Page 1 Agilia SP Agilia SP MC, Agilia SP MC WiFi, Agilia SP TIVA, Agilia SP TIVA WiFi Syringe Infusion Pumps Applicable to software version 2.2 TECHNICAL MANUAL...
Page 2 Symbol Descriptions Warning Name and address of the manufacturing facility (Refer to the Instructions for Use) Refer to the Instructions for Use Protection against electric shock: class II Product reference / part number Non-ionizing electromagnetic radiation Product serial number Fragile, handle with care Input terminal - connector This way up Output terminal - connector...
Page 3: Table Of Contents
Table of Contents INTRODUCTION ..............................6 COPE ............................6 NTENDED ........................6 RINCIPLES OF PERATION ............................ 7 NTENDED SERS ..........................7 ONTRAINDICATIONS ..........................7 NVIRONMENT DESCRIPTION .......................... 8 HYSICAL ESCRIPTION 2.1.1 Housing ..............................8 2.1.2 Keypad ............................... 9 2.1.3 Display Board ............................13 2.1.4 CPU Board ...............................
Page 4 6.2.12 Test 11: Ageing Test ..........................52 6.2.13 Test 12: Battery Life ..........................53 6.2.14 Test 13: Battery Test ..........................53 6.2.15 Test 20: Pump Code ..........................55 6.2.16 Test 21: Power Info ..........................55 6.2.17 Test 22: LCD Voltage ..........................57 6.2.18 Test 23: Temperature..........................
Page 5 12 TECHNICAL CHARACTERISTICS 12.1 ..........................132 OWER UPPLY 12.2 ............................132 ATTERY 12.3 ........................132 OWER ONSUMPTION 12.4 ........................133 OMMUNICATION 12.5 ........................ 133 NFRARED OMMUNICATION 12.6 USB C ..........................133 GILIA ABLE 12.7 ............................133 OMPLIANCE 12.8 ........................134 IMENSIONS EIGHT 12.9...
Page 6: Introduction
The size of a syringe can be 5, 10, 20, 30 or 50-60 mL The Agilia SP range can be used for intermittent or continuous infusions. The Agilia SP range is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime.
Page 7: Intended Users
While being serviced, the device must not be connected to a patient.  Do not modify the pump (except in the case of operations recommended by Fresenius Kabi). For more information, refer to the Instructions for Use of the relevant pump.
Page 8: Description
Syringe Flange Cradle Syringe Barrel Clasp Angle Bracket Plunger Driver The Agilia SP range of pumps is made up of 3 main parts: a cover, a base and an angle bracket.  The cover contains the following: - Display board - Keypad ...
Page 9 2.1.2 Keypad There are different keypads depending on the pump's model and country of destination. Figure 2.2: Keypad for Agilia SP ROW Legend Screen Infusion Indicator Lights Battery Charge Status Indicator Decrement Power Supply Indicator Fast Decrement On / Off...
Page 10 Figure 2.3: Keypad for Agilia SP MC NAM Figure 2.4: Keypad for Agilia SP MC ROW Legend Screen Decrement Battery Charge Status Indicator Fast Decrement Power Supply Indicator Confirm Value / Move to Next Field Wi-Fi Symbol (for Wi-Fi pumps only)
Page 11 Figure 2.5: Keypad for Agilia SP TIVA ROW Legend Screen Decrement Battery Charge Status Indicator Fast Decrement Power Supply Indicator Confirm Value / Move to Next Field Wi-Fi Symbol Stop Cancel Value / Move Back to Previous Field On / Off...
Page 12 Figure 2.6: Keypad for Agilia SP TIVA, Japanese market - available in 2017) Legend Screen Decrement Battery Charge Status Indicator Fast Decrement Power Supply Indicator Confirm Value / Move to Next Field On / Off Stop / Pause Bolus / Prime...
Page 13: Display Board
2.1.3 Display Board The display board is located under the front of the command panel, and contains all essential parts for human-machine interaction:  Keypad  Synoptics and control indicators  LCD screen This board is connected to other parts with the connectors shown below. Figure 2.7: Display Board Legend J1 Connector to Keypad...
Page 14 J1 Connector to Keypad Pin n° Signal Description Ground KBD_COL_0 Column 0 KBD_COL_1 Column 1 KBD_COL_2 Column 2 KBD_LINE_0 Line 0 KBD_LINE_1 Line 1 KBD_LINE_2 Line 2 TON/OFF On/Off key KBD_LINE_3 Line 3 Ground Ground Ground J2 Connector to CPU Board Pin n°...
Page 15 J3 Connector to Display Pin n° Signal Description Ground Anode of the backlight (+5V) Cathode of the backlight Ground SPI clock (HMI_SCK_SCL signal) Ground SPI data (MOSI) (HMI_MOSI_SDA signal) Ground Control/Data (0:control, 1:data) (LCD_CD signal) Ground /RST Reset (RESET/ signal) Ground Chip select (CSLCD/ signal) Ground...
Page 16: Cpu Board
2.1.4 CPU Board The CPU board consists of a main microcontroller, FLASH and RAM memories, and various analog or power functions, such as:  One single-step bipolar motor command  Adjustment of and acquisition from different detectors  Different lines of communication (synchronous and asynchronous serial links). The CPU Board is connected to the Display Board with the J3 connector.
Page 17 J1 Connector to Syringe Barrel Clasp Pin n° Signal Description Ground SW_OUT Flange switch state SW_IN Flange switch power supply DIA+ +3.3 V power supply DIA_OUT Syringe barrel clasp potentiometer value DIA- Ground J2 Connector to Displacement Linear Potentiometer Pin n° Signal Description DISP-...
Page 18 J4 Connector to Wi-Fi Board (for Wi-Fi pumps only) Pin n° Signal Description Floating Not used on Agilia VP range. Leave floating Floating Not used on Agilia VP range. Leave floating Ground Floating Not used on Agilia VP range. Leave floating Floating Not used on Agilia VP range.
Page 19 Pin n° Signal Description +5V power supply CMD_FAIL LED command failure Ground J7 to Motor Connector Pin n° Signal Description MOTP_OUT1B Output B of the coil 1 MOTP_OUT1A Output A of the coil 1 MOTP_OUT2A Output A of the coil 2 MOTP_OUT2B Output B of the coil 2 Ground...
Page 20: Power Supply Board
2.1.5 Power Supply Board The power supply board consists of he following:  An ATtiny26L secondary microcontroller associated with the one on the CPU board.  Different analog or power functions, including: - Power supply management for all boards - Battery charger - Infrared interface - Separate lines of communication (internal and external) to the boards - Speaker...
Page 21 J1 Connector to CPU Board Pin n° Signal Description Ground +5V power supply +5V power supply Ground +VCOMM Common power supply (main or external +10V) +VCOMM Common power supply (main or external +10V) Ground SO_ANA_SPEAK Speaker analog output +3V3-PERM Permanent +3.3V power supply (battery backup) Ground PWR_SCL I²C clock for POWER board...
Page 22 J3 Connector to Internal Battery Pin n° Signal Description VBAT Positive output of the smart battery BAT_DATA One-wire communication link between the SMP and the battery Ground (negative output of the smart battery) Ground Ground J4 Connector to ATtiny 26 Secondary Microcontroller Pin n°...
Page 23: Ac Power Board
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.
Page 24: Wi-Fi Board
2.1.7 Wi-Fi Board For Agilia Wi-Fi pumps only. The Wi-Fi board is securely fixed to a holder above the CPU Board. A ribbon cable connects it to the CPU Board with the J1 connector. Figure 2.14: Wi-Fi Board (Front View) Figure 2.15: Wi-Fi Board (Back View) Legend J1 Connector - Connection to CPU Board...
Page 25: Back View
2.1.8 Back View Figure 2.16: Back View Legend Release Button Power Cord Inlet Rotating Pole Clamp Infrared Cell RS232 Communication Port Attachment Lock Knob 2.1.9 Mechanical Framework Assembly The mechanical framework assembly is made up of a motor-reducer unit which drives a rack screw-nut assembly, made up of 2 flanges and a linear sensor.
Page 26: Principles Of Operation
A force sensor integrated into the plunger driver detects the force exerted on the piston, and triggers an alarm when the limit has been reached. 2.2.3 External Connection Sub-assembly The Agilia SP range of pumps has two plugs located at the back of the angle bracket. See figure 2.16, page 25.  AC power supply plug ...
Page 27: Operation Diagram
Operation Diagram Optical sensor Opening (plunger driver levers head) Plunger driver head Switch (detection) Opening arms Potentiometer Force Syringe barrel clasp sensor Switch (disengagement) Half nuts Gear Optical sensor (disengagement) Optical sensor Stepper Linear motor potentionmeter Pumping mechanism Syringe installation Position sensor Plunger head DISPLAY BOARD...
Page 28: Fundamentals
Preventive Maintenance Any abnormal functioning or failures must be reported to the qualified technical staff in your organization, or to your Fresenius Kabi representative. In these instances, the pump should not be used. Warning In order to maintain the pump’s performance, a preventive maintenance inspection must be carried out at least once every 3 years.
Page 29: Accessing / Exiting The Operating Functions
The Options menu comprises the following:  Pump Settings  Basic Profile Configuration / Basic & TCI configuration (for Agilia SP TIVA pumps only)  Profile Menu  Maintenance 3.3.1...
Page 30: Profile Menu
 Creation date  Modification date  Version Information In addition to Basic Profile, the default profile names are available if specified with Vigilant Drug'Lib. Vigilant Drug'Lib may not be available in some countries. Contact your Fresenius Kabi sales representative.
Page 31 6. Press OK to confirm the loading operation, or C to change the profile. The drug library associated with the selected profile is loaded.
