Professional Documents
Culture Documents
Agilia VP MC
Agilia VP MC WiFi
Volumetric Infusion Pumps
Applicable to software version 1.4
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
For CA only.
Part included in a recycling process
CCSAUS mark
Warning of a potential hazard that could result in serious personal injury and/or product damage if the written
instructions are not followed.
Recommendations to be followed.
2 10401-3_tm_agilia_vp_eng
Table of Contents
1 INTRODUCTION 6
2 DESCRIPTION 7
3 FUNDAMENTALS 26
4 PROFILE MENU 28
6 MAINTENANCE OPERATIONS 34
3
6.2.14 Test 13: Battery Test ................................................................................................................................ 47
6.2.15 Test 14: Air Detector ................................................................................................................................ 49
6.2.16 Test 15: Anti-Free Flow Clamp Motor ...................................................................................................... 50
6.2.17 Test 16: Flow Rate ................................................................................................................................... 52
6.2.18 Test 17: Flow Rate Correction.................................................................................................................. 53
6.2.19 Test 19: Clamp ......................................................................................................................................... 54
6.2.20 Test 20: Pump Code ................................................................................................................................ 55
6.2.21 Test 21: Power Info .................................................................................................................................. 56
6.2.22 Test 22: LCD Voltage ............................................................................................................................... 57
6.2.23 Test 23: Temperature............................................................................................................................... 58
6.2.24 Test 24: Watchdog ................................................................................................................................... 59
6.2.25 Test 25: Wi-Fi Module Information ........................................................................................................... 60
6.2.26 Checking the Pressure Limit Alarm .......................................................................................................... 61
6.2.27 Checking the AC power supply / Battery Operation ................................................................................. 63
6.2.28 Electrical Test........................................................................................................................................... 63
6.2.29 Testing the Flow Rate .............................................................................................................................. 64
6.3 QUALITY CONTROL PROCEDURE............................................................................................................ 66
6.3.1 Running a Quality Control ........................................................................................................................ 66
6.3.2 Quality Control Certificate ........................................................................................................................ 70
8 INTERVENTION PROCEDURES 80
8.1 PROCEDURE #1: BATTERY AND BATTERY DOOR - BOOST CAPACITOR DISCHARGE.................................. 81
8.2 PROCEDURE #2: UPPER CASE .............................................................................................................. 83
8.3 PROCEDURE #3: DISPLAY BOARD/LCD DISPLAY .................................................................................... 85
8.4 PROCEDURE #4: CPU BOARD ............................................................................................................... 87
8.5 PROCEDURE #5: POWER SUPPLY BOARD AND AC POWER BOARD ......................................................... 90
8.6 PROCEDURE #6: WI-FI BOARD .............................................................................................................. 92
8.7 PROCEDURE #7: BASE KIT .................................................................................................................... 95
8.8 PROCEDURE #8: AIR DETECTOR BOARD .............................................................................................. 100
8.9 PROCEDURE #9: PUMPING SYSTEM ..................................................................................................... 103
8.10 PROCEDURE #10: PUMPING SYSTEM MOTOR ...................................................................................... 108
8.11 PROCEDURE #11: PRESSURE SENSORS .............................................................................................. 113
8.12 PROCEDURE #12: ANTI-FREE FLOW CLAMP MOTOR ............................................................................ 118
8.13 PROCEDURE #13: DOOR ..................................................................................................................... 121
8.14 PROCEDURE #14: MEMBRANE ............................................................................................................. 122
8.15 PROCEDURE #15: OCS FLEXIBLE IC................................................................................................... 124
4
12 TECHNICAL CHARACTERISTICS 132
13 SPECIFICATIONS 136
14 RECYCLING 137
15 WARRANTY 138
INDEX 145
5
1 Introduction
1.1 Scope
This Technical Manual is applicable to the following Agilia VP range:
Agilia VP
Agilia VP MC
Agilia VP MC WiFi
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 VP, Agilia VP MC, Agilia VP MC WiFi), 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.
1.4 Contraindications
While being serviced, the device must not be connected to a patient.
Do not modify the pump unless recommended to do so by Fresenius Kabi.
For more information, refer to the Instructions for Use of the relevant pump.
6
2 Description
1
6
6
3 8
7
1
5
Legend
1 Angle Bracket 5 Door Lever
2 Keypad 6 Cover
The Agilia VP 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
- Air detector board
- Air detector
- Pump motor mechanism
- Anti-free flow clamp opto motor and switch board (OCS system)
- Wi-Fi board (for Wi-Fi infusion pumps)
The angle bracket supports the following:
- Power supply board
- AC power board
- Battery
7
2.1.2 Keypad
There are different keypads for the Agilia VP range depending on the pump's country of destination
1
2 14
3
4
13
4 5 6 7 8 9 10 11 12
Figure 2.2: Keypad for Agilia VP ROW
Legend
1 Screen 73
9 Decrement
21 Battery Charge Status Indicator 10
73 Fast Decrement
3 Power Supply Indicator 11
3 Confirm Value / Move to Next Field
4 On / Off 12
3 Stop
5 Bolus / Prime / Advance Air
Menu / Cancel Value / Move Back
63 Fast Increment 13
3 to Previous Field
73 Increment 14
3 Alarm Silence
83 Infusion Indicator Lights
8
1
2 17
3
16
4
15
14
5 6 7 8 9 10 11 12 13
Figure 2.3: Keypad for Agilia VP MC NAM
1
2 17
3
16
4
15
14
5 6 7 8 9 10 11 12 13
Legend
1 Screen 10 Decrement
5 On / Off 14
3 Cancel Value / Move Back to Previous Field
7 Fast Increment 16
3 Primary / Secondary, or Pressure Menu
8 Increment 17
3 Alarm Silence
9
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
Door sensor
This board is connected to other parts with the connectors shown below.
J2
J1
J3
Figure 2.5: Display Board
Legend
J1 J1 Connector to Keypad
10
J1 Connector to Keypad
Pin n° Signal Description
1 GND Ground
2 KBD_COL_0 Column 0
3 KBD_COL_1 Column 1
4 KBD_COL_2 Column 2
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
11
J3 Connector to Display
Pin n° Signal Description
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
12
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:
Two single-step bipolar motor commands
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 J5 connector.
A ribbon cable connects it to the Power Supply Board with the J10 connector.
J1 J2 J3 J4 J5
J6 J7
J8 J9 J10
Figure 2.6: CPU Board (Front View)
J11 J12
Legend
J1 J1 Connector - Connection to Opto Switch Board J7 J7 Connector - Connection to Drop Sensor RJ11
for Anti-Free Flow Clamp Socket. Unavailable in some countries.
J2 J2 Connector - Connection to Downstream J8
J1 J8 Connector - Connection to Motor Connector for
Pressure Sensor Anti-free flow clamp
J3 J3 Connector - Connection to Opto Motor J9 J9 Connector - Connection to Pumping Motor
J4 J4 Connector - Connection to JTAG connector J10 J10 Connector - Connection to Power Supply
(micro programming) Board
J5 J5 Connector - Connection to Display Board J11 J11 Connector - Connection to Upstream Pressure
Sensor
J6 J6 Connector - Connection to Air Detector Board J12 J12 Connector - Connection to Wi-Fi Board if one is
present
13
J1 Connector to Opto Switch Board for Anti-free flow Clamp
Pin n° Signal Description
1 GND Ground
Analog output signal of the photomicrosensor 2 (anti-free flow clamp position:
2 MC_OPTO2
open/closed)
Power supply signal for the photomicrosensor 2 (anti-free flow clamp position:
3 MC_CD_OPTO2
opened/closed)
4 GND Ground
Analog output signal of the photomicrosensor 1 (anti-free flow clamp position:
5 MC_OPTO1
opened/closed)
Power supply signal for the photomicrosensor 1 (anti-free flow clamp position:
6 MC_CD_OPTO1
opened/closed)
7 GND Ground
Analog output signal of the photomicrosensor (anti-free flow clamp presence:
8 S_CLAMP_OPTO
absent/present)
Power supply signal for the photomicrosensor (anti-free flow clamp presence:
9 S_CD_OPTO
absent/present)
10 GND Ground
14
J5 Connector to Display Board
Pin n° Signal Description
1 GND Ground
2 PRES_BOARD/ HMI board presence detection
3 +3V3 +3.3V power supply
4 +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
13 LCD_CD LCD type of the interface cycle: Control/data (0:control, 1:data)
14 LCD_MS LCD mode select
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 ON-OFF On/Off key on keypad
23 +5V +5V power supply
24 +5V +5V power supply
25 CMD_FAIL LED command failure
26 GND Ground
15
J9 Connector to Pumping Motor
Pin n° Signal Description
1 MOTP_OUT1A A+ winding
2 MOTP_OUT1B A- winding
3 MOTP_OUT2A B+ winding
4 MOTP_OUT2B B- winding
5 GND Ground
6 GND Ground
16
J12 Connector to Wi-Fi Board (for Agilia Wi-Fi pumps only)
Pin n° Signal Description
1 Floating Not used on Agilia VP range. Leave floating
2 Floating Not used on Agilia VP range. Leave floating
3 GND Ground
4 Floating Not used on Agilia VP range. Leave floating
5 Floating Not used on Agilia VP range. Leave floating
6 GND Ground
7 WIFI_VCC +3V3 Wi-Fi power supply
8 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
17
2.1.5 Power Supply Board
The power supply board consists of the following:
A Tmega48 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
J5
J3
J4
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
J1 Connector to CPU Board
Pin n° Signal Description
1 GND Ground
2 +5V +5V power supply
3 +5V +5V power supply
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
24 CMD_FAIL LED command failure
25 KON-OFF On/Off key
26 GND Ground
19
J3 Connector to Internal Battery
Pin n° Signal Description
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
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
J2
F1 1
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
J2 Connector to AC Power
Pin n° Signal Description
1 Neutral Neutral wire
2 Line Hot wire
3 GND Ground
21
2.1.7 Air Detector Board
The air detector board consists of input and output amplifiers, which are both linked to the ceramic
elements for reception and transmission.
The air detector board is fixed to the base. See figure 2.1, page 7. It transmits the air bubble volumes
present in the administration set in the form of analog data to the CPU board.
This board is connected to other parts with the connectors shown below.
J1
J3
J2
Legend
J1 J1 Connector - Connection to CPU Board J3 J3 Connector - Connection to Emitter
22
2.1.8 Wi-Fi Board
For Agilia Wi-Fi pumps only.
The Wi-Fi board is securely fixed to the left flange of the pump.
A ribbon cable connects it to the CPU Board with the J1 connector.
J1
Legend
J1 J1 Connector - Connection to CPU Board
23
2.1.9 Back View
5
1
4
2
3
Figure 2.15: Back View
Legend
1 Release Button 53 Power Cord Inlet
Drop Sensor Connection Socket (not available in
21 63 Infrared Cell
some countries)
3 Rotating Pole Clamp 73 Attachment Lock Knob
24
2.2.3 External Connection Sub-assembly
The Agilia VP range of pumps has two plugs located at the back of the angle bracket. See figure 2.15,
page 24.
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
DISPLAY BOARD
Stepper
Motor LEDs Display
Air detector
Interface Keypad
AIR BOARD
Internal
watchdog
Main microprocessor Flash memory
Supervisory circuit RAM memory
Sound Communication Temperature sensor
Watchdog management interface
CPU BOARD
External connector
DC supplies AC/DC EMC filter AC
Different converter
power supply
voltages Power supply
Safety management
AC POWER BOARD
POWER SUPPLY BOARD
25
3 Fundamentals
3.1 Training
The following three training levels outline the specifics needed to maintain and preserve the equipment.
Information
For training, contact your Fresenius Kabi sales representative.
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 and the membrane, 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.
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 pump operating functions. 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
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
27
4 Profile Menu
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 Agilia Vigilant Drug'Lib.
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.
6. Press the arrow keys to select the setting category (User or Ward).
7. Press enter.
Drug
Patient
Call-back alert
Library information
Data Set DS
29
Function Setting Description Range of Settings
User 4: Pressure Mode Selects the mode. Variable / 3 levels
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 / PSI
Maximum pressure value If Mode = Variable, defines the 500 750 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 100 400 mmHg
threshold.
Raise threshold If DPS = Yes, defines a pressure rise 50 600 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 KVO Sets the KVO flow rate. 0 20 mL/h
Silence duration Sets the silence duration alarm in 1 min 12 hours
KVO.
