11396-4 TM Agilia VP Range Eng
11396-4 TM Agilia VP Range Eng
11396-4 TM Agilia VP Range Eng
Agilia VP MC
Agilia VP MC WiFi
Volumetric Infusion Pumps
Technical Manual
Symbol Descriptions
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.
__________________________________________________________________________________________________________________
Labeling symbols
Warning
Name and address of the manufacturing facility
(Refer to the Instructions for Use)
2 11396-4_TM_Agilia_VP_range_ASU_Eng
Table of Contents
1 INTRODUCTION 6
2 DESCRIPTION 8
3 FUNDAMENTALS 27
4 PROFILE MENU 29
6 MAINTENANCE OPERATIONS 35
3
6.2.11 Test 10: Keypad ....................................................................................................................................... 45
6.2.12 Test 11: Ageing Test ................................................................................................................................ 46
6.2.13 Test 12: Battery Life ................................................................................................................................. 48
6.2.14 Test 13: Battery Test ................................................................................................................................ 48
6.2.15 Test 14: Air Detector ................................................................................................................................ 50
6.2.16 Test 15: Anti-Free Flow Clamp Motor ...................................................................................................... 51
6.2.17 Test 16: Flow Rate ................................................................................................................................... 53
6.2.18 Test 17: Flow Rate Correction.................................................................................................................. 54
6.2.19 Test 19: Clamp ......................................................................................................................................... 55
6.2.20 Test 20: Pump Code ................................................................................................................................ 56
6.2.21 Test 21: Power Info .................................................................................................................................. 57
6.2.22 Test 22: LCD Voltage ............................................................................................................................... 58
6.2.23 Test 23: Temperature............................................................................................................................... 59
6.2.24 Test 24: Watchdog ................................................................................................................................... 60
6.2.25 Test 25: Wi-Fi Module Information ........................................................................................................... 61
6.2.26 Checking the Pressure Limit Alarm .......................................................................................................... 62
6.2.27 Checking the AC power supply / Battery Operation ................................................................................. 64
6.2.28 Electrical Test........................................................................................................................................... 64
6.2.29 Testing the Flow Rate .............................................................................................................................. 65
6.3 QUALITY CONTROL PROCEDURE............................................................................................................ 67
6.3.1 Running a Quality Control ........................................................................................................................ 67
6.3.2 Quality Control Certificate ........................................................................................................................ 71
8 INTERVENTION PROCEDURES 84
8.1 PROCEDURE #1: BATTERY AND BATTERY DOOR - BOOST CAPACITOR DISCHARGE.................................. 85
8.2 PROCEDURE #2: UPPER CASE .............................................................................................................. 87
8.3 PROCEDURE #3: DISPLAY BOARD/LCD DISPLAY .................................................................................... 89
8.4 PROCEDURE #4: CPU BOARD ............................................................................................................... 91
8.5 PROCEDURE #5: POWER SUPPLY BOARD AND AC POWER BOARD ......................................................... 94
8.6 PROCEDURE #6: WI-FI BOARD .............................................................................................................. 96
8.7 PROCEDURE #7: BASE KIT .................................................................................................................... 99
8.8 PROCEDURE #8: AIR DETECTOR BOARD .............................................................................................. 104
8.9 PROCEDURE #9: PUMPING SYSTEM ..................................................................................................... 107
8.10 PROCEDURE #10: PUMPING SYSTEM MOTOR ...................................................................................... 112
8.11 PROCEDURE #11: PRESSURE SENSORS .............................................................................................. 117
8.12 PROCEDURE #12: ANTI-FREE FLOW CLAMP MOTOR ............................................................................ 122
8.13 PROCEDURE #13: DOOR ..................................................................................................................... 125
8.14 PROCEDURE #14: MEMBRANE ............................................................................................................. 126
8.15 PROCEDURE #15: OCS FLEXIBLE IC................................................................................................... 128
4
12 TECHNICAL CHARACTERISTICS 136
13 SPECIFICATIONS 140
14 RECYCLING 141
15 WARRANTY 142
INDEX 149
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.
6
1.4 Intended Users
In healthcare facilities, the Agilia VP range must only be used by qualified and trained healthcare
professionals, including but not limited to: nurses (primary users), physicians, nurse practitioners and
physician assistants.
In homecare environments, the pump must only be used by appropriately trained users including
homecare professionals, patients or their relatives (in case of inability to correctly react to pump alarms).
In homecare environments, the IFU must be provided to the homecare nurse.
Service and maintenance must only be performed by biomedical engineers or technicians, or by IT
specialists.
Technical maintenance tasks (including inspections and checks) are performed by trained biomedical
engineers, or by dedicated medical rental and/or service organizations who have been trained and
approved by the manufacturer.
For training, contact your Fresenius Kabi sales representative.
1.5 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.
7
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
8
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
Legend
1 Screen 93
7 Decrement
21 Battery Charge Status Indicator 10
73 Fast Decrement
3 Power Supply Indicator 11
3 Confirm Value / Move to Next Field / Start Infusion
4 On / Off 12
3 Stop / Pause
5 Bolus / Prime / Advance Air 13
3 Menu / Cancel Value / Move Back to Previous Field
63 Fast Increment 14
3 Alarm Silence
73 Increment
83 Infusion Indicator Lights
9
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
Legend
1 Screen 10 Decrement
3 Power Supply Indicator 12 Confirm Value / Move to Next Field / Start Infusion
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
10
2.1.3 Display Board
The display board is located under the front of the command panel, and contains all essential parts for
human-machine interaction:
Keypad
Synoptics and control indicators
LCD screen
Door sensor
This board is connected to other parts with the connectors shown below.
J2
J1
J3
Figure 2.4: Display Board
Legend
J1 J1 Connector to Keypad
11
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
12
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
13
2.1.4 CPU Board
The CPU board consists of a main microcontroller, FLASH and RAM memories, and various analog or
power functions, such as:
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 2.5: 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
14
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
15
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
16
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
17
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
18
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 8. 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
19
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
20
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
21
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 8. 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
22
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 8. 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
23
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
24
2.1.9 Back View
5
1
4
2
3
Figure 2.14: 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
25
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 2.14,
page 25.
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
26
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.
Homecare providers are responsible for periodic maintenance and calibration of pumps used in homecare
environments.
Homecare providers must be informed if the device is dropped or if any malfunctions occur. In this case,
do not use the device and contact your homecare providers.
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.
27
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
28
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.
29
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 29.
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
30
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)
31
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.
32
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 rate 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 default patient weight. weight (kg)"
parameters 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
33
Function Setting Description Range of Settings
Par 30: Required Allows making the drop sensor Enabled / Disabled
Drop sensor mandatory.
Drop sensor on primary Allows making the drop sensor Enabled / Disabled
required on the primary set during a
primary infusion.
Drop sensor on secondary This option allows making drop Enabled / Disabled
sensor required on the secondary
set during secondary infusion.
When drop sensor on secondary
infusion is needed, the user has to
switch the drop sensor from the
primary to the secondary infusion
during the secondary infusion. The
drop sensor returns to the primary
infusion when the secondary is
ended.
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.
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.
Par 39: Automatic Locking modes Automatic lock of the keyboard can Enabled / Disabled
keypad lock management be programmed.
To unlock keypad, a code is
necessary.
Note:
The displayed menu may change depending on the pump configuration and destination country.
µ = mc or micro.
34
6 Maintenance Operations
INFORMATION
This date corresponds to the next preventive maintenance date to be carried out.
See section 3.2.1, page 27.
The date is displayed for consultation only, and cannot be changed here.
35
6.1.4 Data Log Event
1. Access the Maintenance options menu. See section 6.1.1, page 35.
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.
36
6.2 Running Tests
You must systematically run tests after calibrating sensors.
At the end of a full test cycle, you can obtain certificates. See section 6.3.2, page 71.
INFORMATION
Before running Tests/Controls from the pump or with Agilia Partner, it is recommended to work with a pump
configured with the Basic Profile and with Factory (default) settings. Load the Basic Profile from the pump’s
maintenance Profile menu: "Pro3:Restore Basic Profile". See section 4.2, page 29.
List of Tests
Tests Tests
Test 1 Identification. See section 6.2.2, page 38. Test 13 Battery test. See section 6.2.14, page 48.
Test 2 Maintenance options. See section 6.2.3, page 39. Test 14 Air detector. See section 6.2.15, page 50.
Maintenance messages.
Test 3 Test 15 Clamp motor. See section 6.2.16, page 51.
See section 6.2.4, page 39.
Test 4 Events. See section 6.2.5, page 39. Test 16 Flow rate. See section 6.2.17, page 53.
Test 5 Upstream pressure. See section 6.2.6, page 40. Test 17 Flow rate correction. See section 6.2.18, page 54.
Test 6 Downstream pressure. See section 6.2.7, page 41. Test 19 Clamp. See section 6.2.19, page 55.
Test 7 Door. See section 6.2.8, page 42. Test 20 Pump code. See section 6.2.20, page 56.
Test 8 Battery information. See section 6.2.9, page 44. Test 21 Power information. See section 6.2.21, page 57.
Test 9 Indication. See section 6.2.10, page 45. Test 22 LCD voltage. See section 6.2.22, page 58.
Test 10 Keypad. See section 6.2.11, page 45. Test 23 Temperature. See section 6.2.23, page 59.
Test 11 Ageing test. See section 6.2.12, page 46. Test 24 Watchdog. See section 6.2.24, page 60.
Wi-Fi module information
Test 12 Battery life. See section 6.2.13, page 48. Test 25
See section 6.2.25, page 61.
37
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.
38
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.
39
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 2.5, page 14.
- Replace the upstream pressure sensor. See section 8.11, page 117.
40
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 2.5, page 14.
Replace the downstream pressure sensor. See section 8.11, page 117.
41
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
42
1. Access the Tests menu. See section 6.2.1, page 37.
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)
43
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
44
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.
45
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).
46
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.
47
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 48.
Prerequisites
The pump is disconnected from the AC power supply.
