ACIST Medical Systems
ACIST HDi and Kodama Quick Guide Rev 02 Feb 2020
Quick Guide
13 Pages
Preview
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ACIST HDi ACIST Kodama ®
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High-definition IVUS System
QUICK GUIDE
Bracco Group
ACIST HDi | ACIST Kodama
SYSTEM OVERVIEW
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SYSTEM OVERVIEW
Know your ACIST HDi System HDi IVUS System Components
Console
Console Touch Screen DVD/USB Ports
Ports and Controls PIM
Cart
Power Supply
LTS
ACIST Kodama® Catheter 2
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ACIST HDi | ACIST Kodama
SYSTEM OVERVIEW
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SYSTEM OVERVIEW
HDi IVUS System PIM and LTS
HDi IVUS System Consumables
The Patient Interface Module (PIM) has two buttons, one for turning on and off imaging and the other for recording (orange light when recording).
Kodama® Catheter
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Catheter Hub Telescope Anchor
Record Button Imaging Button
10 mL Syringe
PIM Nose
Stopcock
3 mL Syringe Kodama Catheter
The Linear Translation System (LTS) provides a calibrated pullback (either automatic or manual). Controls include starting and stopping pullback, switching between automatic and manual mode, setting the pullback speed, and zeroing the linear distance traversed.
Luer Port
Dispenser Coil
PIM Cradle
Sterile Bag
LTS Groove
Sterile User Hand Folds
Telescope Anchor Window
Control Panel Display Screen Bag Attachment 4
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ACIST HDi | ACIST Kodama
SYSTEM SETUP
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Preparing HDi IVUS System for Use
PIM Port
SYSTEM SETUP
Power Supply Port
LTS Port
Step 1
Step 2*
Step 4
Step 5
Connect PIM to Console PIM Port.
Connect optional LTS to Console LTS Port.
Connect the system power cord and press the power button. The system will self-test and start-up sequence will begin.
When power up sequence completes, enter the System Login password.
Connect Power Supply to Console Power Supply Port.
Step 3*
Step 6
Insert PIM into the cradle on the LTS, rotating the PIM until it is securely seated in place.
Verify the PIM and optional LTS show as white text to ensure the devices are properly connected.
*LTS is optional during the complete system setup and use
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ACIST HDi | ACIST Kodama
SYSTEM SETUP
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Preparing the Kodama® Catheter
SYSTEM SETUP
Step 7
Step 9
Non-sterile operator: Slide PIM/LTS carriage to the fully retracted position.
Using two-operator sterile technique, insert the PIM/LTS assembly into the open bag and grasp the proximal edge of the sterile bag and pull it over the PIM/LTS cables*. *The non-sterile, exposed cables should not come into contact with the sterile field.
Step 8
Step 10
Sterile operator: Unfold the sterile bag, making certain that the bag attachment is on top of the fold-out section.
Fully seat the three-pin bag attachment into the three receptacles on the PIM nose.
Insert your hands into the folds of the sterile bag as indicated.
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ACIST HDi | ACIST Kodama
SYSTEM SYSTEM SETUP SETUP
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Preparing the Kodama® Catheter
Step 11
Step 13
Disconnect 10 mL syringe and fill with saline.
Connect the catheter hub to PIM nose through the sterile bag until click.
Reconnect the syringe to the Luer port on the dispenser coil. Flush coil with saline to activate hydrophilic coating. Reconnect the filled 10 mL syringe to the catheter stopcock.
LTS
NOT MATED
CATHETER
PIM
Step 12
Step 14
Fill 3 mL syringe with saline from the 10 mL syringe.
Ensure CATHETER indicated on touchscreen turns from orange to white.
Rotate the stopcock so that the 3 mL syringe is set to introduce saline into the catheter. The 10 mL syringe is the reservoir for refilling the 3 mL syringe.
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ACIST HDi | ACIST Kodama
SYSTEM SETUP
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Preparing the Kodama® Catheter
LTS Groove
Step 15
Step 17
While pressing the orange button on the side of the LTS, slide the telescope open and insert the telescope anchor into the LTS groove. Ensure the orange hook is fully closed and centered on the telescope anchor.
Flush catheter TWICE using the full 3 mL syringe. Use stopcock and 10 mL syringe to refill as needed.
LTS
MATED
CATHETER
PIM
Step 16
Step 18
Ensure MATED indicator on touchscreen turns from orange to white.
Slide PIM/LTS carriage all the way forward. Press the MANUAL button to lock the PIM in the forward position. Adjust bag as needed.
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ACIST HDi | ACIST Kodama
SYSTEM USE
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Patient Information Manual Entry
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Patient Information Automatic Entry with ACIST Connect™
SYSTEM SETUP
Step 2
Step 1
Step 2
Press ARCHIVE
Enter required patient information or select patient data field you want to modify.
Press ARCHIVE
Press PATIENT LIST
Step 3
Step 3
Step 4
Press ACQUIRE
Using the column heading to sort, find the patient’s name. Press their name to highlight and press SELECT
Verify all patient information is correct. If necessary, enter or modify information.
ARCHIVE opens the section where you can enter patient information, and open, close, delete and export studies.
The system opens to the ACQUIRE interface screen, where imaging and recording occur.