Page 32: Basic Profile Configuration
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 30. Accessing the Basic Profile Configuration 1. Access the Options menu. See section 3.3, page 29. 2.
Page 33 Menu items available for Basic Profile. Volume limit Volume/Time or Dose/Time Pause Patient Wake up conc. (for Agilia SP TIVA only) TCI setup (for Agilia SP TIVA only) Programmed bolus Alarm volume Vol-dose history View event log Library information Data Set...
Page 34 Function Setting Description Range of Settings User 4: Pressure Mode Selects the mode. 3 levels / Variable  Variable: One initial pressure value that can be adjusted during infusion.  3 levels: 3 fixed pressure limits that can be selected during infusion.
Page 35 Agilia SP TIVA only). User 13: Numerical screen Displays or hides menu item: TCI Enabled / Disabled Default TCI display (For Agilia SP TIVA only). Graphical screen Enabled / Disabled Par 1: Key press sound Turns the key press sound on or off.
Page 36 Other functions bolus function. Loading dose or Activates or deactivates the Loading Enabled / Disabled Induction dose dose or Induction dose function. (Agilia SP TIVA) Programmed bolus Activates or deactivates the Enabled / Disabled Programmed bolus function. Par 20: Concentration units...
Page 37 Function Setting Description Range of Settings Par 25: Same therapy screen Displays the same therapy screen Yes / No Same therapy when changing current drug. screen Par 31: Time Sets the remaining time that triggers 30 min  Near end of infusion the Near end of infusion alert.
Page 38: Maintenance Operations
Maintenance Operations Maintenance Options 6.1.1 Accessing the Maintenance Options Menu 1. Access the Options menu. See section 3.3, page 29. 2. Press the arrow keys to select Maintenance. 3. Press enter. 4. Enter the Maintenance access code. 5. Press OK. 6.
Page 39 6.1.4 Data Log Event 1. Access the Maintenance options menu. See section 6.1.1, page 38. 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.
Page 40: Running Tests
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 66. Calibration Associated Tests  Force sensor Occlusion alarm  Syringe barrel clasp Syringe barrel clasp ...
Page 41: Test 1: Identification
6.2.2 Test 1: Identification Test Description This test checks that the Identification parameters of the pump are correct. The Identification parameters are displayed for information only. They cannot be modified here. 1. Access the Tests menu. See section 6.2.1, page 40. 2.
Page 42: Test 2: Maintenance
6.2.3 Test 2: Maintenance Test Description Run this test to check that the pump maintenance data is correct. 1. Access the Tests menu. See section 6.2.1, page 40. 2. Press the arrow keys to select Test 2: Maintenance. 3. Press enter. 4.
Page 43: Test 5: Force
6.2.6 Test 5: Force Test Description The syringe force sensor is used to monitor the pressure and detect occlusions in the syringe. Run this test to validate the accuracy of the force sensor. This test checks the pressure inside the syringe when an occlusion alarm is triggered. Force sensor Force sensor Main...
Page 44 9. Open the syringe barrel clasp, push the disengagement lever down, and move the plunger driver to the right. 10.Place the dynamometer in the syringe cradle, with the flanges correctly inserted in the provided slot. 11.Secure the dynamometer with the syringe barrel clasp. 12.Slide the arm spacer to the left.
Page 45: Test 6: Displacement
6.2.7 Test 6: Displacement Test Description The Displacement sensor is a linear potentiometer used to control the linear motion of the plunger driver and to determine the remaining volume in the syringe. Run this test to validate the accuracy of the displacement sensor. Linear potentiometer Displacement sensor...
Page 46 5. Press the arrow keys to display the Conversion/Position screen. 6. Push the disengagement lever down, and move the plunger driver gently to the right stop. 7. Check the value displayed for Position. The value must be between 4.67 in and 5.41 in (118.5 mm and 137.5 mm).
Page 47: Test 7: Syringe Barrel Clasp
6.2.8 Test 7: Syringe Barrel Clasp Test Description The Syringe barrel clasp sensor is used to maintain the syringe in the pump, to detect the good positioning of the syringe and to measure the diameter of the syringe. Run this test to check: ...
Page 48 4. Press the arrow keys to scroll through the information screens The following data is displayed:  Conversion: Sensor value in mV. The displayed voltage value depends on the syringe diameter installed  Diameter: Syringe diameter in mm. Value measured by the sensor. ...
Page 49 Figure 6.5: Installation of V4 diameter verification gauge 17.Check the value displayed for Diameter. The value must be equal to 28 mm ± 1.5 mm (1.04 in to 1.16 in). The test fails if one of these three Diameter values is outside the tolerance zone. 18.Press exit to return to the Tests menu.
Page 50: Test 8: Battery Info
6.2.9 Test 8: Battery Info Test Description This test provides information about battery usage time, voltage output, current output, and temperature. Run this test to check that the battery data is correct. The battery capacity is acceptable. If this test fails: ...
Page 51: Test 9: Indication
6.2.10 Test 9: Indication Test Description Run this test to check the correct functioning of display, battery charge status indicator, power supply indicator, infusion indicator lights, microphone and buzzer. The pump screen, indicators, microphone and buzzer work properly. If this test fails, replace the display board and LCD display. See section 8.3, page 83. Required Tools and Equipment ...
Page 52: Test 11: Ageing Test
6.2.12 Test 11: Ageing Test Test Description The Ageing test checks that the motor unit is functioning correctly by carrying out displacements between the 115 mm (4.52 in) and 20 mm (0.79 in) positions. The motor unit is functioning correctly. If the test fails, replace the motor unit.
Page 53: Test 12: Battery Life
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"). The battery capacity is acceptable. If the charge is low, connect the pump to an AC power supply to charge the battery. If the displayed "Alarm"...
Page 54 1. Access the Tests menu. See section 6.2.1, page 40. 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.
Page 55: Test 20: Pump Code
6.2.15 Test 20: Pump Code Test Description Run this test to display and modify the code which gives access to the Pump Settings from the Options menu. See section 3.3, page 29. 1. Access the Tests menu. See section 6.2.1, page 40. 2.
Page 56 1. Access the Tests menu. See section 6.2.1, page 40. 2. Press the arrow keys to select Test 21: Power info. 3. Press enter. The DC voltage is displayed:  Conversion: DC voltage conversion value (in mV)  DC voltage: DC voltage charging value (in V) 4.
Page 57: Test 22: Lcd Voltage
The CPU board works properly. If this test fails, replace the CPU board. See section 8.4, page 85. If the problem persists, contact the Fresenius Kabi Technical Service. 1. Access the Tests menu. See section 6.2.1, page 40. 2. Press the arrow keys to select Test 23: Temperature.
Page 58: Test 24: Watchdog
6.2.19 Test 24: Watchdog Test Description This test checks the status of the pump’s microprocessor (free or busy) every 2 seconds. The pump’s microprocessor is not too busy to carry out infusions correctly. If the test fails, it means that the pump’s microprocessor is too busy. An infusion is likely not to be carried out correctly.
Page 59: Test 25: Wi-Fi Module Information
6.2.20 Test 25: Wi-Fi Module Information Test Description This test displays for information the Wi-Fi parameters saved on the pump. Run this test to check that all parameters are correct. If they are not, upload the Wi-Fi configuration to the pump using Agilia Partner maintenance software.
Page 60: Checking The Pressure Limit Alarm
6.2.21 Checking the Pressure Limit Alarm Test Description Run this test to check the triggering of an occlusion alarm when the pressure downstream the pump exceeds the pressure limit stated in the Pressure management menu. Required Tools and Equipment  1 Dynamometer Prerequisites ...
Page 61: Checking The End Of Infusion Alarm
14.Press C to change the syringe. 15.Press the arrow keys to select "BD Precise 50 mL". 16.Press OK. 17.Press 18.Press the arrow keys to select 19.Select a Medium limit of 500 mmHg. (9.67 PSI or 0.67 bar). 20.Select a flow rate of 120 mL/h. 21.Start the infusion at 120 mL/h.
Page 62: Checking The Ac Power Supply / Battery Operation
This test checks the electrical safety of the pump according to the IEC 60601-1 medical electrical equipment standard. The pump is compliant with the IEC 60601-1 medical electrical equipment standard. Contact your biomedical department or your Fresenius Kabi sales representative. Required Tools and Equipment ...
Page 63: Quality Control Procedure
Quality Control Procedure 6.3.1 Running a Quality Control Print the form provided. See section 6.3.2, page 66. Run Test 2: Maintenance. See section 6.2.3, page 42.  Enter the following maintenance data in the form: - Running time in hours since last preventive maintenance date - Last preventive maintenance date ...
Page 64 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 51. Check backlight, all pump LEDs, power supply indicator, battery charge indicator. Check that the speaker and buzzer are functioning correctly.
Page 65 10. 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.
Page 66: Quality Control Certificate
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: Procedure Pass Fail Test 1: Identification and general appearance check. Pump housing, AC power cord, product code, serial number.
Page 67: Testing The Flow Rate
Testing the Flow Rate Test Description During this flow rate test an infusion is carried out at a certain flow rate, and the delivered volume is reported. The volume reported is compared to the theoretical volume, and the flow rate test is stated as passed if the calculated flow rate error is between -3 % and +3 %.
Page 68 0.4 in (1 cm) Figure 6.7: Flow rate test using a scale Legend Catheter extension bracket support Anti-vibration measuring table Scale Information Check that the installation surface is level. 2. Prime the syringe and the extension set using the key. Refer to the Instructions for Use of the relevant pump.
Page 69: Troubleshooting And Messages
Troubleshooting and Messages Alarm Messages and Information Signals Displayed Message Priority Problem / Resolution High (!!!) Technical alarm. See section 7.3, page 74. ERxx(yyyy) !!! The battery is discharged. Battery alarm !!! High (!!!) The pump will power OFF automatically within 5 minutes. ...