User 10: Volume / Rate, Displays the available infusion mode. -
Infusion mode Volume / Time / Rate,
Ramp or Sequential
(depending on the pump's
country of destination)
30
Function Setting Description Range of Settings
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.
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: Primary Sets the maximum flow rate of 50.0 1500 mL/h
Maximum rate primary infusions.
Maximum rate:Secondary Sets the maximum flow rate of 50.0 1000 mL/h
secondary infusions.
Par 9: Direct bolus: Sets the direct bolus rate. 50.0 1500 mL/h
Bolus and loading Flow rate
dose rates Programmed bolus and Sets the upper limit of both 0.1 1500 mL/h
loading dose: Maximum: programmed bolus rate and loading
dose.
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 menu item: Enabled / Disabled
Day/Night mode.
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 of the night 00:00 23:59
mode automatic activation.
Par 19: Direct bolus Activates or deactivates the Direct Enabled / Disabled
Other functions bolus function.
Advance air bubble Activates or deactivates the Enabled / Disabled
Advance air bubble function.
Prime set Activates or deactivates the Prime Enabled / Disabled
set function.
Loading dose Activates or deactivates the Loading Enabled / Disabled
dose function.
Programmed bolus Activates or deactivates the Enabled / Disabled
Programmed bolus function.
31
Function Setting Description Range of Settings
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
mL/kg/min, mL/kg/h, mL/kg/24h,
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 "Max
Patient parameters patient weight. 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 or not the same therapy Yes / No
Same therapy screen, when changing current drug.
screen
Par 27: Total air volume/15 min Sets the accumulated volume of air 10 2000 µL
Air parameter to be detected over 15 minutes for
the pump to trigger an air bubble
alarm.
Bubble filter Sets the air bubble maximum volume 0 and 10 250 µL
that can pass through the air
detector without triggering an alarm.
Par 29: Volume/time/rate Sets the available infusion modes for Enabled / Disabled
Infusion setting fields Volume/rate the infusion mode selected.
Volume/time
Time/rate
Ramp
Sequential
Par 31: Time Sets the remaining time that triggers 0 30 min
Near end of infusion the Near end of infusion alert.
alert % volume Sets the volume of initial VTBI that 0 15 %
triggers the alarm.
Volume Sets the volume of remaining VTBI 0 50 mL
that triggers the alarm.
Par 34: While stopped only If While stopped only is enabled, Enabled / Disabled
Rate titration allows rate modification after an
infusion stop only.
32
Function Setting Description Range of Settings
Par 36: Secondary Manual return to primary If Manual return to primary is Enabled / Disabled
enabled, the user must confirm the
completion of the secondary infusion
before resuming the primary
infusion.
Automatic return to primary If Automatic return to primary is Enabled / Disabled
enabled, the primary infusion
automatically resumes after the
completion of the secondary
infusion.
Alert when switching back If Alert when switching back Enabled / Disabled
to primary primary is enabled, an alert is
triggered at the end of the secondary
infusion before resuming the primary
infusion.
Note:
The displayed menu may change depending on the pump configuration and destination country.
µ = mc or micro.
33
6 Maintenance Operations
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.
34
6.1.4 Data Log Event
1. Access the Maintenance options menu. See section 6.1.1, page 34.
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.
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 16, page 135.
List of Tests
Tests Tests
Test 1 Identification. See section 6.2.2, page 37. Test 13 Battery test. See section 6.2.14, page 47.
Test 2 Maintenance options. See section 6.2.3, page 38. Test 14 Air detector. See section 6.2.15, page 49.
Maintenance messages.
Test 3 Test 15 Clamp motor. See section 6.2.16, page 50.
See section 6.2.4, page 38.
Test 4 Events. See section 6.2.5, page 38. Test 16 Flow rate. See section 6.2.17, page 52.
Test 5 Upstream pressure. See section 6.2.6, page 39. Test 17 Flow rate correction. See section 6.2.18, page 53.
Test 6 Downstream pressure. See section 6.2.7, page 40. Test 19 Clamp. See section 6.2.19, page 54.
Test 7 Door. See section 6.2.8, page 41. Test 20 Pump code. See section 6.2.20, page 55.
Test 8 Battery information. See section 6.2.9, page 43. Test 21 Power information. See section 6.2.21, page 56.
Test 9 Indication. See section 6.2.10, page 44. Test 22 LCD voltage. See section 6.2.22, page 57.
Test 10 Keypad. See section 6.2.11, page 44. Test 23 Temperature. See section 6.2.23, page 58.
Test 11 Ageing test. See section 6.2.12, page 45. Test 24 Watchdog. See section 6.2.24, page 59.
Wi-Fi module information
Test 12 Battery life. See section 6.2.13, page 47. Test 25
See section 6.2.25, page 60.
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.
37
6.2.3 Test 2: Maintenance
Test Description
Run this test to check that the pump maintenance data is correct.
5. Press enter.
The selected event is displayed in detail.
6. Press the arrow keys to scroll through the event detail screen.
38
6.2.6 Test 5: Upstream Pressure
Test Description
The upstream pressure sensor detects any occlusion that may occur upstream the pump.
Run this test to check if the pump correctly detects the occlusion and generates the appropriate
high-priority alarm.
Upstream
pressure sensor Pressure sensor
Main
microprocessor
Interface
CPU BOARD
The pump triggers a high-priority alarm and stops an infusion as soon as an upstream
occlusion is detected.
This test failed if one of these two conditions is encountered:
Upstream pressure sensor is not calibrated. Calibrate the upstream pressure
sensor using Agilia Partner maintenance software.
Upstream pressure sensor is defective or not correctly connected to the CPU board.
This problem leads to an error code 41:
- Check the cable connection to CPU board (J11) connector.
See figure 2.6, page 13.
- Replace the upstream pressure sensor. See section 8.11, page 113.
39
6.2.7 Test 6: Downstream Pressure
Test Description
The downstream pressure sensor detects any occlusion that may occur downstream the pump.
Run this test to check if the pump correctly detects the occlusion and generates the appropriate
high-priority alarm.
Downstream
pressure sensor Pressure sensor
Main
microprocessor
Interface
CPU BOARD
The pump triggers a high-priority alarm and stops an infusion as soon as a downstream
occlusion is detected.
This test failed if one of these two conditions is encountered:
The downstream pressure sensor is not calibrated. Calibrate the downstream
pressure sensor using Agilia Partner maintenance software.
The downstream pressure sensor is defective or not correctly connected to the CPU
board. This problem leads to an error code 42:
- Check the cable connection to CPU board (J2) connector.
See figure 2.6, page 13.
Replace the downstream pressure sensor. See section 8.11, page 113.
40
6.2.8 Test 7: Door
Test Description
Run this test to check the Hall effect door sensor and the correct functioning of the door
fastening system.
Door Magnet
Membrane
Optical sensor
Hall effect sensor
Stepper motor
Optical disk
Main DISPLAY
microprocessor BOARD
CPU BOARD
41
1. Access the Tests menu. See section 6.2.1, page 36.
2. Press the arrow keys to select Test 7: Door.
3. Press enter.
4. Press the arrow keys to scroll through the information screens.
The following data is displayed:
Conversion: Hall effect sensor value in mV. The displayed voltage value
is updated according to the Hall effect sensor
State: Door state (open or closed) according to the Hall effect sensor
Opened: Opened door calibration value in mV (value saved during last
calibration)
Intermediate: Closed door using calibration tool calibration value in mV
(value saved during last calibration)
Closed: Closed door calibration value in mV (value saved during last
calibration)
Date: Date of last calibration
Number: Last calibration number
5. Check that the Conversion value displayed in mV is within the limits shown in the table below. If not,
run a calibration of the door sensor using Agilia Partner maintenance software.
6. Press exit to return to the Tests menu.
Values Limit
Door opened 1737 LSB to 2234 LSB (1400 mV to 1800 mV)
Door closed 744 LSB to 3351 LSB (600 mV to 2700 mV)
42
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.
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 -300 mA
(battery charge status indicator is off)
Temperature +2 °C to +48 °C (+35.6 °F to +118.4 °F) for normal
room temperatures
43
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.
5. Press for at least 5 seconds to exit and return to the Tests menu.
44
6.2.12 Test 11: Ageing Test
Test Description
The Ageing test, equivalent to an OCS, checks the protection of the system against free flow.
The test verifies the pump occlusivity regarding the administration set and its anti-free flow
clamp installed.
This test also verifies that the motor unit is functioning correctly by carrying out forward or
backward running cycles.
10.Press the arrow keys to select the total number of turns or cycles to be
performed by the pump.
Available range:
- 1 to 9999 or
- Continuous (available in forward or backward mode only).
11.Press OK.
12.Press the arrow keys to select the motor command mode (Current).
Available options:
- standard or maximum
13.Press OK to start the test.
Information
If a battery alarm is present, the test cannot be launched (the OK button is not available).
45
While an ageing test is in progress, the pump displays the following information:
Flow rate in mL/h
Motor command mode (Current = standard or maximum)
Mode (forward, backward, forw./back., synchro)
Number of remaining steps/turns to perform
Total number of steps/turns to perform
Displacement type (step or turns)
The test ends if:
The programmed number of steps/turns is reached (Mode = forward, backward or forw./back.).
The required position is reached (Mode = synchro.).
The user presses the exit key. The exit key is the only way to stop a test with a "Number of
steps/turns" = Continuous.
Information
During the test, the motor rotation is tested and the pump triggers an error if a problem is detected.
46
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").
Prerequisites
Run test 13: "Battery test" on the pump before launching this test.
See section 6.2.14, page 47.
Prerequisites
The pump is disconnected from the AC power supply.
47
1. Access the Tests menu. See section 6.2.1, page 36.
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 06h30 (6:30).
If not, replace the battery. See section 8.1, page 81.
5. Press exit to return to the Tests menu.
48
6.2.15 Test 14: Air Detector
Test Description
Run this test to check the correct functioning of the air detector. The air detector allows the
pump to detect air bubbles before an infusion. This test only checks that the detector can
differentiate between air and infused medicine.
Ceramic
Reception
Main Air
microprocessor detector
Emission
AIR DETECTOR
BOARD
Ceramic
CPU BOARD
Communication
The pump triggers a high-priority alarm and stops an infusion as soon as an air bubble with
a width of at least 5 cm (2 in) passes through the pump.
If this test fails:
Calibrate the air detector using Agilia Partner maintenance software.
The air detector board is defective, or not correctly connected to the CPU board.
This problem leads to an error code 33:
- Check the cable connection to CPU board, (J6) connector.
See figure 2.6, page 13.
- Replace the air detector board.
See section 8.8, page 100.
49
6.2.16 Test 15: Anti-Free Flow Clamp Motor
Test Description
Run this test to check the correct functioning of the anti-free flow clamp motor. The anti-free
flow clamp motor drives an endless screw which may deviate from its original position.
Main
microprocessor Interface
Motor driver
CPU BOARD
Information
If a battery alarm is present, the test cannot be launched (the OK button is not available).
50
While a clamp motor test is in progress, the pump displays the following
information:
Displacement mode (forward or backward)
Anti-free flow clamp motor position
Number of remaining steps to perform
Total number of steps to perform
The test ends if:
The programmed number of steps is reached (forward or backward displacement mode).
or the required position is reached (initialization or unclamping displacement mode).
or the user presses the exit key. The exit key is the only way to stop a test in continuous
displacement mode.
Information
During the test, the rotation control is activated and the pump triggers an error if a problem is detected.
51
6.2.17 Test 16: Flow Rate
Test Description
Run this test to check the flow rate correction coefficient stored in memory. This coefficient
comes from the last flow rate calibration performed with Agilia Partner maintenance software.
The flow rate correction coefficient cannot be modified here
If this test fails, calibrate the flow rate using Agilia Partner maintenance software.
1. Setup a flow rate test that conforms to the EN-60601-2-24 standard. See section 6.2.29, page 64.
2. Access the Tests menu. See section 6.2.1, page 36.
3. Press the arrow keys to select Test 16: Flow rate.
4. Press enter.
5. Press the arrow keys to enter the flow rate.
Available range: 1 mL/h to 1500 mL/h. Default value: 100 mL/h.
6. Press OK.
Information
We recommend setting the "Flow rate" and "Volume" to default values. The resulting 25 mL infusion
performed at 100 mL/h best fits the EN-60601-2-24 standard and the equipment requirements
(administration set and scale accuracies).