SYSTEM USE
Step 1
Step 5 Press ACQUIRE
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ACIST HDi | ACIST Kodama
SYSTEM USE
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Start and Stop Live Imaging
SYSTEM USE
Option 1 – Console Touchscreen Control Press IMAGE button on touchscreen, green button will illuminate. Confirm normal system operation by observing the bright ring pattern on the touchscreen.
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Record a Loop PIM only
Option 2 – PIM Control Press the imaging button on the PIM to start imaging.
Step 1
Step 2
Press RECORD on touchscreen or record button on PIM to start recording.
Firmly grasp telescope anchor.
Step 3
Step 4
Without moving anchor, slowly draw back the PIM to pull back the imaging element.
Press RECORD on touchscreen or record button on PIM to stop recording.
Press the imaging button on the PIM to stop imaging.
Press IMAGE button again to stop imaging.
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ACIST HDi | ACIST Kodama
SYSTEM USE
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Record a Loop Manual pullback with LTS
Record a Loop Motorized LTS Pullback
Step 1
Step 1 - Start
Press MANUAL button on LTS. Confirm green light is illuminated on the button.
To start pullback, press PULLBACK on touchscreen or press START button on the LTS.
Step 2
When pullback starts, the following events will occur automatically:
Press RECORD on touchscreen or record button on PIM to start recording. (See previous page for visual)
• Recording starts (if it wasn’t already started)
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• Imaging starts (if it wasn’t already started)
Step 3 Slowly draw back PIM along the tracks of LTS to pull back imaging element.
Step 4
Step 2 - Stop
Press RECORD on touchscreen or record button on PIM to stop recording. (See previous page for visual)
To stop pullback, press PULLBACK on the touchscreen or press START button on the LTS.
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SYSTEM USE
TROUBLESHOOTING
Shut Down
HDi System Messages
ACIST HDi | ACIST Kodama ®
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LTS Error Messages • LTS Communication Error • LTS Pullback Error • LTS Command Fail Error • LTS Download Error Probable Cause(s)
Corrective Actions
An operational failure occurred.
Note the error number. Try the following actions: • Disconnect and reconnect the LTS. • Restart the system. • If the error message reoccurs, connect a different LTS.
Option 1
• Restart the system.
Press ACIST | HDi® to open the information screen.
If the problem persists, contact an ACIST service representative.
Press SHUT DOWN button located at bottom of the screen.
PIM Error Messages • PIM Imaging Error TROUBLESHOOTING
• PIM Communication Error • PIM Recording Error • Short Vector Error Probable Cause(s)
Corrective Actions
An operational failure occurred.
Note the error number. Try the following actions:
Option 2 Or Press the physical power/off button on the side of the console.
• Disconnect and reconnect the PIM. • Restart the system. • If the error message reoccurs, connect a different PIM. Restart the system. If the problem persists, contact an ACIST service representative.
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ACIST HDi | ACIST Kodama
TROUBLESHOOTING
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HDi System Messages
Kodama Catheter Troubleshooting
Internal Error Messages
• Image fades during use.
• Internal System Communication Error
• Image cannot be recovered.
• Internal Systems Initialization Error
Corrective Actions
• Internal Systems Timeout Error
• Flush the Kodama catheter with saline for several seconds.
• Internal Temperature Error
• Remove the Kodama catheter from the PIM and reinsert the Kodama catheter into the PIM (refer Step 13 for visual).
Probable Cause(s)
Corrective Actions
An operational failure occurred.
Note the error number. Restart the system. If the problem persists, contact an ACIST service representative.
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• Confirm the catheter indicator on the touchscreen turns from orange to white. • If the condition persists, withdraw the Kodama catheter and use another. Return the malfunctioning Kodama catheter to an ACIST representative for analysis.
DVD Error Messages • Unable to write the Study to the DVD. Probable Cause(s)
Corrective Actions
The system was unable to write to the DVD.
• Ensure that a blank DVD is inserted. • Try a different DVD.
TROUBLESHOOTING
If the problem persists, contact an ACIST service representative.
USB Error Messages • Export of Logs to USB failed – no writable USB storage partition found. • Disk space error. Unable to perform archive to USB. • Screenshot was not saved to USB. Probable Cause(s)
Corrective Actions
An operational failure occurred.
Insert a USB drive with sufficient free space.
For full operating instructions and troubleshooting, please refer to the HDi System User’s Guide and Kodama IFU. 22
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ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 USA acist.com Service Tel (USA): +1 888 670 7701 Fax: +1 952 253 4524 [email protected] EC
REP
ACIST Europe B.V. Argonstraat 3 6422 PH Heerlen The Netherlands Bracco Pty, Ltd. PO Box 19 Roseville NSW 2069 Australia Tel: 02 9415 8950 Service Tel: +31 (0)45 750 7025 [email protected]
ACIST, ACIST HDi and Kodama are a trademarks of ACIST Medical Systems, Inc. ACIST Medical Systems, Inc. reserves the right to modify the specifications and features described herein or discontinue manufacture of the products described at any time without prior notice or obligation. Please contact your authorized ACIST representative for the most current information. Patents: acist.com/patents
2797 Rx Only © 2020 ACIST Medical Systems, Inc. All rights reserved. P/N: 30-100058_US 2/20 Rev 02