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Fresenius Kabi Agilia SP, Technical Manual

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Fresenius Kabi Agilia SP Technical Manual Download Page 274

126

18.6

Sound Levels

18.6.1

Operating Pump Sound Levels (without alarms)

Note: These values are provided for information purposes only.

18.6.2

Alarms Sound Levels

18.7

Compliance

* After a defibrillation, the pump recovery time is around 2 seconds.
** The functional earth is directly connected to the power supply cord. It reduces residual current that 
may disturb ECG or EEG devices.

Flow Rate (mL/h)

Sound Level (dBA)

0

21

1

23

20

27

100

30

400

49

1200

32

Alarm Priority

Sound Level (dBA)

min

Max

High-priority

55

63

Medium-priority

50

57

Low-priority

45

52

ElectroMedical 
Equipment Safety

Compliant with the following 
standards:

IEC 60601-1

IEC 60601-1-8

IP22

Index of protection against 
ingress of water or particulate 
matter

EMC 
(ElectroMagnetic 
Compatibility)

Compliant with the following 
standard:

IEC 60601-1-2

Protection against leakage 
current: Defibrillation-proof 
type CF applied part*

Particular 
Standards

IEC 60601-2-24

ANSI/AAMI ID26

Protection against electric 
shocks: class II 

Functional earth**

Summary of Contents for Agilia SP

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: ... Atmospheric pressure limitation IP22 Index of protection against solid foreign objects 12 5 mm and driping liquids General symbol for recyclable material Not for use in residential areas Eco packaging symbol Part included in a recycling process For CA only CCSAUS mark Protection against leakage current defibrillation proof type CF applied part For US CA only Caution Federal law restricts this dev...

Page 3: ...FUNDAMENTALS 28 3 1 TRAINING 28 3 2 MAINTENANCE SCHEDULE 28 3 3 ACCESSING EXITING THE OPERATING FUNCTIONS 29 4 PROFILE MENU 30 4 1 ACCESSING THE PROFILE MENU 30 4 2 PROFILE MENU FUNCTIONS 30 5 BASIC PROFILE CONFIGURATION 32 5 1 ACCESSING THE BASIC PROFILE CONFIGURATION 32 5 2 BASIC PROFILE CONFIGURATION FUNCTIONS 32 6 MAINTENANCE OPERATIONS 38 6 1 MAINTENANCE OPTIONS 38 6 2 RUNNING TESTS 40 6 2 1 ...

Page 4: ...RM MESSAGES AND INFORMATION SIGNALS 69 7 2 TROUBLESHOOTING GUIDE 72 7 3 ERROR CODES 74 8 INTERVENTION PROCEDURES 78 8 1 PROCEDURE 1 BATTERY AND BATTERY DOOR BOOST CAPACITOR DISCHARGE 79 8 2 PROCEDURE 2 UPPER CASE 81 8 3 PROCEDURE 3 DISPLAY BOARD LCD DISPLAY 83 8 4 PROCEDURE 4 CPU BOARD 85 8 5 PROCEDURE 5 POWER SUPPLY BOARD AND AC POWER BOARD 88 8 6 PROCEDURE 6 WI FI BOARD 91 8 7 PROCEDURE 7 SYRING...

Page 5: ...12 7 COMPLIANCE 133 12 8 DIMENSIONS WEIGHT 134 12 9 ELECTRONIC BOARDS 134 12 10 MATERIAL CHARACTERISTICS 134 13 SPECIFICATIONS 135 14 RECYCLING 136 15 WARRANTY 137 16 GUIDANCE AND MANUFACTURER S DECLARATION ON EMC 138 17 SPARE PARTS CATALOG 139 18 ORDERING INFORMATION 140 18 1 DATA MANAGEMENT CABLES 140 18 2 ASSOCIATED SOFTWARE 140 18 3 DISPOSABLES 140 19 GLOSSARY OF TERMS 141 INDEX 144 ...

Page 6: ...accepted routes of administration such as intravenous intra arterial or subcutaneous routes in healthcare facilities by trained healthcare professionals and according to healthcare facility protocols The Agilia SP range is intended for use on adults pediatrics and neonatal patients for the intermittent or continuous delivery of parenteral fluids such as solutions colloids parenteral nutrition medi...

Page 7: ...med by trained biomedical engineers or by dedicated medical rental and or service organizations who have been trained and approved by the manufacturer For training contact your Fresenius Kabi sales representative 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 ...

Page 8: ...ilia SP range of pumps is made up of 3 main parts a cover a base and an angle bracket The cover contains the following Display board Keypad The base supports the following CPU board Mechanical framework assembly Plunger driver unit Wi Fi board for Wi Fi infusion pumps The angle bracket supports the following Power supply board AC power board Battery Fixing clamp system 1 3 9 6 2 3 1 9 7 8 4 5 1 6 ...

Page 9: ...on Legend Screen Infusion Indicator Lights Battery Charge Status Indicator Decrement Power Supply Indicator Fast Decrement On Off Confirm Value Move to Next Field Bolus Prime Stop Fast Increment Menu Cancel Value Move Back to Previous Field Increment Alarm Silence 8 13 14 12 11 10 7 9 6 5 4 1 2 3 4 1 8 2 9 3 10 4 11 5 12 6 13 7 3 14 ...

Page 10: ... Indicator Confirm Value Move to Next Field Wi Fi Symbol for Wi Fi pumps only Stop Pause On Off Cancel Value Move Back to Previous Field Bolus Prime Menu Fast Increment Pressure Menu Increment Alarm Silence Infusion Indicator Lights 9 15 14 17 16 13 12 11 8 10 7 6 5 1 2 3 4 9 15 14 17 16 13 12 11 8 10 7 6 5 1 2 3 4 1 10 2 11 3 12 4 13 5 3 14 6 3 15 7 3 16 8 3 17 9 ...

Page 11: ...ement Power Supply Indicator Confirm Value Move to Next Field Wi Fi Symbol Stop On Off Cancel Value Move Back to Previous Field Bolus Prime Fast Increment Menu Increment Graph Infusion Indicator Lights Alarm Silence SP 4 9 15 14 17 16 13 12 11 8 10 7 6 5 1 2 3 1 10 2 11 3 12 4 13 5 3 14 6 7 3 15 8 3 16 9 3 17 ...

Page 12: ...us Indicator Fast Decrement Power Supply Indicator Confirm Value Move to Next Field On Off Stop Pause Bolus Prime Cancel Value Move Back to Previous Field Fast Increment Menu Increment Graph Infusion Indicator Lights Alarm Silence SP 8 14 13 16 15 12 11 10 7 9 6 5 4 1 2 3 4 1 9 2 10 3 11 4 12 5 13 6 3 14 7 3 15 8 3 16 ...

Page 13: ... 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 Legend J1 Connector to Keypad J2 Connector to CPU Board J3 Connector to LCD Display J3 J2 J1 J1 J2 J3 ...

Page 14: ...power supply 5 ANA_VLCD LCD charge pump voltage 6 GND Ground 7 S_ANA_DOOR Door close detection 8 RESET Global reset 9 GND Ground 10 CS_LED KBD LED or keypad selection 11 CS_LCD LCD selection 12 GND Ground 13 LCD_CD LCD type of the interface cycle Control Data 0 control 1 data 14 LCD_MS LCD mode selection 15 GND Ground 16 HMI_MOSI_SDA SPI data written I C data for HMI board 17 GND Ground 18 HMI_MIS...

Page 15: ...ound 7 SDA SPI data MOSI HMI_MOSI_SDA signal 8 GND Ground 9 CD Control Data 0 control 1 data LCD_CD signal 10 GND Ground 11 RST Reset RESET signal 12 GND Ground 13 CS0 Chip select CSLCD signal 14 GND Ground 15 BM0 DB13 Mode select LCD_MS signal 16 GND Ground 17 VLCD Charge pump voltage ANA_VLCD signal 18 GND Ground 19 3V3 3V3 power supply 20 GND Ground 21 GND Ground 22 GND Ground ...

Page 16: ... A ribbon cable connects it to the Power Supply Board with the J6 connector Legend J1 Connector Connection to Syringe Barrel Clasp potentiometer and flange switch J6 Connector Connection to Power Supply Board J2 Connector Connection to Linear Displacement Potentiometer J7 Connector Connection to Motor J3 Connector Connection to Display Board J8Connector Connection to JTAG Connector micro programmi...

Page 17: ...er status 3 DISP 3 3 V power supply Pin n Signal Description 1 GND Ground 2 A Anode of the backlight 5V 3 K Cathode of the backlight K_BACKL signal 4 GND Ground 5 SCK SPI clock HMI_SCK_SCL signal 6 GND Ground 7 SDA SPI data MOSI HMI_MOSI_SDA signal 8 GND Ground 9 CD Control data 0 control 1 data LCD_CD signal 10 GND Ground 11 RST Reset RESET signal 12 GND Ground 13 CS0 Chip select CSLCD signal 14 ...

Page 18: ...ut signal of the photomicrosensor photo transistor collector 3 Power GND Ground photo transistor emitter 4 Power GND Ground photo diode cathode 5 Output OP_CD_OPTO Power supply signal of the photomicrosensor photo diode anode 6 Power GND Ground Pin n Signal Description 1 GND Ground 2 PRES_BOARD HMI board presence detection 3 3V3 3V3 power supply 4 3V3 3V3 power supply 5 ANA_VLCD LCD charge pump vo...

Page 19: ...et 4 TDO Test data output 5 GND Ground 6 TDI Test data input 7 MR Manual reset 8 TMS Test mode select 9 TCK Test clock 10 GND Ground Pin n Signal Description 1 GND Ground 2 PLGH_OPTO Analog output signal of the piston photomicrosensor 3 FORCE Negative input of the force sensor 4 FORCE Positive input of the force sensor 5 3V3 3V3 power supply of force sensor 6 DSG_OPTO Analog output signal of the r...

Page 20: ... Speaker Buzzer Super capacitor The power supply board is located on the angle bracket See figure 2 1 page 8 It supplies power to the electronic unit from the 100 V 240 V AC network or from 9 V DC It also charges a 2 2 Ah battery This board is connected to other parts with the connectors shown below Legend J1 Connector Connection to CPU Board J4 Connector Connection to Secondary Microcontroller J2...

Page 21: ...icrocontroller common power supply switch 17 IRDA_RX Infrared data received 18 SO_CD_SHDN Speaker shutdown command 19 SO_ANA_MIC Analog microphone input 20 GND Ground 21 EXT_TX External transmit data 22 PRES_BOARD HMI and UC board presence detection 23 EXT_RX External receive data 24 CMD_FAIL LED command failure 25 KON OFF On Off key 26 GND Ground Pin n Signal Description 1 SP Negative connection ...

Page 22: ...e SMP and the battery 3 GND Ground negative output of the smart battery 4 GND Ground 5 GND Ground Pin n Signal Description 1 MISO Secondary microcontroller SPI data input 2 3V3 PERM Secondary microcontroller power supply 3 SCK Secondary microcontroller SPI clock 4 MOSI Secondary microcontroller SPI data output 5 RST Secondary microcontroller reset 6 GND Ground Pin n Signal Description 1 Neutral Ne...

Page 23: ... 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 Legend J1 Connector Connection to Power Supply Board Line Fuse F1 J2 Connector Power Cord Inlet Fuse Identification Label Pin n Signal Description 1 Neutral Neutral wire 2 Line Hot wire 3 GND Groun...

Page 24: ...rd Pin n Signal Description 1 Floating Not used on Agilia VP range Leave floating 2 Floating Not used on Agilia VP range Leave floating 3 GND Ground 4 Floating Not used on Agilia VP range Leave floating 5 Floating Not used on Agilia VP range Leave floating 6 GND Ground 7 WIFI_VCC 3V3 Wi Fi power supply 8 WIFI_VCC 3V3 Wi Fi power supply 9 UART RxD Receive data 10 UART TxD Transmit data 11 UART RTS ...

Page 25: ...ducer unit which drives a rack screw nut assembly made up of 2 flanges and a linear sensor The mechanical assembly also contains a photo electric cell dedicated to monitoring the motor s rotation The mechanical plunger driver assembly is located on the mechanical framework The framework ensures the displacement of the plunger via a screw nut system The plunger driver is equipped with a disengageme...

Page 26: ...n It is set in motion by a motor reducer linked to a screw nut system Rotation control is ensured by a pinion attached to a motor shaft end and connected to an opto electric sensor A linear potentiometer mounted on an aluminum profile uses a rolling ball contact to ensure plunger displacement control A micro switch allows the disengagement mechanism position to be checked Correct positioning of th...