The flow rate calibration is also based on the same infusion parameters.
Information
During the test, the rotation control is activated and the pump triggers an error if a problem is detected.
52
9. At end of test, check that the infused volume displayed on the scale or read on the graduated tube is
between:
Maximum volume: infused volume - 5 % rounded up to 1/10 (23.8 mL for a
25 mL infusion)
Minimum volume: infused volume +5 % rounded down to 1/10 (26.2 mL for
a 25 mL infusion)
10.Press exit to end the test and return to the Tests menu.
Information
The test fails if:
the volume read on the scale or the graduated is outside the limits
displayed,
the test ends by a ’Finish’ message.
In both cases, press exit and start a flow rate calibration using Agilia Partner maintenance software.
4. Press the down arrow key to display the last calibration date and number.
This calibration is the one that leads to the flow rate correction coefficient
displayed.
5. Press exit to end the test and return to the Tests menu.
53
6.2.19 Test 19: Clamp
Test Description
Run this test to check the sensors that verify whether the clamp is present or absent, and
clamped or unclamped.
Main
microprocessor Interface
Motor driver
CPU BOARD
54
4. Test the presence and position of the anti-free flow clamp as follows:
Door opened without administration set installed, check:
- Clamp: "absent"
- Position: "opened"
Information
If you do not want to protect access to the Pump settings by a code, enter "0000".
55
6.2.21 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.
56
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
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
57
6.2.23 Test 23: Temperature
Test Description
Run this test to display the temperature measured by the NTC thermistor (for information only).
Values Limit
Temperature -20 °C to +80 °C (-4 °F to +176 °F)
58
6.2.24 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.
4. Press OK to confirm.
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.
59
6.2.25 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.
60
6.2.26 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.
Prerequisites
The manometer’s calibration certificate is valid.
40 in (100 cm)
20 in (50 cm)
Manometer
T 3-way stopcock
Pump
Container
61
17.Check that the alarm is triggered when:
P > 14.5 ± 2.2 PSI
P > 1.00 ± 0.15 bar
P > 750 mmHg ± 115 mmHg
18.Stop the infusion.
62
15.Press the arrow keys to select 750 mmHg for Limit.
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.
63
6.2.29 Testing the Flow Rate
Test Description
During this flow rate test (compliant with the EN-60601-2-24 standard), a 25 mL infusion at
100 mL/h is carried out, and the delivered volume is reported.
The volume reported is compared to the theoretical volume (25 mL), and the flow rate test is
stated as passed if the calculated flow rate error is between -5 % and +5 %.
If the test fails, calibrate the flow rate using Agilia Partner maintenance software.
Prerequisites
The scale’s calibration certificate is valid.
64
20 in (50 cm)
0.4 in
(1 cm)
2
3
Figure 6.1: 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.
65
6.3 Quality Control Procedure
6.3.1 Running a Quality Control
Print the form provided. See section 6.3.2, page 70.
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).
66
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 44.
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 44.
Check the keypad.
6. Run Test 24: Watchdog. See section 6.2.24, page 59.
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 15: Clamp motor. See section 6.2.16, page 50.
Check the anti-free flow clamp motor correct functioning.
8. Run Test 19: Clamp. See section 6.2.19, page 54.
Check the presence and state (open/closed) of the administration set’s anti-free flow clamp.
9. Run Test 7: Door. See section 6.2.8, page 41.
Check the correct functioning of the door fastening system:
Open the door.
Check that "State" = "opened".
Close the door.
Check the message "State" = "closed".
If the state displayed is not coherent:
- Calibrate the door sensor using Agilia Partner maintenance software.
- Repeat Test 7: Door.
10. Run Test 11: Ageing test (occlusivity test). See section 6.2.12, page 45.
Install a manometer at the administration set outlet.
Install a water-filled administration set into the pump.
Run Test 11: Ageing test with the following settings:
- Flow rate: 500 mL/h
- Mode: Forward
- Current: Standard
- Step number: Continuous
Check that:
- No motor errors are triggered
- Maximum pressure is between 24.6 PSI (1.7 bar) and 36.3 PSI (2.5 bar)
- Pressure rises to maximum in less than 45 seconds
67
11. Check the upstream pressure limit alarm:
Install a water-filled administration set into the pump.
Install the roller clamp as close as possible to the drip
chamber.
Close the pump door.
Close the roller clamp upstream the pump.
Start an infusion at 100 mL/h.
68
14. Check the flow rate:
Load a water-filled administration set into the pump.
Carry out an infusion of 25 mL at 100 mL/h to warm up the administration set.
Carry out a flow rate test according to EN/IEC 60601-2-24 standard using a scale or graduated
tube.
Section 6.2.29, page 64.
Check that the flow rate error is between -5 % and +5 %. The volume measured is between
23.75 mL and 26.25 mL.
If the flow rate is out of range, calibrate the flow rate using Agilia Partner maintenance software.
15. 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.
16. 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 47.
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 47.
- Check that the displayed "Alarm" is equal to or greater than 06h30. (06:30)
If not, replace the battery. See section 8.1, page 81.
17. Run the electrical test according to EN/IEC 60601-1 standard. See section 6.2.28, page 63.
18. 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
69
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:
Pass
Fail
Name: Date: Signature:
Technical department:
Observations:
70
7 Troubleshooting and Messages
71
Displayed Message Priority Problem / Resolution
OCS Failure !!! The OCS control system has detected a failure.
The pumping mechanism has not managed to raise the
pressure in the line during the OCS test.
Close the roller clamp, check the administration set
installation, check the door integrity, check the
administration set integrity.
Calibrate then test the pressure sensors using
High (!!!) Agilia Partner maintenance software.
Check the membrane and replace it if necessary.
See section 8.14, page 122.
Check the installation and the integrity of the administration
set.
Check the door integrity.
If the problem cannot be resolved, contact the
Fresenius Kabi Technical Service.
Upstream occlusion !!! The pressure level in the upstream line is too low.
Check the roller clamp. Check the container and line. Check
the container height. Check air vent (if a bottle is used).
Check for kinked line.
High (!!!)
Calibrate then test the pressure sensors using
Agilia Partner maintenance software.
Replace the upstream pressure sensor.
See section 8.11, page 113.
Downstream occlusion !!! The pressure in the infusion line has reached the threshold
level.
Check whether the infusion line is occluded. If necessary,
readjust the pressure threshold.
High (!!!)
Calibrate then test the pressure sensors using
Agilia Partner maintenance software.
Replace the downstream pressure sensor.
See section 8.11, page 113.
End of infusion !!! The VTBI is completed.
High (!!!)
Press to select new infusion settings (if required).
End secondary alarm !!! The secondary infusion is completed (only with manual return
to primary).
High (!!!)
Not available in certain countries.
Restart the primary infusion.
Battery pre-alarm !! Low battery.
Medium (!!)
Connect the pump to a power supply.
Near end of infusion !! One of the near end of infusion alert criteria is reached (time
before the end of infusion, % of VTBI remaining, remaining
VTBI).
Medium (!!)
Check whether the remaining volume in the container
corresponds to the remaining VTBI.
If needed, prepare a container for a new infusion sequence.
Waiting settings !! A value must be entered.
Medium (!!)
Enter a value and press OK to confirm.
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 start !! The infusion settings have been entered but have not been
confirmed with Start.
Medium (!!)
Check infusion parameters and press Start to start the
infusion.
Occlusion pre alarm !! In-line pressure has reached 50 mmHg / 5 kPa / 1 PSI below
the programmed threshold.
Medium (!!) Check the infusion line.
Define the pressure threshold parameter (User 4).
See section 5.2, page 29.
Battery pre alarm !! Low battery.
Medium (!!)
Connect the pump to a power supply.
72
Displayed Message Priority Problem / Resolution
End of infusion ! End of infusion - with KVO
Stop for new infusion ! The VTBI is completed and the KVO is activated according to
Low (!) its configuration in Agilia Vigilant Drug’Lib software or in the
pump options.
Press to select new infusion settings (if required).
Pressure increase ! The pressure is increasing in the infusion line. This warning
can be selected as an option.
Low (!) Check for occlusions in the infusion line (roller clamp or tap
closed, administration set blocked, line kinked or twisted,
etc.).
Drop in pressure ! The pressure is decreasing in the infusion line. This warning
can be selected as an option.
Low (!)
Check the downstream Luer lock connection and the
integrity of the entire line.
AC power failure ! The power supply is inconsistent.
Low (!)
Contact your Technical Service.
Check bags position and line End of secondary infusion.
installation for primary Low (!) Not available in certain countries.
infusion ! Press to acknowledge.
Re-open primary line ! End of secondary infusion.
Close secondary line ! Low (!) Not available in certain countries.
Press to acknowledge.
High internal temperature ! Temperature increase.
Low (!) Check device environment.
Send the pump for maintenance.
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.
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.
Open and close door for OCS Under specific conditions, the pump asks you to open and
test Information signal close the door to perform the OCS test.
Open and close the door.
Keypad lock status The keypad is locked.
Information signal
Unlock the keypad.
Keypad locked The keypad is locked and the door was opened and closed.
Information signal
Unlock keypad to continue Unlock the keypad.
73
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. Close the roller clamp.
3. Disconnect the pump from the power supply.
4. 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.
74
7.2 Troubleshooting Guide
Description Cause Recommended Action
Display defect: LED, LCD display. Control transistors, LEDs 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 85.
Detection of a open door while the door is The door sensor is not calibrated. Calibrate the door sensor using Agilia Partner
closed. maintenance software.
Detection of an closed door while the
door is open.
Occlusion alarm after the pump has been Wrong calibration of the Recalibrate the downstream or upstream
turned on. downstream or upstream sensor using Agilia Partner maintenance
pressure sensor. software.
The downstream or upstream Replace the downstream or upstream sensor.
pressure sensor is damaged. See section 8.11, page 113.
Occlusion alarm during the infusion. The pressure limit selected is too Select a higher pressure limit (Pressure
low. management menu ).
Wrong calibration of the Recalibrate the downstream or upstream
downstream or upstream sensor using Agilia Partner maintenance
pressure sensor. software.
Flexible circuit is cut. Replace the downstream or upstream sensor.
See section 8.11, page 113.
The power supply indicator doesn't light Battery is totally discharged. Connect the pump to the AC power supply.
up. Power supply board is defective. Replace the battery.
See section 8.1, page 81.
Check the power cord and AC power supply.
Replace the power supply board.
See section 8.5, page 90.
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 90.
The pump turns ON or OFF itself. Defective keypad. Replace the upper case. See section 8.2,
Power supply board is damaged. page 83.
Check the keypad by running test 10.
See section 6.2.11, page 44.
Replace the power supply board if necessary.
See section 8.5, page 90.
Some keys of the keypad do not work. Defective keypad. Replace the upper case.
See section 8.2, page 83.
Check the keypad by running test 10.
See section 6.2.11, page 44.
Mechanical elements are damaged. After a fall. Check the status of the casings and the
mechanical system.
75
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 CPU board (J3 connector). See figure 2.6, page 13.
Check the correct functioning of the motor rotation optical switch.
Replace the CPU board. See section 8.4, page 87.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
10 RAM Replace the CPU board. See section 8.4, page 87.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
11 Flash memory (deleting or Replace the CPU board. See section 8.4, page 87.
programming problem) Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
12 Resources Carry out a complete configuration for the pump using the
Agilia Partner maintenance software.
If the problem cannot be resolved:
Replace the CPU board.See section 8.4, page 87.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
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 90.
restarting - Watchdog
problem
15 Secondary microcontroller Check the ribbon cable connection between Power supply board
communication (J1 connector) and CPU board (J10 connector).
See figure 2.6, page 13.
See figure 2.8, page 18.
Replace the Power supply board. See section 8.5, page 90.
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.
See section 6.2.13, page 47.
Replace the battery. See section 8.1, page 81.
17 Battery charge Check the battery charging voltage. Run test 12.
See section 6.2.13, page 47.
Replace the battery. See section 8.1, page 81.
18 AC power presence Remove the battery door. See section 8.1, page 81.
Check the status of the AC power fuse.
Replace the Power supply board. See section 8.5, page 90.
19 Battery temperature Check the battery status. Run test 8. See section 6.2.9, page 43.
Replace the battery. See section 8.1, page 81.
22 Anti-free flow clamp Check that the opto switch is functioning correctly by running
presence opto switch test 19, (line Clamp). See section 6.2.19, page 54.
