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Description

2.1

Front View

Figure 2.1:

Front View

2.2

Bottom View (Device Identification Label)

Legend

Handle

Plunger Driver

Syringe Barrel Clasp

Disengagement Lever

Syringe Flange Cradle

Syringe Guard

The UDI (Unique Device Identifier) is represented in AIDC (Automatic

Identification and Data Capture) and readable text:



(01) Product Identifier GTIN



(21) Product Serial Number



(11) Date of Manufacture



(240) Product Reference

For more information on device identification label symbols, see Symbol

Descriptions, page 2.

Содержание AGILIA SP MC WIFI CA

Страница 1: ...AGILIA SP MC WIFI CA Syringe Infusion Pump Applicable to software version 2 2 Instructions For Use For Use in Healthcare Facilities Disponible en Français sur demande ...

Страница 2: ...ain 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 leakage current defibrillation proof type CF ap...

Страница 3: ...TTOM VIEW DEVICE IDENTIFICATION LABEL 13 2 3 BACK VIEW 14 2 4 KEYPAD 15 2 5 DISPLAY AND SYMBOLS 17 2 5 1 Infusion Status 17 2 5 2 Screen Options 17 2 5 3 Navigation Buttons 17 2 5 4 Alarms and Safety Features 18 2 5 5 Infusion Features 18 2 5 6 Data Communication 18 2 6 PACKAGING 19 3 FUNDAMENTALS 20 3 1 PROFILES 20 3 2 DRUG LIBRARIES 21 3 3 DRUGS 21 3 3 1 Infusion Rates 21 3 3 2 Drug X mL h 21 3 ...

Страница 4: ... OPERATION 32 6 1 FLOWCHART 32 6 2 SELECTING A PROFILE 33 6 3 SELECTING A SYRINGE 33 6 4 SELECTING A DRUG 34 6 5 PROGRAMMING AN INFUSION 35 6 5 1 Programming an Infusion by Flow Rate 35 6 5 2 Programming an Infusion by Dose Rate 35 6 5 3 Programming Beyond Soft Limits 39 6 6 STARTING AN INFUSION 41 6 7 MONITORING AN INFUSION 42 6 8 FUNCTIONS DURING INFUSION 44 6 8 1 Stop 44 6 8 2 Rate Titration 44...

Страница 5: ...UME INFUSED DOSE INFUSED 61 7 7 PAUSE 61 7 8 PROGRAMMED BOLUS 62 7 9 PATIENT 63 7 10 DAY NIGHT MODE 63 7 11 VOLUME TIME DOSE TIME 65 7 12 VOLUME LIMIT 66 7 13 ALARM VOLUME 66 7 14 VOLUME DOSE HISTORY 67 7 15 VIEW FLOW RATE HISTORY 68 7 16 VIEW PRESSURE HISTORY 69 7 17 SYRINGE 70 7 18 VIEW EVENT LOG 70 7 19 DATE TIME 71 7 20 MAINTENANCE 72 7 21 LIBRARY INFORMATION 73 7 22 CLINICAL INFORMATION 74 7 ...

Страница 6: ... 1 SYRINGE LIST 87 12 2 PREPARING A SYRINGE 87 12 3 OPERATIONS FOR SYRINGES 89 12 4 GRAVITY INFUSION IN PARALLEL WITH A PUMP 90 13 DEVICE STORAGE 91 13 1 PRECAUTIONS FOR STORAGE 91 13 2 STORAGE AND TRANSPORT CONDITIONS 91 13 3 PREPARING THE DEVICE FOR STORAGE 91 13 4 USING THE DEVICE AFTER STORAGE 91 14 SPECIFICATIONS 92 14 1 ESSENTIAL FEATURES 92 14 2 FLOW RATE 92 14 3 VOLUME TO BE INFUSED VTBI 9...

Страница 7: ...16 POWER MANAGEMENT 103 16 1 AC POWER SUPPLY PRECAUTIONS 103 16 2 BATTERY PRECAUTIONS 103 16 3 BATTERY OPERATING MODE 104 17 TECHNICAL CHARACTERISTICS 105 17 1 POWER SUPPLY 105 17 2 BATTERY 105 17 3 POWER CONSUMPTION 105 17 4 COMMUNICATION PORT 105 17 5 INFRARED COMMUNICATION 106 17 6 SOUND LEVELS 106 17 7 COMPLIANCE 107 17 8 DIMENSIONS AND WEIGHT 107 17 9 TRUMPET AND START UP CURVES 107 18 WI FI ...