Page 27: ...ch disengagement Optical sensor disengagement Force sensor Integrated amplifier communication Plunger head Electronic interface Switch detection Syringe barrel clasp Potentiometer Syringe installation Electronic interface communication Optical sensor AC power supply if present CPU BOARD AC POWER BOARD Wi Fi BOARD DISPLAY BOARD AC DC converter DC supplies Power supply Safety management HP Different...

Page 28: ...ation For training contact your Fresenius Kabi sales representative 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: ...Access code Description Pump Settings No unless modified by Test20 Please refer to the IFU Profile Yes Section 4 page 30 Basic Profile Configuration Yes Section 5 page 32 Maintenance Yes Section 6 page 38 Information If the wrong access code is entered Error is displayed As long as the pump remains powered on the code does not need to be entered again Operation Key Scroll options and change select...

Page 30: ...e Factory settings Restores the Basic Profile factory settings to the pump Pro 4 Data set information at power on Select Deselect Activates or deactivates Data set screen at startup This configuration is displayed only if a Data set is loaded in the pump Selecting and loading a profile 1 Access the Profile menu 2 Press the arrow keys to select Pro1 Default profile 3 Press enter 4 Press the arrow k...

Page 31: ...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: ... code 0200 5 Press OK 6 Press the arrow keys to select the setting category User or Ward 7 Press enter Function Setting Description Range of Settings User 1 Screen options Vol dose information Displays the volume dose on the infusion monitoring screen Enabled Disabled Time information Displays the remaining infusion time on the infusion monitoring screen Enabled Disabled Battery life information D...

Page 33: ...d Disabled Volume limit Volume Time or Dose Time Pause Patient Wake up conc for Agilia SP TIVA only TCI setup for Agilia SP TIVA only TCI Programmed bolus Alarm volume Vol dose history View event log Library information Data Set Function Setting Description Range of Settings Pro VL V T D T DS ...

Page 34: ... enter pressure limit for the next startup Enabled Disabled Limit If Limit stored is disabled sets the maximum pressure allowed during an infusion If Limit stored is enabled the limit is set to and cannot be changed 50 mmHg Maximum pressure value Drop threshold If DPS Yes sets a pressure drop threshold A message is generated if the pressure drops below this threshold No drop pressure monitoring or...

Page 35: ...abled Par 4 Maximum rate Maximum rate for 50 mL syringe Sets the maximum infusion rate for 50 60 mL syringes 0 1 1200 mL h Maximum rate for 30 mL syringe Sets the maximum infusion rate for 30 mL syringes 0 1 600 mL h Maximum rate for 20 mL syringe Sets the maximum infusion rate for 20 mL syringes 0 1 600 mL h Maximum rate for 10 mL syringe Sets the maximum infusion rate for 10 mL syringes 0 1 350 ...

Page 36: ... Disabled Dose unit Sets the available dose units nanog h nanog kg min nanog kg h µg h µg min µg kg min µg kg h mg min mg h mg 24h mg kg min mg kg h mg kg 24h mg m2 h mg m2 24h g h g kg min g kg h g kg 24h mmol h mmol kg h mmol kg 24h munit min munit kg min munit kg h unit min unit h unit kg min unit kg h kcal h kcal 24h kcal kg h mEq min mEq h mEq kg min mEq kg h mL mL mL kg h mL kg 24h Enabled D...

Page 37: ...s the same therapy screen when changing current drug Yes No Par 31 Near end of infusion alert Time Sets the remaining time that triggers the Near end of infusion alert 1 30 min Par 34 Rate titration While stopped only If While stopped only is enabled allows rate modification after an infusion stop only Enabled Disabled Function Setting Description Range of Settings ...

Page 38: ...ow keys to select Svc 1 Maintenance date 3 Press enter The next scheduled maintenance date is displayed 4 Press exit to return to the Maintenance options menu Information This date corresponds to the next preventive maintenance date to be carried out See section 3 2 1 page 28 The date is displayed for consultation only and cannot be changed here 1 Access the Maintenance options menu See section 6 ...

Page 39: ...the desired clinical or technical event 5 Press enter The details of the event are displayed 6 Press exit to return to the Maintenance options menu 1 Access the Maintenance options menu See section 6 1 1 page 38 2 Press the arrow keys to select Svc 4 Maintenance information 3 Press enter 4 Press to allow or disallow the display of a Maintenance info screen at the next pump startup 5 Press OK to co...

Page 40: ...g test See section 6 2 12 page 52 Test 2 Maintenance options See section 6 2 3 page 42 Test 12 Battery life See section 6 2 13 page 53 Test 3 Maintenance messages See section 6 2 4 page 42 Test 13 Battery test See section 6 2 14 page 53 Test 4 Events See section 6 2 5 page 42 Test 20 Pump code See section 6 2 15 page 55 Test 5 Force See section 6 2 6 page 43 Test 21 Power information See section 6...

Page 41: ...ed Pump name Pump version or revision with software generation date Pump serial number CPU board serial number Power supply board serial number Power supply board software version or software revision with the generation date Battery serial number For each language available Language name Language file version or revision Language file creation date For each parameter zone Parameter zone number ve...

Page 42: ...xit to return to the Tests menu Test Description Run this test to check the maintenance messages entered The maintenance message is displayed for information only It cannot be modified here 1 Access the Tests menu See section 6 2 1 page 40 2 Press the arrow keys to select Test 3 Maintenance messages 3 Press enter Informational messages stored by After Sales Service are displayed 4 Press exit to re...

Page 43: ...alid 1 Access the Tests menu See section 6 2 1 page 40 2 Press the arrow keys to select Test 5 Force 3 Press enter 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 pressure applied on the sensor Force Force value expressed in g 0 sensor Sensor offset value expressed in mV Value ...

Page 44: ...sengagement lever The arms must not be in contact with the arm spacer 15 Apply a force of 0 4 bar 16 Check that the Force value is between 2200 g and 2800 g 17 Press exit to return to the Tests menu 18 Open the syringe barrel clasp push the disengagement lever down and move the plunger driver to the right to zero the pressure 19 Start an infusion at 1000 mL h 20 Check that the pump triggers an Occ...

Page 45: ... 65 mm long Prerequisites The calibration certificate of the displacement verification gauge is valid 1 Access the Tests menu See section 6 2 1 page 40 2 Press the arrow keys to select Test 6 Displacement 3 Press enter 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 plunger hea...

Page 46: ... 60 in 10 mm and 15 2 mm 10 Open the syringe barrel clasp and place the 2 56 in 65 mm gauge in the syringe cradle with the flanges correctly inserted in the provided slot and the 2 56 in 65 mm part positioned to the right 11 Secure the gauge with the syringe barrel clasp 12 Push the disengagement lever down and move the plunger driver gently to the left until it is in contact with the gauge 13 Che...

Page 47: ...is defective or not correctly connected to the CPU board This problem leads to an error code 20 Check the cable connection to CPU board J1 connector See figure 2 8 page 16 Replace the displacement sensor See section 8 7 page 94 Required Tools and Equipment V1 diameter verification gauge 11 5 mm 0 45 in diameter V2 diameter verification gauge 15 5 mm 0 61 in diameter V4 diameter verification gauge ...

Page 48: ...sp push the disengagement lever down and move the plunger driver to the right 7 Place the V1 diameter verification gauge in the syringe cradle with the flanges correctly inserted in the provided slot 8 Secure the V1 diameter verification gauge with the syringe barrel clasp and press OK on the pump 9 Check the value displayed for Diameter The value must be equal to 10 5 mm 1 5 mm 0 35 in to 0 47 in...

Page 49: ...splayed 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 19 Open the syringe barrel clasp and remove the V4 diameter verification gauge ...

Page 50: ... Cycles Number of charge discharge cycles equivalent to Duration in hours divided by 7 Since Date of the first use on battery Conversion and Voltage Voltage value at the battery terminals in V and conversion into mV Conversion and Temperature Battery temperature in C and conversion into LSB Conversion and Current Battery charge discharge current in mA and conversion into LSB 5 Check that the displ...

Page 51: ...rner of the screen 5 Press OK 6 Check that A blue Indication screen is displayed The battery charge status indicator power supply indicator infusion indicator lights are flashing Exit is displayed in the bottom right corner The microphone and buzzer sound 7 Press exit to return to the Tests menu If you do not press exit in the next 10 seconds the pump returns automatically to Tests menu Test Descr...

Page 52: ...lacement type Advance or Go return 9 Press OK to start the test If a battery alarm is present the test cannot be launched the OK button is not available The pump starts moving the plunger forward While an ageing test is in progress the pump displays the following information Flow rate in mL h Motor command mode Current Low High Maximum or Auto Animation representing the plunger displacement The te...

Page 53: ... following data is displayed Charge Battery charge current rate in Auto Off Date of last automatic cut off value saved during last battery test Pre alarm Duration between transition to battery and pre alarm value saved during last battery test Alarm Duration between transition to battery and alarm value saved during last battery test Cut off Duration from alarm to automatic pump power off value sa...

Page 54: ...s equal to as long as the pre alarm is not triggered starts from the pre alarm triggering time then increases up to the alarm triggering time and finally stops Cut off Duration from alarm to automatic pump power off This duration is equal to as long as the alarm is not triggered is reset to 00 00 when the alarm is triggered increases up to the pump cut off Information If the pump is connected to a...

Page 55: ...DC voltage charging value Backup capacitor voltage and temperature 5 V booster voltage Information The backup capacitor voltage and temperature must be systematically checked during the maintenance protocol The AC power board and power supply boards work properly DC voltage out of limits Check the connections between power supply board J5 connector and AC power board Check the fuse on AC power boa...

Page 56: ...ation screens Conversion Backup capacitor conversion value in mV Backup capacitor Backup capacitor voltage in V Conversion Backup capacitor temperature conversion value in mV Backup temperature Backup capacitor temperature in C Conversion 5 V booster conversion value in mV 5 V booster 5 V booster voltage in V 6 Check that the displayed values are within the limits shown in the table below Value Li...

Page 57: ...nu Test Description Run this test to display the temperature measured by the NTC thermistor for information only The CPU board works properly If this test fails replace the CPU board See section 8 4 page 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 3 Press enter The fol...

Page 58: ...d disconnected 1 Access the Tests menu See section 6 2 1 page 40 2 Press the arrow keys to select Test 24 Watchdog 3 Press enter If the pump is connected to the AC power supply Disconnect the AC power cable The OK button becomes available Press OK 4 Press OK to confirm The pump starts checking the fault mode 5 Check that all red LEDs light up and that the buzzer sounds between 1 0 seconds and 2 25...

Page 59: ... refresh Wi Fi module information without powering off the pump then run the test again If after a prolonged period where no information is displayed contact your Biomed or IT service department 1 Access the Tests menu See section 6 2 1 page 40 2 Press the arrow keys to select Test 25 Wi Fi module information 3 Press enter The following data is displayed for information Network SSID Service Set ID...

Page 60: ... 6 Select Mode 3 levels High 900 mmHg 17 4 PSI or 1 20 bar Medium 500 mmHg 9 67 PSI or 0 67 bar Low 200 mmHg 3 87 PSI or 0 27 bar 7 Power the pump off and on again to exit the Options menu and return to standard operation 8 Open the syringe barrel clasp push the disengagement lever down and move the plunger driver to the right 9 Place the dynamometer in the syringe cradle with the flanges correctl...

Page 61: ... to the right 26 Remove the dynamometer 1 Power the pump off and on again to exit the Options menu and return to standard operation 2 Push the disengagement lever down and move the plunger to the right 3 Install a BD Precise 50 mL syringe 4 Secure the syringe with the syringe barrel clasp 5 Position the syringe piston at a remaining VTBI value of at least 10 mL 6 Push the disengagement lever down ...

Page 62: ...ower supply indicator is off 3 Connect the pump to an AC power supply 4 Check that the plug shaped power supply indicator lights up green Test Description This test checks the electrical safety of the pump according to the IEC 60601 1 medical electrical equipment standard The pump is compliant with the IEC 60601 1 medical electrical equipment standard Contact your biomedical department or your Fre...

Page 63: ...next preventive maintenance date Add a maximum of 3 years to the date of last preventive maintenance Fill the Next maintenance date in the form 1 Run Test 1 Identification Identification and general appearance check See section 6 2 2 page 41 Check housing Check AC power cord Check the product code REF and serial number SN on the pump identification label Fill the pump identification data in the fo...

