Agilia SP TIVA WiFi Quick Reference Guide Jan 2019

Note: This Quick Reference Guide is not intended to be comprehensive instructions for the set-up and operation of the Agilia SP TIVA Syringe Infusion Pump. We recommend reading the Instructions For Use before using this device.

Description TCI Mode Plasma Effect-site

Drug Name & Concentration / wake up concentration & duration

Indicators Battery charge status Power supply

Target Concentration (Cet/Cpt)* Plasma Concentration Evolution (Cp)

SP

TIVA

Effect-site Concentration Evolution (Ce)

Dose / Flow rate

Installation  Secure the pump stability. (e.g IV pole fixing)  Plug power cord. The Power Supply Indicator lights up

Installing a syringe Connect the extension set to the syringe according to local practices. Prime and check that there is no air in the syringe or extension set. IMPORTANT: Ensure that the patient is not connected.  Place the syringe into the cradle, the flanges inserted in the provided slot.  Secure the syringe with the syringe barrel clasp.  Move the plunger driver gently until it makes contact with the plunger head.

*Cpt: Target plasma concentration Cet: Target effect concentration

2.

Powering on 1. Press

. An auto-test checks the functionality of the pump.

2. Immediately after powering on the pump, make sure that all LED lights blink.

Selecting a profile • Press the arrow keys to select «Basic & TCI» to access to TCI mode. • Press <OK> to confirm. • The programming mode that was last used is displayed.

• Press <OK> to confirm the TCI mode, or <C> to change the profile (Flow rate or Dose).

Selecting a syringe

• Press <OK> to confirm the displayed syringe, or <C> to change it.

• Press the arrow keys to select a syringe. • Press <OK> to confirm the new syringe.

Selecting a Drug TCI profile

Note: In Basic & TCI, the drug selection step is only applicable with TCI programming mode.

• Press the arrow keys to select the drug name, and press <OK>.

• Press the arrow keys to scroll to the drug’s name, and its associated characteristics. • The following information is displayed: - Drug name & Concentration unit - Pharmacokinetic model / TCI mode (Plasma / Effect-site) • Press <OK>. 3.

Programming a TCI infusion 1. Select a drug concentration

• Press the arrow keys to select a concentration. • Press <OK> to confirm.

2. Selecting the patient’s characteristics

The number of characteristics to be entered depends on the selected pharmacokinetic mode. • Press the arrow keys to enter the patient’s age and press <OK>. • Press the arrow keys to enter the patient’s weight and press <OK>. • Press the arrow keys to enter the patient’s height and press <OK> (if available). • Press the arrow keys to enter the patient’s gender and press <OK> (if available). • Press <OK> to confirm. 3. Programming the infusion

Plasma

Effect-site

• Press the arrow keys to program the target concentration and press <OK>.

If the remaining volume in the syringe is too low for the adjusted target, an alert message is displayed. - Available dose: Dose remaining in the syringe. - Required dose: Dose necessary to reach the target concentration. • Press <OK> to confirm the target concentration or choose one of the following options: - Press to modify the target concentration. - Replace the syringe.

Pause Note: In TCI infusion Mode, «Pause mode» is available only before starting an infusion. You can program a pause as follows: • Press . • Press the arrow keys to select . • Press <enter>. • Press the arrow keys to program the pause duration in hours and minutes, and press <OK>. • Press <OK> to begin the programmed pause. • To restart the infusion before the end of the pause period, press then <start>. 4.

Starting an infusion

Cpt mode

Cet mode

• Press <start> to start the infusion.

During TCI infusion 1. You can press

to switch from the numerical view to the graphical view.

 TCI Mode: Plasma / Effect-site.  Plasma Concentration Evolution (cp).  Drug Name, Concentration & Pk model.  Predicted Plasma Concentration (Cp) Curve.  Effect-site Concentration Evolution (Ce). **

2. Stop during the infusion

• To stop the infusion, press

once. After 2 minutes, an alarm is generated as a reminder that the infusion is stopped.

3. Adjusting infusion parameters: rate titration / target modification • If required, stop the infusion, see section (above). • Press the arrow keys to modify the infusion rate or the target concentration. • Press <OK> to confirm.

4. Adjusting Wake up concentration Wake up concentration is the estimated drug concentration at which the patient will wake up. Wake up duration is the time left to reach the wake up concentration. The pump automatically calculates the wake up duration, in accordance with the information entered in this menu. The Wake up duration is only displayed if relevant. You can modify the wake up concentration as follows: • Press

.

• Press the arrow keys to select

.

• Press the arrow keys to modify the Wake up concentration (Effect Concentration). • Press <OK> to confirm.

**Pharmacokinetic model

5.

Administering a Bolus Note: This feature can be activated or deactivated in Agilia Vigilant Drug’Lib software (custom profiles) or in the pump options (Basic & TCI profile). Bolus functions are not available in TCI infusion mode. To administer a bolus in TCI increase the target to the appropriate value and the pharmacokinetic model will calculate the corresponding bolus.

Operations for Syringes 1. Removing a syringe • Press

to stop the infusion.