Check the cable connection to CPU board (J1 connector).
See figure 2.6, page 13.
Replace the OCS flexible IC.See section 8.15, page 124.
23 Anti-free flow clamp motor Check that the 2 opto switches are functioning correctly by
position opto switches running test 19, (line Position). See section 6.2.19, page 54.
Check the cable connection to CPU board (J1 connector).
See figure 2.6, page 13.
Replace the OCS flexible IC. See section 8.15, page 124.
76
Error Code Description Recommended Actions
24 Unclamping Run test 15. See section 6.2.16, page 50.
Check the status of the Anti-free flow clamp motor.
Check the connection of the Anti-free flow clamp motor to the
CPU board (J8 connector). See figure 2.6, page 13.
Replace the Anti-free flow clamp motor.
See section 8.12, page 118.
25 Door Hall effect sensor Run test 7 to check the "open or closed" door detection.
See section 6.2.8, page 41.
Check that the magnet is present on the door.
Replace the door. See section 8.13, page 121.
Calibrate then test the door sensor using Agilia Partner
maintenance software.
26 Board missing Check the connection between Display board and CPU board.
See section 2.1.3, page 10.
See section 2.1.4, page 13.
Check the connection between Power supply board and CPU
board.
See section 2.1.4, page 13.
See section 2.1.5, page 18.
Replace the faulty part(s).
27 LCD blacklight missing Check the connection between Display board (J3 connector) and
LCD display. See section 2.1.3, page 10.
Replace the LCD display. See section 8.3, page 85.
If the problem cannot be resolved, replace the Display board.
28 Keypad Run test 10 to check the keypad. See section 6.2.11, page 44.
Replace the upper case. See section 8.2, page 83.
Run test 10 to check the keypad.
If the problem cannot be resolved, replace the Display board.
See section 8.3, page 85.
29 Analog/digital converter Replace the CPU board. See section 8.4, page 87.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
30 Time keeper Replace the Power supply board supporting the secondary
microcontroller. See section 8.5, page 90.
Replace the CPU board. See section 8.4, page 87.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
33 Air detector Run test 14. See section 6.2.15, page 49.
Check the status of the air detector using an administration set
filled with water and air.
Calibrate the air detector using Agilia Partner maintenance
software.
34 Infusion flow rate Carry out a complete configuration using Agilia Partner
maintenance software.
35 Motor period Carry out a complete configuration using Agilia Partner
maintenance software.
36 Motor rotation direction Carry out a complete configuration using Agilia Partner
maintenance software.
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 90.
Replace the Display board. See section 8.3, page 85.
Replace the CPU board to check the functionality of the main
microcontroller.See section 8.4, page 87.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
38 OFF key locked Run test 10 to check the functionality of the keypad, and
especially the OFF key. See section 6.2.11, page 44.
Replace the upper case. See section 8.2, page 83.
Replace the Power supply board to check the secondary
microcontroller functionality. See section 8.5, page 90.
77
Error Code Description Recommended Actions
39 Impossible to power off Replace the Power supply board. See section 8.5, page 90.
41 Upstream pressure sensor Run test 5. See section 6.2.6, page 39.
out of range Check the sensor state change by applying pressure on the
upstream sensor.
Check the connections to CPU board (J11 connector).
See figure 2.6, page 13.
Calibrate the upstream sensor using Agilia Partner maintenance
software.
42 Downstream pressure Run test 6. See section 6.2.7, page 40.
sensor out of range Check the sensor state change by applying pressure on the
downstream sensor.
Check the connections to CPU board (J2 connector).
See figure 2.6, page 13.
Calibrate the downstream sensor using Agilia Partner
maintenance software.
43 LCD communication failure Replace the Display board.See section 8.3, page 85.
44 LCD driver failure Replace the Display board.See section 8.3, page 85.
45 Defective LCD voltage Replace the Display board.See section 8.3, page 85.
78
Error Code Description Recommended Actions
99 Activation of the watchdog Replace the Power supply board to check the functionality of the
secondary microcontroller. See section 8.5, page 90.
Replace the CPU board to check the functionality of the main
microcontroller. See section 8.4, page 87.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
79
8 Intervention 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.
80
8.1 Procedure #1: Battery and Battery Door - Boost Capacitor Discharge
Required Tools and Equipment
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.
See section 3.1, page 26.
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
81
4. 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
5
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 66.
82
8.2 Procedure #2: Upper Case
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 81.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
83
8. Disconnect the display board flat cable at [J2].
9. Disconnect the display board / keypad cable (connection at [J1]).
10.Remove the 4 screws [7] that fasten the board unit to the upper case.
7 7
J1
7 J2 7
11.Remove the display board unit from the upper case [8].
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibration using Agilia Partner maintenance software:
Door
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
84
8.3 Procedure #3: Display Board/LCD Display
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 81.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
85
8. Disconnect the display board flat cable at [J2].
9. Disconnect the keypad/display board connection at [J1].
10.Unscrew the 4 screws [7] that fasten the board to the upper case.
11.Remove the display board / LCD display from the upper case.
7 7
J1
7 J2 J3 7
J3
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
Door
LCD contrast
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
86
8.4 Procedure #4: CPU Board
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged. See section 8.1, page 81.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
87
8. Disconnect the display board flat cable at [J2].
J1
J2
9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12].
To remove the Wi-Fi board: See section 8.6, page 92.
10.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
88
11.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
12.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
Pressure sensors
Door
Air detector
Flow rate
Date
LCD contrast
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
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.
89
8.5 Procedure #5: Power Supply Board and AC Power Board
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 81.
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 [3].
4. Disconnect the CPU board flat cable [3] at [J1].
3
J1
90
5. Disconnect flat cable [J2].
6. Unscrew and remove screw [4].
7. 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
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.
4. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
6
5
5. Perform the regular servicing tests. See Quality Control Procedure, page 66.
91
8.6 Procedure #6: Wi-Fi Board
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
This procedure is only applicable to pumps equipped with a Wi-Fi module.
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 81.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
92
8. Disconnect the display board flat cable at [J2].
J1
J2
9. Disconnect flat cable that connects the Wi-Fi board to the CPU board at [J12].
10.Unscrew and remove the screw [6] that holds the Wi-Fi board [7] to the flange.
11.Remove the Wi-Fi board holder.
J12
93
12.Dislodge the Wi-Fi board [7] from the flange.
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibration using Agilia Partner maintenance software:
Door
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
94
8.7 Procedure #7: Base Kit
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged. See section 8.1, page 81.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
95
8. Disconnect the display board flat cable at [J2].
J1
J2
9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12].
To remove the Wi-Fi board: See section 8.6, page 92.
10.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
96
11.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
12.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
13.Unscrew the 2 screws [9] on either side of the right and left flanges, being careful not to
damage the air detector board [10].
9 9
10
97
12 13
15 16
14 11 14
16
15
13
98
21.Separate the base kit [17] from the motor kit [18] pulling the motor out of its axis [19].
17 18
19
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
Pressure sensors
Door
Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
99
8.8 Procedure #8: Air Detector Board
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 81.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
100
8. Disconnect the display board flat cable at [J2].
J1
J2
9. Unscrew the 2 screws [7] from the air detector board [8].
101
10.Remove the air detector board, being careful not to pull out the flat cable [9].
11.Disconnect the flat cable [9] connected to the air detector board at [J1].
J1
8
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
Pressure sensors
Door
Air detector
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
102
8.9 Procedure #9: Pumping System
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged. See section 8.1, page 81.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
103
8. Disconnect the display board flat cable at [J2].
J1
J2
9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12].
To remove the Wi-Fi board: See section 8.6, page 92.
10.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
104
11.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
12.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
13.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].
9
10
105
14.Place the pump with the door facing down..
15.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
16.Unscrew the screw [12] positioned under the base.
17.Remove the pumping plate [13].
18.Unscrew the screw [14] positioned under the base.
12 13
15
11 14
16
15
13
106
20.Pull out the pumping system [16].
16
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
Pressure sensors
Door
Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
107
8.10 Procedure #10: Pumping System Motor
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Weak loctite ref. 248
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged. See section 8.1, page 81.
Dismantling
If a Wi-Fi pump is used, remove the Wi-Fi board then dislodge the CPU board as explained later
in this procedure.
To remove the Wi-Fi board: See section 8.6, page 92.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
108
8. Disconnect the display board flat cable at [J2].
J1
J2
9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12].
To remove the Wi-Fi board: See section 8.6, page 92.
10.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
109
11.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
12.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
13.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].
9
10
110
14.Place the pump with the door facing down..
15.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
16.Unscrew the screw [12] positioned under the base.
17.Remove the pumping plate [13].
18.Unscrew the screw [14] positioned under the base.
12 13
15
11 14
16
15
13
111
21.Unscrew the 4 motor holding nuts [17].
22.Pull out the 4 screws, and remove the motor with its silent blocks.
16
17 17
17 17
Re-assembling
1. Put the motor in position, motor wires on the left side of the mechanical block using a weak
loctite ref. 248 to hold the motor with its nuts.
2. Moderately tighten the motor holding nuts [17].
3. Tighten the 4 motor screws, following the order [A], [B], [C], [D] as shown below.
D B
A C
112
8.11 Procedure #11: Pressure Sensors
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 81.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
113
8. Disconnect the display board flat cable at [J2].
J1
J2
9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12].
To remove the Wi-Fi board: See section 8.6, page 92.
10.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
114
11.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
12.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
13.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].
9
10
115
14.Place the pump with the door facing down..
15.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
16.Unscrew the screw [12] positioned under the base.
17.Remove the pumping plate [13].
18.Unscrew the screw [14] positioned under the base.
12 13
15
11 14
16
15
13
116
20.Pull out the pumping system [16] out of its axis [17].
21.Unscrew the 2 upstream sensor and downstream sensor screws [18] and [19].
19
18
17
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
Pressure sensors
Door
Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
117
8.12 Procedure #12: Anti-Free Flow Clamp Motor
Required Tools and Equipment
1 Torx T-10 screwdriver
1 flat screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 81.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
118
8. Disconnect the display board flat cable at [J2].
J1
J2
9. Unscrew the 2 screws [7] that hold the motor to the flange.
10.Unscrew the 2 screws [8] that hold the air detector board [9] to the flange.
11.Dislodge the air detector board [9].
12.Using a small flat screwdriver, apply a light pressure in order to disengage the motor
positioning spigot .
This operation should be handled with care in order to avoid any damage to the air detector
board flat cable when using a screwdriver.
9
8
7
7
119
13.Disconnect the cable connected to the CPU board at [J8].
14.Remove the anti-free flow clamp motor [10].
J8
10
9
Re-assembling
1. Position the anti-free flow clamp motor into the flask.
2. Position the wires in the guides as shown below at [11].
3. Screw the 2 screws [7] that hold the motor to the flange.
4. Check that the motor is clipped correctly [12].
Check the correct position of the anti-free flow clamp motor fins when assembling the
motor kit. The fins should be on the left side of the OCS optical sensor board.
J8
11
7 12
120
8.13 Procedure #13: Door
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 2 screws [1].
1
1
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
2. Perform the following calibrations using Agilia Partner maintenance software:
Door
Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
121
8.14 Procedure #14: Membrane
Required Tools and Equipment
1 Torx T-10 screwdriver
1 flat screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 2 screws [1].
1
1
122
4. Release the 2 pins [3] using a flat screwdriver.
3 3
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the position of the membrane before clipping it back in place.
2. Perform the following calibrations using Agilia Partner maintenance software:
Pressure sensors
Door
Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
123
8.15 Procedure #15: OCS Flexible IC
Required Tools and Equipment
1 Torx T-10 screwdriver
1 anti-static bracelet
Maintenance level
Level 3 specialist technician.
See section 3.1, page 26.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 81.
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 [6].
4. Disconnect CPU board flat cable [6] at [J1].
5. Pull out the RJ11 cap [4] .
6. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
7. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
124
8. Disconnect the display board flat cable at [J2].
J1
J2
9. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
If a Wi-Fi pump is used, disconnect the flat cable that connects the Wi-Fi board to the CPU
board at [J12].
To remove the Wi-Fi board: See section 8.6, page 92.
10.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
125
11.Dislodge the CPU board from its two retaining clips [8].
While doing this, take care not to pull out the flat cable on the inside.
12.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
13.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].
9
10
126
14.Place the pump with the door facing down.