Page 64: ...e value must be equal to 28 0 mm 1 5 mm 1 04 in to 1 16 in If one of these values is outside the tolerance zone run a calibration of the syringe barrel clasp sensor using Agilia Partner maintenance software 8 Run Test 5 Force occlusion alarm test See section 6 2 6 page 43 Install a dynamometer Start an infusion at 1000 mL h Check that the pump triggers an Occlusion pre alarm then an Occlusion alar...

Page 65: ...ry test See section 6 2 14 page 53 At end of test Connect the pump to an AC power supply Power on the pump Run Test 12 Battery life See section 6 2 13 page 53 Check that the displayed Alarm is equal to or greater than 01h30 01 30 If not replace the battery See section 8 1 page 79 12 Run the electrical test according to EN IEC 60601 1 standard See section 6 2 24 page 62 13 Enter the following ident...

Page 66: ...Clasp Check the syringe barrel clasp sensor Tool V1 Diameter mm between 9 0 mm and 12 0 mm 0 35 in and 0 47 in Tool V2 Diameter mm between 14 0 mm and 17 0 mm 0 55 in and 0 70 in Tool V4 Diameter mm between 26 5 mm and 29 5 mm 1 04 in and 1 16 in 8 Test 5 Force Occlusion alarm test Triggering of an occlusion alarm in less than 60 seconds at PSI between 8 0 PSI 0 55 bar and 10 9 PSI 0 75 bar 9 Test...

Page 67: ...ale s calibration certificate is valid Recommended temperatures for flow rate accuracy Room temperature 10 C to 30 C 50 F to 86 F Temperature of the water in the syringe 10 C to 30 C 50 F to 86 F Information Do not recycle distilled water The test procedure below can be performed with all syringe sizes 50 60 mL 30 mL 20 mL 10 mL 5 mL 1 Setup the equipment Fill the syringe with distilled water at t...

Page 68: ...ht 7 Simultaneously re start the infusion with the same flow rate and start the chronometer 8 After the infusion time e g 10 minutes 15 minutes 1 hour stop the infusion 9 At the end of infusion weigh the beaker with water and write down this new value If the scale was not zeroed at start of infusion calculate the difference with the initial weight 10 Divide the infused volume in mL for water 1 mL ...

Page 69: ... Connect the pump to a power supply Occlusion pre alarm Medium In line pressure has reached the following value 25 mmHg 2 5 kPa 0 5 PSI below the programmed threshold from 50 to 250 mmHg 50 mmHg 5 kPa 1 PSI below the programmed threshold over 250 mmHg Check the infusion line Set the correct pressure threshold Near end of infusion Medium The time remaining is less than the defined time duration adj...

Page 70: ...ng to the drug settings defined in the drug library Lower soft min Information signal The lower soft limit is exceeded according to the drug settings defined in the drug library Reached hard limit Information signal The upper or lower hard limit is reached Power disconnection Information signal The pump is disconnected from the AC power A single beep is emitted Press to acknowledge Check that the ...

Page 71: ... 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 High Immediate response The infusion stops An alarm description is displayed on the pump screen Medium Prompt response The infusion continues Low Awarene...

Page 72: ...olving plunger head position Optical switch and or anti siphon arm finger detection are defective Flexible circuit is cut Check the anti siphon system Check the plunger driver internal mechanism Replace the force sensor See section 8 11 page 110 Unjustified alarm involving syringe barrel clasp and or syringe body Defective syringe barrel clasp potentiometer Flat ribbon cable is defective Switch or...

Page 73: ... 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 The pump must not be used Description Cause Recommended Action ...

Page 74: ...ump using the Agilia Partner maintenance software If the problem cannot be resolved Replace the CPU board See section 8 4 page 85 Carry out a complete configuration calibration control cycle using Agilia Partner maintenance software 13 Secondary Crc16 microcontroller version is incorrect Carry out a complete configuration calibration control cycle using Agilia Partner maintenance software 14 Secon...

Page 75: ...on cable kit See section 8 11 page 110 Calibrate the force sensor using Agilia Partner maintenance software and check the pump functionality 23 Syringe flanges switch Check the syringe flanges switch is functioning correctly by running test 7 See section 6 2 8 page 47 Check the cable connection to CPU board J1 connector See figure 2 8 page 16 Replace the syringe barrel clasp flexible circuit See s...

Page 76: ...e functionality of the secondary microcontroller See section 8 5 page 88 Replace the Display board See section 8 3 page 83 Replace the CPU board to check the functionality of the main microcontroller See section 8 4 page 85 Carry out a complete configuration calibration control cycle using Agilia Partner maintenance software 38 Locked OFF key Run test 10 to check the functionality of the keypad an...

Page 77: ...e the Display board See section 8 3 page 83 Replace the CPU board See section 8 4 page 85 Carry out a complete configuration calibration control cycle using Agilia Partner maintenance software 97 Defective oscillator Replace the CPU board See section 8 4 page 85 Carry out a complete configuration calibration control cycle using Agilia Partner maintenance software 98 Defective reset circuit Replace...

Page 78: ...calibrated according to their specifications and local regulations Disconnect the battery and discharge the boost capacitor before opening the pump see procedure no 1 A risk of electric shock exists when touching a charged boost capacitor For safety reasons the technician should not intervene when the pump is connected to an AC power supply Unplug the power supply cord from the AC power supply Pow...

Page 79: ...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 Unscrew the 2 screws 1 that hold the battery door in place 2 Remove the battery door 2 3 Power on the pump 2 1 1 ...

Page 80: ...Information If the identification labels of the fuse 5 and the battery 4 are damaged they must be replaced Contact Fresenius Kabi to get new labels Re assembling 1 Perform the dismantling procedure in reverse order to re assemble the unit 2 Insert the battery in the correct direction 3 Perform a charge discharge cycle 4 Perform the regular servicing tests See Quality Control Procedure page 63 3 J3...

Page 81: ...nected and the boost capacitor discharged See section 8 1 page 79 Dismantling 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold the upper case 4 to the base 6 Remove the upper case 4 being careful not to pull out the displa...

Page 82: ... the board unit to the upper case 10 Remove the display board unit from the upper case 7 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 regular servicing tests See Quality Control Procedure page 63 6 J2 6 6 6 J1 7 ...

Page 83: ...s disconnected and the boost capacitor discharged See section 8 1 page 79 Dismantling 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold the upper case 4 to the base 6 Remove the upper case 4 being careful not to pull out th...

Page 84: ... board LCD display connection at J3 12 Unclip and separate the LCD display 8 from the display board 7 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 LCD contrast 3 Perform the regular servicing tests S...

Page 85: ...a Wi Fi pump is used remove the Wi Fi board then dislodge the CPU board as described later in this procedure To remove the Wi Fi board See section 8 6 page 91 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold the upper case...

Page 86: ... 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 J2 6 J1 J2 7 J7 J5 6 8 J1 J3 J1 J6 ...

Page 87: ...t cable connections when assembling 2 Perform the following calibrations using Agilia Partner maintenance software Force sensor Syringe barrel clasp Displacement Date LCD contrast 3 Perform the regular servicing tests See Quality Control Procedure page 63 Information When replacing the CPU board carry out a complete configuration of the pump calibrations and tests Each pump has its own CPU board m...

Page 88: ...ismantling If a Wi Fi pump is used remove the Wi Fi board then dislodge the CPU board as described later in this procedure To remove the Wi Fi board See section 8 6 page 91 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold ...

Page 89: ...ard 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 Dislodge the board from slot 6 J2 6 J1 J2 4 5 6 ...

Page 90: ...clip 5 then press the power supply board down locking the board into position with the securing clip 4 Perform the dismantling procedure in reverse order to re assemble the unit Pay attention to the direction of the flat cable connections when assembling 5 Perform the regular servicing tests See Quality Control Procedure page 63 7 5 6 ...

Page 91: ... a Wi Fi module The battery is disconnected and the boost capacitor discharged See section 8 1 page 79 Dismantling 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold the upper case 4 to the base 6 Remove the upper case 4 bei...

Page 92: ...he 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 10 Dislodge the Wi Fi board holder from the right flange slot 9 J2 6 J1 8 7 6 J4 9 ...

Page 93: ...i 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 Perform the regular servicing tests See Quality Control Procedure page 63 10 10 8 11 J1 ...

Page 94: ...isconnected and the boost capacitor discharged See section 8 1 page 79 Dismantling 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold the upper case 4 to the base 6 Remove the upper case 4 being careful not to pull out the d...

Page 95: ... 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 J2 6 J1 6 6 7 J2 ...

Page 96: ...cradle 10 15 Unscrew and remove the 2 screws 11 that hold the base 16 Remove the base 12 While removing the base 12 pay attention to the position of angle bracket clip kit 13 between the base and the aluminum profile When re assembling the base make sure to position this part as it was originally 17 Unscrew and remove the 2 screws 14 18 Remove the syringe barrel clasp bridle 15 9 8 9 12 9 11 11 13...

Page 97: ... 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 Pay attention to the direction of the flat cable connections when assembling 2 Perform the following calibration using Agilia Partner maintenance software Syringe barrel clasp 3 Perform the regular servicing tests See Quality Control Pr...

Page 98: ... disconnected and the boost capacitor discharged See section 8 1 page 79 Dismantling 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold the upper case 4 to the base 6 Remove the upper case 4 being careful not to pull out the...

Page 99: ...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 J2 6 J1 6 6 7 ...

Page 100: ...a flat screwdriver 13 Unscrew and remove the 2 screws 14 Unclip and remove the syringe flange cradle 10 15 Unscrew and remove the 2 screws 11 that hold the base 16 Remove the base 12 While removing the base 12 pay attention to the position of angle bracket clip kit 13 between the base and the aluminum profile When re assembling the base make sure to position this part as it was originally J2 9 8 9...

Page 101: ...yringe detection system 21 comprises syringe detector 19 and membrane 20 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 Pay attention to the direction of the flat cable connections when assembling 2 Perform the following calibration using Agilia Partner mainte...

Page 102: ...cted and the boost capacitor discharged See section 8 1 page 79 Dismantling 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold the upper case 4 to the base 6 Remove the upper case 4 being careful not to pull out the display ...

Page 103: ... 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 J7 8 9 7 7 7 7 6 8 ...

Page 104: ...fixing screws following the order 1 2 3 4 given in the sketch below 4 Perform the dismantling procedure in reverse order to re assemble the unit Pay attention to the direction of the flat cable connections when assembling 5 Perform the following calibration using Agilia Partner maintenance software Displacement 6 Perform the regular servicing tests See Quality Control Procedure page 63 1 4 3 2 ...

Page 105: ...mantling If a Wi Fi pump is used remove the Wi Fi board then dislodge the CPU board as described later in this procedure To remove the Wi Fi board See section 8 6 page 91 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold th...

Page 106: ... 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 J2 6 J1 J2 7 J7 J5 6 8 J1 J3 J1 J6 ...

Page 107: ... 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 J9 9 10 ...

Page 108: ... 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 11 11 11 12 14 13 14 15 ...

Page 109: ...nnections 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 2 Perform the following calibration using Agilia Partner maintenance software Displacement 3 Perform the regular servicing tests See Quality Control Procedure page 63 16 17 ...

Page 110: ...antling If a Wi Fi pump is used remove the Wi Fi board then dislodge the CPU board as described later in this procedure To remove the Wi Fi board See section 8 6 page 91 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold the...

Page 111: ... 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 J2 6 J1 J2 7 J7 J5 6 8 J1 J3 J1 J6 ...

Page 112: ...ews 15 Unclip and remove the syringe flange cradle 11 16 Unscrew and remove the 2 screws 12 that hold the base 17 Remove the base 13 While removing the base 13 pay attention to the position of angle bracket clip kit 14 between the base and the aluminum profile When re assembling the base make sure to position this part as it was originally 18 Unscrew and remove the 3 screws 15 that hold the right ...

Page 113: ... sensor support 23 While removing the pressure sensor support 23 pay attention to the position of spring 24 Do not forget to position this spring as it was before re fixng the support 29 Rotate part 25 in the direction shown in the sketch 30 At the same time dislodge boards 26 and 27 and pull out the force sensor and ribbon cable kit 28 While pulling out the force sensor and ribbon cable kit pay a...

Page 114: ... 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 28 26 27 ...

Page 115: ...g If a Wi Fi pump is used remove the Wi Fi board then dislodge the CPU board as described later in this procedure To remove the Wi Fi board See section 8 6 page 91 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold the upper...

Page 116: ... 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 J2 6 J1 J2 7 J7 J5 6 8 J1 J3 J1 J6 ...