• Disconnect the patient. • Open the syringe barrel clasp. • Press to silence the audible signal for 2 minutes. • Push the disengagement lever down and remove the syringe from its cradle. • Disconnect the syringe from its extension set. • Disconnect the extension set from the access device in accordance with healthcare facility protocol. 2. Changing a syringe with the Same therapy At the End of infusion alarm, change the syringe and restart infusion using the same therapy parameters (Same therapy activated). Note: Not available for TCI MODE. • Prepare and install the new syringe. • Press <OK> to confirm the displayed syringe, or <C> to change it. Important : Prime and check that there is no air in the syringe or extension set. • Press <Yes> to confirm the Same therapy or <no> to change values. • Press <OK> to confirm parameters. • Press <start> to re-start infusion. Important : Prime and check that there is no air in the syringe or extension set. 2. Changing a syringe with the Same infusion parameters After turning off a pump completely, change the syringe and restart infusion using the previous infusion parameters (Same infusion activated). • Press <Yes> to confirm the Same infusion. • Press <OK> to confirm parameters. • Press <start> to re-start infusion. Note: Press <no> to exit infusion. Important : Prime and check that there is no air in the syringe or extension set.

Powering Off • Press

stop the infusion.

• Press and hold

until the pump powers off.

6.

Alarm Message

Stop Priority Infusion

Problem KEYPAD DESCRIPTION Syringe not installed correctly: plunger driver, syringe barrel clasp or flange On / Off detection. Plunger head missing or incorrectly inserted. Increment

Syringe installation

High

Yes

Plunger head alarm Disengagement mechanism Remove completely syringe End of volume limit (KVO not activated)

High

Yes

High

Yes

Disengaged mechanism.

(fast/low)

Low

No

Preventive auto-test on potential failure of plunger head.

Decrement (fast/low)

High

Yes

The volume limit is reached.

Near end of volume Medium limit

No

One of the near end of limit volume alert criteria is reached.

Confirm Value / Move to Next Field

End of volume limit

Low

No

The volume limit is reached and the end of infusion setting is set as KVO or Continuous.

End of volume/time Near end of volume/time

High

Yes

The VTBI is completed.

Medium

No

End of volume/time

Low

No

End of infusion

High

Yes

Occlusion pre alarm Medium

No

One of the near end of volume/time alert criteria is reached. The VTBI is completed and the end of infusion setting is set as KVO or Continuous. The infusion is completed (simple rate). One of the near end of infusion alert criteria is reached. Flow/dose rate has not been confirmed. A value must be entered. Infusion settings have not been confirmed with start. The upper or lower hard limit is reached and cannot be exceeded. Pressure in the infusion line has reached the threshold level. In-line pressure has reached the programmed value.

Pressure increase

Low

No

Pressure is increasing.

Drop in pressure Battery alarm

Low High

No Yes

Very low battery

High

Yes

Pressure is decreasing. Battery is discharged. Very low battery. Battery should be charged before starting infusion.

Battery pre alarm

Medium

No

Low battery.

Low

No

Connect the pump to a power supply.

AC power failure Low Power disconnection Signal Keypad lock status Signal Keypad locked / Unlock keypad to Signal continue

No No No

The power supply is inconsistent. Power supply disconnection. The keypad is locked.

No

The keypad is locked and the door was opened and closed.

Erxx(yyyy)

High

Yes

Technical alarm. Disconnect the pump from the power supply. Contact your qualified technician or your Fresenius Kabi representative

High internal temperature Alarm reporting not available on the Link+

Low

No

Temperature increase.

Low

No

The pump is mounted on a Link+ Agilia rack that has not been upgraded.

High

Yes

Near end of infusion Medium

No

Check settings

Medium

No

Waiting settings

Medium

No

Waiting start

Medium

No

Reached hard limit

Signal

No

Occlusion alarm

Stop / Pause Bolus / Prime Menu/Graph Cancel Value / Move Back to Previous Field Alarm Silence LIGHT INDICATORS

Power Supply Indicator Battery Charge Status Indicator Infusion in Progress: flashing green TCI therapy in progress with no flow rate delivery : 1 constant green light Low-Priority Alarm: constant yellow / Medium-Priority Alarm: flashing yellow High-Priority Alarm: flashing red

7.

This document may contain inaccuracies or typographical errors. Modifications may thus be made, and included in later editions. Due to the evolution of standards, and of legal texts and materials, the characteristics indicated in the text and images of this document are applicable only to the device with which it is included. Technical information has been obtained from the Agilia SP TIVA Instructions For Use (version 2.2). Please refer to Instructions For Use for further details if required.

Fresenius Kabi Australia Pty Limited Level 2, 2 Woodland Way Mount Kuring-gai NSW 2080 Australia Phone: 1300 732 001 www.fresenius-kabi.com/au PM2018.370V3 Published January 2019

Fresenius Kabi New Zealand Limited 60 Pavilion Drive Mangere Auckland 2022 New Zealand Phone: 0800 144 892 www.fresenius-kabi.com/nz TAPSMR5674

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