Страница 8: ... ESD AND PRECAUTIONS TO BE TAKEN 115 22 3 EMC AND ESSENTIAL PERFORMANCE 116 22 4 ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE 116 23 SERVICING 118 23 1 INFORMATION ON DEVICE SERVICING 118 23 2 MAINTENANCE REQUIREMENTS 118 23 3 QUALITY CONTROL 118 24 AGILIA CONNECT INFUSION SYSTEM COMPATIBILITY 119 24 1 DATA MANAGEMENT CABLES 119 24 2 ASSOCIATED SOFTWARE 119 24 3 RACKS AND ACCESSORIES 12...

Страница 9: ...f parenteral fluids medications blood and blood derivatives through clinically accepted routes of administration such as intravenous intra arterial and subcutaneous routes It is intended for use by trained healthcare professionals in healthcare facilities Agilia SP MC is a programmable electronic medical system dedicated to administering a pre determined volume of a syringe at a programmed rate Th...

Страница 10: ...lia SP MC to infuse critical medications in healthcare facilities ensure that adequate monitoring is provided and that backup pumps and syringes are available for immediate use Only use Agilia SP MC for the infusion of fluids that are intended for infusion pumps The pump must only be used by qualified and trained healthcare professionals including but not limited to nurses primary users physicians...

Страница 11: ...he minimum level Warning Specific attention for infusing high risk and life sustaining medication therapies use the smallest compatible syringe size necessary to deliver the fluid or medication this is especially important when infusing high risk or life sustaining medications at low infusion rates e g less than 5 mL per hour and especially flow rates less than 0 5 mL per hour Using a larger syrin...

Страница 12: ...y While the pump is infusing a patient do not connect a computer installed with Agilia Partner software to perform technical operations Agilia SP MC is intended for use in healthcare facilities under the supervision of trained healthcare personnel The pump must be used in the following operational conditions to ensure proper performance Operating temperature range 41 F 5 C to 104 F 40 C Operating ...

Страница 13: ...yringe Flange Cradle Syringe Guard The UDI Unique Device Identifier is represented in AIDC Automatic Identification and Data Capture and readable text 01 Product Identifier GTIN 21 Product Serial Number 11 Date of Manufacture 240 Product Reference 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 ...

Страница 14: ...r Cord Inlet Rotating Pole Clamp Infrared Cell RS232 Communication Port Attachment Lock Knob Symbol Location Description Near Power Cord Inlet Warning See section 17 page 105 Near RS232 Communication Port Warning See section 9 page 78 6 4 3 5 2 1 1 1 4 1 2 3 5 3 3 6 ...

Страница 15: ...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 ...

Страница 16: ...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...

Страница 17: ... 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 Keypad locked symbol This symbol informs the user that the ...

Страница 18: ...t 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 11 page 81 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 to the pump Symbol Description exit C prog ...

Страница 19: ...ish 1 Power cord Packaging weight Approximately 1 16 lb 530 g Packaging consists of Recycled cardboard expanded foam Information It is the healthcare facility s responsibility to check the pump integrity upon receipt If the packaging contents are incomplete or damaged contact your Fresenius Kabi sales representative ...

Страница 20: ...een pre defined with a compatible DERS To program an infusion with Basic Profile choose Basic Profile when selecting a profile Basic Profile has the following characteristics The only infusion rate allowed is flow rate mL h The DERS s safeguards are unavailable The infusion is programmed without drug names Limits on drug infusion rates are not included Configurations and settings accessible in Bas...

Страница 21: ...ed at the healthcare facility and or ward level Drug settings may be adjusted on the pump according to pre defined programming limits such as dose limits Infusion modes defined in a custom drug entry are not adjustable on the pump A drug in a drug library must specify the infusion rate Flow rate Infusion of a volume over a period of time Dose rate Infusion of a specific amount of a drug correspond...

Страница 22: ...e Rate Simple Rate Infusion with a programmed rate Volume Time Dose Time Infusion of a programmed volume or dose over a programmed period of time Volume Limit Infusion with a limitation on the volume or dose to be infused A data set can contain up to 19 custom profiles that can be uploaded to Agilia pumps with a compatible DERS If there is no data set uploaded to the pump the pump can be used with...

Страница 23: ...m Depth from 0 3 to 0 4 in 8 to 10 mm On the Agilia Link Rack Refer to the Agilia Link accompanying documents On a Table See section 4 3 3 page 26 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 4 3 4 page 26 On an Agilia Duo Refer to the Agilia Duo accompanying documents Do not use accessories that appe...

Страница 24: ...om 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 firmly to avoid any movement of the pump Legend Screw Clamp Release Button Rotating Pole Clamp You can secure the rotating pole clamp vertically or horizontally by folding it outward until...