Page 117: ...ews 15 Unclip and remove the syringe flange cradle 11 16 Unscrew and remove the 2 screws 12 that hold the base 17 Remove the base 13 While removing the base 13 pay attention to the position of angle bracket clip kit 14 between the base and the aluminum profile When re assembling the base make sure to position this part as it was originally 18 Unscrew and remove the 3 screws 15 that hold the right ...

Page 118: ...ul not to pull out the flat cable 19 Re assembling 1 Perform the dismantling procedure in reverse order to re assemble the unit Pay attention to the direction of the flat cable connections when assembling 2 Perform the following calibration using Agilia Partner maintenance software Displacement 3 Perform the regular servicing tests See Quality Control Procedure page 63 16 17 16 18 18 18 19 20 ...

Page 119: ... 1 page 28 Prerequisites The battery is disconnected and the boost capacitor discharged See section 8 1 page 79 Dismantling 1 Turn the pump upside down 2 Unscrew and remove the 2 screws 1 that hold the syringe guard 3 Remove the syringe guard 2 4 Remove the 2 plastic caps 3 using a flat screwdriver 5 Unscrew then remove the 2 screws that hold the plunger cover in place 6 Remove the plunger cover 4...

Page 120: ...ntling 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: ...mantling If a Wi Fi pump is used remove the Wi Fi board then dislodge the CPU board as described later in this procedure To remove the Wi Fi board See section 8 6 page 91 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold th...

Page 122: ... 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 J2 6 J1 J2 7 J7 J5 6 8 J1 J3 J1 J6 ...

Page 123: ...ews 15 Unclip and remove the syringe flange cradle 11 16 Unscrew and remove the 2 screws 12 that hold the base 17 Remove the base 13 While removing the base 13 pay attention to the position of angle bracket clip kit 14 between the base and the aluminum profile When re assembling the base make sure to position this part as it was originally 18 Unscrew and remove the 3 screws 15 that hold the right ...

Page 124: ...ovement to remove the pin from the plunger cover Re assembling 1 Perform the dismantling procedure in reverse order to re assemble the unit Pay attention to the direction of the flat cable connections when assembling 2 Perform the following calibrations using Agilia Partner maintenance software Force sensor Displacement 3 Perform the regular servicing tests See Quality Control Procedure page 63 17...

Page 125: ...mantling If a Wi Fi pump is used remove the Wi Fi board then dislodge the CPU board as described later in this procedure To remove the Wi Fi board See section 8 6 page 91 1 Turn the pump upside down 2 Unscrew and remove the 3 screws 1 3 Remove the angle bracket 2 being careful not to pull out the CPU board flat cable 5 4 Disconnect CPU board flat cable 5 at J1 5 Unscrew the 2 screws 3 that hold th...

Page 126: ... 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 J2 6 J1 J2 7 J7 J5 6 8 J1 J3 J1 J6 ...

Page 127: ...ews 15 Unclip and remove the syringe flange cradle 11 16 Unscrew and remove the 2 screws 12 that hold the base 17 Remove the base 13 While removing the base 13 pay attention to the position of angle bracket clip kit 14 between the base and the aluminum profile When re assembling the base make sure to position this part as it was originally 18 Unscrew and remove the 3 screws 15 that hold the right ...

Page 128: ...e assembling 1 Perform the dismantling procedure in reverse order to re assemble the unit Pay attention to the direction of the flat cable connections when assembling 2 Perform the following calibrations using Agilia Partner maintenance software Force sensor Displacement 3 Perform the regular servicing tests See Quality Control Procedure page 63 17 19 16 18 19 ...

Page 129: ... 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: ...ean and disinfect the pump Recommended and prohibited agents Instructions for cleaning and disinfecting Warning The disinfecting procedure must be done immediately after cleaning Disinfecting the pump without prior cleaning is not effective The pump is not intended to be sterilized sterilization may result in damage to the pump ...

Page 131: ...131 11 Power Management Refer to the Instructions for Use of the relevant pump for the following information AC power supply precautions Battery precautions Battery operating mode ...

Page 132: ...Power 15 W Cord Length 3 00 m Maximum length 3 00 m Type SJT3x18AWG Technical data 3x18AWG Green black white dielectric strength 2 kVac 1 min Standard UL62 CSA 22 2 No 49 Plug Type HG TR Technical data 15A 12 5V AC Standard NEMA 5 15 Hospital Grade Connector Type C13 Technical data 10A 250V UL CSA Standard EN 60320 1 C22 2 N 21 UL 817 Disconnect the battery before opening the device Avoid short ci...

Page 133: ...rotocol Proprietary Speed 115 2 kb s max Wavelength 880 nm to 900 nm infrared band with 45 nm spectral bandwidth Eye Safety Class 0 of IEC 62471 Function Allows communication between a pump and a computer on the USB port Connector 8 pin proprietary connector Male A USB connector Input Output power pump 250 mW Input Output Power PC 100 mW Compatibility USB 2 0 compliant Insulation 1500 V compliant ...

Page 134: ... 6 Light guide Polycarbonate 7 Window Polycarbonate 8 Molded base ABS 9 Cover hook Polyamide 6 10 Infrared window Polycarbonate 11 Eccentric bolt POM 12 Bolt front case POM 13 Bolt rear case POM 14 Bolt button POM 15 Bolt button pen POM 16 Molded lever hooks Polyarylamide 17 Motor silent blocks Elastomere 18 Back foot LSR 19 Front foot LSR 20 Syringe barrel clasp stop Polyamide 21 Connector stoppe...

Page 135: ...n Infusion Rate Volume To Be Infused VTBI Infusion Tme Flow Rate Accuracy Occlusion Alarm Response Time Occlusion Alarm Threshold Pressure Management Trumpet and Start up Curves Feature Refer to Flow rate accuracy IFU Time to Detect Occlusion IFU Bolus Volume After Occlusion Release IFU Management of High priority Alarms IFU ...

Page 136: ...d separately and disposed of according to local regulations Information For more information on waste processing regulations contact your local Fresenius Kabi organization or the local distributor For more information on dismantling the device refer to the chapter Intervention Procedures in this document Follow healthcare facility policy regarding proper disposal after use ...

Page 137: ...137 15 Warranty Refer to the Instructions for Use of the relevant pump for the following information General conditions of warranty Limited warranty Warranty conditions for accessories ...

Page 138: ...and manufacturer s declaration Electromagnetic Emissions Table 2 Guidance and manufacturer s declaration Electromagnetic Immunity Table 4 Guidance and manufacturer s declaration Electromagnetic Immunity Table 6 Recommended separation distances between portable and mobile RF communication equipment and Agilia infusion pumps Wi Fi compatibility The Agilia infusion pumps include RF transmitters whose...

Page 139: ...139 17 Spare Parts Catalog Refer to the spare parts catalog of the relevant pump ...

Page 140: ...ciated Software 18 3 Disposables For more information contact your Fresenius Kabi sales representative Refer to the Instructions for Use of the relevant pump Refer to the Instructions for Use of the relevant pump Refer to the Instructions for Use of the relevant pump ...

Page 141: ...ss Telecommunications DEHP Di 2 ethylhexyl phthalate DERS Dose Error Reduction Software DI Dose Infused DPS Dynamic Pressure System DUR Duration ECG Electrocardiogram ECMO ExtraCorporeal Membrane Oxygenation ED Emergency Department EEG Electroencephalogram EMC ElectroMagnetic compatibility ErXX Error message ESD ElectroStatic Discharge FM Frequency Modulation ft Feet GPL General Public License H W...

Page 142: ...ty Check System OR Operating Room PACU Post Anesthesia Care Unit PC Personal Computer PE Protective Earth PSI Pounds per Square Inch RAM Random Access Memory REF Product reference part number RF Radio Frequency RFID Radio Frequency IDentification ROW Rest Of the World other countries than US and Canada RS232 Serial interface connector S N Serial Number SELV Safety Extra Low Voltage SIR Asynchronou...

Page 143: ...143 VTBI Volume to Be Infused W Watts Term Description ...

Page 144: ...ver Kit 119 Linear Sensor Kit 115 M Maintenance Date 38 Display Startup Screen 39 Schedule 28 Maintenance Options Menu 38 Maintenance Test 42 Material Characteristics 134 Motor 102 O Operation Diagram 27 Options Menu 30 P Plunger Cover 119 Plunger Kit 121 Power Information 55 Power Supply Board Description 20 Dismantle Re assemble 88 Pressure Limit Alarm Test 60 Pump Code 55 Pump Identification 41...

Page 145: ...145 W Watchdog 58 Wi Fi Board Description 24 Dismantle Re assemble 91 Wi Fi Module Information 59 ...

Page 146: ... and minor software modifications therefore some screenshots may appear slightly different from what you see on the product This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi Vigilant and Agilia are registered trademarks in the name of Fresenius Kabi in selected countries Made in France Revision date January 2017 Date Software Version Revision Des...

Page 147: ...Local Contacts for Servicing Write your contacts here ...

Page 148: ...11378 2_tm_agilia_sp_eng ...

Page 149: ...Agilia SP MC Agilia SP MC WiFi Syringe Infusion Pumps INSTRUCTIONS FOR USE For use in healthcare facilities Applicable to software version 2 2 ...

Page 150: ...or This way up Electrical fuses Keep away from rain Alternating Current AC Temperature limitation Direct Current DC Humidity limitation IP22 Index of protection against solid foreign objects 12 5 mm and dripping liquids Atmospheric pressure limitation Not for use in residential areas General symbol for recyclable material Part included in a recycling process Eco packaging symbol Protection against...

Page 151: ...ON 15 3 1 FRONT VIEW 15 3 2 BOTTOM VIEW DEVICE IDENTIFICATION LABEL 15 3 3 BACK VIEW 16 3 4 KEYPAD 17 3 5 DISPLAY AND SYMBOLS 19 3 5 1 Infusion Status 19 3 5 2 Screen Options 19 3 5 3 Navigation Buttons 20 3 5 4 Alarms and Safety Features 20 3 5 5 Infusion Features 20 3 5 6 Data Communication 20 3 6 PACKAGING 21 4 FUNDAMENTALS 22 4 1 PROFILES 22 4 2 DRUG LIBRARIES 23 4 3 DRUG LISTS 24 4 4 DRUGS 24...

Page 152: ...TALLING A SYRINGE 34 6 5 PUMP HEIGHT 35 7 OPERATION 36 7 1 FLOWCHART 36 7 2 SELECTING A PROFILE 37 7 3 SELECTING THE INFUSION RATE FLOW RATE OR DOSE 38 7 4 SELECTING A SYRINGE 39 7 5 SELECTING A DRUG 40 7 6 PROGRAMMING AN INFUSION 41 7 6 1 Programming an Infusion by Flow Rate 41 7 6 2 Programming an Infusion by Dose 41 7 6 3 Programming Beyond Soft Limits 47 7 7 STARTING AN INFUSION 49 7 8 MONITOR...

Page 153: ...PROFILE 66 8 3 PRESSURE 67 8 4 KEYPAD LOCK STATUS 70 8 5 BATTERY LIFE 72 8 6 VOLUME INFUSED DOSE INFUSED 73 8 7 PAUSE 74 8 8 PROGRAMMED BOLUS 75 8 9 PATIENT 75 8 10 DAY NIGHT MODE 76 8 11 VOLUME TIME DOSE TIME 78 8 12 VOLUME LIMIT 78 8 13 ALARM VOLUME 79 8 14 VOLUME DOSE HISTORY 80 8 15 VIEW FLOW RATE HISTORY 81 8 16 VIEW PRESSURE HISTORY 82 8 17 SYRINGE 83 8 18 VIEW EVENT LOG 84 8 19 DATE TIME 85...

Page 154: ...CTION 96 12 2 ALARM DESCRIPTIONS 96 12 3 GENERAL REMARKS 97 12 4 LIST OF ALARMS 97 13 SYRINGES 103 13 1 SYRINGE LIST 103 13 2 PREPARING A SYRINGE 104 13 3 OPERATIONS FOR SYRINGES 106 13 4 GRAVITY INFUSION IN PARALLEL WITH A PUMP 107 14 DEVICE STORAGE 108 14 1 PRECAUTIONS FOR STORAGE 108 14 2 STORAGE AND TRANSPORT CONDITIONS 108 14 3 PREPARING THE DEVICE FOR STORAGE 109 14 4 USING THE DEVICE AFTER ...