48
1. Access the Tests menu. See section 6.2.1, page 37.
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 85.
5. Press exit to return to the Tests menu.
49
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 2.5, page 14.
- Replace the air detector board.
See section 8.8, page 104.
50
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).
51
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.
52
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 65.
2. Access the Tests menu. See section 6.2.1, page 37.
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.
53
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.
54
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
55
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".
56
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.
57
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
58
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)
59
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.
60
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.
61
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
62
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.
Adjusting the pressure limit to 750 mmHg
If the Limit cannot be adjusted directly to 750 mmHg carry out the following procedure:
1. Power off the pump.
2. Access the Options menu. See section 3.3, page 28.
3. Press the arrow keys to select Basic Profile configuration.
4. Press enter.
5. Enter the Basic Profile configuration access code "0200".
6. Press OK.
7. Press the arrow keys to select the User setting category.
8. Press the arrow keys to select the User 4: Pressure.
9. Scroll through and write down the Pressure parameters:
Mode, DPS, Unit
High, Medium and Low pressures
Limit stored, Limit, Drop threshold, Raise threshold, DPS stored/DPS state
(enabled/disabled)
10.Press enter.
11.Edit the Mode and High pressure parameters as follows:
Mode = 3 levels
High = 750 mmHg
63
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.
64
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.
65
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.
66
6.3 Quality Control Procedure
6.3.1 Running a Quality Control
Print the form provided. See section 6.3.2, page 71.
Run Test 2: Maintenance. See section 6.2.3, page 39.
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 38.
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).
67
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 45.
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 45.
Check the keypad.
6. Run Test 24: Watchdog. See section 6.2.24, page 60.
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 51.
Check the anti-free flow clamp motor correct functioning.
8. Run Test 19: Clamp. See section 6.2.19, page 55.
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 42.
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 46.
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
68
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.
69
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 65.
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 48.
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 48.
-Check that the displayed "Alarm" is equal to or greater than 06h30. (06:30)
If not, replace the battery. See section 8.1, page 85.
17. Run the electrical test according to EN/IEC 60601-1 standard. See section 6.2.28, page 64.
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
70
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:
Not executed
16 Battery life. Test 13: Battery test and Test 12: Battery life.
Displayed "Alarm": : (greater than 6h30 (06:30))
17 Electrical test.
Pass
Fail
Name: Date: Signature:
Technical department:
Observations:
71
7 Troubleshooting and Messages
72
Displayed Message Priority Problem / Resolution
The pump does not detect the presence of the anti-free flow
clamp.
Install the administration set and close the door.
Check the position of the administration set and the anti-free
flow clamp.
Check the OCS flexible IC (switch board and opto sensors)
and replace if necessary. See section 8.15, page 128.
There is no administration set in front of the upstream or
Check set installation !!! High (!!!) downstream sensor.
Check the administration set installation.
Check that the magnet is present on the door.
Calibrate then test the door sensor using Agilia Partner
maintenance software.
Replace the upper case supporting the HMI board with the
door sensor. See section 8.2, page 87.
73
Displayed Message Priority Problem / Resolution
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
Agilia Partner maintenance software.
OCS Failure !!! High (!!!) Check the membrane and replace it if necessary.
See section 8.14, page 126.
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.
74
Displayed Message Priority Problem / Resolution
During the infusion or when the infusion is stopped, the drop
sensor is connected to the pump.
Disconnect the drop sensor from the pump.
No drop sensor !!! High (!!!)
Not available in certain countries.
75
Displayed Message Priority Problem / Resolution
In-line pressure has reached 50 mmHg / 5 kPa / 1 PSI below
the programmed threshold.
Check the infusion line.
Occlusion pre alarm !! Medium (!!) Define the pressure threshold parameter (User 4).
See section 5.2, page 30.
Note: the key silences the alarm for a time duration from
1 minute to 12 hours.
The pressure is increasing in the infusion line. This warning
can be selected as an option.
Check for occlusions in the infusion line (roller clamp or tap
Pressure increase ! Low (!) closed, administration set blocked, line kinked or twisted,
etc.).
76
Displayed Message Priority Problem / Resolution
At start-up or when the infusion is stopped, the drop sensor is
connected to the pump.
Disconnect the drop sensor from the pump.
No drop sensor ! Low (!)
Not available in certain countries.
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.
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.
77
78
7.2 Troubleshooting Guide
Description Cause Recommended Action
Check the display board.
Check the connectIons between CPU board
Control transistors, LEDs and/or
Display defect: LED, LCD display. and display board.
connections are defective.
Replace the display board/LCD display.
See section 8.3, page 89.
Detection of a open door while the door is Calibrate the door sensor using Agilia Partner
closed. maintenance software.
The door sensor is not calibrated.
Detection of an closed door while the
door is open.
Wrong calibration of the Recalibrate the downstream or upstream
downstream or upstream sensor using Agilia Partner maintenance
Occlusion alarm after the pump has been
pressure sensor. software.
turned on.
The downstream or upstream Replace the downstream or upstream sensor.
pressure sensor is damaged. See section 8.11, page 117.
Select a higher pressure limit (Pressure
The pressure limit selected is too
management menu ).
low.
Recalibrate the downstream or upstream
Wrong calibration of the
Occlusion alarm during the infusion. sensor using Agilia Partner maintenance
downstream or upstream
software.
pressure sensor.
Replace the downstream or upstream sensor.
Flexible circuit is cut.
See section 8.11, page 117.
Connect the pump to the AC power supply.
Replace the battery.
The power supply indicator doesn't light Battery is totally discharged. See section 8.1, page 85.
up. Power supply board is defective. Check the power cord and AC power supply.
Replace the power supply board.
See section 8.5, page 94.
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 94.
Replace the upper case. See section 8.2,
page 87.
Defective keypad. Check the keypad by running test 10.
The pump turns ON or OFF itself.
Power supply board is damaged. See section 6.2.11, page 45.
Replace the power supply board if necessary.
See section 8.5, page 94.
Replace the upper case.
See section 8.2, page 87.
Some keys of the keypad do not work. Defective keypad.
Check the keypad by running test 10.
See section 6.2.11, page 45.
Connect the pump to the AC power supply.
Then, wait few minutes without touching the
At start-up, the pump displays: "Software keypad until the message disappears and the
Pump upgrade from V1.x to V2.x
is upgrading...". pump starts as usual.
Contact your biomedical department or your
Fresenius Kabi sales representative.
Check the status of the casings and the
Mechanical elements are damaged. After a fall.
mechanical system.
79
7.3 Error Codes
Error Code Description Recommended Actions
Check correct functioning of the motor.
Check the ribbon cable connection between the optical switch
and CPU board (J3 connector). See figure 2.5, page 14.
01 Motor rotation Check the correct functioning of the motor rotation optical switch.
Replace the CPU board. See section 8.4, page 91.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
Replace the CPU board. See section 8.4, page 91.
10 RAM Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
Replace the CPU board. See section 8.4, page 91.
Flash memory (deleting or
11 Carry out a complete configuration/calibration/control cycle using
programming problem)
Agilia Partner maintenance software.
Carry out a complete configuration for the pump using the
Agilia Partner maintenance software.
If the problem cannot be resolved:
12 Resources
Replace the CPU board.See section 8.4, page 91.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
Secondary Crc16 Carry out a complete configuration/calibration/control cycle using
13 microcontroller - version is Agilia Partner maintenance software.
incorrect
Secondary microcontroller Replace the Power supply board. See section 8.5, page 94.
14 restarting - Watchdog
problem
Check the ribbon cable connection between Power supply board
(J1 connector) and CPU board (J10 connector).
Secondary microcontroller
15 See figure 2.5, page 14.
communication
See figure 2.7, page 19.
Replace the Power supply board. See section 8.5, page 94.
Check the battery connection to Power supply board
(J3 connector). See section 2.1.5, page 19.
16 Disconnected battery Check the battery charging voltage. Run test 12.
See section 6.2.13, page 48.
Replace the battery. See section 8.1, page 85.
Check the battery charging voltage. Run test 12.
17 Battery charge See section 6.2.13, page 48.
Replace the battery. See section 8.1, page 85.
Remove the battery door. See section 8.1, page 85.
18 AC power presence Check the status of the AC power fuse.
Replace the Power supply board. See section 8.5, page 94.
Check the battery status. Run test 8. See section 6.2.9, page 44.
19 Battery temperature
Replace the battery. See section 8.1, page 85.
Check that the opto switch is functioning correctly by running
test 19, (line Clamp). See section 6.2.19, page 55.
Anti-free flow clamp
22 Check the cable connection to CPU board (J1 connector).
presence opto switch
See figure 2.5, page 14.
Replace the OCS flexible IC.See section 8.15, page 128.
Check that the 2 opto switches are functioning correctly by
running test 19, (line Position). See section 6.2.19, page 55.
Anti-free flow clamp motor
23 Check the cable connection to CPU board (J1 connector).
position opto switches
See figure 2.5, page 14.
Replace the OCS flexible IC. See section 8.15, page 128.
80
Error Code Description Recommended Actions
Run test 15. See section 6.2.16, page 51.
Check the status of the Anti-free flow clamp motor.
Check the connection of the Anti-free flow clamp motor to the
24 Unclamping
CPU board (J8 connector). See figure 2.5, page 14.
Replace the Anti-free flow clamp motor.
See section 8.12, page 122.
Run test 7 to check the "open or closed" door detection.
See section 6.2.8, page 42.
Check that the magnet is present on the door.
25 Door Hall effect sensor
Replace the door. See section 8.13, page 125.
Calibrate then test the door sensor using Agilia Partner
maintenance software.
Check the connection between Display board and CPU board.
See section 2.1.3, page 11.
See section 2.1.4, page 14.
Check the connection between Power supply board and CPU
26 Board missing
board.
See section 2.1.4, page 14.
See section 2.1.5, page 19.
Replace the faulty part(s).
Check the connection between Display board (J3 connector) and
LCD display. See section 2.1.3, page 11.
27 LCD blacklight missing
Replace the LCD display. See section 8.3, page 89.