15.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
16.Unscrew the screw [12] positioned under the base.
17.Remove the pumping plate [13].
18.Unscrew the screw [14] positioned under the base.
12 13
15
11 14
16
15
13
127
20.Unscrew and remove screw [16].
21.Remove the OCS flexible IC [17].
17
Re-assembling
1. Perform the dismantling procedure in reverse order to re-assemble the unit.
Pay attention to the direction of the flat cable connections when assembling.
2. Perform the following calibrations using Agilia Partner maintenance software:
Pressure sensors
Door
Air detector
Flow rate
3. Perform the regular servicing tests. See Quality Control Procedure, page 66.
128
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
129
10 Cleaning and Disinfecting
Refer to the Instructions for Use of the relevant pump for the following information:
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.
130
11 Power Management
Refer to the Instructions for Use of the relevant pump for the following information:
AC power supply precautions
Battery precautions
Battery operating mode
131
12 Technical Characteristics
Power supply
100 V - 240 V ~ / 50 / 60 Hz with functional earth
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.
132
12.4 Communication Port
The connector located at the back of the device allows data communication with a PC.
Compatibility Asynchronous Serial Infrared (SIR) physical layer irPHY 1.0, baseband no carrier
Transport
Proprietary
Protocol
Speed 115.2 kb/s max
Input / Output
250 mW
power (pump)
Input / Output
100 mW
Power (PC)
Compatibility USB 2.0 compliant.
Length 85 in (2.15 m)
133
12.8 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)
134
12.11 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 Left and right flanges Polycarbonate
7 Pumping block plate Polyamide
8 Light guide Polycarbonate
9 Window Polycarbonate
10 Molded base ABS
11 Central hook on the cover Polyamide 6
12 Right and left hook on the cover Polyamide 6
13 Infrared window Polycarbonate
14 Eccentric bolt POM
15 Bolt front case POM
16 Bolt rear case POM
17 Bolt button POM
18 Bolt button pen POM
19 Air detector support ABS
20 Door ABS
21 Door plate Polyarylamide
22 Molded lever + hooks Polyarylamide
23 Left and right door hinge Polyamide 6
24 OCS fuse Polyacetal
25 OCS unclamping finger Polyamide
26 Mechanical spring cap Polyamide
27 OCS detector cradle Polyarylamide
28 Pumping block Polyamide
29 Star motor ring Polyacetal
30 Motor pulley Polyamide
31 Cam shaft pulley Polyamide
32 Belt idler pulley Polyamide
33 Belt idler lever Polyacetal
34 Rotation control disk Polyamide
35 Pumping finger PA6-12
36 Molded cam shaft PA66
37 Bearing motor support Polyarylamide
38 Magnet support ABS
39 Membrane TF3 STE
40 Membrane frame Polypropylene
41 Back foot LSR
42 Front foot LSR
43 RJ11 stopper TPE EPTR
44 Connector stopper TPE EPTR
45 Star motor shock absorber Elastomere
135
13 Specifications
Refer to the Instructions for Use of the relevant pump for the following information:
Infusion Rate
Volume To Be Infused (VTBI)
Infusion Time
Air Detection
Flow Rate Accuracy
Occlusion Alarm Response Time
Bolus Volume at Occlusion Release
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
136
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.
137
15 Warranty
Refer to the Instructions for Use of the relevant pump for the following information:
General conditions of warranty
Limited warranty
Warranty conditions for accessories
138
16 Guidance and Manufacturer's Declaration on EMC
Refer to the Instructions for Use of the relevant pump for the following information:
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.
139
17 Spare Parts Catalog
140
18 Ordering Information
18.3 Disposables
Refer to the Instructions for Use of the relevant pump
141
19 Glossary of Terms
Term Description
A Amperes
AC Alternating Current
Ah Ampere-hours
AM Amplitude Modulation
dBA Decibels
DC Direct Current
DI Dose Infused
DUR Duration
ECG Electrocardiogram
ED Emergency Department
EEG Electroencephalogram
FM Frequency Modulation
ft Feet
HF High Frequency
hPa Hectopascals
Hz Hertz
in Inches
IT Information Technology
142
Term Description
IV Intravenous
kg Kilograms
lb Pounds
mA Milliamperes
mEq Milliequivalents
OR Operating Room
PC Personal Computer
PE Protective Earth
RF Radio Frequency
V Volt
VA Volt-Amperes
VI Volume Infused
143
Term Description
W Watts
144
Index
A L
AC Power Board LCD Display
Description 21 Dismantle/Re-assemble 85
Dismantle/Re-assemble 90 Voltage 57
Ageing Test 45
Air Detector M
Test 49
Maintenance
Air Detector Board
Date 34
Description 22
Display Startup Screen 35
Dismantle/Re-assemble 100
Schedule 26
Alarms 71
Test 38
Anti-Free Flow Clamp Motor
Maintenance Options Menu 34
Dismantle/Re-assemble 118
Material Characteristics 135
Test 50
Membrane 122
B O
Base Kit 95
OCS Flexible IC 124
Basic Profile Configuration 29
Operation Diagram 25
Battery
Options Menu 27
Dismantle/Re-assemble 81
Test 43, 47
P
C Power Information 56
Power Supply Board
Clamp 54
Description 18
CPU Board
Dismantle/Re-assemble 90
Description 13
Pressure
Dismantle/Re-assemble 87 Downstream Sensor 40
Upstream Sensor 39
D Pressure Limit Alarm Test 61
Display Board Pressure Sensors 113
Description 10 Profile Menu 28
Dismantle/Re-assemble 85 Pump Code 55
Door Pump Identification 37
Dismantle/Re-assemble 121 Pumping System
Test 41 Dismantle/Re-assemble 103
Dismantle/Re-assemble Motor 108
E
Electrical Test 63 Q
Error Codes 76 Quality Control
Events Certificate 70
Data Log 35 Maintenance 26
Test 38
R
F Release Notes 147
Flow Rate Test 64
S
I Symbol Descriptions 2
Indication Test 44
K
Keypad
Description 8
Test 44
145
T
Table of Contents 3
Technical Characteristics 132
Temperature Test 58
Tests
Access Menu 36
List 36
Training 26
Troubleshooting 75
U
Upper Case 83
W
Watchdog 59
Wi-Fi Board
Description 23
Dismantle/Re-assemble 92
Wi-Fi Module Information 60
146
Release Notes
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: November 2016
www.fresenius-kabi.com 0123
147
148
Local Contacts for Servicing
Non-ionizing electromagnetic
Product serial number
radiation
2 9464-4_master_ifu_agilia_vp_mc_eng
Table of Contents
1 INTRODUCTION 9
3 DESCRIPTION 15
4 FUNDAMENTALS 22
3
5 INSTALLATION 27
6 GETTING STARTED 33
7 OPERATION 38
4
7.10 INFUSION MODES ..................................................................................68
7.10.1 Volume / Time / Rate (V/T/R) ............................................................. 68
7.10.2 Volume /Rate (V/R) ............................................................................ 68
7.10.3 Volume / Time (V/T) ........................................................................... 68
7.10.4 Time / Rate (T/R)................................................................................ 68
7.10.5 Ramp-up / Ramp-down ...................................................................... 69
7.10.6 Sequential Infusion............................................................................. 71
7.10.7 Drops/min ........................................................................................... 72
7.11 OTHER FUNCTIONS ...............................................................................73
7.11.1 Priming the Administration Set ........................................................... 73
7.11.2 Advancing an Air Bubble .................................................................... 74
7.11.3 Pre-programming the Pump ............................................................... 76
8 MENUS 77
5
8.24 LIBRARY INFORMATION ........................................................................103
8.25 DATA SET ...........................................................................................104
9 OPTIONS 105
6
15 SPECIFICATIONS 128
7
18.10 TRUMPET AND START-UP CURVES .......................................................147
19 WI-FI 150
20 TROUBLESHOOTING 153
21 RECYCLING 154
22 WARRANTY 155
24 SERVICING 165
INDEX 172
8
1 Introduction
1.1 Scope
These Instructions for Use (IFU) are applicable to the Agilia VP MC and
Agilia VP MC WiFi large volume pumps. These devices are referred to
throughout this manual as the "Agilia VP 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 174.
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 Product
Standard solutions
Parenteral Fluids Colloids
Parenteral nutrition
Diluted drugs
Antibiotics
Chemotherapy
Medication
Catecholamines
Short acting drugs
Anaesthesia drugs
Blood
Red blood cells
Transfusion Platelets
Plasma
Albumin
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.
For training, contact your Fresenius Kabi sales representative.
Patient Characteristics
Male
Sex
Female
Neonates
Paediatrics
Age
Adults
Elderly
Weight 0.25 kg to 350 kg
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 VP 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
Information
For a list of compatible accessories, disposables and software, and for
ordering information, refer to the System Components booklet.
14
3 Description
2 3
21 Pump Door
3 Door Lever
15
3.3 Back View
5
1
4
2
3
Warning
Near RS232 See section 10, page 107.
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
4 Wi-Fi Symbol 13
3 Stop / Pause
5 On / Off
Cancel Value / Move Back to Previous
14
3 Field
63 Bolus / Prime / Advance Air
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
Note:
Fast increment and decrement keys have been programmed with different levels corresponding to
standardized volumes of bags and bottles.
Pressing and holding any of the arrow keys results in faster increment or decrement.
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.
18
3.5 Display and Symbols
3.5.1 Infusion Status
Symbol Description
Infusion in Progress (All Profiles)
This symbol shows a drop falling into the drip chamber.
The drop appears in the drip chamber when an infusion is in progress.
19
3.5.3 Navigation Buttons
Symbol Description
start Start
OK Confirm
C Change Selection
Select / Unselect
Power Disconnection
Alarm Silenced
Pressure Increase
Drop in Pressure
Note: For more information on alarms, see section 12, page 111.
20
Symbol Description
Sequential Infusion
seq This symbol is displayed when programming and infusing a sequential
infusion.
Drops/min
This symbol is displayed when programming and infusing a drops/min
infusion.
3.6 Packaging
The Agilia VP MC packaging contains the following:
1 Agilia VP 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.
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, air-in-
line detection, 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.
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
24
4.4.4 Infusion Modes
An infusion can be started according to the following modes:
Infusion Rate
Infusion Mode Description
Flow Rate Dose
Volume / Time / Rate This infusion mode gives access to the 3 infusion
(V/T/R) parameters (V, T, R)
Volume / Rate Infusion of a programmed volume of fluid at a
(V/R) programmed rate
Volume / Time Infusion of a programmed volume of fluid over a
(V/T) programmed period of time
Time / Rate Infusion over a programmed period of time, at a
(T/R) programmed rate
Infusion defined by a total volume, a total infusion
time, a ramp-up and ramp-down time and a plateau
Ramp-up / Ramp-
flow rate. This mode allows the flow rate to be
down
increased gradually by intermediate stages in order
to reach the plateau flow rate.
Infusion by sequences (up to a maximum of 20)
Sequential defined by volume to be infused and the infusion
flow rate for each sequence.
Infusion defined by a flow rate expressed in drops
Drops/min
per minute
25
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.
Profile 1
(Basic)
Profile 2
(Custom)
Profile 3
(Custom)
Profile 4
(Custom) ... Profile 20
(Custom)
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.
26
5 Installation
Location Comments
See section 5.3.1, page 30.
On a Pole Pole specifications:
Diameter: from 15 to 40 mm
See section 5.3.2, page 30.
On the
Link Agilia
Rack
On Another
Pump
27
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.
1 3
2
Figure 5.1: Rotating Pole Clamp System
Legend
1 Screw Clamp
21 Release Button
28
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.
29
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 29.
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.
30
5.3.3 Installing on the Link Agilia Rack
1. Fold the pole clamp up: see section 5.2.2.2, page 29.
2. Position the pump in front of the rack,
and slide it carefully onto the slot in
the pump shelf.
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.
31
5.3.4 Using on a Flat Table
1. Fold the pole clamp up: see section 5.2.2.2, page 29.
2. Place the pump far enough from the
table's edges to prevent it from
accidentally being pushed off.
32
6 Getting Started
6.1 Flowchart
Once the pump is installed at the bedside, you must follow the steps
below in order to install an administration set and power on the pump.
Powering on
Section 6.3, page 34.
Programming an infusion
Section 7, page 38.
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.
33
6.2 Using the Pump for the First Time
1. Make sure the pump is correctly installed at the bedside.
See section 5, page 27.