Page 155: ...HIBITED AGENTS 119 16 3 INSTRUCTIONS FOR CLEANING AND DISINFECTING 119 17 POWER MANAGEMENT 122 17 1 AC POWER SUPPLY PRECAUTIONS 122 17 2 BATTERY PRECAUTIONS 122 17 3 BATTERY OPERATING MODE 123 18 TECHNICAL CHARACTERISTICS 124 18 1 POWER SUPPLY 124 18 2 BATTERY 124 18 3 POWER CONSUMPTION 124 18 4 COMMUNICATION PORT 125 18 5 INFRARED COMMUNICATION 125 18 6 SOUND LEVELS 126 18 7 COMPLIANCE 126 18 8 D...

Page 156: ...R S DECLARATION ON EMC 137 23 1 ELECTROMAGNETIC COMPATIBILITY 137 23 2 ELECTROSTATIC DISCHARGE ESD 138 23 3 ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE 138 23 4 EMC AND ESSENTIAL PERFORMANCES 140 24 SERVICING 147 24 1 INFORMATION ON DEVICE SERVICING 147 24 2 MAINTENANCE REQUIREMENTS 147 24 3 QUALITY CONTROL 148 25 GLOSSARY OF TERMS 149 APPENDIX FACTORY CONFIGURATION 153 INDEX 154 ...

Page 157: ...device The software version of the device is displayed on the start up screen The software version described in this IFU is displayed in the Release Notes page 156 The Agilia SP MC Syringe Pump is intended for use on adults pediatrics and neonatal patients for the intermittent or continuous delivery of parenteral fluids such as solutions colloids parenteral nutrition medications such as diluted dr...

Page 158: ...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 The pump administers products through clinically accepted routes These products include but are not limited to the following Intended Products Parenteral Fluids Standard solutions Colloids Parenteral nutrition Medication Diluted drugs Antibiotics Chemotherapy Ca...

Page 159: ... assistants Typical initial training duration 1 hour It is recommended that users attend a refresher training session of about 20 minutes every year For training contact your Fresenius Kabi sales representative Agilia SP MC is intended to be used according to healthcare facilities protocols on patients with the following characteristics Patient Characteristics Sex Male Female Age Neonates Pediatri...

Page 160: ...ncreased friction and compliance of the syringe plunger head with larger syringes Do not modify the pump except in the case of operations recommended by Fresenius Kabi Do not use the pump with the following fluids Flammable liquids Fluids not suitable for infusion Do not use the pump in the following environments Explosive or flammable environments High humidity environments shower bath etc Ultras...

Page 161: ...ating humidity range 20 to 90 with no condensation Altitude Up to 3000 m above sea level Warning The functionality of the pump can be affected by pressure variations mechanical shocks heat ignition sources and so on Information The pump can be used in ambulances exclusively with the Agilia Holder Ambulance accessory Due to use in road ambulances performances of the device can be modified For more ...

Page 162: ...lia infusion pumps and centralize information coming from infusion pumps for post analysis and reporting Vigilant Insight Infusion Data Reporting Software Software designed to improve the accuracy of clinical settings included into a data set It provides reports about the use of infusion pumps Rack Link Agilia Link Agilia Stacking Rack Systems Rack systems designed to stack 4 6 or 8 Agilia infusio...

Page 163: ...om View Device Identification Label Legend Handle Plunger Driver Syringe Barrel Clasp Disengagement Lever Syringe Flange Cradle Syringe Guard For more information on device identification label symbols see Symbol Descriptions page 2 3 5 6 2 1 4 1 1 4 1 2 3 5 3 3 6 ...

Page 164: ... Cord Inlet Rotating Pole Clamp Infrared Cell RS232 Communication Port Attachment Lock Knob Symbol Location Description Near Power Cord Inlet Warning See section 18 page 124 Near RS232 Communication Port Warning See section 10 page 92 6 4 3 5 2 1 1 1 4 1 2 3 5 3 3 6 ...

Page 165: ...ower Supply Indicator Confirm Value Move to Next Field Wi Fi Symbol Stop On Off Cancel Value Move Back to Previous Field Bolus Prime Fast Increment Menu Increment Pressure Menu Infusion Indicator Lights Alarm Silence 9 15 14 17 16 13 12 11 8 10 7 6 5 1 2 3 4 1 3 7 10 1 2 3 11 3 3 12 4 3 13 5 3 14 3 6 3 7 3 15 3 8 3 16 3 7 9 3 17 ...

Page 166: ...ormation about the infusion in progress or with a low medium or high priority alarm Green indicator lights will continuously flash from right to left while the infusion is running The frequency of flashing varies according to flow rate Indicator Description Power Supply Indicator When the device is attached to an active power supply the indicator light is a constant green If the pump is not connec...

Page 167: ...ttery Logo This symbol shows three different charge levels 30 battery charge 30 70 battery charge 70 battery charge If the Battery logo option is enabled this symbol is displayed constantly If the Battery logo option is disabled this symbol is only displayed when the pump is operating on battery Pressure Logo This symbol gives information about pump pressure settings and measured pressure levels K...

Page 168: ...n Select Unselect See More Information Zoom in Zoom out Move the Event Marker to the Left Right Symbol Description Power Disconnection Alarm Silenced Pressure Increase Drop in Pressure Note For more information on alarms see section 12 page 96 Symbol Description Loading Dose This symbol is displayed when programming a loading dose Symbol Description Data Set Loaded A new data set has been loaded t...

Page 169: ...System Components booklet 1 Power cord Packaging weight Approximately 530 g Packaging consists of Recycled cardboard expanded foam Information It is the healthcare facility s responsibility to check the pump integrity upon reception If the packaging contents are incomplete or damaged contact your Fresenius Kabi sales representative ...

Page 170: ... on only one group of patients we recommend disabling the ability to select the profile thus locking the pumps to the selected profile Basic Profile allows programming of an infusion whose settings have not been pre defined with Agilia Vigilant Drug Lib software To program an infusion with Basic Profile choose Basic Profile when selecting a profile Basic Profile has the following characteristics A...

Page 171: ...using a custom profile when infusing critical drugs We recommend that you create and upload profiles in order to limit usage errors and to better adapt the use of the pump to the local practices of the different care units For example make sure to limit flow rates for sensitive populations We recommend creating a specific profile per patient population and or care unit therapy protocol and so on A...

Page 172: ...aracteristics Fewer limits than the other drugs in the library A full compliment of the Agilia Vigilant Drug Lib software s safeguards are unavailable It is strongly recommended to use Drug X mL h in a limited number of clinical cases and under close patient monitoring by the clinical staff For each custom profile the healthcare facility can enable or disable Drug X mL h using the Agilia Vigilant ...

Page 173: ...n of custom profiles up to a maximum of 19 that can be uploaded to Agilia pumps with Agilia Vigilant Drug Lib software If there is no data set uploaded to the pump the pump can be used with the Basic Profile without the protections of the Agilia Vigilant Drug Lib software Device Configuration factory Device Configuration 2 Device Configuration 3 Device Configuration 4 Device Configuration 20 Drug ...

Page 174: ...ion 5 3 2 page 29 Rail specifications Height from 25 to 35 mm Depth from 8 to 10 mm On the Link Agilia Rack Refer to the Agilia Link accompanying documents On a Table See section 5 3 3 page 30 Only install a pump on a table if it is not possible to attach it to a pole a rail or recommended Agilia accessory On Another Pump See section 5 3 4 page 30 On an Agilia Duo Refer to the Agilia Duo accompany...

Page 175: ...panying documents Warning The pump must be used in a horizontal and stable position to function properly Use recommended Agilia accessories to ensure stability and prevent the pump from falling Do not stack the pump with equipment other than those recommended The rotating pole clamp is located at the back of the pump When installing the pump on a pole or a rail fasten the rotating pole clamp firml...

Page 176: ...olding it outward until the release button clicks into the locked position You can fold the clamp down as follows 1 Push the release button 2 Fold the clamp outward You can fold the clamp up as follows 1 Push the release button 2 Fold the pole clamp inward toward the pump You can rotate the clamp as follows 1 Fold the clamp up see above 2 Rotate the clamp to a vertical position 3 If necessary fold...

Page 177: ... securely attached For more information on installing the pump on a pole consult the pole s Instructions for Use Information When installed on a rolling stand do not tip over the system more than 5 it may fall Only single pumps can be attached to a bed rail or gurney rail 1 Rotate the pole clamp to the vertical position see section 5 2 2 3 page 28 2 Unscrew the clamp attach to the rail and screw t...

Page 178: ...pole 1 Fold both pumps pole clamps up see section 5 2 2 2 page 28 2 Slide the slot on the bottom of the upper pump onto the handle of the lower pump 3 Turn the attachment lock knob on the lower pump handle clockwise until the locked symbol lines up with the marker 4 Make sure the two pumps are securely attached together 5 If needed fold the two pole clamps down and secure them tightly to the pole ...

Page 179: ...ty features of the device are activated make sure that the following instructions are applied The pump is powered on prior to being connected to the patient The pump is not connected to the patient during the set up Preparing and priming the syringe and the extension set Section 13 2 page 106 Powering on Section 6 3 page 32 Installing the syringe Section 6 4 page 34 Programming an infusion Section...

Page 180: ... page 32 5 Install a syringe into the pump See section 6 4 page 34 Information The pump can operate using the battery however we recommend that the pump be connected to a power supply as often as possible during use in order to ensure that the battery remains charged When the pump is connected to the power supply check that the power supply indicator lights up green and that the power cord and the...

Page 181: ...els 30 battery charge 30 70 battery charge 70 battery charge No syringe is installed on the pump Syringe installation is displayed on top of the screen Install a syringe See section 6 4 page 34 Maintenance reminder message optional Same infusion screen optional Press Yes to keep previous infusion settings Profile confirmation screen optional Press Ok to confirm the profile Note This screen is link...

Page 182: ...B down and move the plunger driver to the right 3 Place the syringe in its cradle with the flanges correctly inserted in the provided slot 4 Secure the syringe with the syringe barrel clasp A 5 Push the disengagement lever B and move the plunger driver gently to the left until it is in contact with the plunger head 6 Check the general installation Screen After Powering on Description A B ...

Page 183: ...changes in the height of the pump e g during transport of critically ill patients to prevent unintended fluctuations in the flow rate 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 ...

Page 184: ...1 2 page 23 Selecting the Infusion Rate Section 7 3 page 38 Selecting the Infusion Rate Section 7 3 page 38 Selecting a Syringe Section 7 4 page 39 Selecting a Drug Section 7 5 page 40 Starting the Infusion Section 7 7 page 49 Monitoring the Infusion Section 7 8 page 50 Functions during Infusion Section 7 9 page 52 Completing the Infusion Section 7 10 page 57 Programming an Infusion Section 7 6 pa...

Page 185: ...at corresponds to the target group of patients The lighthouse symbol refers to custom profiles that contain drug libraries and have been configured with Agilia Vigilant Drug Lib software 3 Press OK to confirm The selected profile information is displayed 4 Press OK to confirm the drug library version or C to change the profile The drug library is loaded for the profile selected ...

Page 186: ...le 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 The infusion rate that was last used is displayed 1 Press OK to confirm the infusion rate or press C to change it 2 Press the arrow keys to select a new infusion rate 3 Press OK to confirm Flow rate Dose Flow rate Dose ...

Page 187: ...ew syringe 3 Press OK to confirm the new syringe A clinical advisory message may appear if one is configured for the selected syringe 4 Press OK to acknowledge the clinical advisory message or C to return to the syringe selection screen Warning During programming and prior to starting an infusion verify that the syringe size and model on the syringe pump s display screen matches the syringe size a...

Page 188: ... F G I J L M O P R S U V Z Drug X mL h 1 Press the arrow keys to scroll to the drug s first letter and press OK 2 Press the arrow keys to scroll to the drug s name and press OK A clinical advisory message may appear if one is configured for the selected drug 3 Press OK to acknowledge the clinical advisory message and continue programming or C to change the drug ...

Page 189: ...ing modes Volume Time or Dose Time see section 7 11 2 page 59 Volume Limit see section 7 11 3 page 60 1 Press the arrow keys to program the flow rate Profile Drug Concentration Selection Procedure Basic Profile A Basic Profile and Custom Profiles with a Drug List page 41 Custom Profile with a drug list Custom Profile with a drug library B Custom Profiles page 42 A Basic Profile and Custom Profiles...

Page 190: ...ated and displayed in the unit selected above 4 Press OK to confirm B Custom Profiles The selected drug is configured in Agilia Vigilant Drug Lib software to allow adjustments to its concentration in one of the following ways Within an authorized range At authorized finite values up to 5 If no adjustment of the concentration is allowed see section 7 6 2 2 page 44 ...