If the problem cannot be resolved, replace the Display board.
Run test 10 to check the keypad. See section 6.2.11, page 45.
Replace the upper case. See section 8.2, page 87.
28 Keypad Run test 10 to check the keypad.
If the problem cannot be resolved, replace the Display board.
See section 8.3, page 89.
Replace the CPU board. See section 8.4, page 91.
29 Analog/digital converter Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
Replace the Power supply board supporting the secondary
microcontroller. See section 8.5, page 94.
30 Time keeper Replace the CPU board. See section 8.4, page 91.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
Run test 14. See section 6.2.15, page 50.
Check the status of the air detector using an administration set
33 Air detector filled with water and air.
Calibrate the air detector using Agilia Partner maintenance
software.
Carry out a complete configuration using Agilia Partner
34 Infusion flow rate
maintenance software.
Carry out a complete configuration using Agilia Partner
35 Motor period
maintenance software.
Carry out a complete configuration using Agilia Partner
36 Motor rotation direction
maintenance software.
Check that you have not pressed the OFF key too repeatedly.
Replace the Power supply board to check the functionality of the
secondary microcontroller. See section 8.5, page 94.
OFF key.
Replace the Display board. See section 8.3, page 89.
37 Reading status problem or
Replace the CPU board to check the functionality of the main
key pressed too repeatedly
microcontroller.See section 8.4, page 91.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
Run test 10 to check the functionality of the keypad, and
especially the OFF key. See section 6.2.11, page 45.
38 OFF key locked Replace the upper case. See section 8.2, page 87.
Replace the Power supply board to check the secondary
microcontroller functionality. See section 8.5, page 94.
81
Error Code Description Recommended Actions
39 Impossible to power off Replace the Power supply board. See section 8.5, page 94.
Run test 5. See section 6.2.6, page 40.
Check the sensor state change by applying pressure on the
upstream sensor.
Upstream pressure sensor
41 Check the connections to CPU board (J11 connector).
out of range
See figure 2.5, page 14.
Calibrate the upstream sensor using Agilia Partner maintenance
software.
Run test 6. See section 6.2.7, page 41.
Check the sensor state change by applying pressure on the
downstream sensor.
Downstream pressure
42 Check the connections to CPU board (J2 connector).
sensor out of range
See figure 2.5, page 14.
Calibrate the downstream sensor using Agilia Partner
maintenance software.
43 LCD communication failure Replace the Display board.See section 8.3, page 89.
44 LCD driver failure Replace the Display board.See section 8.3, page 89.
45 Defective LCD voltage Replace the Display board.See section 8.3, page 89.
Backup capacitor Contact the Fresenius Kabi Technical Service.
46
temperature too high
Backup capacitor Contact the Fresenius Kabi Technical Service.
47
temperature out of range
Pump temperature out of Place the pump in normal operating temperature.
48
range Please refer to the Instructions for Use of the relevant pump.
Backup capacitor and safety Replace the Power supply board. See section 8.5, page 94.
49 5 V booster charging circuit
defective
Power supply board voltage Replace the Power supply board. See section 8.5, page 94.
50
out of range
Check the connection to Power supply board (J2 connector).
51 Defective speaker See section 2.1.5, page 19.
Replace the speaker and flexible circuit.
Buzzer sound level too low or defective speaker (see error code 51).
52 Defective buzzer Replace the Power supply board supporting the buzzer.
See section 8.5, page 94.
Battery parameter in Contact the Fresenius Kabi Technical Service.
53
coulometer EPROM
Secondary microcontroller / Contact the Fresenius Kabi Technical Service.
54 coulometer power supply
board communication
Carry out a complete configuration check using Agilia Partner
55 Defective profile
maintenance software.
Replace the Power supply board. See section 8.5, page 94.
CMDFAIL Replace the Display board. See section 8.3, page 89.
56 Autotest failure on starting Replace the CPU board.See section 8.4, page 91.
up the pump. Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
Replace the CPU board. See section 8.4, page 91.
97 Defective oscillator Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
Replace the CPU board. See section 8.4, page 91.
98 Defective reset circuit Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
82
Error Code Description Recommended Actions
Replace the Power supply board to check the functionality of the
secondary microcontroller. See section 8.5, page 94.
Replace the CPU board to check the functionality of the main
99 Activation of the watchdog
microcontroller. See section 8.4, page 91.
Carry out a complete configuration/calibration/control cycle using
Agilia Partner maintenance software.
83
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.
84
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 27.
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
85
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 67.
86
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.
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].
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 67.
88
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.
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
89
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 67.
90
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged. See section 8.1, page 85.
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
91
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].
10.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 96.
11.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
92
12.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.
13.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 67.
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.
93
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.
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
94
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 67.
95
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 27.
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 85.
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
96
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
97
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 67.
98
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged. See section 8.1, page 85.
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
99
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].
10.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 96.
11.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
100
12.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.
13.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
14.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
101
12 13
15 16
14 11 14
16
15
13
102
22.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 67.
103
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.
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
104
8. Disconnect the display board flat cable at [J2].
J1
J2
9. Unscrew the 2 screws [7] from the air detector board [8].
105
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 67.
106
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged. See section 8.1, page 85.
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
107
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].
10.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 96.
11.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
108
12.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.
13.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
14.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].
9
10
109
15.Place the pump with the door facing down..
16.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
17.Unscrew the screw [12] positioned under the base.
18.Remove the pumping plate [13].
19.Unscrew the screw [14] positioned under the base.
12 13
15
11 14
16
15
13
110
21.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 67.
111
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged. See section 8.1, page 85.
Dismantling
1. 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 96.
2. Turn the pump upside down.
3. Unscrew and remove the 3 screws [1].
1 1
4. Remove the angle bracket [2], being careful not to pull out the CPU board flat cable [6].
5. Disconnect CPU board flat cable [6] at [J1].
6. Pull out the RJ11 cap [4] .
7. Unscrew the 2 screws [3] that hold the upper case [5] to the base.
8. Remove the upper case [5], being careful not to pull out the display board flat cable.
6
J1
5
3
3
4
112
6
J1
J2
10.Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J6], [J7], [J8],
[J9] and [J11].
11.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 96.
12.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
113
13.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.
14.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
15.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].
9
10
114
16.Place the pump with the door facing down..
17.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
18.Unscrew the screw [12] positioned under the base.
19.Remove the pumping plate [13].
20.Unscrew the screw [14] positioned under the base.
12 13
15
11 14
16
15
13
115
23.Unscrew the 4 motor holding nuts [17].
24.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
116
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.
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
117
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].
10.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 96.
11.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
118
12.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.
13.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
14.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].
9
10
119
15.Place the pump with the door facing down..
16.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
17.Unscrew the screw [12] positioned under the base.
18.Remove the pumping plate [13].
19.Unscrew the screw [14] positioned under the base.
12 13
15
11 14
16
15
13
120
21.Pull out the pumping system [16] out of its axis [17].
22.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 67.
121
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.
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
122
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
123
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
124
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 27.
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 67.
125
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 27.
Dismantling
1. Turn the pump upside down.
2. Unscrew and remove the 2 screws [1].
1
1
126
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 67.
127
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 27.
Prerequisites
The battery is disconnected and the boost capacitor discharged.
See section 8.1, page 85.
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
128
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].
10.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 96.
11.Unscrew the screw [7] that holds the CPU board to the flange.
J2
J1 J3
8 J6
J12
J7
J8
J11
J8 J9
129
12.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.
13.Disconnect the flat cables [J10] and [J5].
J5
J7
J10
14.Unscrew the screw [9] on the side of the left flanges being careful not to damage the air
detector board [10].
9
10
130
15.Place the pump with the door facing down.
16.Unscrew the button screw [11] and pull it out.
- Push the button, turn it to the left and remove it.
- Remove the spring.
17.Unscrew the screw [12] positioned under the base.
18.Remove the pumping plate [13].
19.Unscrew the screw [14] positioned under the base.
12 13
15
11 14
16
15
13
131
21.Unscrew and remove screw [16].
22.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 67.
132
9 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.
133
10 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
134
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
135
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.
136
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)
137
12.8 Compliance
Compliant with the following standards:
ElectroMedical Index of protection against solid foreign objects
IEC 60601-1 IP22
Equipment Safety (> 12.5 mm) and driping liquids
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)
12.10Electronic Boards
The Agilia VP MC and Agilia VP pumps are equipped with 5 electronic boards:
Power supply board
AC Power board
CPU board
Display board
Air detection board
The Agilia VP MC WiFi pumps are equipped with 6 electronic boards:
Power supply board
AC Power board
CPU board
Display board
Air detection board
Wi-Fi board
138
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
139
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
140
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.
141
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
142
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.