Page 70 (for Agilia SP TIVA). The upper soft limit for concentration is exceeded, according to High concentration Information signal the drug settings defined in the drug library (for Agilia SP TIVA). The lower soft limit for concentration is exceeded, according to Low concentration...
Page 71 Warning If the alarms persist when the pump is powered on again, do not use the device on a patient, and contact qualified biomedical engineering staff in your healthcare facility, or your Fresenius Kabi sales representative. Alarm Priority Required Operator Response Description ...
Page 72: Troubleshooting Guide
Troubleshooting Guide Description Cause Recommended Action  End of infusion detected too early (at The installed syringe doesn't Replace or confirm the right syringe brand.  approximately 10 mL). correspond to the selected Calibrate the displacement sensor using No end of infusion pre-alarm and alarm syringe.
Page 73 Then, wait few minutes without touching the keypad until the message disappears and the pump starts as usual.  - Contact your biomedical department or your Fresenius Kabi sales representative.  Mechanical elements are damaged. After a fall. Check the status of the casings and the mechanical system.
Page 74: Error Codes
Error Codes Error Code Description Recommended Actions  Motor rotation Check correct functioning of the motor.  Check the ribbon cable connection between the optical switch and the CPU board (J5 connector). See figure 2.8, page 16.  Check the correct functioning of the motor rotation optical switch. ...
Page 75 Error Code Description Recommended Actions  Syringe barrel clasp Check the syringe barrel clasp calibration. Run test 7. potentiometer See section 6.2.8, page 47.  Calibrate the syringe barrel clasp using Agilia Partner maintenance software.  If the error remains, check the cable connection to CPU board (J1 connector).
Page 76 Restart the pump.  (for Agilia SP TIVA) Program and start an infusion with a TCI profile. Please refer to the Agilia SP TIVA Instructions for Use.  LCD communication failure Replace the Display board. See section 8.3, page 83.
Page 77 Buzzer sound level too low or defective speaker (see error code 51).  Replace the Power supply board supporting the buzzer. See section 8.5, page 88.  Battery parameter in Contact the Fresenius Kabi Technical Service. coulometer EPROM  Secondary microcontroller / Contact the Fresenius Kabi Technical Service. coulometer power supply board communication ...
Page 78: 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.
Page 79: Procedure #1: Battery And Battery Door - Boost Capacitor Discharge
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 28. Dismantling 1.
Page 80 The buzzer sounds and red LEDs light during this discharge (approximately 20 minutes). 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.
Page 81: Procedure #2: Upper Case
Procedure #2: Upper Case Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged. See section 8.1, page 79.
Page 82 7. Disconnect the display board flat cable at [J2]. 8. Disconnect the display board / keypad cable (connection at [J1]). 9. Remove the 4 screws [6] that fasten the board unit to the upper case. 10.Remove the display board unit from the upper case [7]. Re-assembling 1.
Page 83: Procedure #3: Display Board/Lcd Display
Procedure #3: Display Board/LCD Display Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged. See section 8.1, page 79.
Page 84 7. Disconnect the display board flat cable at [J2]. 8. Disconnect the display board / keypad cable (connection at [J1]). 9. Remove the 4 screws [6] that fasten the board unit to the upper case. 10.Remove the display board unit from the upper case. J2 J3 11.Disconnect the display board / LCD display connection at [J3].
Page 85: Procedure #4: Cpu Board
Procedure #4: CPU Board Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged. See section 8.1, page 79.
Page 86 7. Disconnect the display board flat cable at [J2]. 8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7]. 9. Unscrew and remove the screw [6] that holds the CPU board [7] and the motor ground wire [8] to the flange.
Page 87 10.Remove the CPU board. While doing this, take care not to pull out the flat cable on the inside. 11.Disconnect the flat cable [J9]. 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.
Page 88: Procedure #5: Power Supply Board And Ac Power Board
Procedure #5: Power Supply Board and AC Power Board Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged.
Page 89 7. Disconnect the display board flat cable at [J2]. 8. Disconnect flat cable [J2]. 9. Unscrew and remove screw [4]. 10.Remove the power supply board:  Pull the board out by its corner edge to dislodge it from securing clip [5]. ...
Page 90 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.
Page 91: Procedure #6: Wi-Fi Board
Procedure #6: Wi-Fi Board Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  This procedure is only applicable to pumps equipped with a Wi-Fi module. ...
Page 92 7. Disconnect the display board flat cable at [J2]. 8. Disconnect the flat cable connected to the CPU board at [J4] (Wi-Fi board connection). 9. Unscrew and remove the screw [7] that holds the Wi-Fi board holder [8] and the motor ground wire [6] to the CPU board.
Page 93 11.Dislodge the Wi-Fi board [10] from the holder [8]. 12.Disconnect flat cable [11] from Wi-Fi board [10] (connection at [J1]). 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.
Page 94: Procedure #7: Syringe Barrel Clasp
Procedure #7: Syringe Barrel Clasp Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged. See section 8.1, page 79.
Page 95 7. Disconnect the display board flat cable at [J2]. 8. Unscrew and remove the 2 screws [6] that hold the syringe guard. 9. Remove the syringe guard [7]. 10.Disconnect the cable that connects the CPU board to displacement linear potentiometer at [J2].
Page 96 11.Push the disengagement lever [8] down and move the plunger driver to its maximum. 12.Remove the 2 plastic caps [9] using a flat screwdriver. 13.Unscrew and remove the 2 screws. 14.Unclip and remove the syringe flange cradle [10]. 15.Unscrew and remove the 2 screws [11] that hold the base. 16.Remove the base [12].
Page 97 19.Unclip and remove clip [18]. 20.Pull syringe barrel clasp kit [16] out of its base location. 21.Disconnect the syringe detector [17] from the syringe barrel clasp kit [16]. 22.Remove syringe barrel clasp kit [16] Re-assembling 1. Perform the dismantling procedure in reverse order to re-assemble the unit. Do not forget to clip part [18] into the groove of syinge barrel clasp before attaching bridle [15].
Page 98: Procedure #8: Syringe Detection System
Procedure #8: Syringe Detection System Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged. See section 8.1, page 79.
Page 99 7. Disconnect the display board flat cable at [J2]. 8. Unscrew and remove the 2 screws [6] that hold the syringe guard. 9. Remove the syringe guard [7].
Page 100 10.Disconnect the cable that connects the CPU board to displacement linear potentiometer at [J2]. 11.Push the disengagement lever [8] down and move the plunger driver to its maximum. 12.Remove the 2 plastic caps [9] using a flat screwdriver. 13.Unscrew and remove the 2 screws. 14.Unclip and remove the syringe flange cradle [10].
Page 101 17.Unscrew and remove the 2 screws [14]. 18.Remove the syringe barrel clasp bridle [15]. 19.Unscrew and remove the 2 screws [16]. 20.Unclip and remove clip [18]. 21.Pull syringe barrel clasp kit [17] out of its base location. 22.Disconnect the syringe detector [19] from the syringe barrel clasp kit [17]. 23.Remove the syringe detector [19].
Page 102: Procedure #9: Motor
Procedure #9: Motor Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged. See section 8.1, page 79.
Page 103 7. Disconnect the cable that connects the motor to the CPU board at [J7]. 8. Unscrew and remove the screw [6] that holds the motor ground wire [9] to the flange. 9. Unscrew and remove the 4 screws [7] that hold the motor [8] to the mechanical framework. 10.Remove the motor [8].
Page 104 Re-assembling 1. Place the motor in position being careful not to damage the gear wheel teeth. 2. Engage the 2 gear wheels together without forcing, and turn them slightly. 3. Tighten the 4 motor fixing screws, following the order [1], [2], [3], [4] given in the sketch below.
Page 105: Procedure #10: Disengagement Flexible Circuit
8.10 Procedure #10: Disengagement Flexible Circuit Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged. See section 8.1, page 79.
Page 106 7. Disconnect the display board flat cable at [J2]. 8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7]. 9. Unscrew and remove the screw [6] that holds the CPU board [7] and the motor ground wire [8] to the flange.
Page 107 10.Remove the CPU board. While doing this, be careful not to pull out the flat cable on the inside. 11.Disconnect the flat cable [J9]. 12.Unscrew the upper screw [9] that holds the board disengagement flexible circuit to the carriage kit [10].
Page 108 13.Removeself-locking ring [11] using a flat screwdriver. Thisself-locking ring holds the board disengagement flexible circuit to the carriage kit. 14.Disconnect the plunger driver flat cable [12] from the board [13]. 15.Unscrew and remove the screw [14] that holds the upper 1/2 band to the lower 1/2 band. 16.Dislodge the disengagement flexible circuit [15].
Page 109 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. Insert aperture [16] in spur [17]. Replaceself-locking ring [11] with a new one when assembling the board disengagement flexible circuit to the carriage kit.
Page 110: Procedure #11: Force Sensor + Ribbon Cable Kit
8.11 Procedure #11: Force Sensor + Ribbon Cable Kit Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged.
Page 111 7. Disconnect the display board flat cable at [J2]. 8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7]. 9. Unscrew and remove the screw [6] that holds the CPU board [7] and the motor ground wire [8] to the flange.
Page 112 10.Remove the CPU board. While doing this, take care not to pull out the flat cable on the inside. 11.Disconnect the flat cable [J9]. 12.Push the disengagement lever down [9] and move the plunger driver to its maximum. 13.Remove the 2 plastic caps [10] using a flat screwdriver. 14.Unscrew and remove the 2 screws.
