Agilia SP MC (including
cables), than the recommended
separation distance calculated from the
transmitter frequency equation.
3 Vrms
150 kHz to Recommended separation distance:
Conducted RF
80 MHz 10 Vrms D = 0.35  P,
IEC 61000-4-6
-------------- for a frequency of 150 kHz to 80 MHz
Not applicable
Radiated RF 3 V/m 10 V/m D = 0.35  P,

IEC 61000-4-3 80 MHz to for a frequency of 80 MHz to 800 MHz
2.5 GHz D = 0.7  P,
-------------- for a frequency of 800 MHz to 2.5 GHz
10 V/m
80 MHz to P is the maximum output power rating of
2.5 GHz the transmitter in Watts (W) according to
the transmitter manufacturer, and D is the
recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey (a), should be less than compliance
level (b).
Interference may occur in the vicinity of

equipment marked with the following
symbol:
142
Notes:
 At 80 MHz and 800 MHz, the highest frequency range applies.
 These guidelines may not apply to all situations. Absorption and reflection from structures, objects
and people may affect the electromagnetic propagation.
 (a) Field strengths from fixed transmitters, such as base stations for radio (cell / cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast
cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to
the fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location where Agilia SP MC is used exceeds the applicable RF compliance
level above, Agilia SP MC should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating Agilia SP MC,
or installing magnetic shielding.
 (b) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
143
23.2.6 Table 6 - Recommended Separation Distances
Between Portable and Mobile RF Communication
Equipment and Agilia SP MC
Information
 Agilia SP MC and its accessories are intended for use in
electromagnetic environments in which radiated RF disturbances
are controlled.
 Users of Agilia SP MC may prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile
RF communication equipment (transmitters) and Agilia SP MC as
recommended below, and according to the maximum output
power of the communication equipment (transmitters).
 The device should not be used next to other equipment. If
adjacent use is necessary, observe the device to verify that it
operates normally in the configuration in which it will be used
(pump with a AC power cord, an RS232 cable).
Separation Distance According

Rated Maximum to Transmitter Frequency in Meters (m)
Output Power of
Transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
D = 0.35  P D = 0.35  P D = 0.7  P
0.01 0.04 0.04 0.07
0.1 0.11 0.11 0.22
1 0.3 0.3 0.7
10 1.1 1.1 2.2
100 3.5 3.5 7
For transmitters rated at a maximum output power not listed above, the
recommended separation distance D in meters (m) can be estimated
using the equation applicable to the transmitter frequency, where P is
the maximum output power rating of the transmitter in watts (W) as
designated by the transmitter manufacturer.
Information
 At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from
structures, objects and people.
144
24 Servicing
24.1 Information on Device Servicing

If the device must be sent for servicing, proceed as follows:
1. Contact Fresenius Kabi to have packaging shipped to your facility.
2. Clean and disinfect the device.
3. Pack the device in the provided packaging.
4. Ship the device to Fresenius Kabi.
Information
 Fresenius Kabi is not liable for loss or damage to the device
during transport.
 For more information on servicing, contact your Fresenius Kabi
sales representative.
24.2 Maintenance Requirements

Warning
Perform preventive maintenance at least once every 3 years. This
includes replacing the battery.
To ensure the device continues to operate normally, follow the

instructions below:
 Preventive maintenance should be performed by trained and
qualified technical personnel in compliance with the technical
manual and procedures. Only authorized service personnel
should attempt to repair the device.
 The qualified personnel must be informed if the device is
dropped or if any malfunctions occur. In this case, do not use the
device and contact your biomedical department or
Fresenius Kabi.
 Failure to comply with these maintenance procedures could
damage the device and lead to a functional failure. Internal
inspection of the device requires compliance with special
procedures to avoid damage to the device.
 When replacing components, only use spare parts from
Fresenius Kabi.
145
The life cycle of the pump is 10 years provided that the maintenance is
properly performed as described above.
Information
If the device needs upgrading, Fresenius Kabi or its representative will
provide relevant instructions. It is the healthcare facility's responsibility
to follow Fresenius Kabi’s instructions.
24.3 Quality Control