143
17 Spare Parts Catalog
144
18 Ordering Information
18.3 Disposables
Refer to the Instructions for Use of the relevant pump
145
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
146
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
147
Term Description
W Watts
148
Index
A L
AC Power Board LCD Display
Description 22 Dismantle/Re-assemble 89
Dismantle/Re-assemble 94 Voltage 58
Ageing Test 46
Air Detector M
Test 50 Maintenance
Air Detector Board Date 35
Description 23 Display Startup Screen 36
Dismantle/Re-assemble 104 Schedule 27
Alarms 72 Test 39
Anti-Free Flow Clamp Motor Maintenance Options Menu 35
Dismantle/Re-assemble 122 Material Characteristics 139
Test 51 Membrane 126
B O
Base Kit 99 OCS Flexible IC 128
Basic Profile Configuration 30 Operation Diagram 26
Battery Options Menu 28
Dismantle/Re-assemble 85
Test 44, 48
P
C Power Information 57
Power Supply Board
Clamp 55
Description 19
CPU Board Dismantle/Re-assemble 94
Description 14 Pressure
Dismantle/Re-assemble 91
Downstream Sensor 41
Upstream Sensor 40
D Pressure Limit Alarm Test 62
Display Board Pressure Sensors 117
Description 11 Profile Menu 29
Dismantle/Re-assemble 89 Pump Code 56
Door Pump Identification 38
Dismantle/Re-assemble 125 Pumping System
Test 42 Dismantle/Re-assemble 107
Dismantle/Re-assemble Motor 112
E
Electrical Test 64 Q
Error Codes 80 Quality Control
Events Certificate 71
Data Log 36 Maintenance 27
Test 39
R
F Release Notes 151
Flow Rate Test 65
S
I Symbol Descriptions 2
Indication Test 45
K
Keypad
Description 9
Test 45
149
T
Table of Contents 3
Technical Characteristics 136
Temperature Test 59
Tests
Access Menu 37
List 37
Training 27
Troubleshooting 79
U
Upper Case 87
W
Watchdog 60
Wi-Fi Board
Description 24
Dismantle/Re-assemble 96
Wi-Fi Module Information 61
150
Release Notes
The screenshots and illustrations 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: May 2020
0123
www.fresenius-kabi.com
First CE Mark: Agilia VP MC WiFi: December 2015
Agilia VP MC: November 2016
151
Local Contacts for Servicing
11396-4_TM_Agilia_VP_range_ASU_Eng
Non-ionizing electromagnetic
Product serial number
radiation
0123
CE mark
2 11106-6_Master_IFU_Agilia_VP_MC_Eng
Table of Contents
1 INTRODUCTION 9
1.1 SCOPE ..................................................................................................9
1.2 INTENDED USE ........................................................................................9
1.3 PRINCIPLES OF OPERATION ....................................................................9
1.4 INTENDED PRODUCTS TO BE INFUSED ....................................................10
1.5 INTENDED USERS ..................................................................................11
1.6 INTENDED PATIENTS .............................................................................11
1.7 CONTRAINDICATIONS .............................................................................12
1.8 USE ENVIRONMENT .............................................................................12
1.9 SPECIFICITIES FOR HOMECARE ENVIRONMENTS ....................................13
2 AGILIA CONNECT INFUSION SYSTEM 14
3 DESCRIPTION 16
3.1 FRONT VIEW .........................................................................................16
3.2 BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) .....................................16
3.3 BACK VIEW ...........................................................................................17
3.4 KEYPAD ................................................................................................18
3.5 DISPLAY AND SYMBOLS .........................................................................20
3.5.1 Infusion Status.................................................................................... 20
3.5.2 Screen Options................................................................................... 20
3.5.3 Navigation Buttons ............................................................................. 21
3.5.4 Alarms and Safety Features............................................................... 21
3.5.5 Infusion Features................................................................................ 21
3.5.6 Data Communication .......................................................................... 22
3.6 PACKAGING ..........................................................................................22
4 FUNDAMENTALS 23
4.1 PROFILES ............................................................................................23
4.2 DRUG LIBRARIES...................................................................................24
4.3 DRUG LISTS..........................................................................................24
4.4 DRUGS .................................................................................................24
4.4.1 Infusion Rates .................................................................................... 24
4.4.2 Drug X (mL/h)..................................................................................... 25
4.4.3 Hard Limits and Soft Limits ................................................................ 25
4.4.4 Infusion Modes ................................................................................... 25
4.5 DATA SET .............................................................................................26
3
5 INSTALLATION 27
5.1 TYPES OF INSTALLATIONS .....................................................................27
5.2 USING THE ROTATING POLE CLAMP.......................................................28
5.3 ATTACHING THE PUMP(S) ......................................................................29
5.3.1 Attaching to a Pole ............................................................................. 29
5.3.2 Attaching to a Rail .............................................................................. 30
5.3.3 Using on a Flat Table ......................................................................... 30
5.3.4 Attaching Two Pumps Together ......................................................... 31
6 GETTING STARTED 32
6.1 FLOWCHART .........................................................................................32
6.2 USING THE PUMP FOR THE FIRST TIME ..................................................33
6.3 POWERING ON ......................................................................................33
6.4 INSTALLING THE ADMINISTRATION SET IN THE PUMP ..............................35
6.5 CONNECTING A DROP SENSOR .............................................................36
6.6 PUMP HEIGHT ......................................................................................37
7 OPERATION 38
7.1 FLOWCHART .........................................................................................38
7.2 SELECTING A PROFILE ..........................................................................39
7.3 SELECTING THE INFUSION RATE (FLOW RATE OR DOSE) ........................40
7.4 SELECTING A DRUG .............................................................................41
7.5 PROGRAMMING AN INFUSION .................................................................41
7.5.1 Programming an Infusion by Flow Rate ............................................. 42
7.5.2 Programming an Infusion by Dose ..................................................... 43
7.5.3 Programming Beyond Soft Limits ....................................................... 48
7.6 STARTING AN INFUSION .........................................................................49
7.7 MONITORING AN INFUSION .....................................................................50
7.8 FUNCTIONS DURING INFUSION ...............................................................52
7.8.1 Stop .................................................................................................... 52
7.8.2 Rate Titration...................................................................................... 52
7.8.3 Secondary (Piggyback) Infusions ...................................................... 52
7.8.4 Administering a Bolus ........................................................................ 58
7.9 COMPLETING AN INFUSION ....................................................................60
7.9.1 Near End of Infusion Alert ................................................................ 60
7.9.2 End of Infusion ................................................................................... 61
7.9.3 Powering off ....................................................................................... 62
7.10 INFUSION MODES ..................................................................................62
4
7.10.1 Volume / Time / Rate (V/T/R) ............................................................. 62
7.10.2 Volume / Rate (V/R) ........................................................................... 62
7.10.3 Volume / Time (V/T) ........................................................................... 62
7.10.4 Time / Rate (T/R)................................................................................ 62
7.10.5 Simple Rate (only with Drop Sensor) ................................................. 63
7.10.6 Ramp-up / Ramp-down ...................................................................... 63
7.10.7 Sequential Infusion............................................................................. 65
7.10.8 Drops/min ........................................................................................... 67
7.11 OTHER FUNCTIONS ...............................................................................68
7.11.1 Priming the Administration Set ........................................................... 68
7.11.2 Advancing an Air Bubble ................................................................... 69
7.11.3 Auto-restart......................................................................................... 70
7.11.4 Pre-programming the Pump ............................................................... 71
8 MENUS 72
8.1 OVERVIEW ............................................................................................72
8.2 PROFILE ...............................................................................................74
8.3 PRESSURE ............................................................................................75
8.4 VOLUME TO BE INFUSED (VTBI) ...........................................................77
8.5 KEYPAD LOCK STATUS ..........................................................................78
8.6 BATTERY LIFE .......................................................................................80
8.7 VOLUME INFUSED / DOSE INFUSED ........................................................81
8.8 PAUSE ..................................................................................................82
8.9 DRUG ...................................................................................................83
8.10 PATIENT ...............................................................................................84
8.11 DAY/NIGHT MODE .................................................................................85
8.12 PRIMARY / SECONDARY .........................................................................87
8.13 PROGRAMMED BOLUS ...........................................................................87
8.14 FLOW RATE (ML/H) / DOSE ...................................................................88
8.15 RAMP-UP / RAMP-DOWN ........................................................................89
8.16 SEQUENTIAL INFUSION ..........................................................................89
8.17 ALARM VOLUME ....................................................................................90
8.18 CALL-BACK ALERT ................................................................................91
8.19 VIEW FLOW RATE HISTORY ...................................................................93
8.20 VIEW PRESSURE HISTORY ....................................................................94
8.21 VIEW EVENT LOG ................................................................................95
8.22 DATE / TIME .........................................................................................96
8.23 MAINTENANCE ......................................................................................97
5
8.24 LIBRARY INFORMATION ..........................................................................98
8.25 CLINICAL INFORMATION .........................................................................99
8.26 DATA SET ...........................................................................................100
9 OPTIONS 101
9.1 COMMANDS ........................................................................................101
9.2 OPTION DESCRIPTIONS .......................................................................101
9.3 PUMP SETTINGS .................................................................................102
10 DATA COMMUNICATION 103
10.1 OVERVIEW .........................................................................................103
10.2 COMMUNICATION VIA AGILIA CABLES ...................................................103
10.3 COMMUNICATION VIA WI-FI ................................................................104
10.4 DATA SET UPLOAD ...........................................................................104
11 USER TEST 105
6
15.2 FLOW RATE ........................................................................................124
15.3 VOLUME TO BE INFUSED (VTBI) .........................................................125
15.4 DOSE TO BE INFUSED (DTBI) .............................................................125
15.5 INFUSION TIME ....................................................................................125
15.6 CONCENTRATION ................................................................................126
15.7 PATIENT DATA ....................................................................................126
15.8 AIR DETECTION...................................................................................126
15.9 PRESSURE MANAGEMENT ...................................................................127
15.10 ACCURACY .........................................................................................128
15.11 CALCULATION RULES ..........................................................................130
15.12 UNITS AND CONVERSION RULES ..........................................................131
16 CLEANING AND DISINFECTING 133
16.1 WHEN TO CLEAN AND DISINFECT THE PUMP ........................................133
16.2 RECOMMENDED AND PROHIBITED AGENTS ...........................................134
16.3 INSTRUCTIONS FOR CLEANING AND DISINFECTING ................................134
17 POWER MANAGEMENT 137
17.1 AC POWER SUPPLY PRECAUTIONS......................................................137
17.2 BATTERY PRECAUTIONS ......................................................................137
17.3 BATTERY OPERATING MODE ...............................................................138
18 TECHNICAL CHARACTERISTICS 140
18.1 POWER SUPPLY ..................................................................................140
18.2 BATTERY ............................................................................................140
18.3 POWER CONSUMPTION........................................................................140
18.4 COMMUNICATION PORT ......................................................................141
18.5 INFRARED COMMUNICATION ................................................................141
18.6 DROP SENSOR CONNECTOR ...............................................................141
18.7 SOUND LEVELS ...................................................................................141
18.8 COMPLIANCE ......................................................................................142
18.9 DIMENSIONS AND WEIGHT ...................................................................142
18.10 TRUMPET AND START-UP CURVES .......................................................143
19 WI-FI 146
19.1 GENERAL INFORMATION ......................................................................146
19.2 SPECIFICATIONS .................................................................................147
7
20 TROUBLESHOOTING 149
21 RECYCLING 151
22 WARRANTY 152
22.1 GENERAL WARRANTY CONDITIONS ......................................................152
22.2 LIMITED WARRANTY ............................................................................152
22.3 WARRANTY CONDITIONS FOR ACCESSORIES ........................................152
23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 153
23.1 ELECTROMAGNETIC COMPATIBILITY ..................................................153
23.2 ELECTROSTATIC DISCHARGE (ESD) ....................................................153
23.3 ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE .154
23.4 EMC AND ESSENTIAL PERFORMANCES ................................................156
24 SERVICING 162
24.1 INFORMATION ON DEVICE SERVICING ...................................................162
24.2 MAINTENANCE REQUIREMENTS ............................................................162
24.3 QUALITY CONTROL .............................................................................163
25 GLOSSARY OF TERMS 164
INDEX 169
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 173.