Page 113 20.Remove theself-locking ring [16]. 21.Unscrew and remove the linking band that holds screw [17]. 22.Disconnect the flat cable [18]. 23.Remove the carriage kit [19]. 24.Remove the 2 plastic caps [20] using a flat screwdriver. 25.Unscrew then remove the 2 screws that hold the plunger cover in place. 26.Remove the plunger cover and lever kit [21].
Page 114 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:  Force sensor 3. Perform the regular servicing tests. See Quality Control Procedure, page 63.
Page 115: Procedure #12: Linear Sensor Kit
8.12 Procedure #12: Linear Sensor Kit Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged. See section 8.1, page 79.
Page 116 7. Disconnect the display board flat cable at [J2]. 8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7]. 9. Unscrew and remove the screw [6] that holds the CPU board [7] and the motor ground wire [8] to the flange.
Page 117 10.Remove the CPU board. While doing this, take care not to pull out the flat cable on the inside. 11.Disconnect the flat cable [J9]. 12.Push the disengagement lever down [9] and move the plunger driver to its maximum. 13.Remove the 2 plastic caps [10] using a flat screwdriver. 14.Unscrew and remove the 2 screws.
Page 118 20.Remove theself-locking ring [16]. 21.Remove gear wheel [17]. 22.Unscrew and remove the 3 screws [18] that hold the linearity sensor kit in place. 23.Remove the linearity sensor kit [20] being careful not to pull out the flat cable [19]. Re-assembling 1.
Page 119: Procedure #13: Plunger Cover And Lever Kit
8.13 Procedure #13: Plunger Cover and Lever Kit Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 flat screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites ...
Page 120 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:  Force sensor  Displacement 3. Perform the regular servicing tests. See Quality Control Procedure, page 63.
Page 121: Procedure #14: Plunger Kit
8.14 Procedure #14: Plunger Kit Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 flat screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged.
Page 122 7. Disconnect the display board flat cable at [J2]. 8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7]. 9. Unscrew and remove the screw [6] that holds the CPU board [7] and the motor ground wire [8] to the flange.
Page 123 10.Remove the CPU board. While doing this, take care not to pull out the flat cable on the inside. 11.Disconnect the flat cable [J9]. 12.Push the disengagement lever down [9] and move the plunger driver to its maximum. 13.Remove the 2 plastic caps [10] using a flat screwdriver. 14.Unscrew and remove the 2 screws.
Page 124 20.Remove theself-locking ring [16]. 21.Unscrew and remove the linking band that holds screw [17]. 22.Disconnect the flat cable [18]. 23.Remove the carriage kit [19]. 24.Take apart the plunger kit [20] using a rotating movement to remove the pin from the plunger cover.
Page 125: Procedure #15: Carriage Kit
8.15 Procedure #15: Carriage Kit Required Tools and Equipment  1 Torx T-10 screwdriver  1 Torx T-8 screwdriver  1 flat screwdriver  1 anti-static bracelet Maintenance level Level 3 specialist technician. See section 3.1, page 28. Prerequisites  The battery is disconnected and the boost capacitor discharged.
Page 126 7. Disconnect the display board flat cable at [J2]. 8. Disconnect the flat cables connected to the CPU board at [J1], [J2], [J3], [J5], [J6] and [J7]. 9. Unscrew and remove the screw [6] that holds the CPU board [7] and the motor ground wire [8] to the flange.
Page 127 10.Remove the CPU board. While doing this, take care not to pull out the flat cable on the inside. 11.Disconnect the flat cable [J9]. 12.Push the disengagement lever down [9] and move the plunger driver to its maximum. 13.Remove the 2 plastic caps [10] using a flat screwdriver. 14.Unscrew and remove the 2 screws.
Page 128 20.Remove the self-locking ring [16]. 21.Unscrew and remove the linking band that holds screw [17]. 22.Disconnect the flat cable [18]. 23.Remove the carriage kit [19]. 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.
Page 129: Device Storage
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...
Page 130 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.
Page 131 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...
Page 132: Technical Characteristics
Technical Characteristics 12.1 Power Supply Use the power supply cord supplied with the pump. For use in the US, it is mandatory to use an Agilia power cord compliant with USA standards and with the IEC 60227 standard. Maximum admissible apparent electrical cable network impedance: 50 Ω. The power cord conductor must have a cross section of at least 0.75 mm Power supply 100 V - 240 V ~ / 50 / 60 Hz with functional earth...
Page 133: Communication Port
12.4 Communication Port The connector located at the back of the device allows data communication with a PC. Serial Cable TTL output Power Input 10 V / 15 W to power supply the product Power Output 5 VDC / 150 mA to power Agilia USB cable 12.5 Infrared Communication The pump is equipped with an infrared cell located at the back of the device.
Page 134: Dimensions - Weight
Screen Size 70 x 35 mm (2.7 x 1.4 in) 12.9 Electronic Boards The Agilia SP MC, Agilia SP MC WiFi and Agilia SP TIVA pumps are equipped with 4 electronic boards:  Power supply board  AC Power board ...
Page 135: Specifications
Specifications Refer to the Instructions for Use of the relevant pump for the following information:  Infusion Rate  Volume To Be Infused (VTBI)  Infusion Tme  Flow Rate Accuracy  Occlusion Alarm Response Time  Occlusion Alarm Threshold ...
Page 136: Recycling
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.
Page 137: Warranty
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...
Page 138: Guidance And Manufacturer's Declaration On Emc
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 ...
Page 139: Spare Parts Catalog
Spare Parts Catalog Refer to the spare parts catalog of the relevant pump.
Page 140: Ordering Information
Ordering Information For more information, contact your Fresenius Kabi sales representative. 18.1 Data Management Cables Refer to the Instructions for Use of the relevant pump 18.2 Associated Software Refer to the Instructions for Use of the relevant pump 18.3 Disposables...
Page 141: Glossary Of Terms
Glossary of Terms Term Description Amperes Alternating Current Ampere-hours Amplitude Modulation Body Surface Area Critical Care Unit Centers for Disease Control Clinical Information System CISPR Special International Committee on Radio Interference CT Scan Computed Tomography Decibels Direct Current DECT Digital Enhanced Cordless Telecommunications DEHP Di(2-ethylhexyl) phthalate DERS...
Page 142 Term Description Intravenous Kilograms Keep Vein Open Pounds Light Emitting Diode Least Significant Bit Milliamperes Milliequivalents mL/h Milliliters per hour mmHg Millimeters of Mercury Metal Oxyde Semiconductor Magnetic Resonance Imaging mW/sr Milliwatts per steradian North America NICU, PICU Neonatal and Pediatric Intensive Care Units Nuclear Magnetic Resonance Occlusivity Check System Operating Room...
Page 143 Term Description VTBI Volume to Be Infused Watts...
Page 144 Index AC Power Board Maintenance Description 23 Date 38 Dismantle/Re-assemble 88 Display Startup Screen 39 Ageing Test 52 Schedule 28 Alarms 69 Maintenance Options Menu 38 Maintenance Test 42 Material Characteristics 134 Motor 102 Basic Profile Configuration 32 Battery Dismantle/Re-assemble 79 Test 50 Operation Diagram 27 Options Menu 30...
Page 145 Watchdog 58 Wi-Fi Board Description 24 Dismantle/Re-assemble 91 Wi-Fi Module Information 59...
Page 146 ® ® 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.
Page 147 Local Contacts for Servicing Write your contacts here:...
Page 149 Agilia SP MC Agilia SP MC WiFi Syringe Infusion Pumps Applicable to software version 2.2 INSTRUCTIONS FOR USE For use in healthcare facilities...
Page 150 Symbol Descriptions Warning Name and address of the (Refer to the Instructions for Use) manufacturer / Date of manufacture Name and address of the Refer to the Instructions for Use manufacturing facility Protection against electric shock: Product reference / part number class II Non-ionizing electromagnetic Product serial number...
Page 151 Table of Contents INTRODUCTION ....................9 COPE ..................9 NTENDED ..............10 RINCIPLES OF PERATION ............10 NTENDED RODUCTS TO BE NFUSED ..................11 NTENDED SERS ................11 NTENDED ATIENTS ................12 ONTRAINDICATIONS ................13 NVIRONMENT AGILIA CONNECT INFUSION SYSTEM DESCRIPTION ..................15 RONT ) ........15 OTTOM EVICE DENTIFICATION ABEL ...................16 ....................17...
Page 152 4.4.4 Infusion Modes ................... 25 .....................25 INSTALLATION ..............26 YPES OF NSTALLATIONS ............27 SING THE OTATING LAMP ) ..............29 TTACHING THE PUMP 5.3.1 Attaching to a Pole ................29 5.3.2 Attaching to a Rail ................29 5.3.3 Using on a Flat Table ................. 30 5.3.4 Attaching Two Pumps Together ............
Page 153 7.10.2 End of Infusion ................... 58 7.10.3 Powering off ..................58 7.11 ..................59 NFUSION ODES 7.11.1 Simple Rate..................59 7.11.2 Volume/Time & Dose/Time ..............59 7.11.3 Volume Limit..................60 7.12 ................62 THER UNCTIONS 7.12.1 Priming the Syringe and the Extension Set........62 7.12.2 Pre-programming the Pump ...............
Page 154 OPTIONS ..................90 OMMANDS .................90 PTION ESCRIPTIONS ...................91 ETTINGS 10 DATA COMMUNICATION 10.1 ....................92 VERVIEW 10.2 .............92 OMMUNICATION VIA GILIA ABLES 10.3 ..............93 OMMUNICATION VIA 10.4 ................94 PLOAD 11 USER TEST 12 ALARMS AND SAFETY FEATURES 12.1 ..................96 NTRODUCTION 12.2 ................96 LARM ESCRIPTIONS 12.3...