Страница 25: ... above 1 Fold the pole clamp down to the horizontal position see section 4 2 2 1 page 24 2 Unscrew the clamp attach to the pole and screw the clamp until the pump is fully secured to the pole 3 Make sure that the pump is securely attached For more information on installing the pump on a pole consult the pole s Instructions for Use Only single pumps can be attached to a bed rail or gurney rail 1 Ro...

Страница 26: ...pole 1 Fold both pumps pole clamps up see section 4 2 2 2 page 25 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 ...

Страница 27: ...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 12 2 page 87 Powering on Section 5 3 page 28 Installing the syringe Section 5 4 page 30 Programming an infusion Section ...

Страница 28: ... page 28 5 Install a syringe into the pump See section 5 4 page 30 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...

Страница 29: ...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 5 4 page 30 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 linked to t...

Страница 30: ...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 ...

Страница 31: ... may result in a decrease in delivery or under infusion until the flow rate stabilizes Precautions for pump position If using multiple syringe pumps and it is not clinically feasible to have all pumps level with the distal tip of the catheter or the site of fluid delivery place the high risk or life sustaining medications as close to level with the distal tip of the catheter as possible When infus...

Страница 32: ... 2 page 43 Flow Rate Programming Section 6 5 1 page 35 Starting an Infusion Section 6 6 page 41 Monitoring an Infusion Section 6 7 page 42 Functions during Infusion Section 6 8 page 44 Completing an Infusion Section 6 9 page 47 Basic Profile Section 3 1 1 page 20 Custom Profile Section 3 1 2 page 20 Selecting a Syringe Section 6 3 page 33 ...

Страница 33: ...nds to the target group of patients The lighthouse symbol indicates a drug from a drug library 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 The pump automatically detects the size of the installed syringe 1 Press OK to confirm the displayed syringe or...

Страница 34: ...ge 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 and model loaded onto the syringe pump After selecting a syringe you must select a drug to infuse Drugs are sorted alphabetically by the first letter of their names A C D F G I J L M O P R...

Страница 35: ...inue programming or C to change the drug This section describes the programming of an infusion with the Simple Rate infusion mode You can also program an infusion with the following modes Volume Time or Dose Time see section 6 10 2 page 49 Volume Limit see section 6 10 3 page 50 1 Press the arrow keys to program the flow rate A drug selected from a drug library can allow adjustments of concentrati...

Страница 36: ... 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 1 Press the arrow keys to enter the patient s weight or body surface area 2 Press OK to confirm Range Finite values Weight Body Surface Area ...

Страница 37: ...he dose rate value 2 Press OK to confirm Note This feature can be activated or deactivated with a compatible DERS custom profiles Information The loading dose is only available with the first start of an infusion If no is pressed inadvertently power the pump off and then on to access the loading dose again If enabled for the selected drug you can program a loading dose after programming an infusio...

Страница 38: ...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 ...

Страница 39: ...ress no or to stop the loading dose and proceed to the programmed infusion Press start to continue with the loading dose You can override soft limits and adjust flow rate and dose rate within the authorized ranges You cannot override a hard limit Legend Unauthorized Range Hard Limits Programmable Range warning and confirmation Soft Limits Authorized Range Default Value ...

Страница 40: ...he displayed settings correspond to the intended flow rate or dose rate 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 Dose Rat...

Страница 41: ...infusion Warning When connecting the syringe s extension set to the patient s access device always use aseptic technique according to your healthcare facility s 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 syringe is not corre...

Страница 42: ...s displayed with the largest 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 a compatible DERS for this drug Syringe Name Ward Name configurable Custom Profile Sign When infusing a drug selected from a drug library this lighthouse sign is displayed on the screen...

Страница 43: ... infusion see section 6 8 2 page 44 Dose rate 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 a drug 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 ...

Страница 44: ...g 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 6 8 1 page 44 2 Press the arrow keys to modify the flow rate or dose rate 3 Press OK to confirm A bolus is an extra dose that a pump can deliver during an infusion There are two ways to deliver a bolus dose during an infusion Direc...

Страница 45: ...irm access to the Direct 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 Note This feature can be activated or deactivated with a compatible DERS custom profiles or in the pump options Basic profile ...

Страница 46: ...ion resumes its previous rate after the bolus is delivered Press exit or to exit the bolus function and save the programmed bolus settings If you press again this screen appears immediately and displays the settings of the last bolus Interrupting a Programmed Bolus 1 Press to interrupt the bolus 2 Answer the question Continue Press no to return to the infusion Press start to continue the bolus Flo...

