Abbott OPTIS Mobile Next Imaging System User Guide
- June 2, 2024
- Abbott
Table of Contents
Abbott OPTIS Mobile Next Imaging System
Product Specifications
- Power Consumption: 400 VA
- Max Input: 100-240 V~ 50/60 Hz
- Video Out: SXGA 1280 x 1024 DVI-D
- Angio Video Output Requirements:
- Video Types: Digital (DVI or HDMI), Analog (VGA, BNC-1 or BNC-3)
- Video Resolution: minimum of 1024 x 1024, maximum 1920 x 1200
- Frame Rate: 15-30 FPS
- CD/DVD Drive: Mono plane
Product Usage Instructions
Product Components and Descriptions
The OPTISTM MOBILE NEXT IMAGING SYSTEM includes the following components:
- OPTISTM Mobile Next Console: Contains imaging engine, computer, keyboard, mouse, monitors, and isolated power supply. Easy to move by a single user.
- Tableside Controller (TSC): Provides OCT andFFR/RFR control at tableside. Clamps to table rail in the procedure room. Drives the OCT imaging catheter.
- Wi-BoxTM System for FFR/RFR (optional): Provides wireless aortic pressure and interfaces with the angio and boom video for the OPTISTM Mobile Next.
- Connectivity Box: Provides wireless connection to OPTISTM Mobile Next (Bluetooth) and interfaces with the boom monitor video connection and angiography system connection.
Connections
The system requires connections to the Boom monitor video, Angiography
system via Ethernet, and DICOM server for efficient operation.
Dimensions and Weight
- OPTISTM Mobile Next Console: 145 cm x 61 cm x 71 cm (H/W/D), 80 kg
- Tableside Controller (TSC): 14 cm x 9 cm x 21 cm (H/W/D), 0.7 kg
- Wi-BoxTM System: 8.7 cm x 10.8 cm x 3.3 cm (H/W/D), 0.13 kg
Frequently Asked Questions (FAQ)
-
Q: Can the OPTISTM Mobile Next Imaging System be used in multiple cath labs?
A: Yes, the system is designed for use in multiple cath labs via easy pre- installed connections. -
Q: What software does the OPTISTM Mobile Next Imaging System use?
A: The system uses UltreonTM 2.0 Software for providing actionable OCT and angiographic insights. -
Q: How is the Tableside Controller connected to the OPTISTM Mobile Next Console?
A: The Tableside Controller can establish a connection with the OPTISTM Mobile Next Console via a wireless Bluetooth connection or USB cable. -
Q: What are the power input requirements for the OPTISTM Mobile Next System?
A: The power input requirement is 100-240 V~ 50/60 Hz with a maximum of 0.3 A.
OPTIS™
Mobile Next Imaging System
THE OPTIS™ MOBILE NEXT IMAGING SYSTEM is a transportable system designed
for use in multiple cath labs via easy pre-installed connections. With
Ultreon™ 2.0
Software, this powerful OCT imaging system provides you with actionable OCT
and angiographic insights to enable PCI procedural efficiencies and better
outcomes.1-5
PRODUCT FEATURES
- High-powered processors supporting artificial intelligence (AI) technology for faster information display and workflow efficiency
- Wireless tableside controller (TSC) for full control of image acquisition and analysis at the bedside
- OCT with FFR/RFR are immediately available during percutaneous coronary intervention (PCI)
- Seamless and secure integration with cath lab IT system and DICOM
- Compatible with Dragonfly OpStar™ Imaging Catheter and Dragonfly™ OPTIS™ Imaging Catheter
Hong, SJ., et al., on behalf of the IVUS-XPL Investigators. Effect of
Intravascular Ultrasound–Guided vs Angiography-Guided Everolimus-Eluting Stent
Implantation: The IVUS-XPL Randomized Clinical Trial. JAMA 2015;314:2155-63.
2. Zhang, J., et al. Intravascular ultrasound versus angiography-guided drug-
eluting stent implantation: the ULTIMATE trial. J Am Coll Cardiol.
2018;72(24):3126-3137. 3. Lee, JM., et al., on behalf of the RENOVATE-COMPLEX-
PCI Investigators. Intravascular Imaging–Guided or Angiography-Guided Complex
PCI.