Page 155 15.3 (VTBI) ............111 OLUME NFUSED 15.4 (DTBI) .............112 NFUSED 15.5 ..................112 NFUSION 15.6 ................112 ONCENTRATION 15.7 ..................113 ATIENT 15.8 ..............113 RESSURE ANAGEMENT 15.9 ..................114 CCURACY 15.10 U ............116 NITS AND ONVERSION ULES 16 CLEANING AND DISINFECTING 16.1 ........118 HEN TO LEAN AND ISINFECT THE 16.2...
Page 156 20 TROUBLESHOOTING 21 RECYCLING 22 WARRANTY 22.1 ............136 ENERAL ARRANTY ONDITIONS 22.2 ................136 IMITED ARRANTY 22.3 ........136 ARRANTY ONDITIONS FOR CCESSORIES 23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 23.1 ..........137 LECTROMAGNETIC OMPATIBILITY 23.2 (ESD) ............138 LECTROSTATIC ISCHARGE 23.3 .138 LECTROMAGNETIC OMPATIBILITY AND NTERFERENCE UIDANCE...
Page 157: Introduction
Introduction Scope These Instructions for Use (IFU) are applicable to the Agilia SP MC and Agilia SP MC WiFi pumps. These devices are referred to throughout this manual as the "Agilia SP MC". The user must adhere to the instructions specified in this IFU. Failure to adhere to these instructions may result in damage to the equipment, injury to patients or injury to users.
Page 158: Principles Of Operation
The size of a syringe can be 5, 10, 20, 30 or 50-60 mL. Agilia SP MC can be used for intermittent or continuous infusions. Agilia SP MC is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime.
Page 159: Intended Users
It is recommended that users attend a refresher training session of about 20 minutes every year. For training, contact your Fresenius Kabi sales representative. Intended Patients Agilia SP MC is intended to be used according to healthcare facilities protocols on patients with the following characteristics: Patient Characteristics Male...
Page 160: Contraindications
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 ...
Page 161: Use Environment
Use Environment Agilia SP MC is intended for use in healthcare facilities, under the supervision of trained healthcare personnel. The pump must be used in the following operational conditions to ensure proper performance:  Operating temperature range: 5 °C to 40 °C ...
Page 162: Agilia Connect Infusion System
Agilia VP range infusion container (bag or bottle) through a line connected to a patient. Pump Syringe Infusion Pump Agilia SP range Pumps designed to deliver the contents of a syringe through a line connected to a patient. Medication Safety Software Agilia Software designed to create, customize and manage data Vigilant Drug’Lib...
Page 163: Description
Description Front View Figure 3.1: Front View Legend Handle Plunger Driver Syringe Barrel Clasp Disengagement Lever Syringe Flange Cradle Syringe Guard Bottom View (Device Identification Label) For more information on device identification label symbols, see Symbol Descriptions, page 2.
Page 164: Back View
Back View Figure 3.2: Back View Legend Release Button Power Cord Inlet Rotating Pole Clamp Infrared Cell RS232 Communication Port Attachment Lock Knob Symbol Location Description Warning See section 18, page 124. Near Power Cord Inlet Warning Near RS232 See section 10, page 92. Communication Port...
Page 165: Keypad
Keypad 3.4.1 Keypad Description Figure 3.3: Keypad Legend Screen Decrement 3 7 10 Battery Charge Status Indicator 3 11 Fast Decrement Power Supply Indicator 3 12 Confirm Value / Move to Next Field Wi-Fi Symbol 3 13 Stop On / Off Cancel Value / Move Back to Previous 3 14 Field...
Page 166 3.4.2 Keypad Details 3.4.2.1 Selection Keys Description Arrow Keys Keys for selecting volume, time, flow rate and other values. Fast Access to Maximum Value or Top of a List Fast Access to Minimum Value or Bottom of a List Note: ...
Page 167: Display And Symbols
Display and Symbols 3.5.1 Infusion Status Symbol Description Infusion in Progress (Basic Profile + Custom Profiles with a drug list) Symbols for infusion in progress. Infusion in Progress (Custom Profiles with a drug library) This symbol is displayed when the pump is infusing a drug customized with Agilia Vigilant Drug’Lib software.
Page 168: Navigation Buttons
3.5.3 Navigation Buttons Symbol Description start Start Confirm enter Access Function New ? Access Function and Clear Settings exit Exit Function Change Selection prog Program Function Select / Unselect See More Information Zoom in / Zoom out Move the Event Marker to the Left / Right 3.5.4 Alarms and Safety Features Symbol...
Page 169: Packaging
Packaging The Agilia SP MC packaging contains the following:  1 Agilia SP MC pump  1 Instructions for Use manual (this document + System Components booklet)  1 Power cord Packaging weight: Approximately 530 g. Packaging consists of: Recycled cardboard, expanded foam.
Page 170: Fundamentals
Fundamentals 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.
Page 171: Drug Libraries
4.1.2 Custom Profiles Custom profiles can be configured and loaded to the pump with Agilia Vigilant Drug’Lib software. A custom profile contains the following:  a specific device configuration (pump settings that control the mechanical functions of the pump such as alarm volume, and so ...
Page 172: Drug Lists
Drug Lists A drug list is a list of drugs that does not include limits on drug infusion rates. 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: ...
Page 173: Infusion Modes
4.4.4 Infusion Modes An infusion can be started according to the following modes: Infusion Rate Infusion Mode Description Flow Rate Dose Simple Rate Infusion with a programmed rate   Volume/Time Infusion of a programmed volume or dose over a ...
Page 174: Installation
Installation Types of Installations A pump can be installed on any of the following: Location Comments  See section 5.3.1, page 29. On a Pole Pole specifications:  Diameter: from 15 to 40 mm  See section 5.3.2, page 29. On a Rail Rail specifications: ...
Page 175: Using The Rotating Pole Clamp
Location Comments  Refer to the Agilia Holder Ambulance accompanying documents. In an Agilia Holder Ambulance Do not use accessories that appear to be damaged. For more information on accessories, refer to their respective accompanying documents. Warning  The pump must be used in a horizontal and stable position to function properly.
Page 176 5.2.2 Using the Rotating Pole Clamp You can secure the rotating pole clamp vertically or horizontally by folding it outward until the release button clicks into the locked position. 5.2.2.1 Folding the Clamp Down (outward) You can fold the clamp down as follows: 1.
Page 177: Attaching The Pump(S)
Attaching the pump(s) 5.3.1 Attaching to a Pole 1. Fold the pole clamp down to the horizontal position: see section 5.2.2.1, page 28. 2. Unscrew the clamp, attach to the pole, and screw the clamp until the pump is fully secured to the pole. 3.
Page 178: Using On A Flat Table
5.3.3 Using on a Flat Table 1. Fold the pole clamp up: see section 5.2.2.2, page 28. 2. Place the pump far enough from the table's edges to prevent it from accidentally being pushed off. 5.3.4 Attaching Two Pumps Together You can attach two pumps together either for transport, or before fixing them to a pole.
Page 179: Getting Started
Getting Started Flowchart Once the pump is installed at the bedside, you must follow the steps below in order to install a syringe and power on the pump. Preparing and priming the syringe and the extension set Section 13.2, page 106. Powering on Section 6.3, page 32.
Page 180: Using The Pump For The First Time
Using the Pump for the First Time 1. Make sure the pump is correctly installed at the bedside. See section 5, page 26. 2. Plug the pump into the AC power supply. See section 17.1, page 122. 3. Before starting the pump for the first time, you must charge the battery for approximately 6 hours.
Page 181 Screen After Powering on Description Startup screen: the following information is displayed:  Product name / Ward name  Wi-Fi module status (if applicable)  Date & time  The pump is operating on battery. The symbol shows three different charge levels: <...
Page 182: Installing A Syringe
Screen After Powering on Description  Data Set information (optional) Installing a Syringe Warning This must only be done when the patient is not connected. 1. Open the syringe barrel clasp [A]. 2. Push the disengagement lever [B] down and move the plunger driver to the right.
Page 183: Pump Height
Pump Height Warning Ideally, the syringe pump should be level with the distal tip of the catheter (e.g., the site of fluid delivery; if accessing a central line the syringe pump should be at the level of the patient’s heart). If the pump height is raised relative to the distal tip of the catheter (e.g., during patient transport), the increase in height of the syringe pump can result in a temporary increase in fluid delivery or bolus until the flow rate...
Page 184: Operation
Operation Flowchart Selecting a Profile Section 7.2, page 37. Custom Profile Custom Profile Basic Profile (with a Drug Library) (with a Drug List) Section 4.1.1, page 22. Section 4.1.2, page 23. Section 4.1.2, page 23. Selecting the Selecting the Infusion Rate Infusion Rate Section 7.3, page 38.
Page 185: Selecting A Profile
Selecting a Profile You can only select a profile if more than one profile is loaded in the pump. 1. Press to power on the pump. 2. Press the arrow keys to select a profile that corresponds to the target group of patients. (lighthouse) symbol refers to custom profiles that contain drug libraries and have been configured with Agilia Vigilant Drug’Lib software.
Page 186: Selecting The Infusion Rate (Flow Rate Or Dose)
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.
Page 187: Selecting A Syringe
Selecting a Syringe The pump automatically detects the size of the installed syringe. 1. Press OK to confirm the displayed syringe, or C to change it. 2. If you have chosen to select another syringe, press the arrow keys to select a new syringe. 3.
Page 188: Selecting A Drug
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:                ...
Page 189: Programming An Infusion
Programming an Infusion  This section describes the programming of an infusion with the Simple Rate infusion mode.  You can also program an infusion with the following modes: - Volume/Time (or Dose/Time), see section 7.11.2, page 59. - Volume Limit, see section 7.11.3, page 60. 7.6.1 Programming an Infusion by Flow Rate 1.