Page 191: ...horized Finite Concentrations Legend Unauthorized Range Hard Limits Authorized Range Default Value Finite Values Selecting the Drug Concentration 1 Press the arrow keys to select the concentration 2 Press OK to confirm Range Finite values ...

Page 192: ...se rate calculations The body surface area entry screen only appears if the selected drug uses body surface area for dose rate calculations A pre populated default weight or body surface area will be configured with the Agilia Vigilant Drug Lib software Note This step is only applicable with Basic Profile and custom profiles that contain a drug list The infusion units for each drug of a drug libra...

Page 193: ...s only available with the first start of an infusion If no is pressed inadvertently power the pump off and then on to access the loading dose again If enabled for the selected drug you can program a loading dose after programming an infusion defined by dose The screens below will appear prior to starting the infusion Selecting a Loading Dose On the loading dose screen Press no to return to the pro...

Page 194: ...nd press OK to confirm each time segment The VTBI and the flow rate are automatically calculated based on dose and duration settings 3 Press OK to confirm the loading dose settings If needed press C or to change the loading dose settings before starting 4 Press start to initiate the loading dose Once the loading dose is finished the pump automatically starts the programmed infusion ...

Page 195: ...d proceed to the programmed infusion Press start to continue with the loading dose Note This step is only available with custom profiles that contain a drug library You can override soft limits and adjust flow rate and dose within the authorized ranges You cannot override a hard limit Legend Unauthorized Range Hard Limits Programmable Range warning and confirmation Soft Limits Authorized Range Def...

Page 196: ...ded 2 If the displayed settings correspond to the intended flow rate or dose press OK 3 Carefully review the program settings The original infusion settings continue until you confirm the new settings 4 Press OK or start to confirm the soft limit override During infusion the upper or lower soft limit message will alternate with the drug name and concentration at the top of the screen Flow rate Dos...

Page 197: ... start to start the infusion Warning When connecting the syringe s extension set to the patient s access device always use aseptic technique according to your healthcare facility policy During programming and prior to starting an infusion verify that the syringe size and model on the syringe pump s display screen matches the syringe size and model loaded onto the syringe pump Information If the sy...

Page 198: ...rgest font size Infusion Duration At the current rate the remaining infusion time in hours and minutes Infusion duration may or may not be displayed depending on the configuration preset with Agilia Vigilant Drug Lib software for this drug Syringe Name Ward Name configurable Custom Profile Sign When infusing a drug selected from the Agilia Vigilant Drug Lib software library this lighthouse sign is...

Page 199: ... 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 When infusing a drug selected from the Agilia Vigilant Drug Lib software library this lighthouse sign is displayed on the screen continuously 6 7 1 3 2 5 4 1 1 2 3 4 5 6 7 ...

Page 200: ...y the programming settings then start the infusion See section 7 6 page 41 You can adjust the infusion rate flow rate or dose during the infusion Depending on your pump configuration stopping the infusion may be required before modifying the infusion rate 1 If required stop the infusion see section 7 9 1 page 52 2 Press the arrow keys to modify the flow rate or dose 3 Press OK to confirm Flow rate...

Page 201: ...ays to deliver a bolus dose during an infusion Direct bolus Programmed bolus Direct Bolus Programmed Bolus Access Key or Occlusion Pressure Level Set to its maximum value 900 mmHg 120 kPa 17 4 PSI Information The bolus volume is added to the Volume Infused VI The key is not active when the menu screen is displayed ...

Page 202: ...pump options Basic profile 1 During the infusion press 2 Press bolus to confirm access to bolus function 3 To administer a direct bolus press and hold 4 Monitor the volume infused on the main display until the desired bolus is reached 5 To stop the bolus release the key The infusion resumes its previous rate after the bolus is delivered ...

Page 203: ...n program a bolus in one of the following two ways Press then prog Press and select in the menu Press enter to confirm Programming a Bolus 1 Press the arrow keys to program the bolus volume or dose and press OK 2 Press the arrow keys to program the bolus duration __ h __ min __ and press OK The flow rate is calculated automatically 3 Press start to start the bolus Flow rate Dose Flow rate Dose ...

Page 204: ... and save the programmed bolus settings If you press again this screen appears immediately and displays the settings of the last bolus Interrupting a Programmed Bolus 1 Press to interrupt the bolus 2 Answer the question Continue Press no to return to the infusion Press start to continue the bolus Flow rate Dose ...

Page 205: ...e 10 of the syringe capacity N A N A Near end of infusion alert settings are configurable with Agilia Vigilant Drug Lib software custom profiles or in the pump options Basic Profile For more information refer to the technical manual Silencing Near End of Infusion Alert 1 Press to silence the alarm 2 If required press OK to confirm the empty syringe mode Depending on the pump configuration the foll...

Page 206: ...d End of infusion settings are configurable with Agilia Vigilant Drug Lib software custom profiles or in the pump options Basic Profile For more information refer to the technical manual Silencing the Alarm 1 Press to silence the alarm 2 Prepare a new syringe and adjust the settings for a new infusion You can power off the pump as follows 1 Press to stop the infusion 2 Press and hold until the pum...

Page 207: ... program a volume to be infused VTBI over a programmed period of time When the VTBI is reached an alarm is triggered 1 For information on how to access the Volume Time or Dose Time menu see section 8 11 page 78 2 Press the arrow keys to set the volume or dose to be infused VTBI DTBI and press OK The infusion rate is automatically calculated Information If you program a volume to be infused that is...

Page 208: ...r the VTBI is completed the infusion continues at a preset flow rate to keep the access device open Continuous After the VTBI is completed the infusion continues at the programmed flow rate 5 Press start to start the infusion You can use this infusion mode to set a limit to the volume infused When the limit is reached an alarm is triggered 1 Access the Volume Limit menu see section 8 12 page 78 2 ...

Page 209: ... taken into account 3 Press the arrow keys to configure the end of infusion settings and press OK to confirm Stop The infusion stops when the volume limit is reached Keep Vein Open KVO After the volume limit is reached the infusion continues at a preset flow rate to keep the access device open Continuous After the volume limit is reached the infusion continues at the programmed flow rate 4 Press s...

Page 210: ...rime the line before infusion Not displayed The pump does not remind the user to prime the line before infusion Information We strongly recommend to always use the prime function especially for life sustaining drugs Priming the syringe and the extension set removes all the mechanical gaps and ensures that the programmed flow rate is reached within the smallest delay once the start button is presse...

Page 211: ...low rate 120 mL h until the pump s plunger driver starts pushing the syringe plunger head The flow rate then automatically switches to the programmed value At the beginning of an infusion quick start is triggered or not triggered in the following situations Prime Function Configuration Quick start Trigger Rule Mandatory Not triggered Advised Not triggered Not displayed Triggered if flow rate is eq...

Page 212: ... pump Syringe installation is displayed on top of the pump screen 2 Make sure the syringe barrel clasp is folded up against the pump The prog symbol is displayed 3 Press prog 4 Program the infusion See section 7 6 page 41 5 Press exit to confirm 6 When ready install the syringe 7 Press start to start the infusion ...

Page 213: ...g the battery life page 72 Volume Infused NO Viewing and clearing the volume or dose infused page 73 Dose Infused Pause YES Programming a pause page 74 Programmed bolus NO Programming a bolus page 75 Patient NO Changing a patient s weight or body surface area page 75 Day Night mode NO Switching between day mode and night mode page 76 Volume Time YES Programming a Volume Time or Dose Time infusion ...

Page 214: ...age 84 Date Time NO Setting the date and time page 85 Maintenance NO Displaying maintenance information page 86 Library information NO Displaying drug library information page 87 Clinical information NO Viewing remaining time before clinical information display page 88 Data Set NO Displaying active data set information page 89 Symbol Procedure Displaying active profile information You can display ...

Page 215: ...5 8 page 113 Warning When addressing or clearing an occlusion Ensure the fluid flow to the patient is OFF to prevent administering an unintended bolus An occlusion may pressurize the infusion tubing and syringe which can result in an unintended bolus of drug when the occlusion is cleared In order to prevent this additional bolus disconnect the tubing or relieve the excess pressure through a stopco...

Page 216: ... following ways Press Through the Menu Press Press the arrow keys to select 2 Press enter to access the pressure limit screen 3 Press the arrow keys to increase or decrease the pressure limit 4 Press OK to validate 5 Press to enable or disable the DPS function optional 6 Press OK to confirm ...

Page 217: ...s the amount of friction and compliance i e stiffness of the syringe plunger head Because syringe pumps infuse fluids by precisely controlling the plunger smaller syringes provide more precise fluid delivery than larger syringes Use the prime feature on the pump when changing a syringe and or tubing Use extension set which have the smallest internal volume or deadspace e g use microbore tubing whe...

Page 218: ...te 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 Unlock code The user must enter a code to unlock the keypad Locking the Keypad You can lock the keypad as follows 1 Press 2 Press the arrow keys to select 3 Press enter ...

Page 219: ...t will lock again automatically after a time out 5 Press OK to confirm Unlocking the Keypad You can unlock the keypad as follows 1 Press 2 Press the arrow keys to select 3 Press enter 4 Unlock the keypad as follows If a code is required press the keys to enter the unlock code The keypad is unlocked If no code is required press and press OK to confirm The keypad is unlocked and the screen displays ...

Page 220: ... memorized when the pump is powered off In case of forgotten unlock code contact your biomedical department Symbol Procedure Viewing the battery life You can view the battery life as follows 1 Press 2 Use the arrow keys to select The time remaining under current flow rate conditions is displayed The bar graph shows a visual representation of battery life The symbol displayed shows the following Th...

Page 221: ...arrow keys to select The total volume or total dose infused includes the programmed infusion loading doses and boluses The length of time over which they were infused is also displayed 3 To clear the volume or dose infused press enter 4 Press OK to confirm Information When the pump is powered off or a new drug is selected the volume or dose infused is cleared mL Flow rate Dose mL ...

Page 222: ...in hours and minutes and press OK 6 Press the button to activate the Start infusion at pause end feature optional 7 Press OK to begin the programmed pause 8 To restart the infusion before the end of the pause period press then start Information If you do not activate the Start infusion at pause end option an audible alarm is generated at the end of the pause The infusion must be started manually t...

Page 223: ...page 55 Symbol Procedure Changing a patient s weight or body surface area Information If the selected dose rate unit is weight based kg the screen displays the patient s weight If the selected dose rate unit is body surface area based m the screen displays the patient s body surface area Weight Body Surface Area ...

Page 224: ...witches between day mode and night mode The default night mode settings are as follows The key press beep is silenced Infusion indicators and screen brightness are dimmed Depending on your pump configuration the switch between day and night mode may be managed either through this menu manual mode or according to pre defined settings auto mode For more information refer to the technical manual Swit...

Page 225: ...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 Press to activate day mode The screen displays 5 Press OK to confirm ...

Page 226: ...e or Dose Time infusion 1 Press 2 Press the arrow keys to select or 3 Press enter For more information on how to program a Volume Time or Dose Time infusion see section 7 11 2 page 59 Symbol Procedure Programming a Volume Limit infusion V T D T Volume Time Dose Time V T D T VL Flow rate Dose ...

Page 227: ...ram a Volume Limit infusion see section 7 11 3 page 60 Symbol Procedure Adjusting the alarm volume You can adjust the alarm volume as follows 1 Press 2 Press the arrow keys to select 3 Press enter 4 Press the arrow keys to select the alarm volume The pump emits an alarm at the selected volume level 5 Press OK VL ...

Page 228: ...the pump You can view the infusion history as follows 1 Press 2 Press the arrow keys to select 3 Press enter 4 Press the arrow keys to select the desired infusion The selected infusion s details are displayed Drug name Drug concentration Volume or dose infused Infusion total duration Infusion date time 5 Press exit to return to the menu ...

Page 229: ...e arrow keys to select 3 Press enter The following information is displayed An event marker cursor The event details time and flow rate The measured flow rate solid line 4 Press the and buttons to browse the events 5 Press to view information about the selected event Information The history is not refreshed while the history screen is displayed To refresh the history data exit and select the histo...

Page 230: ...ct 3 Press enter The following information is displayed An event marker cursor The event details time and pressure limit The pressure limit dotted line The measured pressure solid line 4 Press the and buttons to browse the events 5 Press to view information about the selected event Information The history is not refreshed while the history screen is displayed To refresh the history data exit and s...