Страница 47: ... syringe 10 of the syringe capacity N A N A Near end of infusion alert settings are configurable with a compatible DERS custom profiles or in the pump options Basic Profile For more information refer to the technical manual Silencing Near End of Infusion Alert 1 Press to silence the alarm 2 If required press OK to confirm the empty syringe mode Depending on the pump configuration the following hap...

Страница 48: ...ump 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 pump powers off You can program an infusion with the different infusion modes available depending on the pump con...

Страница 49: ...is greater than the actual volume in the syringe make sure to replace the syringe when it is empty see section 12 3 2 page 89 3 Press the arrow keys to set the infusion time and press OK The infusion rate is automatically readjusted 4 Press the arrow keys to configure the end of infusion settings and press OK to confirm Stop The infusion stops when the VTBI is completed Keep Vein Open KVO After th...

Страница 50: ...en it is empty see section 12 3 2 page 89 The volume already infused VI before accessing the volume limit mode is taken into account 3 Press the arrow keys to configure the end of infusion settings and press OK to confirm Stop The infusion stops when the volume limit is reached Keep Vein Open KVO After the volume limit is reached the infusion continues at a preset flow rate to keep the access devi...

Страница 51: ... function before infusion Advised A message is displayed to encourage the user to prime the line with the pump prime function before infusion Not displayed The pump does not remind the user to prime the line before infusion 1 Press to power on the pump 2 Press 3 Make sure the extension set is not connected to the patient as indicated on the screen 4 Press OK to proceed 5 Press and hold the key to ...

Страница 52: ...he menu screen is displayed During priming the occlusion pressure level is set to its maximum value 900 mmHg 120 kPa 17 4 PSI Priming is limited to 5 mL maximum Above 5 mL you must release and press the key again to restart priming Quick Start Quick start is designed to decrease the delay of therapy when the pump s prime function is not used When quick start is triggered the infusion starts at a h...

Страница 53: ... life sustaining drugs You can program the pump before installing the syringe 1 Press to power on the 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 6 5 page 35 5 Press exit to confirm 6 When ready install the syringe 7 Press start to sta...

Страница 54: ... and clearing the volume or dose infused page 61 Dose Infused Pause YES Programming a pause page 61 Programmed bolus NO Programming a bolus page 62 Patient NO Changing a patient s weight or body surface area page 63 Day Night mode NO Switching between day mode and night mode page 63 Volume Time YES Programming a Volume Time or Dose Time infusion page 65 Dose Time YES Volume limit YES Programming a...

Страница 55: ...tenance NO Displaying maintenance information page 72 Library information NO Displaying drug library information page 73 Clinical information NO Viewing remaining time before clinical information display page 74 Data Set NO Displaying active data set information page 75 Symbol Procedure Displaying active profile information You can display the active profile name as follows 1 Press 2 Press the arr...

Страница 56: ...learing 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 stopcock if present The healthcare professional...

Страница 57: ...ing the shorter the occlusion detection time However when infusing viscous or thick fluids e g lipids the occlusion pressure threshold setting may need to be adjusted to reduce false alarms Use the smallest compatible syringe size necessary to deliver the fluid or medication This minimizes the amount of friction and compliance i e stiffness of the syringe plunger head Because syringe pumps infuse ...

Страница 58: ...s are used in parallel it is recommended that their pressure thresholds be adjusted to the same level Symbol Procedure Locking Unlocking the keypad You can use this feature to avoid inadvertent key presses Note The following features can be activated or deactivated in the pump options Automatic lock The keypad will lock automatically at infusion start or after a time out Unlock code The user must ...

Страница 59: ...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 ...

Страница 60: ...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 Press 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 T...

Страница 61: ...lect 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 Symbol Procedure Programming a pause mL Flow rate Dose...

Страница 62: ...o 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 and start Information If you do not activate the Start infusion at pause end option an audible alarm is generated at the end of the pause The infusion must be started manually to continue the infusion Symbol Procedure Programming a ...

Страница 63: ...elect 3 Press enter 4 Press OK to change the patient s weight or body surface area 5 Press OK to confirm the infusion settings Symbol Procedure Switching between day mode and night mode This function switches between day mode and night mode The default night mode settings are as follows The key press beep is silenced Infusion indicators and screen brightness are dimmed Depending on your pump confi...

Страница 64: ... as follows 1 Press 2 Press the arrow keys to select 3 Press enter 4 Press to activate night mode The screen displays 5 Press OK to confirm Switching from Night Mode to Day Mode You can switch to day mode as follows 1 Press 2 Press the arrow keys to select 3 Press enter ...