9
1.4 Intended Products to be Infused
Warning
In homecare environment, the pump must only be used to infuse
noncritical drugs. Otherwise, there is a risk of interruptions in the therapy
which could have critical consequences for the patient. The following
fluids can only be infused under the permanent supervision of a trained
healthcare professional:
Catecholamines
Morphine
Chemotherapy
Other critical drugs
The pump administers products through clinically accepted routes.
These products include but are not limited to the following:
Intended Products
Standard solutions
Parenteral Fluids Colloids
Parenteral nutrition
Diluted drugs
Antibiotics
Chemotherapy
Medication
Catecholamines
Short acting drugs
Anaesthesia drugs
Blood
Red blood cells
Transfusion Platelets
Plasma
Albumin
10
1.5 Intended Users
In healthcare facilities, 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.
In homecare environments, the pump must only be used by
appropriately trained users including homecare professionals, patients
or their relatives (in case of patient's inability to correctly react to pump
alarms). In homecare environments, the IFU must be provided to the
homecare nurse.
Two Quick Reference Guides are available (one for homecare
professionals, one for the patient) in order to describe the typical
operations performed at home. We recommend using them and keeping
the Quick Reference Guide for the patient near the pump.
Typical initial training duration: 1 hour.
It is recommended that users attend a refresher training session of about
20 minutes every year.
For training, contact your Fresenius Kabi sales representative.
Patient Characteristics
Male
Sex
Female
Neonates (except in homecare environment)
Pediatrics
Age
Adults
Elderly
Weight 0.25 kg to 350 kg
When using the pump with a very sensitive population such as the
neonates, make sure to:
Switch to night mode
Set the alarm volume to the minimum level
11
1.7 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 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
1.9 Specificities for Homecare Environments
Warning: Product version
Only pumps with software version 2.2 or above can be used in
homecare environments. In early versions, all homecare functionalities
are unavailable.
If your software version is not compatible with homecare environments,
contact your Fresenius Kabi representative.
Environment Considerations
Consider the following operational conditions to ensure proper
device performance:
- Do not expose to sun light, keep in dry place, at room
temperature, normal pressure.
- Keep in clean environment.
- Keep away from objects which can potentially damage the
device.
- Keep away from any noise disturbance which could prevent
patient or relatives from hearing the pump alarms.
- Keep away from heat source, dust, fluff, direct and prolonged
light exposure.
- Keep away from animals, pests or children.
Do not share an outlet with another electrical device.
General Considerations
Healthcare professionals should not divulge to the patient or
relatives the pump's lock system or any information that may allow
an access to all programming and operating functions.
The responsibility of using the pump is shared between the
healthcare professional and the patient.
Homecare providers or healthcare facilities are responsible for
disposal of administration sets and bags used at home according to
current standards in order to limit the risk of harm and infection.
Warning
It is the healthcare professional’s responsibility to ensure that the
patient or his/her relatives have the required capacity (physical,
cognitive or perceptive) to use the pump in homecare environments.
Otherwise, there is a risk of usage errors and incorrect therapy which
could have critical consequences for the patient.
Homecare providers must ensure that they can provide backup sets
and a backup pump within a short time period to avoid interruptions
of administration which could have critical consequences in case of
pump failure in the patient’s home.
Give particular attention to the risk of strangulation with cables and
sets, and with the small parts that could be swallowed or inhaled.
Maintenance Requirements
Homecare providers are responsible for periodic maintenance and
calibration of pumps used in homecare environments.
Homecare providers must be informed if the device is dropped or if any
malfunctions occur. In this case, do not use the device and contact your
homecare providers.
13
2 Agilia Connect Infusion System
14
Agilia Range Description
Administration Sets
Disposables Volumat Lines Administration sets can be in contact with the patient
(applied part).
Information
For a list of compatible accessories, disposables and software, and for
ordering information, refer to the System Components booklet.
15
3 Description
3
2
Figure 3.1: Front View
Legend
1 Handle 3 Door Lever
21 Pump Door
16
3.3 Back View
7
5
1
4
2
3
Figure 3.2: Back View
Legend
1 Release Button 53 Power Cord Inlet
Warning
Near RS232 See section 10, page 103.
Communication Port
17
3.4 Keypad
3.4.1 Keypad Description
1
2 17
3
16
4
15
14
5 6 7 8 9 10 11 12 13
Figure 3.3: Keypad
Legend
1 Screen 10
73 Decrement
4 Wi-Fi Symbol 13
3 Stop
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
18
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.
19
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.
20
3.5.3 Navigation Buttons
Symbol Description
start Start
OK Confirm
C Change Selection
Select / Unselect
Alarm Silenced
Pressure Increase
Drop in Pressure
Note: For more information on alarms, see section 12, page 106.
21
3.5.6 Data Communication
Symbol Description
Data Set Loaded
A new data set has been loaded to the pump.
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.
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.
22
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.
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.
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
4.4.2 Drug X (mL/h)
Drug X (mL/h) is an open entry that can be selected if the intended drug
is not found in the drug library. It has the following characteristics:
Fewer limits than the other drugs in the library.
A full compliment of the Agilia Vigilant Drug’Lib software’s
safeguards are unavailable.
It is strongly recommended to use Drug X (mL/h) in a limited number of
clinical cases and under close patient monitoring by the clinical staff.
For each custom profile, the healthcare facility can enable or disable
Drug X (mL/h) using the Agilia Vigilant Drug’Lib software.
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 flow rate. Only available with
Simple Rate the optional drop sensor fixed to the drip chamber
and connected to the pump.
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)
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 29.
On a Pole Pole specifications:
Diameter: from 15 to 40 mm
Rail specifications:
On a Rail
Height: from 25 to 35 mm
Depth: from 8 to 10 mm
On the
Agilia Link
Rack
On Another
Pump
27
Location Comments
Refer to the Agilia Holder Ambulance
In an Agilia accompanying documents.
Holder
Ambulance
1 3
2
Figure 5.1: Rotating Pole Clamp System
Legend
1 Screw Clamp
21 Release Button
28
5.2.2.1 Folding the Clamp Down (outward)
You can fold the clamp down as follows:
1. Push the release button.
2. Fold the clamp outward.
29
5.3.2 Attaching to a Rail
Only single pumps can be attached to a bed rail or gurney rail.
1. Rotate the pole clamp to the vertical
position: see section 5.2.2.3, page 29.
30
5.3.4 Attaching Two Pumps Together
You can attach two pumps together either for transport, or before fixing
them to a pole.
31
6 Getting Started
6.1 Flowchart
Once the pump is installed at the bedside, you must follow the steps
below in order to install an administration set and power on the pump.
Powering on
Section 6.3, page 33.
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.
32
6.2 Using the Pump for the First Time
1. Make sure the pump is correctly installed at the bedside.
See section 5, page 27.
2. Plug the pump into the AC power supply.
See section 17.1, page 137.
3. Before starting the pump for the first time, you must charge the
battery for approximately 6 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 116.
5. Power on the pump.
See section 6.3, page 33.
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.
33
Screen After Powering on Description
The pump is operating on battery.
The symbol shows three different charge
levels:
< 30 % battery charge
30 % - 70 % battery charge
> 70 % battery charge
34
Screen After Powering on Description
Data Set information (optional)
35
6.5 Connecting a Drop Sensor
Using a drop sensor is recommended if the actual volume of the fluid
container is not known accurately.
The pump automatically detects the presence of a drop sensor. The
presence of the drop sensor can be set as mandatory in the pump
options. For more information on drop sensor options, refer to the
technical manual.
Always connect a drop sensor when the pump is off.
1. Before powering on the pump, connect
the drop sensor plug to the connection
socket on the back of the pump.
2. Press the drop sensor clip and align the
vertical part of the drop sensor with the
drip chamber’s air vent.
3. Release the clip.
4. Check the following:
The drop sensor and the drip chamber
are in a vertical position.
The drop sensor is correctly aligned
with the drip chamber’s air vent.
Note: The drop sensor is equipped with two circular magnets. You can use
these magnets to fix the drop sensor and the drip chamber on the right
side of the pump.
36
Information
When a drop sensor is detected on a pump, the following happens
Simple Rate infusion mode is available and recommended,
Programmable infusion ranges are different.
Warning
For transport during infusion, the pump with a drop sensor connected on
it must be installed on a rolling stand.
20 to 80 cm
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 49.
Monitoring an Infusion
Section 7.7, page 50.
Completing an Infusion
Section 7.9, page 60.
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
7.5.2.1 Selecting the Drug Concentration
Profile Drug Concentration Selection Procedure
Basic Profile
Custom Profile A- Basic Profile and Custom Profile (with a Drug List), page 43.
(with a drug list)
Custom Profile
B- Custom Profiles, page 43.
(with a drug library)
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.
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 44.
43
Authorized Concentration Range Authorized Finite Concentrations
Legend
Unauthorized Range Hard Limits
Finite Values
2. Press the arrow keys to program the infusion duration (__ h __), and
press OK.
