Related Manuals for Abbott OPTIS 1014933
Summary of Contents for Abbott OPTIS 1014933
- Page 1 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release OPTIS Integrated Next ™ Imaging System 1014933 Operation and Maintenance Manual...
- Page 2 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release...
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Page 3: Table Of Contents
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Contents Symbols ....................................1 OPTIS™ Integrated Next Imaging System ..........................5 Safety Information ................................. 6 Patient Safety ....................................6 Operator Safety ....................................8 Avoiding Electrical Hazards.................................. 9 Electromagnetic Interference ................................12 Safety Functions Built Into the OPTIS Integrated Next .......................... - Page 4 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release...
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Page 5: Symbols
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Symbols The following symbols may be found on the product or product label: Symbol Definition Equipotentiality For indoor use only Protection from a spray of water in any direction when the device is up to 60° any direction from vertical for at least 5 minutes. - Page 6 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Symbols (continued) Symbol Definition Separate collection for waste electrical / electronic equipment. Mass; weight Fuse Software Unique device identifier Medical device Manufacturer Consult instructions for use Caution Do not use if package is damaged Keep dry Humidity limitation Temperature limit...
- Page 7 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Symbols (continued) Symbol Definition Date of manufacture Catalogue number Serial number Non-ionizing electromagnetic radiation Japan Ministry of Internal Affairs and Communications High Frequency Mark Refer to instruction manual/booklet Symbol with certification number denotes radio type approval for Brazil by Agência Nacional de Telecomunicações (Anatel) Defibrillation-proof type CF applied part Authorized representative in the European Community...
- Page 8 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release...
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Page 9: Optis™ Integrated Next Imaging System
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release OPTIS™ Integrated Next Imaging System About This Manual This manual describes the Abbott Medical OPTIS Integrated Next system and accessories. It provides information on: • Safety and risk statements • System components •... -
Page 10: Safety Information
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Safety Information CAUTION: Before using the OPTIS™ Integrated Next for the first time, be sure to read and understand all of the information in this chapter. Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions;... - Page 11 WARNING: Do not use the PressureWire™ Guidewire if there are any signs of damage. CAUTION: Please note Abbott Medical makes no representation or warranty that use of the OPTIS Integrated Next complies with applicable privacy, security, and confidentiality laws, but encourages you to assess your own risk as you use, disclose, control, process, or transfer patient health information with the OPTIS Integrated Next.
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Page 12: Operator Safety
IEC 60825-1. Although no harmful effects have been demonstrated for the near-infrared light wavelengths, intensities, and exposure times used during examinations with the OPTIS Integrated Next, Abbott Medical recommends that you carefully read the warning labels on the system (refer to “Avoiding Operator Light Emission Hazards”... -
Page 13: Avoiding Electrical Hazards
WARNING: All system components MUST be powered as directed in these Instructions for Use ONLY. Do not modify how the system components are connected to power without first contacting an Abbott Technical Service representative. WARNING: Failure to abide by the precautions detailed below causes the system and its use to be out of compliance with regulations and places the patient and the operator at risk of injury or death. - Page 14 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Safety Information When transferring files inside the catheterization laboratory, use only port-powered USB drives. WARNING: Inside the catheterization laboratory only port-powered USB drives may be connected to the USB port. Connecting externally powered devices to the USB port in the patient vicinity may compromise electrical isolation and cause patient injury.
- Page 15 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Safety Information • Replacement fuses are available through Abbott Medical. • The power cord is to be used for disconnection from main power. • Make sure any devices that connect to the network interface of the OPTIS Integrated Next comply with the appropriate IEC / national standard and are certified to IEC 60950.
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Page 16: Electromagnetic Interference
Please answer these questions before contacting Abbott Service. The answers will help determine if the problem is in the system or in the imaging environment. Safety Functions Built Into the OPTIS Integrated Next The following safety functions have been built into the system: •... -
Page 17: Indications For Use
CAUTION: The OPTIS Integrated Next is intended for use by medical personnel who are knowledgeable in OCT and physiological procedures. Abbott Medical and its employees cannot give instructions in the interpretation or diagnosis of recordings and makes no attempt to do so. -
Page 18: Complications
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Complications Complications The risks involved in vascular imaging include those associated with all catheterization procedures. The following complications may occur as a consequence of intravascular imaging and may necessitate additional medical treatment including surgical intervention. -
Page 19: Precautions (Oct)
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Warnings and Precautions • If resistance is encountered during advancement or withdrawal of the Dragonfly Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the Dragonfly Imaging Catheter and guide wire as a unit from the patient. -
Page 20: Warnings And Precautions (Fractional Flow Reserve [Ffr], Resting Full-Cycle Ratio [Rfr])
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Warnings and Precautions Warnings and Precautions (Fractional Flow Reserve [FFR], Resting Full-Cycle Ratio [RFR]) WARNING: • The PressureWire Guidewire is sterilized by ethylene oxide and is intended for one-time use only. Non-pyrogenic. Do not use if the package is opened or damaged. -
Page 21: Mechanical Enclosure
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Warnings and Precautions CAUTION: • No connections to other systems or components are to be made to the OPTIS Integrated Next except through the Connector Panel. No connections are to be made through the Connector Panel except as described in this manual. -
Page 22: Electronic Interference
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Warnings and Precautions • Never use a converter adapter to connect the AC plug to an ungrounded wall outlet. Doing so may result in electric shock to the patient or operator and damage to equipment. CAUTION: •... -
Page 23: System Overview
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Overview System Features Optical Coherence Tomography (OCT) is an imaging modality that uses fiber-optic technology. The OPTIS™ Integrated Next uses optical imaging catheters that emit near-infrared light to produce high-resolution real-time images. -
Page 24: System Components
Next. The hardware and software must not be modified in any way by the customer. Making such modifications may interfere with correct operation and will void system warranties. Contact an Abbott Technical Service representative for more information. Note: The OPTIS Integrated Next can only be installed and serviced by an Abbott Technical Service representative. - Page 25 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Overview OPTIS Integrated Next - Cabinet and Control Room Components Figure 3. OPTIS Integrated Next - Cabinet and Control Room Components Control room monitor Standby button/indicator CD/DVD eject button CD/DVD tray Wired mouse Wired keyboard with USB ports...