2. Plug the pump into the AC power supply.
See section 17.1, page 142.
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.
4. Prepare the administration set.
See section 13.1, page 118.
5. Power on the pump.
See section 6.3, page 34.
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.
When plugged into a power supply, the pump automatically
powers on when the pump door is opened. You can deactivate
this option in the pump options. For more information, refer to the
technical manual.
34
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
35
6.4 Installing the Administration Set in the Pump
Warning
Do not open the roller clamp until the OCS test has successfully
completed.
During all manipulations of the pump with administration set
(administration set installation, door opening, administration set
removal), close the roller clamp and make sure the line is closed.
36
6.5 Pump Height
Warning
Do not place the pump more than 1.3 meter above or below the
patient.
Make sure that the height between the patient and the pump, and
between the container and the pump (as illustrated below), is
respected.
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.
20 to 80 cm
37
7 Operation
7.1 Flowchart
Selecting a Profile
Section 7.2, page 39.
Selecting a Drug
Section 7.4, page 41.
Starting an Infusion
Section 7.6, page 52.
Monitoring an Infusion
Section 7.7, page 53.
Completing an Infusion
Section 7.9, page 65.
38
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.
39
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.
40
7.4 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.
41
7.5.1 Programming an Infusion by Flow Rate
Information
Ensure VTBI is not greater than actual volume in the container to
avoid air-in-line at the end of infusion.
All volumes added or removed must be taken into consideration,
including the volume of fluid contained in the administration set
and lost during priming (priming volume varies by administration
set; see the administration set IFU for priming volumes).
2. Press the arrow keys to program the infusion duration (__ h __), and
press OK.
3. Press the arrow keys to program the flow rate, and press OK.
42
7.5.2 Programming an Infusion by Dose
1. Press the arrow keys to select the drug concentration unit, and
press OK.
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.
4. Press OK to confirm.
43
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 on the concentration is allowed, see section 7.5.2.2,
page 45.
Legend
Unauthorized Range Hard Limits
Finite Values
44
Selecting the Drug Concentration
1. Press the arrow keys to enter the patient's weight or body surface
area.
2. Press OK to confirm.
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.
45
7.5.2.3 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.
Information
Ensure VTBI is not greater than actual volume in the container to
avoid air-in-line at the end of infusion.
All volumes added or removed must be taken into consideration,
including the volume of fluid contained in the administration set
and lost during priming (priming volume varies by administration
set; see the administration set IFU for priming volumes).
46
2. Press the arrow keys to program the infusion duration (__ h __), and
press OK.
3. Press the arrow keys to program the dose, and press OK.
47
7.5.2.5 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.
48
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.
49
Interrupting a Loading Dose
Legend
Unauthorized Range Hard Limits
Programmable Range
Soft Limits
(warning and confirmation)
50
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
During infusion, the upper or lower soft limit message will alternate with
the drug name and concentration at the top of the screen.
51
7.6 Starting an Infusion
Warning
When connecting the administration set to the patient's IV access
device, always use aseptic technique according to your healthcare
facility policy.
52
7.7 Monitoring an Infusion
7.7.1 Monitoring an Infusion when Programmed by
Flow Rate
7 6 5
2 3
Legend
Custom Profile Sign
1
When infusing a drug selected from the Agilia Vigilant Drug’Lib software library,
this lighthouse sign is displayed on the screen continuously.
VI (Volume Infused).
21
Will increase during the infusion. To clear VI, see section 8.7, page 86.
Infusion Flow Rate (mL/h)
3
To change the flow rate during an infusion, see section 7.8.2, page 55.
The flow rate is displayed with the largest font size.
Infusion in Progress
4
The infusion in progress indicator displays falling drops.
Infusion Duration
5
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.
VTBI (Volume To Be Infused) remaining.
6
Will decrease during the infusion.
To change VTBI during an infusion, see section 8.4, page 82.
53
7.7.2 Monitoring an Infusion when Programmed by Dose
9 8 7 6
1
2 3 4
Legend
Custom Profile Sign
1
When infusing a drug selected from the Agilia Vigilant Drug’Lib software library,
this lighthouse sign is displayed on the screen continuously.
VI (Volume Infused).
21
Will increase during the infusion. To clear VI, see section 8.7, page 86.
Dose
3
To change the dose during an infusion, see section 7.8.2, page 55.
Dose is displayed with the largest font size.
Infusion in Progress
5
The infusion in progress indicator displays falling drops.
Infusion Duration
6
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.
7 Drug Concentration
54
7.8 Functions During Infusion
7.8.1 Stop
55
7.8.3 Secondary (Piggyback) Infusions
Note: This feature can be activated or deactivated in Agilia
Vigilant Drug’Lib software (custom profiles) or in the pump options
(Basic profile).
Information
You can only add a secondary infusion when the primary infusion
is programmed by flow rate.
The secondary infusion drug must be programmed by flow rate.
You can configure the end of secondary infusion settings in the
pump options.
A end of secondary alert may be activated or deactivated in the
pump options.
56
7.8.3.1 Connecting the Secondary Line
1. Prime the secondary administration set.
2. Lower the primary container and hang the secondary approximately
30 cm higher than the primary container.
1 2
21 Secondary Line
Information
Specific administration sets are available for secondary infusions.
For more information, refer to the instructions on the
administration set packaging.
It is recommended to use a primary administration set with a back
check valve above the upper access port.
57
7.8.3.2 Accessing Secondary Infusion
Press .
58
2. Press the arrow keys to program the secondary VTBI, and
press OK.
3. Press the arrow keys to program the infusion duration, and
press OK.
4. Press the arrow keys to program the secondary flow rate and
press OK.
5. Press OK to proceed.
Information
The current volume infused displayed becomes the secondary
volume infused while infusing the secondary.
Pri VI indicates the total primary volume infused since it was last
cleared.
Sec VI indicates the volume infused since the start of the current
secondary infusion.
59
7.8.3.5 End of Secondary Infusion
Information
The near end of infusion alert is not activated in secondary infusion.
60
5. Press start to resume primary infusion.
61
7.8.4 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
Access Key or
Occlusion Set to its maximum value: 750 mmHg / 100 kPa / 14.5 PSI
Pressure Level
Information
The bolus volume is added to the Volume Infused (VI).
In Basic Profile, programmed bolus is only available for primary
infusion, not secondary infusion.
The key is not active when the menu screen is displayed.
The key is not active when the following infusion modes are
selected:
- Ramp-up / ramp-down
- Sequential
62
3. To administer a direct bolus, press and hold .
4. Monitor the volume infused on the main display until the desired
bolus is reached.
During the infusion, you can program a bolus in one of the following two
ways:
Press , then prog.
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.
63
3. Press start to start the bolus.
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.
64
7.9 Completing an Infusion
7.9.1 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 first of the three criteria
below is reached.
Default Pump
Setting Range of Values
Setting
65
7.9.2 End of Infusion
When the VTBI reaches zero, 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 yellow.
KVO (Keep Vein Open) rate is maintained.
Information
If KVO is disabled, the infusion indicator lights flash red, and
pump stops infusing.
If the programmed infusion rate is lower than the configured KVO
rate, the pump stays at the programmed rate.
66
7.9.3 Powering off
67
7.10 Infusion Modes
You can program an infusion with the different infusion modes available,
depending on the pump configuration, and on the selected drug.
To select an infusion mode, see section 8.14, page 93.
For more information on calculation rules, see section 15.11, page 135.
68
7.10.5 Ramp-up / Ramp-down
In ramp mode, you can divide an infusion into three different phases:
Ramp-up: the flow rate increases by 10 intermediate steps up to
a programmed value
Plateau: the flow rate remains constant
Ramp-down: the flow rate gradually falls to zero by
10 intermediate steps
4. Press the arrow keys to program the VTBI, and press OK.
5. Press the arrow keys to program the total infusion duration
(__ h __), and press OK.
6. Press the arrow keys to program the ramp-up duration (__ h __),
and press OK.
7. Press the arrow keys to program the ramp-down duration (__ h __),
and press OK.
8. Press the arrow keys to program the plateau flow rate, and
press OK.
69
9. Press OK to confirm, or C to cancel the settings.
Information
During the infusion, a part of the ramp symbol blinks. This part
corresponds to the current infusion phase ( : Ramp-up, : Plateau,
: Ramp-down).
70
7.10.6 Sequential Infusion
You can program up to 20 infusion sequences with the sequential
infusion mode, each with their own VTBI and flow rate.
You can also program the following sequences:
Stop: programming of a pause between two sequences
KVO: programming of a KVO sequence
Repeat: Up to 20 repetitions of the already programmed
sequences (limited by the total VTBI)
End: end of the programming sequences
To program a sequential infusion, proceed as follows:
1. In the "flow rate (mL/h)" menu, select the sequential infusion mode,
see section 8.14, page 93.
2. Press OK to confirm the new infusion mode.
3. Press OK to confirm the drug.
Sequence Programming
Press the arrow keys to program the VTBI, and press OK.
The infusion duration is automatically calculated.
Press the arrow keys to program the flow rate, and press OK.
VTBI
The infusion duration is automatically readjusted.
Press the arrow keys to activate or mute the end of sequence beep, and
press OK.
Press the arrow keys to select Stop, and press OK.
Press the arrow keys to select the pause duration, and press OK.
Stop Press the arrow keys to activate or mute the end of sequence beep, and
press OK.
Other sequences can be programmed after a "Stop" sequence.
71
Sequence Programming
Press the arrow keys to select KVO, and press OK.
Press the arrow keys to select the KVO duration, and press OK.
KVO Press the arrow keys to activate or mute the end of sequence beep, and
press OK.
Other sequences can be programmed after a "KVO" sequence.
Press the arrow keys to select Repeat, and press OK.
Repeat Press the arrow keys to select the number of repetitions, and press OK.
No other sequence can be programmed after a "Repeat" sequence.
Press the arrow keys to select End.
End Press OK.
No other sequence can be programmed after a "End" sequence.
Information
To modify a sequential infusion, see section 8.16, page 94.
You can only modify a sequence that has not started yet.
7.10.7 Drops/min
You can program an infusion with the drops/min infusion mode as
follows:
1. Select the drops/min infusion mode, see section 8.14, page 93.
2. Press OK to confirm the new infusion mode.
3. Press OK to confirm the drug.
72
4. Check the equivalent quantity of drops per mL and press OK.
Note: The conversion in drops/min can differ according to the choice
of the drug.
5. Press the arrow keys to program the VTBI and press OK.
6. Press the arrow keys to program the flow rate or the number of
drops per minute and press OK.
The setting to program depends on the pump configuration.
73
1. Press to power on the pump.
2. Press .
3. Make sure the administration set is not connected to the patient, as
indicated on screen.
4. Press OK to proceed.
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 750 mmHg / 100 kPa / 14.5 PSI, and the air-in-line alarm is
disabled.
Priming is limited to 3 mL maximum. Above 3 mL, you must
release and press the key again to restart priming.
The pump does not detect air bubbles or occlusions when
priming.
When an air bubble is detected by the air detector (behind the pump
door), an alarm is triggered.
You can use the advance air bubble function to advance the air bubble
beyond the air detector, avoiding the need to remove the administration
set.
74
1. Press to silence the audible signal for 2 minutes.
2. Press .
3. Press OK to advance the air bubble.
4. Press and hold to advance the air past the air detector.
5. Restart the infusion, or press C to cancel the advance air bubble
function.
Information
Air that has advanced past the air detector is still in the
administration set.
Ask for medical advice on whether or not the infusion can be
restarted due to air in the set. If you decide to remove the air
bubble, follow facility procedures for priming or changing the
administration set.
The air bubble advances at the programmed rate. The maximum
volume advanced equals the configured air bubble detection
setting.
75
7.11.3 Pre-programming the Pump
You can program the pump before installing the administration set.
1. Press to power on the pump.
Install set !!! is displayed on top of the pump screen.
2. Make sure the pump door is closed.
The prog symbol is displayed.
3. Press prog.
4. Program the infusion.
See section 7.5, page 41.
76
8 Menus
8.1 Overview
8.1.1 Commands
Operation Key
Select
Select / Deselect
Patient NO
Changing a patient’s weight or body surface area,
page 89.
Day/Night mode NO
Switching between day mode and night mode,
page 90.
Flow Rate
(mL/h) mL/h YES
Changing the infusion mode, page 93.