Страница 65: ...Press OK to confirm Symbols Procedure Programming a Volume Time 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 6 10 2 page 49 V T D T Volume Time Dose Time V T D T ...

Страница 66: ...o program a Volume Limit infusion see section 6 10 3 page 50 7 13 Alarm Volume 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 Flow rate Dose Rate VL ...

Страница 67: ...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 ...

Страница 68: ...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...

Страница 69: ...ct 3 Press enter The following information is displayed An event marker cursor The event details time and pressure threshold The pressure threshold dotted line The measured pressure solid line 4 Press the and buttons to browse the events 5 Press to view details on the selected event Information The history is not refreshed while the history screen is displayed To refresh the history data exit and ...

Страница 70: ...g the event log The event log displays details of the last events that occurred on the pump Events are stored in the log even after the pump is powered off and on again The log can store up to 1500 events Older events are overwritten Note When the AC Power is disconnected for a period of time or when the batteries are not operating the log file is kept in a non volatile memory for approximately 10...

Страница 71: ... event are displayed 6 Press exit to return to the previous screen Symbol Procedure Setting up 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 Month Day Year Hours Minutes 5 Press OK to confirm ...

Страница 72: ...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 mm dd yyyy Pump model Software version Total operating time since last maintenance ...

Страница 73: ...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 ...

Страница 74: ...a compatible DERS 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 ...

Страница 75: ... 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 ...

Страница 76: ...er programming 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 Pump Settings No Section 8 3 page 77 Basic Profile Configuration Yes Technical Manual Profile Yes Technical Manual Maintenance Yes Technical Manual Information If the wrong access code is e...

Страница 77: ...le 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 12 1 page 87 Par 13 AC power disconnection alert Enable Disable AC power disconnection message and Device operating on battery message at power on Enabled Par 28 Automatic power on with disengagement Enable...

Страница 78: ...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 and appropriately trained staff All IT devices including computers hubs and switches inside the patien...

Страница 79: ...data set may be uploaded to the pump while it is infusing The new data set will be installed at the next pump start up When a new data set has been uploaded since the last start up of the pump the symbol is displayed on the screen 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 ...

Страница 80: ...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...

Страница 81: ...ironmental noise There are several 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 alarm ...

Страница 82: ...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 driver syringe barrel clasp or flange de...

Страница 83: ...me 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 is completed simple rate Near end of infusion Medium No The time remaining is less than the defined time duration adjustable between 1 and 30 minutes and the remaining volume of fluid...

Страница 84: ...See section 7 3 page 56 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 threshold over 250 mmHg Check the infusion line Set the correct pressure threshold Pressure increase Low No The pressure is increasing in the infusion line Check for occlusions in t...

Страница 85: ...rom 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 disconnection was unintentional check the power connection Message Priority Stops Infusion Problem Resolution Keypad lock status Information signal No The keypad is locked Unlock the keypad Keypad locked Information signal No The keypad is locked and th...

Страница 86: ...resentative Type Comment Stops Infusion Activation Switch mode Beep until key is released No Beep starts when action is not allowed End of loading dose 3 beeps No At the end of the loading dose End of programmed bolus 3 beeps No At the end of a programmed 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 ...

Страница 87: ...ifications introduced by the manufacturer Ensure syringe sizes and models are compatible with the syringe pump see Section 24 4 page 120 Use of incompatible syringes can cause injury to the patient and improper pump operation resulting in inaccurate fluid delivery insufficient occlusion sensing and other potential problems 1 Prepare the fluid to be infused according to your healthcare facility s p...

Страница 88: ...sidual volumes between the syringe and the patient when administering medications or fluids at low infusion rates e g less than 5mL per hour and especially flow rates less than 0 5 mL per hour This reduces the amount of time it takes for fluid to reach the patient maintains delivery accuracy and reduces occlusion detection times For example Tubing internal diameter Small bore or microbore tubing i...

Страница 89: ... Disconnect the extension set from the access device in accordance with healthcare facility protocol 1 Remove the syringe See section 12 3 1 page 89 2 Prepare a new syringe and follow the steps described in the flowchart See section 5 1 page 27 3 After the new syringe is installed acknowledge the same therapy screen optional screen Warning Electronically prime the syringe pump system after replaci...

Страница 90: ...line This will prevent the back up of IV fluid or medication into the gravity line If there is no back check valve on a gravity infusion line during a multi line infusion it will be impossible to detect patient side occlusions Such an occlusion could cause the pumped drug to back up into the gravity line and later be infused in an uncontrolled manner when the occlusion is released Be careful about...