Page 231: ...cedure 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: ...an store up to 1500 events Older events are overwritten Note When the AC Power is disconnected for a period of time or when the batteries are not operating the log file is kept in a non volatile memory for approximately 10 years You can view the event log as follows 1 Press 2 Press the arrow keys to select 3 Press enter 4 Press the arrow keys to select the desired event 5 Press enter The details o...

Page 233: ...previous screen 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 Press the arrow keys to set the following Day Month Year Hours Minutes 5 Press OK to confirm ...

Page 234: ...rmation 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 Pump serial number Next maintenance date dd mm yyyy Pump model Software version Total operating time since last maintenance ...

Page 235: ...rug 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 4 Press the arrow keys to select a drug 5 Press to view information on the selected drug ...

Page 236: ...ia 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 Press 2 Press the arrow keys to select The remaining time before clinical information is displayed 3 Press enter The clinical information message is displayed ...

Page 237: ... 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 DS DS ...

Page 238: ...rogramming To return to the normal menus power off then power on again Four different option groups are available on the pump This IFU only describes the Pump Settings options Option Access Code Description Location Pump Settings No Section 9 3 page 91 Basic Profile Configuration Yes Technical Manual Profile Yes Technical Manual Maintenance Yes Technical Manual Information If the wrong access code...

Page 239: ...al language of the target country User 14 Wi Fi module Enable Disable the Wi Fi module Enabled Par 5 Syringe selection Enable Disable selected syringe confirmation screen Enabled Par 6 Syringes Checkbox list with the names of available syringes and other syringes sizes Section 13 1 page 106 Par 13 AC power disconnection alert Enable Disable AC power disconnection message and Device operating on ba...

Page 240: ...val Information Ensure that all hospital information systems have been approved by Fresenius Kabi For more information contact your technical services representative Before connecting the pump to a hospital information system ask your IT or biomedical department to configure the device Information Only use recommended Agilia cables All connections and disconnections must be performed by qualified ...

Page 241: ...transferred The Wi Fi option allows the pump to connect to a hospital information system without cables To know if your pump is equipped with a Wi Fi module check for the presence of the Wi Fi logo on the pump s keypad See section 3 4 1 page 17 To activate or deactivate the Wi Fi module see section 9 3 page 94 For more information on the Wi Fi module refer to the technical manual Information Wi Fi...

Page 242: ...t start up of the pump the symbol is displayed on the screen 1 Power on the pump 2 Press OK to acknowledge The data set information is displayed 3 Press OK to acknowledge this information or C to return to the previous screen The data set is installed in the pump Information It is the hospital s responsibility to define a data set and upload it to the Centerium Server for distribution to the devic...

Page 243: ...s or other visible damage 2 Check for the absence of visible damage on the power cord inlet and the power cord 3 When used on a pole or a rail check that the pump is securely attached 4 Connect the pump to the AC power supply and check that the power indicator lights up and a beep is emitted 5 Power on the pump and wait for the auto test to complete Check the display and light indicators 6 Press a...

Page 244: ...ental noise There are several different levels of alarm priorities High priority alarms Medium priority alarms Low priority alarms Information signals Alarm Priority Required Operator Response Description High Immediate response The infusion stops The infusion indicator lights flash red The pump emits audible alarm signals An alarm description is displayed on the pump screen The key silences the a...

Page 245: ...ndition For all alarms except occlusion alarms the amount of time between the alarm condition and the alarm generation is less than 5 seconds If the AC power is disconnected and if the battery is discharged the alarms settings are not modified and are stored indefinitely Message Priority Stops Infusion Problem Resolution Syringe installation High Yes The syringe is not installed correctly plunger ...

Page 246: ...ime remaining is less than the defined time duration adjustable between 1 and 30 minutes and the remaining VTBI has dropped to less than 10 of the syringe capacity Near end of dose time End of volume time Low No The VTBI is completed and the end of infusion setting is set as KVO or continuous End of dose time Message Priority Stops Infusion Problem Resolution End of infusion High Yes The infusion ...

Page 247: ...sion alarm High Yes The pressure in the infusion line has reached the threshold level Check whether the infusion line is occluded If necessary readjust the pressure threshold See Section 8 3 page 67 Occlusion pre alarm Medium No In line pressure has reached the following value 25 mmHg 2 5 kPa 0 5 PSI below the programmed threshold from 50 to 250 mmHg 50 mmHg 5 kPa 1 PSI below the programmed thresh...

Page 248: ...nd wait until the battery is charged Message Priority Stops Infusion Problem Resolution AC power failure Low No The power supply is inconsistent Contact your technical support Power disconnection Information signal No The pump is disconnected from the AC power A single beep is emitted Press to acknowledge Check that the battery life is sufficient for the expected infusion duration If the disconnec...

Page 249: ... upgraded Contact your qualified technician or your Fresenius Kabi sales representative In the case of a system malfunction the alarm sounds and an error message Erxx yyyy is displayed 1 Record the error message Erxx yyyy 2 Disconnect the pump from the power supply 3 Reset the device by pressing the key for 10 15 seconds and release it when the device powers off Warning If the alarms persist when ...

Page 250: ...rammed bolus Start infusion at the end of pause 3 beeps N A At the end of a pause when the infusion automatically starts AC power connection 1 beep No When power is connected Forbidden key 1 beep No Repeated until key is released Key beep 1 beep No For each key pressed Other non validation beep 1 beep No For each key pressed Manual bolus 1 beep No Repeated for each mL infused Syringe prime 1 beep ...

Page 251: ...expiration date storage sterility and so on refer to the syringe manufacturer s instructions Warning Fresenius Kabi cannot accept responsibility for any flow rate errors that are due to changes to syringe specifications introduced by the manufacturer Ensure syringe sizes and models are compatible with the syringe pump refer to the System Components booklet Use of incompatible syringes can cause in...

Page 252: ...emperature conditions 18 30 C It is recommended to prime the set immediately before starting the infusion Do not use in conjunction with positive pressure infusion devices that could generate back pressure higher than 2000 hPa 1500 mmHg doing so will damage the administration set and the pump Some extension sets may have components such as a filter that require special instructions Certain drugs m...

Page 253: ...g at low rates Tubing length Tubing length should be minimized when possible Filters Internal volume deadspace of in line filters should be minimized Connection sites The number of connection sites such as stopcocks and Y sites should be limited and high risk or life sustaining solutions should be connected as close to the intravenous access site as possible Avoid use of extension sets with ports ...

Page 254: ... Disconnect the extension set from the access device in accordance with healthcare facility protocol 1 Remove the syringe See section 13 3 1 page 106 2 Prepare a new syringe and follow the steps described in the flowchart See section 6 1 page 31 3 After the new syringe is installed acknowledge the same therapy screen optional screen Warning Electronically prime the syringe pump system after replac...

Page 255: ... line This will prevent the back up of IV fluid or medication into the gravity line If there is no back check valve on a gravity infusion line during a multi line infusion it will be impossible to detect patient side occlusions Such an occlusion could cause the pumped drug to back up into the gravity line and later be infused in an uncontrolled manner when the occlusion is released Be careful abou...

Page 256: ...han 2 months it is recommended that the battery be removed from the device and put in storage by authorized personnel If the battery cannot be removed or the device will be used in less than 2 months charge the battery at least once a month by connecting the device to the AC power supply for at least 6 hours Observe the following conditions for storage and transport Temperature 10 C to 60 C Pressu...

Page 257: ...mp with care and store it in a compliant area For detailed instructions refer to the related chapters in this document The device can be used immediately after storage without any cooling or warm up period If the battery has been removed for long term storage contact your biomedical department in order to reinstall the battery prior to use We recommend charging the battery for at least 6 hours We ...

Page 258: ...n Agilia Vigilant Drug Lib software custom profiles Increment rules may be modified by Agilia Vigilant Drug Lib software custom profiles The pump s essential features are defined in standard operating conditions Feature Refer to Flow Rate Accuracy Section 15 9 1 page 114 Section 18 9 page 127 Time to Detect Occlusion Section 15 9 3 page 114 Bolus Volume After Occlusion Release Section 15 9 4 page ...

Page 259: ...0 99 9 100 1200 Direct Bolus mL h 50 1200 50 600 50 600 50 350 50 250 50 Priming mL h 1200 600 600 350 250 N A Programmed Bolus mL h 0 1 1200 0 1 600 0 1 600 0 1 350 0 1 250 0 01 0 1 1 0 10 9 99 10 0 99 9 100 1200 KVO mL h 0 1 5 0 1 5 0 1 5 0 1 5 0 1 5 0 1 Loading Dose mL h 0 1 1200 0 1 600 0 1 600 0 1 350 0 1 250 0 01 0 1 1 0 10 9 99 10 0 99 9 100 1200 Format Range of Settings Default Value Minim...

Page 260: ...0 01 0 1 1 0 01 9 99 10 99 9 100 9999 Loading Dose Unit 0 01 9999 N A 0 01 0 1 1 0 01 9 99 10 0 99 9 100 9999 Format Range of Settings Default Value Minimum Increment Infusion Rate __ h __ min __ 00h00min01 96h00min00 N A 00h00min01 Programmed Bolus __ h __ min __ 00h00min01 24h00min00 00h02min00 00h00min01 Loading Dose __ h __ min __ 00h00min01 24h00min00 00h02min00 00h00min01 KVO Silence Alarm D...

Page 261: ...menu Yes No Yes Unit Pressure unit selection mmHg kPa PSI mmHg Limit Stored The last pressure limit adjustment is automatically stored in memory for the next startup Enabled Disabled Disabled DPS Stored The last DPS adjustment is automatically stored in memory for the next startup Enabled Disabled Disabled Format Range of Settings Default Value Minimum Increment 3 Levels Low mmHg 50 300 100 50 Med...

Page 262: ...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 Accuracy Flow Rate 3 Back Pressure Accuracy From Mean Values 39 9 kPa 13 33 kPa 13 33 kPa 3 1 5 1 5 Accuracy Occlusion Alarm Response Time Syringe Rate Occlusion Alarm Threshold 50 mmHg 900 mmHg 5...

Page 263: ...above the patient a bolus 0 05 X 0 35 mL may occur 15 9 5 Pressure 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 Release 50 mmHg 900 mmHg 50 mL 5 mL h 0 05 X 0 35 mL 0 05 X 0 35 mL Accuracy Pressure 500 mmHg 75 mmHg 500 mmHg 15 ...

Page 264: ...its Dose 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 m h mg m 24h g h g kg min g kg h g kg 24h mmol h mmol kg h mmol kg 24h mUnit min mUnit kg min mUnit kg h Unit min Unit h Unit kg min Unit kg h kcal h kcal 24h kcal kg h mEq min mEq h mEq kg min mEq kg h mL kg min mL kg h mL kg 24h ...

Page 265: ... unit m2 h dose m2 body surface area Conversion of a dose including the unit m2 into volume flow rate mL h unit mL concentration mL h unit h dose Expression of a volumetric flow rate unit mL concentration mL unit kg dose kg weight Conversion of a dose including the unit kg into volume mL unit mL concentration mL unit m2 dose m2 body surface area Conversion of a dose including the unit m2 into volu...

Page 266: ...by your local practices and healthcare facility policies immediately perform the quick cleaning described below Always follow your local protection rules Quick Cleaning Only Note This quick cleaning does not replace the need for a complete cleaning 1 Check that the keypad is locked in order to avoid unintended modification of the infusion parameters Do not move the pump 2 Use ready to use wipes to...

Page 267: ... provided to ensure effective cleaning and disinfecting of the equipment Use the agents according to the manufacturer s instructions This may include wearing personal protective equipment gloves lab coat glasses and so on or diluting the agent according to the manufacturer s guidelines For disinfectants respect the contact time required for the antimicrobial agents to act the time the agent must b...

Page 268: ... down the sides avoid wetting the connector sockets Do not allow liquids to run leak or drip into the pump housing 4 Make sure the pump remains damp for at least 1 minute 5 Set down the pump and wipe down the silver handle the attachment lock knob the screw clamp and the release button 6 Use a fresh ready to use wipe to gently wipe down the back side of the syringe barrel clasp and all exposed sur...

Page 269: ...ch areas You can use the silver handle to lift and move the pump When wiping down the sides avoid wetting the connector sockets Do not allow liquids to run leak or drip into the pump housing 3 Set down the pump and wipe down the silver handle the attachment lock knob the screw clamp and the release button 4 Use a fresh ready to use wipe to gently wipe down the back side of the syringe barrel clasp...