Dose Dose YES
77
Stop
Menu Symbol Infusion Associated Procedure
Required
View flow rate history NO Viewing flow rate history, page 98.
Note: The displayed menu may change depending on the pump configuration.
For more information on factory configuration, refer to Appendix: Factory Configuration, page 171.
78
8.2 Profile
Symbol Pro
Procedure Displaying active profile information
79
8.3 Pressure
Symbol
The pump pressure limit is pre-defined in the pump options in one of the
following modes:
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 15.9, page 132.
Press .
Through the Menu:
- Press .
- Press the arrow keys to select .
2. Press enter to access the pressure limit screen.
80
3. Press the arrow keys to increase or decrease the pressure limit.
4. Press OK to validate.
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.
81
8.4 Volume To Be Infused (VTBI)
Symbol VTBI
Procedure Changing VTBI
82
8.5 Keypad Lock Status
Symbol
Information
If a key is pressed, the screen will display a keypad lock symbol.
The and keys remain functional when the keypad is
locked.
83
Unlocking the Keypad
84
8.6 Battery Life
Symbol
85
8.7 Volume Infused / Dose Infused
Symbol mL?
Procedure Viewing and clearing the volume or dose infused
You can view and clear the volume or dose infused as follows:
1. Press .
Information
When the pump is powered off or a new drug is selected, the volume or
dose infused is cleared.
86
8.8 Pause
Symbol
2. Press .
8. To restart the infusion before the end of the pause period, press ,
and 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.
87
8.9 Drug
Symbol
2. Press .
88
Information
Changing a drug resets the infusion settings.
If the previous infusion was programmed by flow rate, the new
drug’s confirmation screen will display VI (Volume Infused).
If the previous infusion was programmed by dose, the new drug’s
confirmation screen will display DI (Dose Infused).
8.10 Patient
Symbol
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.
You can change the patient’s weight or body surface area as follows:
1. Press .
89
8.11 Day/Night Mode
Symbol
90
Switching from Night Mode to Day Mode
91
8.12 Primary / Secondary
Symbol P/S
Procedure Programming a secondary infusion
92
8.14 Flow Rate (mL/h) / Dose
mL/h
Symbols
Dose
Procedure Changing the infusion mode
93
8.15 Ramp-up / Ramp-down
Symbol
94
8.17 Alarm Volume
Symbol
95
8.18 Call-back Alert
Symbol
The call-back alert notifies the user when the set time interval has
elapsed.
4. Press the arrow keys to set the interval in hours and minutes
(__h__) before the alert.
5. Press OK.
Information
The activation time is calculated according to the device time,
which is indicated at the bottom of the screen.
If the device is powered off during the call-back period, a warning
message is displayed when the device is powered on.
96
Deactivating the Call-back Alert
97
8.19 View Flow Rate History
Symbol
This function allows the user to check the current infusion’s history
information in order to verify the dose administered.
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.
98
8.20 View Pressure History
Symbol
This function allows the user to check the current infusion’s history
information in order to verify changes in pressure.
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.
99
8.21 View Event Log
Symbol
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.
100
6. Press exit to return to the previous screen.
101
8.23 Maintenance
Symbol
102
8.24 Library Information
Symbol
103
8.25 Data Set
Symbol DS
Procedure Displaying active data set information
104
9 Options
9.1 Commands
Operation Key
Options access +
Option selection
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.
Information
If the wrong access code is entered, error is displayed.
105
9.3 Pump Settings
The following options have different functions that you can select or
deselect to customize your Agilia VP MC.
Default
Function Choice
Pump Setting
Battery logo: display or hide battery logo Disabled
Pressure logo: display or hide pressure Disabled
pictogram
[User 1]:
Screen option Priority for Vigilant logo: Select priority of
displaying Agilia Vigilant Drug’Lib software Enabled
logo compared to pressure logo
Selection assistance Enabled
Maintenance: display or hide maintenance Disabled
[User 2]: menu
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
106
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 and a number of identified pumps for the
Data set upload (via Agilia Vigilant Drug’Lib 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.
107
10.2.2 Using the Communication Port
1. Remove the protective cap from the
pump’s RS232 communication port.
Information
Do not disconnect communication cables while data is being transferred.
To activate or deactivate the Wi-Fi module, see section 9.3, page 106.
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.
108
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.
Information
It is the hospital's responsibility to define a data set and upload it to the
Centerium Server for distribution to the device.
109
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.
110
12 Alarms and Safety Features
12.1 Introduction
Agilia VP 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.
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).
The infusion continues.
Information Signals Awareness An information message is displayed on the pump
screen.
111
12.3 General Remarks
Alarms are not configurable.
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.
112
Stops
Message Priority Problem / Resolution
Infusion ?
An air bubble has been detected (at start-up,
during the infusion, or while the infusion is
Air bubble !!! High (!!!) Yes stopped).
Remove the air from the administration set.
An air bubble has been detected during the
Air alarm !!! High (!!!) Yes infusion).
Remove the air from the administration set.
113
Stops
Message Priority Problem / Resolution
Infusion ?
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.
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.
End of infusion ! End of infusion - with KVO
The VTBI is completed and the KVO is
activated according to its configuration in
Stop for new Low (!) No Agilia Vigilant Drug’Lib software or in the
infusion ! pump options.
Press to select new infusion settings
(if required).
Re-open primary
line ! End of secondary infusion.
Low (!) No
Close secondary Press to acknowledge.
line !
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
Upstream
Check the roller clamp. Check the
occlusion !!!
High (!!!) Yes container and line. Check the container
height. Check air vent (if a bottle is used).
Check for kinked line.
114
Stops
Message Priority Problem / Resolution
Infusion ?
In-line pressure has reached 50 mmHg / 5 kPa
Occlusion
/ 1 PSI below the programmed threshold.
Medium (!!) No
pre alarm !! Check the infusion line.
Set the correct pressure threshold.
The pressure is increasing in the infusion line.
Pressure increase ! Low (!) No This warning can be selected as an option.
Check for occlusions in the infusion line.
The pressure is decreasing in the infusion line.
This warning can be selected as an option.
Drop in pressure ! Low (!) No Check the downstream Luer lock
connection and the integrity of the entire
line.
115
Stops
Message Priority Problem / Resolution
Infusion ?
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.
4. Reset the device by pressing the key for 10-15 seconds, and
release it when the device powers off.
116
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.
117
13 Volumat Lines
Warning
Only use recommended Agilia Volumat Lines. Use of any other
administration sets may affect the accuracy of the infusion, and
result in injury to the patient and damage to the pump.
Do not use an administration set if its packaging appears to be
damaged or opened.
118
Information
The fluid in the administration set, the administration set and the
bag or bottle must be within normal operating temperature
conditions: 18 °C to 30 °C.
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 administration sets may have components such as a
burette or filter that require special instructions.
For administration sets with two spikes, only open one line at a
time.
When administering a manual bolus using Luer lock syringe via
the needle-free downstream port, it is recommended to stop the
infusion and close the Roberts clamp (pinch clamp).
Certain drugs may require specific administration sets for infusion
or transfusion.
When using an administration with a filter, verify that the fluid to
be infused is compatible with the size of the filter.
Follow your healthcare facility’s protocol for installing and
replacing the fluid container.
119
13.2 Priming the Administration Set Before Use
The administration set is primed with fluid to displace air from the set.
It is recommended to prime the administration set immediately before
starting the infusion.
Certain administration sets may require specific priming procedures.
Refer to the specific IFU provided with the administration sets.
Warning
During priming, make sure that the administation set is not connected to
the patient.
1. Remove the cap from the spike and insert the spike into the bag.
2. After hanging the bag, close the roller clamp.
3. Fill the drip chamber approximately 1/2 full.
4. Slowly open the roller clamp for priming.
Invert the needle-free port while priming, and gently tap the valve to
remove all air.
5. When the administration set is fully primed, close the roller clamp
and check carefully for the absence of air bubbles.
For gravity infusions, the flow rate is regulated by the roller clamp.
120
13.2.2 With a Bottle
The following diagram shows how to prime the administration set with a
bottle:
5
1 3
2
4
1. Open the roller clamp, close the air vent, and push the spike down
into the bottle.
2. Close the roller clamp.
3. Hang the bottle upside down, then squeeze and release the drip
chamber in order to fill it approximately 1/2 full.
4. Slowly open the roller clamp for priming.
5. Open the air vent, and allow the liquid to flow into the
administration set.
Invert the needle-free port while priming, and gently tap the valve to
remove all air.
6. When the administration set is fully primed, close the roller clamp
and check carefully for the absence of air bubbles.
For gravity infusions, the flow rate is regulated by the roller clamp.
121
13.3 Other Uses of Administration Sets
13.3.1 Access Ports
The administration set may be equipped with access ports, that can be
used to connect a gravity line, a secondary line, or administer a manual
bolus (needle-free port).
Information
Use aseptic technique when accessing the ports.
Stop the infusion before accessing the ports.
Do not use the upstream access ports to deliver a manual bolus
into the line. They should only be used to connect a secondary
infusion line.
Do not use the downstream ports to connect a secondary line.
For multi-line infusions, connect administration sets as close as
possible to the patient.
122
13.3.2 Use of Administration Sets for Gravity Infusion
123
13.3.2.2 Gravity Infusion in Parallel with a Pump
124
13.4 Removal and Replacement of
Administration Sets
13.4.1 Removing an Administration Set
1. Press to stop the infusion.
2. Close the roller clamp.
3. Open the pump door.
Information
Properly dispose of used administration sets as per the healthcare
facility’s guidelines.
125
14 Device 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.
126
14.3 Preparing the Device for Storage
Prepare the device for storage as follows:
1. Power the pump OFF and remove the administration set.
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.
127
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).
Feature Refer to
Section 15.10.1, page 133.
Flow Rate Accuracy
Section 18.10, page 147.
Time to Detect Occlusion Section 15.10.3, page 133.
128
15.2 Flow Rate
Default Minimum
Format Range of Settings
Value Increment
0.01 (0.10 9.99)
Primary Infusion mL/h 0.1 1500* N/A 0.1 (10.0 99.9)
1 (100 1500)
KVO mL/h 0 20 1 1
* The maximum value can be adjusted between 50 and 1500 in the pump options (Basic Profile).
** The maximum value can be adjusted between 50 and 1000 in the pump options (Basic Profile).
For more information, refer to the technical manual.
129
15.4 Dose To Be Infused (DTBI)
Default Minimum
Format Range of Settings
Value Increment
0.001 (0.010 4.999)
0.01 (5.00 9.99)
Dose Unit 0.010 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 (10.0 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)
00h00min01
__ h __
Programmed Bolus 00h02min00 00h00min01
min __
24h00min00
00h00min01
__ h __
Loading Dose 00h02min00 00h00min01
min __
24h00min00
KVO Silence Alarm
__ h __ 00h01 12h00 01h00 00h01
Duration
Ramp (Total
__ h __ 00h01 48h00** 12h00 00h01
Duration)
Ramp (Ramp-up /
__ h __ 00h00 06h00 00h01 00h01
Ramp-down)
* If the calculated infusion time exceeds this value, ↑ 168h00 will be displayed on the pump.
** If the calculated infusion time exceeds this value, ↑ 48h00 will be displayed on the pump.
15.6 Concentration
Default Minimum
Format Range of Settings
Value Increment
0.01 (0.01 9.99)
Concentration Unit 0.01 70000 0.01 0.1 (10.0 99.9)
1 (100 70000)
130
15.7 Patient Data
Default Minimum
Format Range of Settings
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
131
15.9 Pressure Management
Information
You can change the Basic Profile’s infusion pressure settings in
the pump options. See section 9, page 105.
You can pre-configure custom profiles’ infusion pressure settings
with Agilia Vigilant Drug’Lib software.
Default Minimum
Format Range of Settings
Value Increment
Low mmHg 50 300 100 50
3 Levels
25 (50 250)
Full Range mmHg 50 750 500
Variable
50 (250 750)
Maximum
mmHg 300 750 750 50
Limit
Raise
mmHg 50 400 300 50
Threshold
DPS
Drop
mmHg 100 400 200 50
Threshold
Note: 1 bar = 750 mmHg = 100 kPa = 14.5 PSI.
132
15.10 Accuracy
Warning
Accuracy (flow rate, time, volume infused, pressure) can be influenced
by administration set model, administration 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.