Page 190 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:...
Page 191 Authorized Concentration Range Authorized Finite Concentrations Legend Unauthorized Range Hard Limits Authorized Range Default Value Finite Values Selecting the Drug Concentration Range Finite values 1. Press the arrow keys to select the concentration. 2. Press OK to confirm.
Page 192 7.6.2.2 Selecting the Patient’s Characteristics Note: This step is only applicable with custom profiles that contain a drug library. Weight Body Surface Area 1. Press the arrow keys to enter the patient's weight or body surface area. 2. Press OK to confirm. Information ...
Page 193 7.6.2.4 Programming the Infusion 1. Press the arrow keys to program the dose rate value. 2. Press OK to confirm. 7.6.2.5 Programming a Loading Dose Note: This feature can be activated or deactivated in Agilia Vigilant Drug’Lib software (custom profiles). Information The loading dose is only available with the first start of an infusion.
Page 194 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.
Page 195: Programming Beyond Soft Limits
Interrupting a Loading Dose 1. To pause the loading dose, press The screen displays Continue? 2. Choose one of the following options:  Press no or to stop the loading dose and proceed to the programmed infusion.  Press start to continue with the loading dose. 7.6.3 Programming Beyond Soft Limits Note: This step is only available with custom profiles that contain a drug...
Page 196 Overriding a Soft Limit 1. If you reach a soft limit when programming an infusion, the pump displays a message at the top of the screen:  = the upper soft limit is exceeded Upper soft max  = the lower soft limit is exceeded Lower soft min Flow rate Dose...
Page 197: Starting An Infusion
Starting an Infusion Flow rate Dose 1. Check the delivery path integrity, (syringe and access device). 2. Check that there is no air in the syringe or in the extension set. 3. Confirm that the syringe is correctly installed in the pump. 4.
Page 198: Monitoring An Infusion
Monitoring an Infusion 7.8.1 Monitoring an Infusion when Programmed by Flow Rate Legend Drug Name (Custom profiles only) Infusion Flow Rate (mL/h) To change the flow rate during an infusion, see section 7.9.2, page 52. The flow rate is displayed with the largest font size. Infusion Duration At the current rate, the remaining infusion time in hours and minutes.
Page 199 7.8.2 Monitoring an Infusion when Programmed by Dose Legend Drug Name (Custom profiles only) Dose To change the dose during an infusion, see section 7.9.2, page 52. Dose is displayed with the largest font size. Drug Concentration Infusion Flow Rate Syringe Name / Ward Name (configurable) Patient Characteristics Custom Profile Sign...
Page 200: Functions During Infusion
Functions During Infusion 7.9.1 Stop Flow rate Dose To stop the infusion, press After 2 minutes, an alarm is generated as a reminder that the infusion is stopped. To restart the infusion, first confirm or modify the programming settings, then start the infusion. See section 7.6, page 41. 7.9.2 Rate Titration You can adjust the infusion rate (flow rate or dose) during the infusion.
Page 201: Administering A Bolus
7.9.3 Administering a Bolus A bolus is an extra dose that a pump can deliver during an infusion. There are two ways to deliver a bolus dose during an infusion:  Direct bolus  Programmed bolus Direct Bolus Programmed Bolus Access Key Occlusion Set to its maximum value: 900 mmHg / 120 kPa / 17.4 PSI...
Page 202 7.9.3.1 Direct Bolus Note: This feature can be activated or deactivated in Agilia Vigilant Drug’Lib software (custom profiles) or in the pump options (Basic profile). 1. During the infusion, press 2. Press bolus to confirm access to bolus function. 3. To administer a direct bolus, press and hold 4.
Page 203 7.9.3.2 Programmed Bolus Note: This feature can be activated or deactivated in Agilia Vigilant Drug’Lib software (custom profiles) or in the pump options (Basic profile). During the infusion, you can program a bolus in one of the following two ways: ...
Page 204 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.
Page 205: Completing An Infusion
7.10 Completing an Infusion 7.10.1 Near End of Infusion Alert Prior to the end of an infusion, a near end of infusion alert is automatically triggered. The following happens:  An audible alarm is triggered.  An alarm message appears on the pump screen. ...
Page 206: End Of Infusion
7.10.2 End of Infusion When the infusion is complete, the following happens:  An audible alarm is triggered.  An alarm message appears on the pump screen.  The infusion indicator lights flash red. End of infusion settings are configurable with Agilia Vigilant Drug’Lib software (custom profiles), or in the pump options (Basic Profile).
Page 207: Infusion Modes
7.11 Infusion Modes You can program an infusion with the different infusion modes available, depending on the pump configuration, and on the selected drug. 7.11.1 Simple Rate 1. Press the arrow keys to select the infusion rate. 2. Press OK. For more information, see section 7.6, page 41.
Page 208: Volume Limit
3. Press the arrow keys to set the infusion time, and press OK. The infusion rate is automatically readjusted. 4. Press the arrow keys to configure the end of infusion settings and press OK to confirm.  Stop: The infusion stops when the VTBI is completed. ...
Page 209 Information  If you program a volume limit that exceeds the actual volume in the syringe, make sure to replace the syringe when it is empty, see section 13.3.2, page 106.  The volume already infused (VI) before accessing the volume limit mode is taken into account.
Page 210: Other Functions
7.12 Other Functions 7.12.1 Priming the Syringe and the Extension Set Note: The prime function can be configured with Agilia Vigilant Drug’Lib (custom profiles) or in the pump options (Basic profile):  Mandatory: A message is displayed and the user is required to prime the line before infusion.
Page 211 5. Press and hold the key to prime. 6. To end priming, release the key. 7. Make sure there is no air in the extension set. Information  Priming is only accessible prior to starting the infusion.  key is not active when the menu screen is displayed. ...
Page 212: Pre-Programming The Pump
7.12.2 Pre-programming the Pump You can program the pump before installing the syringe. 1. Press to power on the pump. is displayed on top of the pump Syringe installation !!! screen. 2. Make sure the syringe barrel clasp is folded up against the pump. The prog symbol is displayed.
Page 213: Menus
Menus Overview 8.1.1 Commands Operation Access menu or exit menu Select Confirm (corresponds to enter on the screen) Select  / Deselect  8.1.2 Menu Description Stop Menu Symbol Infusion Associated Procedure Required  Profile Displaying active profile information, page 66. ...
Page 214: Profile
Stop Menu Symbol Infusion Associated Procedure Required  View flow rate history Viewing flow rate history, page 81.  View pressure history Viewing pressure history, page 82.  Syringe Displaying on-pump syringe information, page 83.  View event log Viewing the event log, page 84. ...
Page 215: Pressure
Pressure Symbol Procedure Modifying the pressure limit The pump pressure limit is pre-defined in the pump options in one of the following modes:  3 levels (low , medium , high The pressure limit is adjustable according to 3 pre-set values. ...
Page 216 You can modify the pressure limit as follows: 1. Open the pressure menu in one of the two following ways:  Press  Through the Menu: - Press - Press the arrow keys to select 2. Press enter to access the pressure limit screen. 3.
Page 217 Warning To avoid the presence of air and to minimize the amount of time it takes the pump to recognize an occlusion and generate an alarm while infusing at low rates (e.g., less than 5 mL per hour, and especially flow rates less than 0.5 mL per hour): ...
Page 218: Keypad Lock Status
Keypad Lock Status Symbol Procedure Locking / Unlocking the keypad You can use this feature to avoid inadvertent key presses. Note: The following features can be activated or deactivated in the pump options:  Automatic lock: The keypad will lock automatically at infusion start, or after a time-out.
Page 219 4. Lock the keypad as follows:  Press to lock the keypad. The keypad is locked and the screen displays  Press to activate the automatic lock. The keypad will lock automatically at infusion start. If the keypad is unlocked during the infusion, it will lock again automatically after a time-out.
Page 220: Battery Life
Information  keys remain functional when the keypad is locked.  During keypad lock, the key is functional when the infusion is stopped.  During keypad lock, the key is functional when an alarm occurs, or at the end of infusion. ...
Page 221: Volume Infused / Dose Infused
Volume Infused / Dose Infused Symbol Procedure Viewing and clearing the volume or dose infused Flow rate Dose You can view and clear the volume or dose infused as follows: 1. Press 2. Press the arrow keys to select The total volume, or total dose, infused includes the programmed infusion, loading doses and boluses.
Page 222: Pause
Pause Symbol Procedure Programming a pause You can program a pause as follows: 1. Press to stop the infusion. 2. Press 3. Press the arrow keys to select 4. Press enter. 5. Press the arrow keys to program the pause duration in hours and minutes, and press OK.
Page 223: Programmed Bolus
Programmed Bolus Symbol Procedure Programming a bolus To program a bolus, see section 7.9.3.2, page 55. Patient Symbol Procedure Changing a patient’s weight or body surface area Information  If the selected dose rate unit is weight-based (kg), the screen displays the patient’s weight.
Page 224: Day/Night Mode
You can change the patient’s weight or body surface area as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. 4. Press OK to change the patient’s weight or body surface area. 5. Press OK to confirm the infusion settings. 8.10 Day/Night Mode Symbol...
Page 225 4. Press to activate night mode. The screen displays 5. Press OK to confirm. Switching from Night Mode to Day Mode You can switch to day mode as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. 4.
Page 226: Volume/Time & Dose/Time
8.11 Volume/Time & Dose/Time Symbols Procedure Programming a Volume/Time or Dose/Time infusion Volume/Time Dose/Time 1. Press 2. Press the arrow keys to select 3. Press enter. For more information on how to program a Volume/Time or Dose/Time infusion, see section 7.11.2, page 59. 8.12 Volume Limit Symbol...