Upon request by the healthcare facility, a quality control check can be
performed on the device every 12 months.
A regular quality control check (not included in the guarantee) consists
of various inspection operations listed in the technical manual.
Information
 These control checks must be performed by trained technical
personnel, and are not covered by any contract or agreement
provided by Fresenius Kabi.
 For more information, refer to the technical manual, or contact
your Fresenius Kabi sales representative.
146
25 Glossary of Terms
Term Description
A Amperes
AC Alternating Current
Ah Ampere-hours
AM Amplitude Modulation
A/m Amperes per meter
BPSK Binary Phase Shift Keying
BSA Body Surface Area
cal Calorie
CCK Complementary Code Keying
CDC Centers for Disease Control
CISPR Special International Committee on Radio Interference
CT Scan Computed Tomography
dBA Decibels
dBm Decibels-Milliwatts
DC Direct Current
DECT Digital Enhanced Cordless Telecommunications
DEHP Di(2-ethylhexyl) phthalate
DERS Dose Error Reduction Software
DHCP Dynamic Host Configuration Protocol
DTBI Dose to Be Infused
DI Dose Infused
DPS Dynamic Pressure System
DSSS Direct Sequence Spread Spectrum
DUR Duration
ECG Electrocardiogram
147
Term Description
ECMO ExtraCorporeal Membrane Oxygenation
EEG Electroencephalogram
EMC Electromagnetic compatibility
ErXX Error message
ESD Electrostatic Discharge
FCC Federal Communications Commission
FM Frequency Modulation
ft Feet
GPL General Public License
H/W/D Height / Width / Depth
HF High Frequency
hPa Hectopascals
HTTP HyperText Transfer Protocol
Hz Hertz
IC Industry Canada
IEC International Electrotechnical Commission
IEEE Institute of Electrical and Electronics Engineers
IFU Instructions for Use
in Inches
IT Information Technology
IV Intravenous
kg Kilograms
KVO Keep Vein Open
lb(s) Pound(s)
LED Light Emitting Diode
mA Milliamperes
mEq Milliequivalents
148
Term Description
mL/h Milliliters per hour
mmHg Millimeters of Mercury
mmol Millimole
MOS Metal Oxyde Semiconductor
MRI Magnetic Resonance Imaging
mW/sr Milliwatts per steradian
N/A Not Applicable
NMR Nuclear Magnetic Resonance
OCS Occlusivity Check System
OFDM Orthogonal Frequency Division Multiplexing
OR Operating Room
PC Personal Computer
PSI Pounds per Square Inch
PSK Phase Shift Keying
QAM Quadrature Amplitude Modulation
QPSK Quadrature Phase Shift Keying
REF Product reference / part number
RF Radio Frequency
RFID Radio Frequency IDentification
RS232 Serial interface connector
SN Serial Number
SELV Safety Extra Low Voltage
SIR Asynchronous Serial Infrared
TCP Transmission Control Protocol
USB Universal Serial Bus
Ut Test specification level
V Volts
149
Term Description
VA Volt-Amperes
VDC Volts Direct Current
VI Volume Infused
Vrms Root Mean Square Voltage
VTBI Volume to Be Infused
V/m Volts per meter
W Watts
WPA Wi-Fi Protected Access
150
Appendix: Factory Configuration
Feature Availability Feature Availability

Profile  Simple Rate 
Volume/Time
Pressure  Infusion
Dose / Time

Modes
Keypad lock
status
 Volume Limit 
Battery life  Direct Bolus 

Volume infused Programmed
/ Dose infused
 Bolus

Pause  Loading Dose 

Programmed Infusion
bolus
 Features KVO 
Patient  Prime Set 

Dynamic
Day/Night
mode
 Pressure 
System (DPS)
Volume/Time
Dose/Time

Menus
Volume Limit 
Alarm volume 
Volume-Dose
history

View flow rate
history

View pressure
history

Syringe 
View event log 
Date / Time 
Maintenance 
Library
information

Data Set 
 = Activated with factory configuration (Basic Profile).

 = Not activated with factory configuration. Can be activated in the pump options or with Agilia Vigilant
Drug’Lib software. Otherwise can be activated on request.
151
Index
A F
Agilia Connect Infusion System 14 Factory Configuration 151
Agilia USB Cable 94 First Use 33
Alarm Flow Rate 24, 41, 50
Adjust Volume 81
List 98 G
Priority 97 Glossary 147
Sound Level 126 Graphics
Arrow Keys 18 Flow Rate History 83
Pressure History 84
B
Battery H
Characteristics 124 Hard Limit 24
Charge Level 34, 72
Full Charge Time 33 I
Operating Mode 123 Infusion
Bolus 53 Change Infusion Rate 52
Direct 54 End 57
Programmed 55, 75 Monitor 50
Pause 74
C Program 41
Cables 93 Start 49
Cleaning 118 Stop 52
Contraindications 12 View History 82
Infusion Modes 25, 59
D Installation 26
Data Communication 93
Data Set 25 K
Display Information 90 Keypad
Upload 95 Description 17
Date / Time 87, 92 Lock / Unlock 70
Day Mode 77 KVO 60, 61
Dimensions and Weight 127
Disinfecting 118 L
Dose 24, 41, 51 Language Selection 92
Dose/Time 59, 79 Link Agilia 30
Drug 24 Loading Dose
Concentration Selection 41 Pause 47
Select 40 Program 46
Drug Library 23 Select 45
Display Information 89 Stop 47
Drug X (mL/h) 24
M
E Maintenance 145
Electromagnetic Guidance 136 Display Information 88
Empty Syringe 57 Reminder Message 34
Essential Features 110 Requirements 145
Event Log 86
152
Menu Selection Keys 18
Customization 92 Servicing 145
List 65 Simple Rate 59
Soft Limit 24
N Override 47
Navigation Buttons 20 Software Version 154
Near End of Infusion Alert 57 Sound Levels 126
Night Mode 77 Storage 108
Symbol Descriptions 2
O Syringe 104
Options 91 Change 106
Display Information 85
P Install 33
Packaging 21 List 104
Patient Characteristics 11, 113 Remove 106
Change 76 Replacement Interval 106
Select 44 Select 39
Power Cord 124
Power Supply 124 T
Powering Off 58 Table of Contents 3
Powering On 33 Temperature
Pre-programming 64 Operating Range 13
Pressure Training 11
DPS 69 Troubleshooting 133
Management 113 Trumpet Curves 127
Modify Limit 68
Operating Range 13 U
Priming Units 116
Manual Prime 104 User Test 96
Prime With Pump 62
Profile 22 V
Basic Profile 22 Volume Infused 73
Custom Profile 23 Volume Limit 60, 80
Display Information 67 Volume/Time 59, 79
Select 37 VTBI 59, 111
Q W
Quick-Start 63 Warranty 135
Wi-Fi 92, 94, 130
R
Recycling 134
Release Notes 154
Rotating Pole Clamp 27
S
Screen
Contrast 92
Display and Symbols 19
Logo Display 92
153
Release Notes
Date Software Version Description