45
3. Press the arrow keys to program the dose, and press OK.
Information
The loading dose is only available with the first start of an infusion. If no
is pressed inadvertently, power the pump off and then on to access the
loading dose again.
If enabled for the selected drug, you can program a loading dose after
programming an infusion defined by dose.
The screens below will appear prior to starting the infusion.
Selecting a Loading Dose
46
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.
47
7.5.3 Programming Beyond Soft Limits
Note: This step is only available with custom profiles that contain a drug
library.
You can override soft limits, and adjust flow rate and dose within the
authorized ranges. You cannot override a hard limit.
Legend
Unauthorized Range Hard Limits
Programmable Range
Soft Limits
(warning and confirmation)
Authorized Range Default Value
48
Flow rate Dose
During infusion, the upper or lower soft limit message will alternate with
the drug name and concentration at the top of the screen.
Warning
When connecting the administration set to the patient's access device,
always use aseptic technique according to your healthcare facility policy.
49
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 81.
Infusion Flow Rate (mL/h)
3
To change the flow rate during an infusion, see section 7.8.2, page 52.
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 77.
50
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 81.
Dose
3
To change the dose during an infusion, see section 7.8.2, page 52.
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
51
7.8 Functions During Infusion
7.8.1 Stop
52
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.
An end of secondary alert may be activated or deactivated in the
pump options.
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.
53
7.8.3.2 Accessing Secondary Infusion
54
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.
55
7.8.3.5 End of Secondary Infusion
Information
The near end of infusion alert is not activated in secondary infusion.
56
Automatic Return to Primary Infusion
At the end of secondary infusion, a short beep is emitted.
An alert message is displayed (optional).
57
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
Direct Bolus Programmed Bolus
Access Key or
Occlusion Pressure Level Set to its maximum value: 750 mmHg / 100 kPa / 14.5 PSI
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
58
3. To administer a direct bolus, press and hold .
4. Monitor the volume infused on the main display until the desired
bolus is reached.
5. To stop the bolus, release the key.
The infusion resumes its previous rate after the bolus is delivered.
During the infusion, you can program a bolus in one of the following two
ways:
Press , then prog.
Press , and select in the menu. Press enter to confirm.
Programming a Bolus
1. Press the arrow keys to program the bolus volume or dose, and
press OK.
2. Press the arrow keys to program the bolus duration
(__ h __ min __), and press OK.
The flow rate is calculated automatically.
59
The infusion resumes its previous rate after the bolus is delivered.
Press exit or to exit the bolus function and save the programmed
bolus settings.
If you press again, this screen appears immediately and displays the
settings of the last bolus.
Interrupting a Programmed Bolus
1. Press to interrupt the bolus.
60
Silencing Near End of Infusion Alert
61
7.9.3 Powering off
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.
63
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.
64
2. If ramp-down is selected, check the ramp-down values and
press OK.
65
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.
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.
Warning
When editing a stopped infusion with repetition (on infusion screen by
pressing Cancel/C), you can change a step with a repetition.
There is no change on all other repetitions and steps.
Information
To modify a sequential infusion, in the sequential menu, see section
8.16, page 89.
In this case, you can only modify a sequence that has not started yet.
66
7.10.8 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 88.
2. Press OK to confirm the new infusion mode.
3. Press OK to confirm 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.
67
7.11 Other Functions
7.11.1 Priming the Administration Set
Note: This feature can be activated or deactivated in Agilia
Vigilant Drug’Lib software (custom profiles) or in the pump options
(Basic profile).
68
7.11.2 Advancing an Air Bubble
Note: This feature can be activated or deactivated in Agilia
Vigilant Drug’Lib software (custom profiles) or in the pump options
(Basic profile).
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.
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.
69
7.11.3 Auto-restart
Auto-restart is an optional feature that alters the pump’s response when
a downstream occlusion is detected.
When this feature is activated, and when a downstream occlusion is
detected, the following occurs:
An alert is generated to inform the user that the pressure limit is
reached.
The infusion is stopped.
The pressure sensor measures the pressure evolution during a
configurable period of time:
- If the pressure decrease is significant, the infusion automatically
restarts.
- If the pressure does not decrease, the downstream occlusion
alarm is generated.
Information
When the alert is generated, we recommend checking that the
infusion line is not kinked.
When this feature is deactivated, an alarm is immediately generated
when a downstream occlusion is detected.
For more information on how to activate or deactivate this feature,
see section 8.3, page 75.
70
7.11.4 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.
71
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 84.
Day/Night mode NO
Switching between day mode and night mode,
page 85.
Flow Rate
(mL/h) mL/h YES
Changing the infusion mode, page 88.
Dose Dose YES
72
Stop
Menu Symbol Infusion Associated Procedure
Required
View flow rate history NO Viewing flow rate history, page 93.
Clinical information NO
Viewing remaining time before clinical information
display, page 99.
Note: The displayed menu may change depending on the pump configuration.
For more information on factory configuration, refer to Appendix: Factory Configuration, page 168.
73
8.2 Profile
Symbol Pro
Procedure Displaying active profile information
74
8.3 Pressure
Symbol
The pump pressure limit is pre-defined in the pump options in one of the
following modes:
75
3. Press the arrow keys to increase or decrease the pressure limit.
4. Press OK to validate.
Information
For more information on the Auto-restart function, see section 7.11.3,
page 70.
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.
76
8.4 Volume To Be Infused (VTBI)
Symbol VTBI
Procedure Changing VTBI
77
8.5 Keypad Lock Status
Symbol
78
Unlocking the Keypad
79
8.6 Battery Life
Symbol
80
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.
81
8.8 Pause
Symbol
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.
82
8.9 Drug
Symbol
83
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 .
84
8.11 Day/Night Mode
Symbol
85
Switching from Night Mode to Day Mode
86
8.12 Primary / Secondary
Symbol P/S
Procedure Programming a secondary infusion
87
8.14 Flow Rate (mL/h) / Dose
mL/h
Symbols
Dose
Procedure Changing the infusion mode
88
8.15 Ramp-up / Ramp-down
Symbol
Prerequisite Sequential infusion mode must be selected, see Section 8.14, page 88.
89
8.17 Alarm Volume
Symbol
90
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.
91
Deactivating the Call-back Alert
92
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.
93
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.
94
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.
95
8.22 Date / Time
Symbol
96
8.23 Maintenance
Symbol
97
8.24 Library Information
Symbol
98
8.25 Clinical Information
Symbol
You can view the remaining time before clinical information display as
follows:
1. Press .
99
8.26 Data Set
Symbol DS
Procedure Displaying active data set information
100
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.
101
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
Selection assistance: display or hide selection
[User 1]:
assistance banner at the bottom of the screen Enabled
Screen option
to help the user program an infusion
Maintenance: display or hide maintenance
[User 2]: Disabled
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
102
10 Data Communication
10.1 Overview
Cable Communication Wi-Fi Communication
Connection of 1 pump to a PC for the following Communication between a hospital information
purposes: system server and a number of identified pumps
Data set upload (via Agilia Vigilant Drug’Lib for the following purposes:
software) Data set upload
Maintenance (via Agilia Partner software) Pump history retrieval
Information
Ensure that all hospital information systems have been approved by
Fresenius Kabi. For more information, contact your technical
services representative.
Before connecting the pump to a hospital information system, ask
your IT or biomedical department to configure the device.
Information
Do not disconnect communication cables while data is being transferred.
103
10.3 Communication via Wi-Fi
The Wi-Fi option allows the pump to connect to a hospital information
system without cables.
To know if your pump is equipped with a Wi-Fi module, check for the
presence of the Wi-Fi logo on the pump’s keypad.
See section 3.4.1, page 18.
2. Press OK to acknowledge.
The data set information is displayed.
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.
105
12 Alarms and Safety Features
12.1 Introduction
Agilia VP MC has a continuous monitoring system that begins when the
pump is started.
When an alarm is triggered, a message is displayed on the pump
screen. We recommend that the user stand in front of the pump to read
the message before acknowledgment.
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.
The pump emits audible alarm signals.
Immediate
High (!!!) An alarm description is displayed on the pump screen.
response
The key silences the alarm for no time limit or for a
defined duration. For detailed description of each alarm,
please refer to List of Alarms, page 107.
Prompt The infusion continues.
Medium (!!)
response The infusion indicator lights flash yellow.
The pump emits audible alarm signals.
Depending on the alarm, the key silences the
Low (!) Awareness alarm for no time limit or for a defined duration. For
detailed description of each alarm, please refer to List of
Alarms, page 107.
The infusion continues.
Information Signals Awareness An information message is displayed on the pump
screen.
106
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.
107
Stops
Message Priority Problem / Resolution
Infusion?
The administration set is incorrectly positioned
in front of the air sensor.
Set / air
Check the administration set installation in
installation !!!
High (!!!) Yes front of the air sensor and close the door.
Air alarm !!! High (!!!) Yes Remove the air from the administration set.
108
12.4.3 Infusion Alarms
Stops
Message Priority Problem / Resolution
Infusion?
The VTBI is completed.
Press to select new infusion settings
End of infusion !!! High (!!!) Yes (if required).
109
Stops
Message Priority Problem / Resolution
Infusion?
End of infusion ! End of infusion - with KVO
The VTBI is completed and the KVO is
activated according to its configuration in
Agilia Vigilant Drug’Lib software or in the
pump options.
Stop for new Low (!) No
infusion ! Press to select new infusion settings
(if required).
110
Stops
Message Priority Problem / Resolution
Infusion?
A downstream occlusion has been detected by
the device.
Check the line.
Wait during pressure
measurement High (!!!) Yes If the occlusion is released before the end
checking !!! of temporization, the infusion will restart
automatically.
Otherwise, a downstream occlusion alarm
is triggered.
In-line pressure has reached 50 mmHg / 5 kPa
/ 1 PSI below the programmed threshold.
Check the infusion line.
Occlusion
pre alarm !!
Medium (!!) No Set the correct pressure threshold.
111
Stops
Message Priority Problem / Resolution
Infusion?
Low battery.