Страница 91: ...re 14 F 10 C to 140 F 60 C Pressure 500 hPa 375 mmHg 7 25 PSI to 1060 hPa 795 mmHg 15 37 PSI Relative humidity 10 to 90 without condensation Altitude Up to 9842 52 ft 3000 m Prepare the device for storage as follows 1 Power the pump OFF and remove the disposable 2 If necessary long term storage disconnect the pump s power cord and all data communication cables 3 Remove the pump from its mounting p...

Страница 92: ...ature Refer to Flow Rate Accuracy Section 14 9 1 page 95 Section 17 9 page 107 Time to Detect Occlusion Section 14 9 3 page 96 Bolus Volume After Occlusion Release Section 14 9 4 page 96 Management of High priority Alarms Section 11 page 81 Format Syringe Minimum Increment 50 mL 60 mL 30 mL 20 mL 10 mL 5 mL Infusion Rate 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 ...

Страница 93: ... 1 0 1 Format Range of Settings Default Value Minimum Increment Dose Rate Unit 0 01 9999 N A 0 001 0 01 0 1 1 0 010 4 999 5 00 9 99 10 0 99 9 100 9999 Programmed Bolus Unit 0 01 9999 N A 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_s 00h00min01s 96h00min00s...

Страница 94: ...g 0 25 350 70 0 01 0 1 1 0 25 9 99 10 0 19 9 20 350 Patient Body Surface Area m 0 05 4 5 2 0 01 Setting Description Setting Format Default Value Mode Infusion pressure mode 3 levels Variable 3 levels DPS Allows DPS option activation on the pump pressure menu Yes No Yes Unit Pressure unit selection mmHg kPa PSI mmHg Threshold Stored The last pressure threshold adjustment is automatically stored in ...

Страница 95: ...00 900 50 DPS Raise Threshold mmHg 50 400 100 50 Drop Threshold mmHg 100 400 100 50 Warning Accuracy flow rate time volume infused pressure can be influenced by syringe model syringe configuration extension set configuration fluid viscosity and fluid temperature Note All tests below are in accordance with the IEC 60601 2 24 standard and ANSI AAMI ID26 Values are representative of syringes used dur...

Страница 96: ... Accuracy Occlusion Alarm Response Time Syringe Rate Occlusion Alarm Threshold 50 mmHg 900 mmHg 50 mL 0 1 mL h 1 mL h 5 mL h 5 hours 30 minutes 7 minutes 28 hours 3 hours 30 minutes 20 mL 0 1 mL h 1 mL h 5 mL h 4 hours 20 minutes 5 minutes 14 hours 75 minutes 15 minutes 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...

Страница 97: ...q Units Dose Rate Units nanog h nanog kg min nanog kg h mcg min mcg h mcg kg min mcg 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 ...

Страница 98: ...it 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 volume ...

Страница 99: ... described below Always follow your local protection rules Quick Cleaning Only Note This quick cleaning does not replace the need for a complete cleaning 1 Check that the keypad is locked in order to avoid unintended modification of the infusion parameters Do not move the pump 2 Use ready to use wipes to wipe down all exposed surfaces of the pump 3 At the end of the infusion perform the complete c...

Страница 100: ...e wearing personal protective equipment gloves lab coat glasses and so on or diluting the agent according to the manufacturer s guidelines For disinfectants respect the contact time required for the antimicrobial agents to act the time the agent must be left on the pump for disinfection to be effective The following warning is provided to protect staff against electric shock and to protect the pum...

Страница 101: ...sp etc of the pump from top to bottom You can use the silver handle to lift and move the pump When wiping down the sides avoid wetting the connector sockets Do not allow liquids to run leak or drip into the pump housing 6 Make sure the pump remains damp for at least 1 minute 7 Set down the pump and wipe down the silver handle the attachment lock knob the screw clamp and the release button 8 Dampen...

Страница 102: ... to reach areas You can use the silver handle to lift and move the pump When wiping down the sides avoid wetting the connector sockets Do not allow liquids to run leak or drip into the pump housing 3 Set down the pump and wipe down the silver handle the attachment lock knob the screw clamp and the release button 4 Use a fresh ready to use wipe to gently wipe down the back side of the syringe barre...

Страница 103: ...ion or fire which could result in deterioration of performance failure damage to the equipment or injury to the user Incorrect handling of a Lithium ion battery Replacement of the battery by inadequately trained personnel Information Do not replace with a battery other than the one provided by Fresenius Kabi Do not use the pump without the battery connected Do not disconnect the battery when the d...

