ACIST CVi Quick Guide Rev 1 Sept 2020

SYSTEM OVERVIEW

Know your ACIST CVi System CVi Contrast Injector Components

Armed Light

Standby Button

Control Panel Luminescent Backlight

Hand Controller Connection Points

Saline Pump

Saline Bag Hanger Injector Head

Mobile Cart

Power Supply*

*Cables not pictured.

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SYSTEM OVERVIEW

Adjustable Contrast Hanger

Air Column Detect Sensor

Strain Relief Latch Contrast Sensor

Manifold Clip and Sensor

Syringe Chamber

Pressure Transducer Backplate Syringe Door Pin

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SYSTEM OVERVIEW

SYSTEM OVERVIEW

CVi Contrast Injector Consumables

Contrast*

Hand Controller Hand Controller Connection

Patient Tubing

Saline Tubing

Manifold

Saline Bag* Stopcock Pressure Transducer

Multi-Use Syringe Product – A2000/A2000V**

Air Vent Slide Clamp

Rotating Luer Connection

*Not supplied by ACIST. **A2000V is available in select geographies.

Contrast Spike

Contrast Syringe

ACIST CVi

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Automated Manifold Product – Single-Use Pressure Transducer Cartridge

Cap

Manifold Valve Hand Syringe Manifold

Saline Tubing

Saline Spike

Hand Controller Product – Single-Use 3-Way High Pressure Stopcock Luer Connections

Patient Tubing

Hand Controller

Contrast Delivery Button

Saline Delivery Button 5

SYSTEM SETUP

Load Syringe Assembly

WARNING: Aseptic technique must be followed when performing setup. See User Guide for more detail.

Step 2 Press START. Choose CARDIAC or PERIPHERAL. Wait for system to calibrate (about 60 seconds).

Step 1 Turn on the power supply.

Step 3 When prompted on screen, pull the syringe door pin to open the syringe chamber. Prep the contrast bottle: Wipe the contrast septum with the antiseptic agent approved for your institution’s use. Allow septum to dry. Place the syringe into chamber. Close the chamber. Press DONE. The plunger will move to the fill syringe position. 6

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Load Contrast

SYSTEM SETUP

Step 1

Step 2

Connect the manifold to the syringe assembly using aseptic technique.

Snap the manifold assembly into the manifold clip and sensor. An audible click will occur when the connection is secure.

Hanger Clamp

Step 3

Step 4

Hold and spike the contrast at a downward angle to avoid contrast spills.

Place the contrast onto the hanger. Squeeze clamp to adjust contrast hanger height to accommodate contrast bottle. (Load Contrast continued)

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SYSTEM SETUP SETUP

Load Contrast

Contrast Sensor

SYSTEM SETUP

Step 5

Step 6

Place the tubing in the contrast sensor and close the contrast sensor latch. An audible click will occur when the connection is secure.

 nsure the air vent is open E on the contrast spike.

Step 7

Step 8

Before beginning the case, verify the slide clamp is in open position and above contrast sensor.

Press DONE to fill the syringe.

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Load Saline Tubing Assembly

Step 1

Step 2

Remove protective cover from pressure transducer cartridge and insert by sliding it into pressure transducer back plate until it clicks into place.

Spike and hang the saline bag.

Tubing Guide

Step 3

Step 4

Attach the hand syringe to the manifold and slowly draw saline through the saline tubing.

Using the black latch, open the saline pump and place the saline tubing inside. Close the pump latch. Adjust the rear guide downward until it is stopped by the tubing.

IMPORTANT: To remove air, attach the hand syringe to the manifold and slowly draw saline through the saline tubing. Repeat until air is removed from the saline tubing and transducer.

Press DONE.

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SYSTEM SETUP

Purge & Flush the Tubing

Step 1

Step 2

Purge the air from the manifold tubing into the hand syringe by pressing the PURGE button for 1-2 seconds.

Press FLUSH. Beginning at the saline bag, gently tap tubing, transducer cartridge, and manifold to remove air bubbles. Repeat until all bubbles are removed.

Repeat as needed.

IMPORTANT: Inspect system to ensure all air is removed from saline spike, saline tubing, transducer cartridge, and manifold assembly before proceeding with the set-up. 10

ACIST CVi

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1. Air Column Detect Sensor

2. Strain Relief Latch

Step 3

Step 4

Detach hand syringe from manifold and replace with patient tubing.