Connect the pump to a power supply.
Battery pre alarm !! Medium (!!) No
Note: the key silences the alarm for 2
minutes.
If the pump is not used during an extended
Low (!) No period, connect to a power supply and wait
until the battery is charged.
112
12.4.8 Drop sensor
Stops
Message Priority Problem / Resolution
Infusion?
This message displays only if the drop sensor
is mandatory.
113
Stops
Message Priority Problem / Resolution
Infusion?
At start-up or when the infusion is stopped, a
free flow is detected by the drop sensor.
Close roller clamp.
Uncontrolled Check the drop sensor and the
flow !!!
High (!!!) Yes
administration set installation.
High internal
Check device environment.
temperature !
Low (!) No
Note: the key silences the alarm for 2
minutes.
The pump is mounted on a Link+ Agilia rack
that has not been upgraded.
Alarm reporting not
available on the Low (!) No Contact your qualified technician or your
Link ! Fresenius Kabi sales representative.
114
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.
115
13 Volumat Lines
116
Precautions for the use of administration sets
Use administration sets which have the smallest internal volume or
“deadspace” to minimize residual volumes when administering
medications or fluids at low infusion rates (e.g., less than 5mL per
hour, and especially flow rates less than 0.5 mL per hour). This
reduces the amount of time it takes for fluid to reach the patient,
maintains delivery accuracy, and reduces occlusion detection times.
For example:
- Administration set internal diameter: Small bore or microbore
tubing is recommended when infusing at low rates
- Administration set length: Administration set length should be
minimized, when possible
- Filters: Internal volume (deadspace) of in-line filters should be
minimized
- Connection sites: The number of connection sites such as
stopcocks and Y-sites should be limited, and high risk or life
sustaining solutions should be connected as close to the
intravenous access site as possible.
Avoid use of manifolds with ports containing high pressure valves.
High pressure valves require additional pressure (e.g., 50-200
mmHg) to open and allow fluid flow. These high pressure valves may
cause a significant delay in therapy followed by a sudden bolus once
the valve is opened, particularly at low infusion rates (e.g., less than
5 mL per hour, and especially flow rates less than 0.5 mL per hour).
Warning
During priming, make sure that the administration set is not connected
to the patient.
117
13.2.1 With a Bag
The following diagram shows how to prime the administration set with a
bag:
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.
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.
118
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).
Legend
Upstream port (before
1
the pump)
Downstream port (after
2
the pump)
2
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.
119
13.3.2 Use of Administration Sets for Gravity Infusion
13.3.2.1 Gravity Infusion (without pump)
In order to use the administration set to infuse the contents of the fluid
container via gravity, without the pump, release the SafeClip as follows:
1. Close the roller clamp.
2. Slide the blue part of the SafeClip to the open position.
3. Adjust the roller clamp on the administration set to regulate gravity
flow.
Closed position after removing Open position
from the pump (stops flow) (allows flow from gravity)
120
Information
Fresenius Kabi recommends the use of a back check valve or
positive pressure infusion devices when an infusion on the pump is
connected to a gravity line. This will prevent the back-up of IV fluid or
medication into the gravity line.
If there is no back check valve on a gravity infusion line during a
multi-line infusion, it may be impossible to detect patient-side
occlusions. Such an occlusion could cause the pumped drug to back
up into the gravity line, and later be infused in an uncontrolled
manner when the occlusion is released.
When connecting a pump-based infusion to a gravity line, connect
the pump administration set as close as possible to the patient, to
minimize dead space and the impact of the gravity line flow rate
changes.
Information
Properly dispose of used administration sets as per the healthcare
facility’s guidelines.
121
14 Device Storage
122
14.4 Using the Device After Storage
The device can be used immediately after storage without any cooling
or warm up period.
If the battery has been removed for long-term storage, contact your
biomedical department in order to reinstall the battery prior to use.
We recommend charging the battery for at least 6 hours.
We recommend that the "User test" is performed when the device is
installed after storage, and before being used on a patient, see section
11, page 105.
123
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 128.
Flow Rate Accuracy
Section 18.10, page 113.
Time to Detect Occlusion Section 15.10.3, page 128.
124
15.3 Volume To Be Infused (VTBI)
Default Minimum
Format Range of Settings
Value Increment
0.1 (0.1 99.9)
VTBI (Primary) mL 0.1 9999 N/A 1 (100 9999)
0.1 (0.1 99.9)
VTBI (Secondary) mL 0.1 9999* N/A 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
125
Default Minimum
Format Range of Settings
Value Increment
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)
Patient Body
m² 0.05 4.5 2 0.01
Surface Area
126
15.9 Pressure Management
Information
You can change the Basic Profile’s infusion pressure settings in the
pump options. See section 9, page 101.
You can pre-configure custom profiles’ infusion pressure settings
with Agilia Vigilant Drug’Lib software.
Default Minimum
Format Range of Settings
Value Increment
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.
127
15.10Accuracy
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.
128
15.10.4Volume 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*
15.10.5Pressure Accuracy
Accuracy
< 500 mmHg: ± 75 mmHg
Pressure*
> 500 mmHg: ± 15 %
* Test condition: Back pressure: 0 mmHg, Container height: 50 cm
129
15.11Calculation 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
130
15.12Units and Conversion Rules
15.12.1Concentration Units
Units Suffix
mmol
Concentration
mUnit, Unit /mL, /--mL
Units
cal, kcal
mEq
15.12.2Dose Units
Units
nanog/h,
nanog/kg/min, nanog/kg/h
microg/min, microg/h,
microg/kg/min, microg/kg/h
mg/min, mg/h, mg/24h,
mg/kg/min, mg/kg/h, mg/kg/24h,
mg/m²/h, mg/m²/24h
131
15.12.3Conversion Rules
1 micro unit = 1000 nano unit
1 unit/h = 24 unit/24 h
1 unit/min = 60 unit/h
132
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.
133
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.
134
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.
135
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.
136
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.
137
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.
138
139
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.
140
18.4 Communication Port
The connector located at the back of the device allows data
communication with a PC.
0 21
1 30
100 37
400 33
1500 46
Note: These values are provided for information purposes only.
141
18.7.2 Alarms Sound Levels
Sound Level (dBA)
Alarm Priority
min Max
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*
Weight Approximately 2 kg
Screen Size 70 x 35 mm
142
18.10Trumpet and Start-up Curves
The trumpet curve shows the variation of the mean flow rate accuracy
over specific observation periods. The variations are presented only as
maximum and minimum deviations from the overall mean flow within the
observation window.
Trumpet curves are presented below for a number of representative flow
rates.
The test protocol used to obtain these results is described in ANSI/AAMI
ID26.
The curves can be helpful in determining the suitability of infusion
parameters for specific drugs and concentrations.
Administration set used: VLST00
Fluid used: distilled water
Recommendations to improve performances and safety when the pump
is commonly used at low flow rates (≤ 20 mL/h):
Limit the range of available flow rates in accordance with the
maximum flow rate to be used.
Lower the pressure limit in order to gain in time to detect occlusion.
For the infusion of very short half-life at flow rate below 5 mL/h, we
recommend using syringe pumps that usually offer better
performances of instant flow rates.
143
18.10.1Flow 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)
144
18.10.2Flow 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)
145
19 Wi-Fi
Information
For more information on differentiation between Wi-Fi and non Wi-Fi
pumps, see section 10.3, page 104.
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
146
19.2 Specifications
19.2.1 Technical Specifications
Description
147
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.
148
20 Troubleshooting
149
Issue Recommended Actions
Connect the pump to the AC power supply. Then, wait few
minutes without touching the keypad until the message
At start-up, the pump displays:
disappears and the pump starts as usual.
"Software is upgrading...".
Contact your biomedical department, or your
Fresenius Kabi sales representative.
150
21 Recycling
Before disposal, remove the battery from the device. Batteries and
devices with this label must not be disposed of with the general waste.
They must be collected separately and disposed of according to local
regulations.
Information
For more information on waste processing regulations, contact your
Fresenius Kabi sales representative or the local distributor.
For more information on dismantling the device, refer to the technical
manual.
Follow healthcare facility policy regarding proper disposal after use.
151
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.
152
23 Guidance and Manufacturer's Declaration on
EMC
153
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 the
Agilia pump.
For maintenance operations performed on the Agilia pump, place the
device on a conductive working surface, and wear a special ESD
conductive wristband.
154
Warning
Use of the Agilia pump adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If
such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of the Agilia pump could
result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.
Portable RF communications equipment (including peripherals such
as antenna cables, internal and external antennas) should be used
no closer than 10 cm for cell phones and 30 cm for other equipments,
to any part of the Agilia pump, including cables specified by the
manufacturer. Otherwise, degradation of the essential performances
of Agilia pump could result.
Electrosurgical equipment (including base unit, cables, electrodes)
should be used no closer than 30 cm, to any part of the Agilia pump,
including cables specified by the manufacturer. Otherwise,
degradation of the essential performances of Agilia pump could
result.
The user might be required to take mitigation measures, such as
relocating or re-orienting the equipment.
If the Agilia pump is placed near RF communication equipment such as
cell phones, DECT phones or wireless access points, RFID reader &
tags,... It is essential to observe a minimum distance between the Agilia
pump and this equipment specified above. If the Agilia pump causes
harmful interference or if it is itself disrupted, the user is encouraged to
try to correct the interference by one of the following actions:
- Reorient or relocate the Agilia pump, the patient or disruptive
equipment.
- Change the routing of cables.
- Connect the Agilia pump power plug to a protected / backed-up /
filtered supply or directly to the UPS circuit (uninterruptible power
supply).
- Increase the separation between the Agilia pump and disruptive
equipment.
- Plug the Agilia pump 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.
155
23.4 EMC and essential performances
In the case of electromagnetic disturbances, if the essential
performance, Section 15.1, page 124, is lost or degraded, the
consequences for the patient are as follows: overdose, underdose,
delay of therapy, air embolism, trauma, exsanguination.