Page 227: Alarm Volume
1. Press 2. Press the arrow keys to select 3. Press enter. For more information on how to program a Volume Limit infusion, see section 7.11.3, page 60. 8.13 Alarm Volume Symbol Procedure Adjusting the alarm volume You can adjust the alarm volume as follows: 1.
Page 228: Volume-Dose History
8.14 Volume-Dose History Symbol Procedure Viewing the infusion history This function allows the user to view the infusion history on the pump. You can view the infusion history as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. 4.
Page 229: View Flow Rate History
8.15 View Flow Rate History Symbol Procedure Viewing flow rate history This function allows the user to check the current infusion’s history information in order to verify the dose administered. You can view flow rate history as follows: 1. Press 2.
Page 230: View Pressure History
8.16 View Pressure History Symbol Procedure Viewing pressure history This function allows the user to check the current infusion’s history information in order to verify changes in pressure. You can view pressure history as follows: 1. Press 2. Press the arrow keys to select 3.
Page 231: Syringe
8.17 Syringe Symbol Procedure Displaying on-pump syringe information You can display on-pump syringe information as follows: 1. Press 2. Use the arrow keys to select 3. Press enter. The following information is displayed: - Syringe capacity - Syringe brand / name...
Page 232: View Event Log
8.18 View Event Log Symbol Procedure Viewing the event log The event log displays details of the last events that occurred on the pump. Events are stored in the log even after the pump is powered off and on again. The log can store up to 1500 events. Older events are overwritten.
Page 233: Date / Time
6. Press exit to return to the previous screen. 8.19 Date / Time Symbol Procedure Setting the date and time You can set the date and time as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. 4.
Page 234: Maintenance
8.20 Maintenance Symbol Procedure Displaying maintenance information You can display maintenance information as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. 4. Press the arrow keys to scroll through the maintenance information. The following information is displayed: ...
Page 235: Library Information
8.21 Library Information Symbol Procedure Displaying drug library information You can display drug library information as follows: 1. Press 2. Press the arrow keys to select The number of drugs contained in the drug library is displayed. 3. Press enter. All the drugs contained in the drug library are displayed.
Page 236: Clinical Information
8.22 Clinical Information Symbol Procedure Viewing remaining time before clinical information display If configured for the selected drug with Agilia Vigilant Drug’Lib, a protocol message will be displayed on the pump screen after a pre- defined period of time. You can view the remaining time before clinical information display as follows: 1.
Page 237: Data Set
8.23 Data Set Symbol Procedure Displaying active data set information You can display active data set information as follows: 1. Press 2. Press the arrow keys to select 3. Press enter. The active data set information is displayed.
Page 238: Options
Options Commands Operation Options access Option selection Confirm (corresponds to enter on the screen) Select  / Deselect  Selected current values are stored when the device is powered off after programming. To return to the normal menus, power off then power on again. Option Descriptions Four different option groups are available on the pump.
Page 239: Pump Settings
Pump Settings The following options have different functions that you can select or deselect to customize your Agilia SP MC. Default Function Choice Pump Setting  Maintenance: display or hide maintenance Disabled [User 2]: Menu items  Date / Time: display or hide date/time menu Disabled ...
Page 240: Data Communication
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.
Page 241 10.2.2 Using the Communication Port 1. Remove the protective cap from the pump’s RS232 communication port. 2. Connect the cable to the RS232 communication port by turning the cable wheel. Information Do not disconnect communication cables while data is being transferred. 10.3 Communication via Wi-Fi The Wi-Fi option allows the pump to connect to a hospital information...
Page 242: Data Set Upload
10.4 Data Set Upload A new data set may be uploaded to the pump while it is infusing. The new data set will be installed at the next pump start-up. When a new data set has been uploaded since the last start-up of the pump, the symbol is displayed on the screen.
Page 243: User Test
User Test The following protocol provides the user with a quick integrity check guide to ensure that the pump system is functional. Perform this user test before each use of the pump. 1. Check the external appearance of the pump for the absence of cracks or other visible damage.
Page 244: Alarms And Safety Features
Alarms and Safety Features 12.1 Introduction Agilia SP 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.
Page 245: General Remarks
12.3 General Remarks  When two alarms occur at the same time, the higher priority alarm is displayed.  When two alarms with the same priority level are triggered at the same time, the pump software assigns them a priority. ...
Page 246 12.4.2 Volume Limit Alarms Stops Message Priority Problem / Resolution Infusion? End of volume High (!!!) The volume limit is reached. limit !!! The time remaining is less than the defined time duration (adjustable between 1 and Near end of volume Medium (!!) 30 minutes), and the remaining VTBI until the limit !!
Page 247 Stops Message Priority Problem / Resolution Infusion? The infusion settings have been entered, but have not been confirmed with start. Medium (!!) Waiting start !!  Check the infusion settings, and press start to start the infusion. Information The upper soft limit is exceeded, according to Upper soft max signal the drug settings defined in the drug library.
Page 248 12.4.6 Battery Alarms Stops Message Priority Problem / Resolution Infusion? The battery is discharged.  The pump will power OFF automatically High (!!!) within 5 minutes. Battery alarm !!!  Connect the pump to a power supply immediately. Very low battery. ...
Page 249 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.
Page 250 12.4.10 Audio-only Information Signals Stops Type Comment Activation Infusion? Beep until key is Switch mode Beep starts when action is not allowed released End of loading dose 3 beeps At the end of the loading dose End of programmed 3 beeps At the end of a programmed bolus bolus Start infusion at the end...
Page 251: Syringes
13.1 Syringe List Information  Agilia SP pump offers a maximum 100 syringes of different types, brands and sizes. For a list of compatible syringes, and for ordering information, refer to the System Components booklet.  The list of available syringes on your pump is accessible from the pump options.
Page 252 13.2 Preparing a Syringe 1. Prepare the fluid to be infused according to your healthcare facility’s protocol. 2. Select a syringe. 3. Check the syringe and access device integrity. 4. Connect the extension set to the syringe according to local practices. 5.
Page 253 Precautions for the use of extension sets  Use extension sets which have the smallest internal volume or “deadspace” to minimize residual volumes between the syringe and the patient 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).
Page 254: Operations Fors
13.3 Operations for Syringes 13.3.1 Removing a Syringe 1. Press to stop the infusion. 2. Disconnect the patient. 3. Open the syringe barrel clasp. 4. Press to silence the audible signal for 2 minutes. 5. Push the disengagement lever down and remove the syringe from its cradle.
Page 255: Gravity Infusion In
Figure 13.1: Gravity Infusion (in parallel with a pump) Information  Fresenius Kabi recommends the use of a back check valve or positive pressure infusion devices when an infusion on the pump is connected to a gravity line. This will prevent the back-up of IV fluid or medication into the gravity line.
Page 256: Device Storage
Device Storage 14.1 Precautions for Storage  Handle the device with care during storage.  Store the device in a cool, dry place. The storage area must be clean and organized.  Clean and disinfect the device prior to storage. Warning If the device is not used for an extended period (longer than 2 months), it is recommended that the battery be removed from the device and put...
Page 257: Preparing Thed
14.3 Preparing the Device for Storage Prepare the device for storage as follows: 1. Power the pump OFF and remove the disposable. 2. If necessary (long-term storage), disconnect the pump’s power cord and all data communication cables. 3. Remove the pump from its mounting point. 4.
Page 258 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).
Page 259: Essential Features 15.2 Flow Rate
15.2 Flow Rate Syringe Minimum Format 50 mL Increment 30 mL 20 mL 10 mL 5 mL 60 mL 0.01 (0.10  9.99) Infusion Rate mL/h      (10.0  99.9) 1200 (100  1200) Direct Bolus* mL/h ...
Page 260: Dose T O B E Infused
15.4 Dose To Be Infused (DTBI) Default Minimum Format Range of Settings Value Increment 0.001 (0.010  4.999) 0.01 (5.00  9.99) Dose Unit 0.01 9999  (10.0  99.9) (100  9999) 0.01 (0.01  9.99) Programmed Bolus Unit 0.01 9999 (10 ...
Page 261: Patient Data
15.7 Patient Data Default Minimum Format Range of Settings Value Increment 0.01 (0.25  9.99) Patient Weight 0.25  (10.0  19.9) (20  350) Patient Body m² 0.05 0.01  Surface Area 15.8 Pressure Management Setting Description Setting Format Default Value Mode Infusion pressure mode.
Page 262: Accuracy
15.9 Accuracy Warning Accuracy (flow rate, time, volume infused, pressure) can be influenced by syringe model, syringe configuration, extension set configuration, fluid viscosity, and fluid temperature. Note: All tests below are in accordance with the IEC 60601-2-24 standard and ANSI/AAMI ID26. Values are representative of syringes used during internal tests and are provided as indicators only.
Page 263 15.9.4 Volume Accuracy Warning Accuracy may be reduced when the infusion flow rate is below 1 mL/h. Accuracy Direct Bolus* ≤ 10 mL: ± 0.2 mL > 10 mL: ± 3% Programmed Bolus* Bolus Volume at Occlusion Release Syringe** Rate Bolus Volume at Occlusion 50 mmHg 900 mmHg...
Page 264: Units Andc
15.10 Units and Conversion Rules 15.10.1 Concentration Units Units Suffix nanog, microg, mg, g mmol Concentration mUnit, Unit /mL, /--mL Units cal, kcal 15.10.2 Dose Units Units nanog/h, nanog/kg/min, nanog/kg/h microg/min, microg/h, microg/kg/min, microg/kg/h mg/min, mg/h, mg/24h, mg/kg/min, mg/kg/h, mg/kg/24h, mg/m²/h, mg/m²/24h g/h, g/kg/min, g/kg/h, g/kg/24h Dose Units...