N Engl J Med 2023;Mar 5. 4. Truesdell, AG., et al., Intravascular Imaging
During Percutaneous Coronary Intervention: JACC State-of-the-Art Review. J Am
Coll Cardiol. 2023;81(6):590-605. doi:10.1016/j.jacc.2022.11.045, 2023
ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology
(Coronary, Peripheral Vascular, and Structural Heart Interventions): A Report
of the ACC Competency Management Committee | Circulation: Cardiovascular
Interventions (ahajournals.org). 5. West, DM., Allen, JR., How Artificial
Intelligence is Transforming the World, 4/19/2023,
https://www.brookings.edu/research/how-artificial-intelligence-is-
transforming-the-world/, page 1.
OPTIS™ Next Imaging System Instructions for Use (IFU). Refer to IFU for
additional information.
Information contained herein for DISTRIBUTION outside of the U.S. ONLY.
Check the regulatory status of the device in areas where CE marking is not the
regulation in force.
©2023 Abbott. All rights reserved. MAT-2310894 v1.0
PRODUCT COMPONENTS
COMPONENT| DESCRIPTION| CONNECTIONS| DIMENSIONS / WEIGHT|
MISCELLANEOUS SPECIFICATIONS
---|---|---|---|---
OPTIS ™ Mobile Next Console|
- Contains imaging engine, computer, keyboard, mouse, monitors and isolated power supply
- Easy to move by a single user
|
- Boom monitor video connection
- Angiography system connection
- DICOM‡ server via Ethernet
| 145 cm x 61 cm x 71 cm (H/W/D) 80 kg|
- Power consumption: 400 VA Max Input: 100-240 V~ 50/60 Hz
- Video Out: SXGA 1280 x 1024 DVI-D
- Angio Video Output Requirements: Video Types: Digital (DVI or HDMI), Analog (VGA, BNC-1 or BNC-3)
- Video output must be dedicated or properly split
Video Resolution: minimum of
1024 x 1024, maximum 1920 x 1200
Frame Rate: 15-30 FPS CD/DVD Drive
Mono plane
Tableside Controller (TSC)|
- Provides OCT and FFR/RFR control at tableside
- Clamps to table rail in procedure room
| Wireless Bluetooth‡ connection or USB cable to OPTIS™ Mobile Next console| 14 cm x 9 cm x 21 cm (H/W/D)
0.7 kg
|
- Bluetooth‡ mode requires separate power source at tableside
- Input (Bluetooth Mode): 100–240 V~ 50/60 Hz 0.5 A
Drive-motor and Optical Controller (DOC)| Drives the OCT imaging catheter| Established connection with OPTIS™ Mobile Next Console| 10 cm x 9 cm x 24 cm (H/W/D)
1.5 kg
| While in operation, the DOC is bagged and placed on the procedure table
When not in operation, it is stored in the OPTIS™ Mobile Next cart tray
Wi-Box ™ System for FFR/RFR optional| Provides wireless aortic pressure| Wireless connection to OPTIS™ Mobile Next (Bluetooth‡)| 8.7 cm x 10.8 cm x 3.3 cm (H/W/D)
0.13 kg
|
Connectivity Box| Contains the interface to the angio and boom video
for the OPTIS™ Mobile Next|
- Boom monitor video connection
- Angiography system connection
| 9 cm x 15 cm x 27.5 cm 2.5 kg|
- Power Input: 100-240 V~
- 50/60 Hz
- 0.3 A maximum
ROOM CONFIGURATIONS
Configuration 1: OPTIS™ Mobile Next System under bed mount; video cables in floor or ceiling conduit
Configuration 2: OPTIS™ Mobile Next System wall mount; video cables in floor or ceiling conduit
Configuration 3: OPTIS™ Mobile Next System boom mount; video cables in ceiling conduit
ORDERING INFORMATION
Data on file at Abbott.
CAUTION: This product is intended for use by or under the direction of a
physician. Prior to use, reference the Instructions for Use, inside the
product carton (when available) or at vascular.eifu.abbott or at
medical.abbott/manuals for more detailed information on Indications,
Contraindications, Warnings, Precautions and Adverse Events. This material is
intended for use with healthcare professionals only.
Information contained herein for DISTRIBUTION outside of the U.S. ONLY. Check
the regulatory status of the device in areas where CE marking is not the
regulation in force.
Illustrations are artist’s representations only and should not be considered
as engineering drawings or photographs. Photos on file at Abbott.
Abbott International BVBA
Park Lane, Culliganlaan 2B, 1831 Diegem, Belgium, Tel: 32.2.714.14.11
™ Indicates a trademark of the Abbott Group of Companies.
‡ Indicates a third-party trademark, which is property of its respective
owner.
www.cardiovascular.abbott
©2023 Abbott. All rights reserved. MAT-2310894 v1.0