Compliance
Emission Test Obtained by Electromagnetic Environment - Guidance
the Device
The Agilia pump 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
The Agilia pump is suitable for use in all establishments
Harmonic emissions
Class A other than domestic and those directly connected to the
IEC61000-3-2
public low-voltage power supply network that supplies
Voltage fluctuations buildings used for domestic purposes.
Flicker emissions Compliant
IEC 61000-3-3
Conducted
emissions 150 kHz - Class 5
108 Mhz CISPR25 The Agilia pump is suitable for use in automotive
Radiated emissions environments.
150 kHz - 2.5 Ghz Class 3
CISPR25
156
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
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
the Agilia pump is used exceeds the
applicable magnetic field compliance level
above, observe the Agilia pump to verify
that it is operating normally. If you notice
abnormal performance, additional
measures may be necessary, such as
reorienting or relocating the Agilia pump,
or installing magnetic shielding.
Note: "Ut" is the AC Power voltage prior to applying the test level.
157
23.4.3 Table 4 - Guidance and Manufacturer's Declaration -
Electromagnetic Immunity
Warning
The Agilia pump and its accessories are intended to be used in the
electromagnetic environments specified below.
The customer or the user of the Agilia pump should ensure 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 the Agilia pump (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 3 Vrms D = 0.35 P,
IEC 61000-4-6
-------------- for a frequency of 150 kHz to 80 MHz
Not applicable
Radiated RF 3 V/m 10 V/m D = 0.35 P,
IEC 61000-4-3 80 MHz to for a frequency of 80 MHz to 800 MHz
2.5 GHz D = 0.7 P,
-------------- for a frequency of 800 MHz to 2.5 GHz
10 V/m P is the maximum output power rating of
80 MHz to the transmitter in Watts (W) according to
2.5 GHz the transmitter manufacturer, and D is the
recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey (a), should be less than compliance
level (b).
Interference may occur in the vicinity of
equipment marked with the following
symbol:
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 the Agilia pump is used
exceeds the applicable RF compliance level above, the Agilia SP pump should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the Agilia pump, or installing magnetic shielding.
(b) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
158
23.4.4 Table 6 - Recommended Separation Distances Between Portable
and Mobile RF Communication Equipment and the Agilia Pump
Information
The Agilia pump and its accessories are intended for use in
electromagnetic environments in which radiated RF disturbances are
controlled.
Users of the Agilia pump may prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF
communication equipment (transmitters) and the Agilia pump 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.
159
23.4.5 EMC test deviations and suplementary tests
To ensure compatibility with the new EMC standard IEC / EN 60601-1-2 Ed4 and special
environments, specific, additional or deviating tests are listed below with respect to the
basic tests, in accordance to manufacturer risk analysis.
IEC 60601-1-2 Compliance level
Electromagnetic
Immunity test IEC 60601-2-24 obtained
environment – guidance
Test level by the device
Discharge (ESD) ± 8 kV contact ± 8 kV contact Wooden, tiled or concrete flooring, with a
IEC 61000-4-2 relative humidity level at least 30%, makes it
possible to guarantee the level of necessary
conformity. If it is not possible to guarantee this
environment, the additional precautions must
± 15 kV air ± 15 kV air be taken, such as: use of anti-static material,
preliminary user discharge and wearing anti-
static clothing.
710 MHz, PM 217 Hz, 28 V/m 710 MHz, PM 217 Hz, 28 V/m
787 MHz, PM 217 Hz, 28 V/m 787 MHz, PM 217 Hz, 28 V/m 250 mW average power for 28 V/m
test level
810 MHz, PM 217 Hz, 44 V/m 810 MHz, PM 217 Hz, 44 V/m
830 MHz, PM 217 Hz, 44 V/m 830 MHz, PM 217 Hz, 44 V/m 600 mW average power for 44 V/m
Near field radiated
test level
RF - special test
870 MHz, PM 217 Hz, 44 V/m 870 MHz, PM 217 Hz, 44 V/m
IEC 61000-4-39
Portable and mobile RF
test method
1750 MHz, PM 217 Hz, 28 V/m 1750 MHz, PM 217 Hz, 28 V/m communications equipment should be
used no closer to any part of the Agilia
1875 MHz, PM 217 Hz, 28 V/m 1875 MHz, PM 217 Hz, 28 V/m pump, including cables, than the
recommended minimal separation
1970 MHz, PM 217 Hz, 28 V/m 1970 MHz, PM 217 Hz, 28 V/m distance (10 cm) for these frequencies
2560 MHz, PM 217 Hz, 28 V/m 2560 MHz, PM 217 Hz, 28 V/m
2655 MHz, PM 217 Hz, 28 V/m 2655 MHz, PM 217 Hz, 28 V/m
160
IEC 60601-1-2 Compliance level
Electromagnetic
Immunity test IEC 60601-2-24 obtained
environment – guidance
Test level by the device
Electrical Fast ± 2 kV for power ± 2 kV for power Electricity power quality should be that
transient / Burst supply lines supply lines of a typical domestic, commercial or
IEC 61000-4-4 ± 1 kV for input ± 1 kV for input hospital environment
output lines output lines
100 KHz repetition 100 KHz repetition
Electricity power quality should be that
of a typical domestic, commercial or
± 1 kV ± 1 kV hospital environment. For very
Surge differential mode differential mode exposed establishments or buildings
IEC 61000-4-5 ± 2 kV ± 2 kV with the lightning, a protection must be
common mode common mode installed on electricity power. Class II
product and no earth connexion.
161
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.
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.
162
24.3 Quality Control
Upon request by the healthcare facility, a quality control check can be
performed on the device every 12 months.
A regular quality control check (not included in the guarantee) consists
of various inspection operations listed in the technical manual.
Information
These control checks must be performed by trained technical
personnel, and are not covered by any contract or agreement
provided by Fresenius Kabi.
For more information, refer to the technical manual, or contact your
Fresenius Kabi sales representative.
163
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
164
Term Description
ECG Electrocardiogram
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)
165
Term Description
mA Milliamperes
mEq Milliequivalents
mmol Millimole
OR Operating Room
PC Personal Computer
RF Radio Frequency
SN Serial Number
166
Term Description
USB Universal Serial Bus
V Volts
VA Volt-Amperes
VI Volume Infused
W Watts
167
Appendix: Factory Configuration
Data Set
168
Index
A Drop Sensor 36, 63
Drops/min 25, 67
Administration Set
Drug 24
Change 121
Change 83
Install 35
Concentration Selection 43
Other Uses 119
Select 41
Prepare 116
Drug Library 24
Prime 68, 117
Display Information 98
Remove 121
Drug X (mL/h) 25
Replacement Interval 121
Agilia Connect Infusion System 14
Agilia USB Cable 104
E
Air Bubble Electromagnetic Guidance 153
Advance 69 Environment 12
Specifications 126 Essential Features 124
Alarm Event Log 95
Adjust Volume 90
List 107 F
Priority 106 Factory Configuration 168
Sound Level 142 First Use 33
Arrow Keys 19 Flow Rate 24, 42, 50
Auto-restart 76
G
B Glossary 164
Battery Graphics
Characteristics 140 Flow Rate History 93
Charge Level 34, 80 Pressure History 94
Full Charge Time 33 Gravity Infusion 120
Operating Mode 138
Bolus 58 H
Direct 58 Hard Limit 25
Programmed 59, 87 Homecare
Intended Products 10
C Intended Users 9
Cables 103 Warnings 13
Call-back Alert 91
Cleaning 133 I
Clinical Information Message 99 Infusion
Contraindications 12 Change Infusion Rate 52
End 61
D Monitor 50
Data Communication 103 Pause 82
Data Set 26 Program 41
Display Information 100 Start 49
Upload 22, 104 Status 20
Date / Time 96, 102 Stop 52
Day Mode 85 Infusion Modes 25, 88
Dimensions and Weight 142 Installation 27
Disinfecting 133 Intended Products 10
Dose 24, 43, 51 Intended Use 9
169
K Pressure
DPS 76
Keypad
Management 127
Description 18
Modify Limit 75
Lock / Unlock 78
Operating Range 12
Unlock Code 102
Priming
KVO 61, 65
Manual Prime 117
L Prime With Pump 68
Profile 23
Language Selection 102
Basic Profile 23
Loading Dose
Custom Profile 23
Pause 47
Display Information 74
Program 47
Select 39
Select 46
Stop 47
R
M Ramp-up / Ramp-down 25
Modify 89
Maintenance 162
Program 63
Display Information 97
Recycling 151
Reminder Message 34
Rotating Pole Clamp 28
Requirements 162
Menu
Customization 102
S
SafeClip 35, 120
List 72
Screen
Monitoring
Contrast 102
Dose 51
Display and Symbols 20, 22
Flow Rate (ml/h) 50
Logo Display 102
N Secondary Infusion 52, 87
Automatic Return 57
Navigation Buttons 21
Manual Return 56
Near End of Infusion Alert 60
Selection Keys 19
Night Mode 85
Sequential Infusion 25
Modify 89
O Program 65
OCS 34, 35
Servicing 162
Options 101
Simple Rate 25, 63
Soft Limit 25
P Override 48
Packaging 22 Software Version 173
Patient Characteristics 11, 126 Sound Levels 141
Change 84 Stop function 52
Select 44 Storage 122
Power Cord 140 Symbol Descriptions 2
Power Supply 19, 140
Powering Off 62 T
Powering On 33 T/R 25, 62
Pre-programming 71 Table of Contents 3
Temperature
Operating Range 12
Titration 52
170
Training 11
Troubleshooting 149
Trumpet Curves 143
U
Units 131
User Test 105
Users 11
V
V/R 25, 62
V/T 25, 62
V/T/R 25, 41, 62
Volume Infused 81
VTBI 77, 125
W
Warranty 152
Wi-Fi 20, 102, 104
Communication 146
Specifications 147
171
172
Release Notes
The screenshots and illustrations 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: May 2020
www.fresenius-kabi.com 0123
173
Local Contacts for Servicing
11106-6_Master_IFU_Agilia_VP_MC_Eng