133
15.10.4 Volume Accuracy
Accuracy
< 10 mL: ± 0.5 mL
Direct Bolus*
> 10 mL: ± 5 %
< 8 mL: ± 0.4 mL
Programmed Bolus*
> 8 mL: ± 5 %
Limit to Detect Upstream
≤ 1.0 mL
Occlusion*
134
15.11 Calculation Rules
Infusion Stopped During Infusion
Modify V,
T is calculated according to T = V/R Modify R,
V/T
Modify T, T is calculated according to T = V/R
R is calculated according to R = V/T
Modify V,
T is calculated according to T = V/R Modify R,
V/R
Modify R, T is calculated according to T = V/R
T is calculated according to T = V/R
Modify T,
V is calculated according to V = R x T Modify R,
T/R
Modify R, T is calculated according to T = V/R
V is calculated according to V = R x T
Modify V,
T is calculated according to T = V/R
Modify T, Modify R,
V/T/R
R is calculated according to R = V/T T is calculated according to T = V/R
Modify R,
T is calculated according to T = V/R
V = Volume To Be Infused, T = Infusion Time, R = Rate
135
15.12 Units and Conversion Rules
15.12.1 Concentration Units
Units Suffix
mmol
Concentration
mUnit, Unit /mL, /--mL
Units
cal, kcal
mEq
136
15.12.3 Conversion Rules
1 micro unit = 1000 nano unit
1 unit/h = 24 unit/24 h
1 unit/min = 60 unit/h
137
16 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.
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.
138
16.2 Recommended and Prohibited Agents
We recommend the following cleaning and disinfecting agents:
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.
139
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,
pump door, door lever, 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. Open the pump door, and gently wipe down the exposed surfaces
(tube guides, blue clamp).
7. Using a fresh ready-to-use wipe, thoroughly wipe down all exposed
surfaces, including the tube guides and the back of the door lever.
8. Make sure the pump remains damp for at least 1 minute to dissolve
all organic matter.
9. 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.
10.Wipe down the power cord and any pump accessories.
11.Allow the pump to dry completely at room temperature.
Warning
To avoid short circuits, make sure that the air sensor is completely dry
after cleaning.
140
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. Open the pump door, and gently wipe down the exposed surfaces
(tube guides, blue clamp).
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.
141
17 Power Management
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.
142
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.
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.
143
18 Technical Characteristics
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.
= Wi-Fi enabled
= Wi-Fi disabled or not used
144
18.4 Communication Port
The connector located at the back of the device allows data
communication with a PC.
145
18.7 Sound Levels
18.7.1 Operating Pump Sound Levels (without alarms)
Flow Rate (mL/h) Sound Level (dBA)
0 21
1 30
100 37
400 33
1500 46
Note: These values are provided for information purposes only.
High-priority 55 63
Medium-priority 50 57
Low-priority 49 53
18.8 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*
146
18.9 Dimensions and Weight
H/W/D 135 x 190 x 170 mm
Weight Approximately 2 kg
Screen Size 70 x 35 mm
147
18.10.1 Flow Rate: 1 mL/h
Legend
4
Instantaneous
flow rate
Set flow rate
3
Sampling time: 10 s
Flow rate (mL/h)
0
0 10 20 30 40 50 60 70 80 90 100 110 120
-1
Time (minutes)
4,3 0,6
1,7
0 Sampling time: 10 s
-3,7 -4,2
-7,7
-20 -11,7
-40
-43,2
-60
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
(1 mL/h over first 2 hours on 96 hours)
Legend
60
Measured
variance from
flow rate
40 31,7
Error
Flow rate
20 15,2 9,0 3,6
Flow rate (mL/h)
5,2
0 Sampling time: 10 s
-2,0 -1,2
-4,7
-20 -10,2
-40
-47,4
-60
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Time (minutes)
Figure 18.3: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
(1 mL/h over last 2 hours on 96 hours)
148
18.10.2 Flow Rate: 25 mL/h
Legend
50
Instantaneous
45
flow rate
Set flow rate
40
35
Sampling time: 10 s
Flow rate (mL/h)
30
25
20
15
10
0
0 10 20 30 40 50 60 70 80 90 100 110 120
Time (minutes)
0 Sampling time: 10 s
-2,5
-4,3
-3,5 -4,1 -4,2
-5
-4,7 -4,7 -4,5
-5,3
-6,3
-10
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Time (minutes)
Figure 18.5: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
(25 mL/h over first 2 hours on 96 hours)
Legend
10
Measured
variance from
flow rate
Error
5
Flow rate
Flow rate (mL/h)
1,1
-0,8
0,0 -0,5 -0,7
0 Sampling time: 10 s
-10
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Time (minutes)
Figure 18.6: Trumpet curves for 2, 5, 11, 19, 31 minutes observation windows
(25 mL/h over last 2 hours on 96 hours)
149
19 Wi-Fi
Information
For more information on differentiation between Wi-Fi and non Wi-Fi
pumps, see section 10.3, page 108.
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
150
19.2 Specifications
19.2.1 Technical Specifications
Description
151
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.
152
20 Troubleshooting
153
21 Recycling
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.
154
22 Warranty
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.
155
23 Guidance and Manufacturer's
Declaration on EMC
156
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 VP MC.
For maintenance operation performed on Agilia VP MC, place the
device on a conductive working surface, and wear a special ESD
conductive wristband.
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 VP MC system.
157
If Agilia VP MC causes harmful interference, or if it is disrupted by
external interference, try the following:
Reorient or relocate Agilia VP MC, the patient or disruptive
equipment.
Change the routing of cables.
Separate power cords from the communication cables / signals.
Connect the Agilia VP 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 VP MC
circuit and the circuit of the remote equipment.
Increase the separation between Agilia VP MC and the patient or
disruptive equipment.
Plug Agilia VP 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.
158
23.2.3 Table 1 - Guidance and Manufacturer's Declaration -
Electromagnetic Emissions
Warning
Agilia VP MC and its accessories are intended to be used in the
electromagnetic environments specified below.
The customer or the user of Agilia VP MC should assure that it is
used in such environments.
Compliance
Emission Test Obtained by Electromagnetic Environment - Guidance
the Device
Agilia VP 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 VP 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 N/A
IEC 61000-3-3
Conducted
emissions 150 kHz - Class 5
108 Mhz CISPR25 Agilia VP MC is suitable for use in automotive
Radiated emissions environments.
150 kHz - 2.5 Ghz Class 3
CISPR25
159
23.2.4 Table 2 - Guidance and Manufacturer's Declaration -
Electromagnetic Immunity
Warning
Agilia VP MC and its accessories are intended to be used in the
electromagnetic environments specified below.
The customer or the user of Agilia VP MC should assure that it is
used in such environments.
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
160
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
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 VP MC is used exceeds the
applicable magnetic field compliance level
above, observe Agilia VP MC to verify that
it is operating normally. If you notice
abnormal performance, additional
measures may be necessary, such as
reorienting or relocating Agilia VP MC, or
installing magnetic shielding.
Note: "Ut" is the AC Power voltage prior to applying the test level.
161
23.2.5 Table 4 - Guidance and Manufacturer's Declaration -
Electromagnetic Immunity
Warning
Agilia VP MC and its accessories are intended to be used in the
electromagnetic environments specified below.
The customer or the user of Agilia VP MC should assure that it is
used in such environments.
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
Portable and mobile RF communication
equipment should be used no closer to
any part of Agilia VP 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
162
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 VP MC is used exceeds the applicable RF compliance
level above, Agilia VP MC should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating Agilia VP 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.
163
23.2.6 Table 6 - Recommended Separation Distances
Between Portable and Mobile RF Communication
Equipment and Agilia VP MC
Information
Agilia VP MC and its accessories are intended for use in
electromagnetic environments in which radiated RF disturbances
are controlled.
Users of Agilia VP MC may prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile
RF communication equipment (transmitters) and Agilia VP 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).
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.
164
24 Servicing
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.
165
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.
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.
166
25 Glossary of Terms
Term Description
A Amperes
AC Alternating Current
Ah Ampere-hours
AM Amplitude Modulation
cal Calorie
dBA Decibels
dBm Decibels-Milliwatts
DC Direct Current
DI Dose Infused
DUR Duration
ECG Electrocardiogram
167
Term Description
EEG Electroencephalogram
FM Frequency Modulation
ft Feet
HF High Frequency
hPa Hectopascals
Hz Hertz
IC Industry Canada
in Inches
IT Information Technology
IV Intravenous
kg Kilograms
lb(s) Pound(s)
mA Milliamperes
mEq Milliequivalents
168
Term Description
mmol Millimole
OR Operating Room
PC Personal Computer
RF Radio Frequency
SN Serial Number
V Volts
169
Term Description
VA Volt-Amperes
VI Volume Infused
W Watts
170
Appendix: Factory Configuration
Pause Drops/min
Drug Direct Bolus
Programmed
Patient Bolus
Day/Night
mode
Loading Dose
Primary / Secondary
Secondary
Infusion
Infusion
Programmed Features
bolus
KVO
Menus
Infusion mode Prime Set
Ramp-up / Advance Air
Ramp-down
Bubble
Dynamic
Sequential Pressure
System (DPS)
Alarm volume
Call-back
View flow rate
history
View pressure
history
Data Set
171
Index
A Change 88
Concentration Selection 43
Administration Set
Select 41
Change 125
Install 36 Drug Library 23
Display Information 103
Other Uses 122
Drug X (mL/h) 24
Prepare 118
Prime 73, 120
Remove 125
E
Replacement Interval 125 Electromagnetic Guidance 156
Agilia Connect Infusion System 14 Essential Features 128
Agilia USB Cable 108 Event Log 100
Air Bubble
Advance 74 F
Specifications 131 Factory Configuration 171
Alarm First Use 34
Adjust Volume 95 Flow Rate 24, 42, 53
List 112
Priority 111 G
Sound Level 146 Glossary 167
Arrow Keys 18 Graphics
Flow Rate History 98
B Pressure History 99
Battery Gravity Infusion 123
Characteristics 144
Charge Level 35, 85 H
Full Charge Time 34 Hard Limit 24
Operating Mode 143
Bolus 62 I
Direct 62 Infusion
Programmed 63, 92 Change Infusion Rate 55
End 66
C Monitor 53
Cables 107 Pause 87
Call-back Alert 96 Program 41
Cleaning 138 Start 52
Contraindications 12 Stop 55
Infusion Modes 25, 93
D Installation 27
Data Communication 107
Data Set 26 K
Display Information 104 Keypad
Upload 109 Description 17
Date / Time 101, 106 Lock / Unlock 83
Day Mode 90 KVO 66, 71
Dimensions and Weight 147
Disinfecting 138 L
Dose 24, 43, 54 Language Selection 106
Drops/min 25, 72 Link Agilia 31
Drug 24 Loading Dose
172
Pause 50 Program 69
Program 49 Recycling 154
Select 48 Release Notes 174
Stop 50 Rotating Pole Clamp 28
M S
Maintenance 165 SafeClip 36, 123
Display Information 102 Screen
Reminder Message 35 Contrast 106
Requirements 165 Display and Symbols 19, 21
Menu Logo Display 106
Customization 106 Secondary Infusion 56, 92
List 77 Automatic Return 61
Manual Return 60
N Selection Keys 18
Navigation Buttons 20 Sequential Infusion 25
Near End of Infusion Alert 65 Modify 94
Night Mode 90 Program 71
Servicing 165
O Soft Limit 24
OCS 35, 36 Override 50
Options 105 Software Version 174
Sound Levels 146
P Storage 126
Packaging 21 Symbol Descriptions 2
Patient Characteristics 11, 131
Change 89 T
Select 45 T/R 25, 68
Power Cord 144 Table of Contents 3
Power Supply 144 Temperature
Powering Off 67 Operating Range 13
Powering On 34 Training 11
Pre-programming 76 Troubleshooting 153
Pressure Trumpet Curves 147
DPS 81
Management 132 U
Modify Limit 80 Units 136
Operating Range 13 User Test 110
Priming
Manual Prime 120 V
Prime With Pump 73 V/R 25, 68
Profile 22 V/T 25, 68
Basic Profile 22 V/T/R 25, 41, 68
Custom Profile 23 Volume Infused 86
Display Information 79 VTBI 82, 129
Select 39
W
R Warranty 155
Ramp-up / Ramp-down 25 Wi-Fi 106, 108, 150
Modify 94
173
Release Notes
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 2016
www.fresenius-kabi.com 0123
174
Local Contacts for Servicing