Страница 104: ...The battery charges when the pump is connected to AC power supply Before starting for the first time charge the battery for approximately 6 hours by plugging in the power supply cord with the pump powered off Information During operation leave the device connected to the power supply in order to maintain the battery s charge and maximum capacity and to maximize battery lifetime and performance ...

Страница 105: ...t the battery before opening the device Avoid short circuits and extreme temperatures If the device is not used for more than 3 months the date is erased all other settings are stored permanently When you power on the pump you must set the date again Characteristics 7 2 V 2 2 Ah Li ion Smart battery Weight Approximately 100 g Battery Life Flow Rate mL h Wi Fi Battery Life hours 5 5 6 11 Battery Re...

Страница 106: ...e 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 Safety Class 0 of IEC 62471 Flow Rate mL h Sound Level dBA 0 21 1 23 20 27 100 30 400 49 1200 32 Alarm Priority Sound Level dB...

Страница 107: ...13 6 x 6 7 in 135 x 345 x 170 mm Weight Approximately 4 6 lbs 2 1 kg Screen Size 2 7 x 1 4 in 70 x 35 mm The trumpet curve shows the variation of the mean flow rate accuracy over specific observation periods The variations are presented only as maximum and minimum deviations from the overall mean flow within the observation window Trumpet curves are presented below for a number of representative f...

Страница 108: ...ours on 96 hours Legend Instantaneous flow rate Set flow rate Sampling time 120 s Legend Measured variance from flow rate Error Flow rate Sampling time 120 s Legend Instantaneous flow rate Set flow rate Sampling time 10 s Flow rate mL h Time minutes 0 0 0 1 0 2 0 120 240 360 480 600 720 840 960 1080 1200 Flow rate mL h Time minutes 21 7 5 8 2 6 1 0 1 4 24 9 9 2 6 8 3 7 3 6 60 40 20 0 20 40 60 0 20...

Страница 109: ...d Measured variance from flow rate Error Flow rate Sampling time 10 s 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 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 Flow rate mL h Time minutes 0 1 2 3 4 5 6 7 8 9 10 0 10 20 30 40 50 60 7...

Страница 110: ...ts from Centerium server to pump Transfer pump history from pump to a server Communicate general information on the operating status of the pump Agilia infusion pumps contain transmitter with the following IDs FCC ID XF6 RSWC301 IC ID 8407A RSWC301 Agilia Wi Fi pumps must be installed to provide a separation distance of at least 8 in 20 cm from all persons and must not be co located or operating i...

Страница 111: ...ls for Canada This wireless functionality references and uses the following protocols and standards IEEE 802 11a b g n standard WPA WPA2 Entreprise WPA WPA2 PSK Wi Fi protected access is a long term security solution for wireless networks For more information refer to the IEEE 802 11 TCP Transmission Control Protocol Internet Protocol IPv4 Internet Protocol Version 4 DHCP Dynamic Host Configuratio...

Страница 112: ... 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 biomedical department or your Fresenius Kabi sales representative The power supply indicator does not light up Connect the pump to the AC po...

Страница 113: ...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 ...

Страница 114: ...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...

Страница 115: ...vice in such environments When mounted on the Agilia Link rack the pump is intended to be used in the electromagnetic environment specified in the Agilia Link rack IFU Outside the normal use described in this IFU pump operation must be systematically checked by a qualified operator if the pump is installed in the vicinity of other electrical devices Points for example screws or battery contacts an...

Страница 116: ...ace and wear a special ESD conductive wristband In standard operating conditions see section 1 8 page 12 the essential performance of the Agilia pump is defined in section 14 1 page 92 In the event of electromagnetic disturbances above the limits defined in the applicable EMC standards if the essential performance is lost or degraded the consequences for the patient are overdose underdose delay of...

Страница 117: ...gradation of the essential performance of Agilia pump could result The user might be required to take mitigation measures such as relocating or reorienting the equipment If the Agilia pump is placed near RF communication equipment such as cell phones DECT phones or wireless access points portable RFID reader large scale RFID reader and RFID tags it is essential to observe a minimum distance betwee...

Страница 118: ...ons occur In this case do not use the device and contact your biomedical department or Fresenius Kabi Failure to comply with these maintenance procedures could damage the device and lead to a functional failure Internal inspection of the device requires compliance with special procedures to avoid damage to the device When replacing components only use spare parts from Fresenius Kabi The life cycle...

Страница 119: ...on contact your Fresenius Kabi sales representative Warning Only use recommended items that are compatible with the Agilia Connect Infusion System Use of any other items may damage the pump Information Additional power cords and Instructions for Use documents must be ordered separately Contact your Fresenius Kabi sales representative for ordering Agilia USB Cable US Communication cable for USB con...