Page 265 15.10.3 Conversion Rules 1 micro unit = 1000 nano unit 1 m unit = 1000 micro unit 1 k unit = 1000 unit 1 unit/h = 24 unit/24 h 1 unit/min = 60 unit/h Conversion of a dose unit/kg/h (dose) × kg (weight) mL/h = including the unit/kg into unit/mL (concentration)
Page 266: Cleaning And Disinfecting
Cleaning and Disinfecting To avoid the risks of infection and microbial transmission, make sure to adequately clean and disinfect the equipment. Warning  The disinfecting procedure must be done immediately after cleaning. Disinfecting the pump without prior cleaning is not effective.
Page 267: Instructions For
16.2 Recommended and Prohibited Agents We recommend the following cleaning and disinfecting agents: 16.2.1 Recommended Agents Recommended Agent Didecyldimethylammonium chloride Cleaning (example: Wip’Anios Excel by Anios) Didecyldimethylammonium chloride Disinfecting (example: Wip’Anios Excel by Anios) 16.2.2 Prohibited Agents The following cleaning and disinfecting agents are prohibited: ...
Page 268 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.
Page 269 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.
Page 270: 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.
Page 271: Battery Operating
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.
Page 272: Technical Characteristics
Technical Characteristics 18.1 Power Supply It is mandatory to use an Agilia power cord compliant with USA standards and with the IEC 60227 standard. The power cord conductor must have a cross section of at least 0.75 mm 100 V - 240 V ~ / 50 / 60 Hz with functional Power supply earth AC Power...
Page 273 18.4 Communication Port The connector located at the back of the device allows data communication with a PC. Serial Cable TTL output Power Input 10 V / 15 W to power supply the product Power Output 5 VDC / 150 mA to power Agilia USB cable 18.5 Infrared Communication The pump is equipped with an infrared cell located at the back of the...
Page 274: C P 18.5 Infrared C 18.6 Sound Levels
18.6 Sound Levels 18.6.1 Operating Pump Sound Levels (without alarms) Flow Rate (mL/h) Sound Level (dBA) 1200 Note: These values are provided for information purposes only. 18.6.2 Alarms Sound Levels Sound Level (dBA) Alarm Priority High-priority Medium-priority Low-priority 18.7 Compliance Compliant with the following Index of protection against ElectroMedical...
Page 275: Dimensions Andw
18.8 Dimensions and Weight H / W / D 135 x 345 x 170 mm Weight Approximately 2.1 kg Screen Size 70 x 35 mm 18.9 Trumpet and Start-up Curves The trumpet curve shows the variation of the mean flow rate accuracy over specific observation periods.
Page 276 18.9.1 Flow rate: 1 mL/h Legend Instantaneous flow rate Set flow rate Sampling time: 10 s Time (minutes) Figure 18.1: Start-up and instantaneous flow rate (1 mL/h over first 2 hours on 96 hours) Legend Measured variance from flow rate Error Flow rate Sampling time: 10 s...
Page 277 18.9.2 Flow rate: 5 mL/h Legend Instantaneous flow rate Set flow rate Sampling time: 10 s Time (minutes) Figure 18.3: Start-up and instantaneous flow rate (5 mL/h over first 2 hours on 96 hours) Legend Measured variance from flow rate Error Flow rate Sampling time: 10 s...
Page 278 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...
Page 279: General Information 19.2 Specifications
19.2 Specifications 19.2.1 Technical Specifications Description Technology IEEE 802.11 a/b/g/n  2.400 2.500 GHz (2.4 GHz is ISM band)  Frequency Band  4.900 5.850 GHz (High Band)  OFDM with BPSK, QPSK, 16-QAM, and 64-QAM 802.11b with CCK and Modulation DSSS Wireless Security...
Page 280 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.
Page 281: Troubleshooting
Remove the power cord.  something abnormal (unusual noise, Contact your biomedical department or your abnormal heat or smoke). Fresenius Kabi sales representative immediately.  The pump has been dropped or was Do not use the pump.  subjected to a force that may have Contact your biomedical department or your produced internal damage.
Page 282 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.
Page 283: Recycling
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. ...
Page 284: Warranty
Warranty 22.1 General Warranty Conditions Fresenius Kabi guarantees that this product is free from defects in material and workmanship during the period defined by the accepted sales conditions, except for the batteries and the accessories. 22.2 Limited Warranty To benefit from the materials and workmanship guarantee from our...
Page 285: Guidance And Manufacturer's Declaration On Emc
Guidance and Manufacturer's Declaration on EMC 23.1 Electromagnetic Compatibility Warning  Agilia pump and its accessories are intended to be used in the electromagnetic environments specified below.  The customer or the user of Agilia pump should ensure that it is used in such environments.
Page 286 23.2 Electrostatic Discharge (ESD) Information  Electronic components and semiconductors can be destroyed by electrostatic discharge (ESD). In particular, components made with metal oxide semiconductor (MOS) can be damaged from direct or indirect discharges. Damage caused by ESD may not be immediately identifiable, and malfunctions can even occur after a longer period of operation.
Page 287 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.
Page 288 23.4 EMC and essential performances In the case of electromagnetic disturbances, if the essential performance, Section 15.1, page 139, is lost or degraded, the consequences for the patient are as follows: overdose, underdose, delay of therapy, air embolism, trauma, exsanguination. 23.4.1 Table 1 - Guidance and Manufacturer's Declaration - Electromagnetic Emissions...
Page 289 23.4.2 Table 2 - Guidance and Manufacturer's Declaration - Electromagnetic Immunity Warning  Agilia pump and its accessories are intended to be used in the electromagnetic environments specified below.  The customer or the user of Agilia pump should ensure that it is used in such environments.
Page 290 IEC 60601-1-2 - - - - - - - - - - - - - - Compliance Level Electromagnetic Environment - IEC 60601-2-24 Immunity Test Obtained by Guidance and ANSI/AAMI the Device ID26 Test Level Power frequency 3 A/m 400 A/m If necessary, the power of the magnetic (50/60 Hz) - - - - - - - - - - - - - -...
Page 291 IEC 60601-1-2 - - - - - - - - - - - - - - Compliance Level Electromagnetic Environment - IEC 60601-2-24 Immunity Test Obtained by Guidance and ANSI/AAMI the Device ID26 Test Level D = 0.35  P, Radiated RF 3 V/m 10 V/m...
Page 292 23.4.4 Table 6 - Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and Agilia pump Information  Agilia pump and its accessories are intended for use in electromagnetic environments in which radiated RF disturbances are controlled.  Users of Agilia pump may prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and Agilia pump as recommended below, and according to the maximum output...
Page 293: Electromagnetic
EMC test deviations and suplementary tests 23.4.5 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...
Page 294: Electromagnetic
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...
Page 295: Servicing
3. Pack the device in the provided packaging. 4. Ship the device to Fresenius Kabi. Information  Fresenius Kabi is not liable for loss or damage to the device during transport.  For more information on servicing, contact your Fresenius Kabi sales representative.
Page 296: Quality Control
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.
Page 297 Glossary of Terms Term Description Amperes Alternating Current Ampere-hours AIDC Automatic Identification and Data Capture Amplitude Modulation Amperes per meter BPSK Binary Phase Shift Keying Body Surface Area Calorie Complementary Code Keying Centers for Disease Control CISPR Special International Committee on Radio Interference CT Scan Computed Tomography Decibels...
Page 298 Term Description Electrocardiogram ECMO ExtraCorporeal Membrane Oxygenation Electroencephalogram Electromagnetic compatibility ErXX Error message Electrostatic Discharge Federal Communications Commission Frequency Modulation Feet General Public License GTIN Global Trade Item Number H/W/D Height / Width / Depth High Frequency Hectopascals HTTP HyperText Transfer Protocol Hertz Industry Canada International Electrotechnical Commission...
Page 299 Term Description Milliamperes Milliequivalents mL/h Milliliters per hour mmHg Millimeters of Mercury mmol Millimole Metal Oxyde Semiconductor Magnetic Resonance Imaging mW/sr Milliwatts per steradian Not Applicable Nuclear Magnetic Resonance Occlusivity Check System OFDM Orthogonal Frequency Division Multiplexing Operating Room Personal Computer Pounds per Square Inch Phase Shift Keying Quadrature Amplitude Modulation...
Page 300 Term Description Universal Serial Bus Test specification level Volts Volt-Amperes Volts Direct Current Volume Infused Vrms Root Mean Square Voltage VTBI Volume to Be Infused Volts per meter Watts Wi-Fi Protected Access...
Page 301 Appendix: Factory Configuration Feature Availability Feature Availability   Profile Simple Rate Volume/Time Infusion   Pressure Dose / Time Modes Keypad lock   Volume Limit status   Battery life Direct Bolus Volume infused Programmed   / Dose infused Bolus ...
Page 302 Index Event Log 84 Agilia Connect Infusion System 14 Agilia USB Cable 93 Factory Configuration 153 Alarm First Use 32 Adjust Volume 79 Flow Rate 24, 41, 50 List 97 Priority 18, 96 Sound Level 126 Glossary 149 Arrow Keys 18 Graphics Flow Rate History 81 Pressure History 82...
Page 303 Release Notes 156 Rotating Pole Clamp 27 Maintenance 147 Display Information 86 Reminder Message 33 Screen Requirements 147 Contrast 91 Menu Display and Symbols 19 Customization 91 Selection Keys 18 List 65 Servicing 147 Monitoring Simple Rate 59 Dose 51 Soft Limit 24 Flow Rate (ml/h) 50 Override 47...
Page 304 This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. ® ®...
Page 305 Local Contacts for Servicing Write your contacts here:...

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Fresenius Kabi Agilia SP Technical Manual

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