November 2015 1.5 Creation
August 2016 1.6 Software improvements (no user impact)
This document may contain inaccuracies or typographical errors.

Modifications may thus be made, and included in later editions.
Due to the evolution of standards, and of legal texts and materials, the characteristics indicated in the
text and images of this document are applicable only to the device with which it is included.
This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi.
Vigilant® and Agilia® are registered trademarks in the name of Fresenius Kabi in selected countries.
Made in France
Revision date: September 2017
Fresenius Kabi AG Fresenius Vial S.A.S

61346 Bad Homburg Le Grand Chemin
Germany 38590 Brézins
France
www.fresenius-kabi.com 0123
First CE Mark: Agilia SP MC WiFi: December 2015

Agilia SP MC: November 2016
154
Local Contacts for Servicing
Write your contacts here:

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Agilia SP

Product reference / part number Non-ionizing electromagnetic radiation

Product serial number Fragile, handle with care

Input terminal - connector This way up

Output terminal - connector Keep away from rain

Electrical fuses Temperature limitation

Alternating Current (AC) Humidity limitation

Direct Current (DC) Atmospheric pressure limitation

Index of protection against ingress of water or

Not for use in residential areas Eco packaging symbol

For US/CA only.

Name and address of the manufacturer / Date of

1.1 SCOPE ................................................................................................................................................... 6

2.1 PHYSICAL DESCRIPTION .......................................................................................................................... 7

3.1 TRAINING .............................................................................................................................................. 26

4.1 ACCESSING THE PROFILE MENU ............................................................................................................ 28

5 BASIC PROFILE CONFIGURATION 29

5.1 ACCESSING THE BASIC PROFILE CONFIGURATION .................................................................................. 29

6.1 MAINTENANCE OPTIONS ........................................................................................................................ 34

7 TROUBLESHOOTING AND MESSAGES 68

7.1 ALARM MESSAGES AND INFORMATION SIGNALS ..................................................................................... 68

9 DEVICE STORAGE 127

10 CLEANING AND DISINFECTING 128

11 POWER MANAGEMENT 129

12.1 POWER SUPPLY .................................................................................................................................. 130

16 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 136

17 SPARE PARTS CATALOG 137

18 ORDERING INFORMATION 138

18.1 DATA MANAGEMENT CABLES............................................................................................................... 138

19 GLOSSARY OF TERMS 139

1.2 Intended Use

1.3 Intended Users

1.5 Use Environment

2.1 Physical Description

Figure 2.1: Housing

2 Keypad 7 Syringe Guard

3 Base 8 Syringe Flange Cradle

4 Syringe Barrel Clasp 9 Angle Bracket

2 Battery Charge Status Indicator 9 Decrement

3 Power Supply Indicator 10 Fast Decrement

4 On / Off 11 Confirm Value / Move to Next Field

5 Bolus / Prime 12 Stop

2 Battery Charge Status Indicator 11 Fast Decrement

3 Power Supply Indicator 12 Confirm Value / Move to Next Field

4 Wi-Fi Symbol (for Wi-Fi pumps only) 13 Stop / Pause

9 Infusion Indicator Lights

2 Battery Charge Status Indicator 10 Fast Decrement

3 Power Supply Indicator 11 Confirm Value / Move to Next Field

4 On / Off 12 Stop / Pause

5 Bolus / Prime 13 Cancel Value / Move Back to Previous Field

8 Infusion Indicator Lights 16

Figure 2.6: Display Board

J2 J2 Connector to CPU Board

J3 J3 Connector to LCD Display

J2 Connector to CPU Board

Figure 2.8: CPU Board (Back View)

J2 Connector to Displacement Linear Potentiometer

J3 Connector to Display Board

J5 Connector to Opto Motor

J6 Connector to Power Supply Board

J8 to JTAG Connector (micro programming)

J9 Connector to Plunger Driver

Figure 2.9: Power Supply Board (Front View)