Place the patient tubing into air column detect sensor (1) and strain relief (2). Fully close both latches. An audible click will occur when the air column detect connection is secure.

Ensure there are no sharp bends or kinks in the tubing.

Step 5

Step 6

Attach stopcock to distal end of patient tubing.

Press FLUSH to completely flush the patient tubing and stopcock with saline. Press PURGE to automatically remove all air through the air column detect sensor. Inspect that all the air has been removed. Press DONE when ready to proceed. 11

SYSTEM SETUP

Set Up AngioTouch® Hand Controller

Step 1

Step 2

Attach hand controller luer connections to control panel. Tightly secure both luer fittings.

When STARTING HAND CONTROLLER CALIBRATION is visible press OK button. Completely depress contrast button on hand controller within 4 seconds of pressing OK button.

IMPORTANT: Calibration will fail if the contrast button: • Is not depressed within 4 seconds after pressing OK • Is not depressed far enough to register a value of 10 on the system • Is pressed before pressing OK on the system

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Contrast Delivery Button

Saline Delivery Button

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SYSTEM USE

Perform an Injection

SELECT MODE INJECT SALINE PURGE

Step 1 - Arm

Step 2

In Select Mode, press INJECT.

Press OK to confirm arming. NOTE: Large Injections (over 20 ml or flow rate over 10 ml/sec) will require additional confirmation.

Step 3 - Inject Press and hold C (Contrast) button on the hand controller to vary injection flow rate. Releasing contrast button after desired image is achieved will stop the flow of contrast. 14

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Fill Information

Automatic 1. The CVi System will automatically refill the syringe from the contrast container when the amount of contrast left in the syringe is less than the programmed next injection. To stop the system from refilling, press STOP REFILL on control panel or C button on hand controller. SYSTEM USE

Manual 1. Press START REFILL on control panel. 2. The system will continue to refill the syringe until either the syringe is full, STOP REFILL or C button on hand controller is pressed, or the contrast bottle is empty.

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SYSTEM USE SETUP

Between Case Activities Multi-use Syringe Procedure

Ready To Inject.

OK to end case?

CANCEL

CANCEL

OK

Step 1

Step 2

Disarm the system from Inject Mode by pressing CANCEL.

On touchscreen, press END CASE, then press OK.

SYSTEM USE

IMPORTANT: All case data are cleared when the case is ended.

Shut Down System?

YES

CANCEL

NO

Step 3

Step 4

Select NO when prompted to shut down.

Select NO, start a new case with current syringe.

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Step 5

Step 6

Close white contrast slide clamp.

Remove all single-use consumables including: patient tubing, stopcock, saline tubing, saline bag, hand controller, and manifold.

Step 7

Step 8

Press OK.

Remove red cap from plastic bag. Twist cap onto end of syringe´s male luer connector. Load new Manifold. See page 7.

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SYSTEM USE

Syringe Removal Activities

Ready To Inject.

OK to end case?

CANCEL

CANCEL

OK

Step 1

Step 2

Disarm the system from Inject Mode by pressing CANCEL.

On touchscreen, press END CASE, then press OK.

Shut Down System?

YES

CANCEL

NO

Step 3

Step 4

Select NO when prompted to shutdown.

Select YES, start a new case with new syringe.

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OK to turn power off or Restart.

RESTART

Step 5

Step 6

Remove syringe spike from contrast container.

Press RESTART.

Open syringe chamber. Remove and discard all consumables including: contrast, syringe, saline bag, hand controller, patient tubing, and manifold assembly. Then close syringe chamber.

Step 7 Load new Syringe Assembly. See page 6.

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SYSTEM USE

Shut Down

Ready To Inject.

OK to end case?

CANCEL

CANCEL

OK

Step 1

Step 2

Disarm the system from Inject Mode by pressing CANCEL.

Press END CASE, then OK.

Shut Down System?

YES

CANCEL

NO

Step 3

Step 4

Select YES when prompted to shutdown.

Turn off power switch.

Open syringe chamber. Remove and discard all consumables including: contrast syringe, saline bag, hand controller, patient tubing, and manifold assembly. Then close syringe chamber. 20