Страница 120: ...46 0 1 250 0 21 Braun Omnifix 50 mL 4617509F 0 1 1200 0 34 Braun Omnifix 30 mL 4617304F 0 1 600 0 19 Braun Omnifix 20 mL 4617207V 0 1 600 0 16 Braun Omnifix 10 mL 4617100V 0 1 350 0 13 Braun Omnifix 5 mL 461705V 0 1 250 0 13 Braun OPS 50 mL 8728844F 0 1 1200 0 22 Braun OPS 20 mL 8728615 0 1 600 0 13 Codan 50 mL 62 8426 0 1 1200 0 10 Codan 30 mL 62 9555 0 1 600 0 10 Codan 20 mL 62 7704 0 1 600 0 11...

Страница 121: ... Monoject Soft 12 mL 1181200777 0 1 350 0 20 Monoject Soft 6 mL 11800600777 0 1 250 0 13 Injectomat Spr 50 mL 9000711 0 1 1200 0 33 SCHOTT TopPac 50 mL M087566 00PT 0 1 1200 0 04 SCHOTT TopPac 20 mL 0 1 600 0 04 SCHOTT TopPac 10 mL 0 1 350 0 17 Terumo 60 mL SS 60L 0 1 1200 0 32 Terumo 30 mL SS 30L 0 1 600 0 26 Terumo 20 mL SS 20L2 0 1 600 0 32 Terumo 10 mL SS 10L 0 1 350 0 17 Terumo 5 mL SS 05L 0 ...

Страница 122: ...yl phthalate DERS Dose Error Reduction Software DHCP Dynamic Host Configuration Protocol DTBI Dose to Be Infused DI Dose Infused DPS Dynamic Pressure System DSSS Direct Sequence Spread Spectrum DUR Duration ECG Electrocardiogram ECMO ExtraCorporeal Membrane Oxygenation EEG Electroencephalogram EMC Electromagnetic compatibility ErXX Error message ESD Electrostatic Discharge FCC Federal Communicatio...

Страница 123: ...g OR Operating Room PC Personal Computer PSI Pounds per Square Inch PSK Phase Shift Keying QAM Quadrature Amplitude Modulation QPSK Quadrature Phase Shift Keying REF Product reference part number RF Radio Frequency RFID Radio Frequency IDentification RS232 Serial interface connector SN Serial Number SELV Safety Extra Low Voltage SIR Asynchronous Serial Infrared TCP Transmission Control Protocol UD...

Страница 124: ...s Profile Infusion Modes Simple Rate Pressure management Volume Time Keypad lock status Volume Limit Battery life Infusion Features Direct Bolus Volume infused Programmed Bolus Pause Loading Dose Programmed bolus KVO Patient Prime Set Day Night mode Dynamic Pressure System DPS Volume Time Volume Limit Alarm volume Volume Dose history View flow rate history View pressure history Syringe View event ...

Страница 125: ...Rate 21 35 43 Dose Time 49 65 Drug 21 Concentration Selection 35 Select 34 Drug Library 21 Display Information 73 Drug X mL h 21 E Electromagnetic Guidance 115 Empty Syringe 47 Environment 12 Essential Features 92 Event Log 70 F Factory Configuration 124 First Use 28 Flow Rate 21 35 42 G Glossary 122 Graphics Flow Rate History 68 Pressure History 69 H Hard Limit 22 I Infusion Change Infusion Rate ...

Страница 126: ...e 20 Basic Profile 20 Custom Profile 20 Display Information 55 Select 33 Q Quick Start 52 R Recycling 113 Release Notes 127 Rotating Pole Clamp 24 S Screen Contrast 77 Display and Symbols 17 Selection Keys 16 Servicing 118 Simple Rate 48 Soft Limit 22 Override 39 Software Version 127 Sound Levels 106 Stop function 44 Storage 91 Symbol Descriptions 2 Syringe 87 Change 89 Display Information 70 Inst...

Страница 127: ...h it is included The screenshots in this document are for illustrative purposes only Screen contents may vary based on individual configurations and minor software modifications therefore some screenshots may appear slightly different from what you see on the product This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi Vigilant and Agilia are regist...

Страница 128: ...ervice and maintenance information please contact your distributor Fresenius Vial S A S Le Grand Chemin 38590 Brézins France Fresenius Kabi AG 61346 Bad Homburg Germany 14209 2_master_ifu_agilia_sp_mc_eng_CA ...

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