Page 270: ...wer supply with the power cord supplied by Fresenius Kabi or with a power supply accessory from the Agilia product range Do not use an extension cord when connecting the pump to the AC power supply Pumps must be plugged into a medical grade power strip if one is used The device uses a Lithium ion rechargeable battery The following actions may cause leakage overheating smoke explosion or fire which...

Page 271: ...ures refer to the operating conditions for use and the storage instructions Do not try to charge or discharge the battery outside of the device For more information on replacing the battery refer to the technical manual The device is provided with an internal battery that automatically provides power to the device in case of power failure or disconnection from the AC power supply The battery charg...

Page 272: ... 15 VA Protective fuse 1 X T1 6AH 250V accessible in the battery compartment Disconnect the battery before opening the device Avoid short circuits and extreme temperatures If the device is not used for more than 3 months the date is erased all other settings are stored permanently When you power on the pump you must set the date again Characteristics 7 2 V 2 2 Ah Li ion Smart battery Weight Approx...

Page 273: ...put 5 VDC 150 mA to power Agilia USB cable The pump is equipped with an infrared cell located at the back of the device Mode Wireless optical communication using infrared light Compatibility Asynchronous Serial Infrared SIR physical layer irPHY 1 0 baseband no carrier Transport Protocol Proprietary Speed 115 2 kb s max Wavelength 880 nm to 900 nm infrared band with 45 nm spectral bandwidth Eye Saf...

Page 274: ...nd Level dBA 0 21 1 23 20 27 100 30 400 49 1200 32 Alarm Priority Sound Level dBA min Max High priority 55 63 Medium priority 50 57 Low priority 45 52 ElectroMedical Equipment Safety Compliant with the following standards IEC 60601 1 IEC 60601 1 8 IP22 Index of protection against ingress of water or particulate matter EMC ElectroMagnetic Compatibility Compliant with the following standard IEC 6060...

Page 275: ...are presented below for a number of representative flow rates The test protocol used to obtain these results is described in ANSI AAMI ID26 The curves can be helpful in determining the suitability of infusion parameters for specific drugs and concentrations Syringe used BD Precise 50 mL Fluid used distilled water Recommendations to improve performances and safety when the pump is commonly used at ...

Page 276: ... windows 1 mL h over first 2 hours on 96 hours Legend Instantaneous flow rate Set flow rate Sampling time 10 s Legend Measured variance from flow rate Error Flow rate Sampling time 10 s Flow rate mL h Time minutes 0 1 2 0 10 20 30 40 50 60 70 80 90 100 110 120 Flow rate mL h Time minutes 6 0 3 9 1 0 1 1 8 6 6 5 4 4 1 9 1 6 10 5 0 5 10 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 ...

Page 277: ... mL h over first 2 hours on 96 hours Legend Instantaneous flow rate Set flow rate Sampling time 10 s Legend Measured variance from flow rate Error Flow rate Sampling time 10 s Flow rate mL h Time minutes 0 1 2 3 4 5 6 7 8 9 10 0 10 20 30 40 50 60 70 80 90 100 110 120 Flow rate mL h Time minutes 1 7 1 0 0 7 0 4 0 2 1 9 1 0 0 7 0 5 0 3 10 5 0 5 10 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 ...

Page 278: ...wing via periodic communication cycles Transfer data sets from Centerium server to pump Transfer pump history from pump to a server Communicate general information on the operating status of the pump Agilia infusion pumps contain transmitter with the following IDs FCC ID XF6 RSWC301 IC ID 8407A RSWC301 Agilia Wi Fi pumps must be installed to provide a separation distance of at least 8 in 20 cm fro...

Page 279: ...ork Protocols TCP IPv4 DHCP HTTP Typical Transmit Power 2 dBm 17 dBm for 802 11b DSSS 17 dBm for 802 11b CCK 15 dBm for 802 11g n OFDM 12 dBm in 802 11a mode For information on electromagnetic compatibilty see section 23 2 3 page 174 The users manual or instruction manual for an intentional or unintentional radiator shall caution the user that changes or modifications not expressely approved by th...

Page 280: ...ransfer Protocol are standard data transport protocol used for the internet and other similar networks Agilia infusion pumps do not require an active wireless communication to function as intended infuse All wireless transactions are initiated by the device and are periodic in nature The absence of connection for example out of range does not affect the device ability to infuse Data that is pendin...

Page 281: ... Fresenius Kabi sales representative Flow rate variance is higher than flow rate accuracy Check the infusion line configuration Check the fluid viscosity Check that the fluid temperature is within the recommended range Contact your biomedical department or your Fresenius Kabi sales representative Keypad problem keys LEDs Check the general condition of the keypad Check the contrast Contact your bio...

Page 282: ...ng Connect the pump to the AC power supply 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 Issue Recommended Actions ...

Page 283: ...ust be collected separately and disposed of according to local regulations Information For more information on waste processing regulations contact your Fresenius Kabi sales representative or the local distributor For more information on dismantling the device refer to the technical manual Follow healthcare facility policy regarding proper disposal after use ...

Page 284: ...in other accompanying documents The device must not have been damaged while being stored or repaired and must not show signs of improper handling The device must not have been altered or repaired by unqualified personnel The internal battery of the device must not have been replaced by a battery other than that specified by the manufacturer The serial number SN must not have been altered changed o...

Page 285: ...e device and influence the flow rate accuracy For a safe usage we recommend to always put the device at the maximum distance from the patient and the source limit the presence of the device in such environments When mounted on the Link Agilia the pump is intended to be used in the electromagnetic environment specified in the Link Agilia IFU Excluding the cases described in this manual pump operati...

Page 286: ...od tiles or concrete Relative humidity of at least 30 If it is not possible to guarantee this environment the following additional precautions must be taken Use of anti static equipment Preliminary user discharge explained below Anti static clothing The best precaution is preliminary user discharge on a grounded metal object such as a rail a pole or a metal part located at the rear of Agilia pump ...

Page 287: ...ncluding cables specified by the manufacturer Otherwise degradation of the essential performances of Agilia pump could result The user might be required to take mitigation measures such as relocating or re orienting the equipment If the Agilia pump is placed near RF communication equipment such as cell phones DECT phones or wireless access points RFID reader tags It is essential to observe a minim...

Page 288: ...n Test Compliance Obtained by the Device Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 Agilia pump only uses RF energy for its internal operation Its RF emissions are therefore very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B Agilia pump is suitable for use in all establishments other than domestic and those dir...

Page 289: ...earing of antistatic clothing 8 kV contact 15 kV air Electrical fast Transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines AC power quality should be that of a typical commercial or healthcare facility environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mod...

Page 290: ...gnetic shielding 400 A m 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 Immunity Test IEC 60601 1 2 Compliance Level Obtained by the Device Electromagnetic Environment Guidance IEC 60601 2 24 andANSI AAMI ID26 Test Level Portable and mobile...

Page 291: ...tion If abnormal performance is observed additional measures may be necessary such as reorienting or relocating Agilia pump or installing magnetic shielding b Over the frequency range of 150 kHz to 80 MHz field strengths should be less than 10 V m Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 10 V m 80 MHz to 2 5 GHz 10 V m D 0 35 P for a frequency of 80 MHz to 800 MHz D 0 7 P for a frequency ...

Page 292: ...uration in which it will be used pump with a AC power cord an RS232 cable Rated Maximum Output Power of Transmitter W Separation Distance According to Transmitter Frequency in Meters m 150 kHz to 80 MHz D 0 35 P 80 MHz to 800 MHz D 0 35 P 800 MHz to 2 5 GHz D 0 7 P 0 01 0 04 0 04 0 07 0 1 0 11 0 11 0 22 1 0 3 0 3 0 7 10 1 1 1 1 2 2 100 3 5 3 5 7 For transmitters rated at a maximum output power not...

Page 293: ...18 Hz 28V m 1720 MHz PM 217 Hz 28 V m 1845 MHz PM 217 Hz 28 V m 1970 MHz PM 217 Hz 28 V m 2450 MHz PM 217 Hz 28 V m 5240 MHz PM 217 Hz 9 V m 5500 MHz PM 217 Hz 9 V m 5785 MHz PM 217 Hz 9 V m Not tested Not tested Not tested Not tested Not tested Not tested Not tested Not tested Not tested Not tested Not tested 2450 MHz PM 217 Hz 28 V m 5240 MHz PM 217 Hz 9 V m 5500 MHz PM 217 Hz 9 V m 5785 MHz PM ...

Page 294: ...ion to make sure it is lower than the compliance level If the measured field in the location where the Agilia pump is used exceeds the applicable magnetic field compliance level above the Agilia pump should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Agilia pump or installing magnetic shieldin...

Page 295: ...placing the battery To ensure the device continues to operate normally follow the instructions below Preventive maintenance should be performed by trained and qualified technical personnel in compliance with the technical manual and procedures Only authorized service personnel should attempt to repair the device The qualified personnel must be informed if the device is dropped or if any malfunctio...

Page 296: ... s instructions Upon request by the healthcare facility a quality control check can be performed on the device every 12 months A regular quality control check not included in the guarantee consists of various inspection operations listed in the technical manual Information These control checks must be performed by trained technical personnel and are not covered by any contract or agreement provide...

Page 297: ...ary Code Keying CDC Centers for Disease Control CISPR Special International Committee on Radio Interference CT Scan Computed Tomography dBA Decibels dBm Decibels Milliwatts DC Direct Current DECT Digital Enhanced Cordless Telecommunications DEHP Di 2 ethylhexyl phthalate DERS Dose Error Reduction Software DHCP Dynamic Host Configuration Protocol DTBI Dose to Be Infused DI Dose Infused DPS Dynamic ...

Page 298: ...t GPL General Public License GTIN Global Trade Item Number H W D Height Width Depth HF High Frequency hPa Hectopascals HTTP HyperText Transfer Protocol Hz Hertz IC Industry Canada IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronics Engineers IFU Instructions for Use in Inches IT Information Technology IV Intravenous kg Kilograms KVO Keep Vein Open lb s Pound ...

Page 299: ...M Orthogonal Frequency Division Multiplexing OR Operating Room PC Personal Computer PSI Pounds per Square Inch PSK Phase Shift Keying QAM Quadrature Amplitude Modulation QPSK Quadrature Phase Shift Keying REF Product reference part number RF Radio Frequency RFID Radio Frequency IDentification RS232 Serial interface connector SN Serial Number SELV Safety Extra Low Voltage SIR Asynchronous Serial In...

Page 300: ...Bus Ut Test specification level V Volts VA Volt Amperes VDC Volts Direct Current VI Volume Infused Vrms Root Mean Square Voltage VTBI Volume to Be Infused V m Volts per meter W Watts WPA Wi Fi Protected Access Term Description ...

Page 301: ...rofile Infusion Modes Simple Rate Pressure Volume Time Dose Time Keypad lock status Volume Limit Battery life Infusion Features Direct Bolus Volume infused Dose infused Programmed Bolus Pause Loading Dose Programmed bolus KVO Patient Prime Set Day Night mode Dynamic Pressure System DPS Volume Time Dose Time Volume Limit Alarm volume Volume Dose history View flow rate history View pressure history ...

Page 302: ...8 Dose 24 41 51 Dose Time 59 78 Drug 24 Concentration Selection 41 Select 40 Drug Library 23 Display Information 87 Drug X mL h 24 E Electromagnetic Guidance 137 Empty Syringe 57 Environment 13 Essential Features 110 Event Log 84 F Factory Configuration 153 First Use 32 Flow Rate 24 41 50 G Glossary 149 Graphics Flow Rate History 81 Pressure History 82 H Hard Limit 24 I Infusion Change Infusion Ra...

Page 303: ...Basic Profile 22 Custom Profile 23 Display Information 66 Select 37 Q Quick Start 63 R Recycling 135 Release Notes 156 Rotating Pole Clamp 27 S Screen Contrast 91 Display and Symbols 19 Selection Keys 18 Servicing 147 Simple Rate 59 Soft Limit 24 Override 47 Software Version 156 Sound Levels 126 Stop function 52 Storage 108 Symbol Descriptions 2 Syringe 103 Change 106 Display Information 83 Instal...

Page 304: ...dual configurations and minor software modifications therefore some screenshots may appear slightly different from what you see on the product This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi Vigilant and Agilia are registered trademarks in the name of Fresenius Kabi in selected countries Made in France Revision date January 2017 Date Software V...

Page 305: ...Local Contacts for Servicing Write your contacts here ...

Page 306: ...11103 2_master_ifu_agilia_sp_mc_eng ...

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