- Page 26 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Overview Tableside Controller (TSC) Figure 4. Tableside Controller (TSC) Rail clamp USB connection Wireless connectivity indicator Note: • If the TSC is connected by USB cable, the wireless connectivity indicator does not illuminate. •...
- Page 27 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Overview Drive Motor and Optical Controller (DOC) The DOC provides bed-side control of the most important OCT imaging functions. Refer to the installed software User Manual for Dragonfly™ Imaging Catheter connection details.
- Page 28 Wi-Box AO Transmitter • Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter • Sterile DOC cover • 3 ml syringe Note: Contact Abbott Service for order numbers of accessories. OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A...
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Page 29: System Setup
The TSC and DOC holster are custom fit during installation. If either component is not clamped onto the rail securely, contact Abbott Service. System components that are suitable for use within the patient environment are the DOC, DOC holster, TSC, and catheter as specified in the Instructions for Use. - Page 30 DOC Holster Boom Mount Configuration In some installations, Abbott Medical may install the DOC holster directly onto the monitor boom (DOC holster boom mount configuration). When performing a procedure using the OPTIS Integrated Next with a DOC holster boom mount configuration, remove the DOC holster from the DOC holster boom mount and secure it to the procedure table rail.
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Page 31: Connecting The System
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Setup Connecting the System WARNING: All connections to the OPTIS Integrated Next except the TSC in Bluetooth mode must be made through the System Connector Panel. Making ‡ connections directly to internal components of the system may bypass isolation features and compromise patient safety. -
Page 32: Shutting Down
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Setup Shutting Down CAUTION: Do not unplug from AC power or turn off main power until the shutdown is complete, the screens turn black, and the green monitor LEDs turn amber. -
Page 33: Cleaning And Maintenance
Return the OPTIS Integrated Next to Abbott Medical at the end of its operating life. Cleaning The following OPTIS Integrated Next items require cleaning: •... -
Page 34: Maintenance
CAUTION: Only a qualified Abbott Technical Service representative can perform maintenance or service components of the system. Any attempt to open the system components by anyone other than a qualified Abbott Technical Service representative will void the warranty. Service can be contacted at: Email: OCTservice@abbott.com... - Page 35 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Cleaning and Maintenance Click Service. The Service menu displays. In the DOC Service section of the Service menu, click Enter. The DOC optical carriage moves all the way to the front and locks into position for one minute.
- Page 36 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Cleaning and Maintenance In the DOC Service section of the Service menu, click Exit. The DOC optical carriage moves all the way to the back and all DOC functions are returned to their normal state.
- Page 37 Optical Adapter Replacement Procedure The optical adapter should be replaced every 200 cycles or 1 year (whichever occurs first), or if cleaning does not improve image quality. Contact Abbott Service to purchase optical adapters. CAUTION: This procedure should not be performed during a patient case on a sterile Dragonfly Imaging Catheter.
- Page 38 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Cleaning and Maintenance Pull the adapter straight out of the DOC. Note: Ensure that the adapter does not rotate while it is being removed, as this could damage the DOC or break the adapter. Remove the cap and plug from the replacement optical adapter.
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Page 39: Infection Control
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Cleaning and Maintenance Cable Connection Inspection Procedure Ensure that the power connection to the system is fully seated and secured with the strain-relief clip. If a secondary ground connection is being used, ensure that both ends of the cable are secure. -
Page 40: User Troubleshooting
Shut down the system, turn off the main system power, and wait 15 seconds. engine initialization failed" is by several problems, including Then turn the system back on. If the error is displayed again, contact Abbott displayed at startup. loose or damaged system Service for instructions. -
Page 41: System Disposal
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Cleaning and Maintenance Table 1. User Troubleshooting Tips (continued) Symptom Possible Causes Remedy Imaging OCT image dim, with no Monitor contrast and Set monitor contrast and brightness using monitor controls. background noise visible. brightness set incorrectly. -
Page 42: System Specifications
Regulatory Approvals European conformity, affixed according to the relevant provisions of EU MDR 2017/745 and 2011/65/EU, and RED directive 2014/53/EU Annex II. Hereby, Abbott Medical declares that this device complies with the essential requirements and other relevant provisions of these directives. -
Page 43: System - Electrical And Physical
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Specifications Table 2. System Safety and Regulatory Specifications (continued) Category Specifications Leakage and Auxiliary Current Chassis Leakage Current < 100 µa rms normal condition < 500 µa rms single-fault condition Patient Leakage Current Measured at patient end of DOC: <... -
Page 44: Imaging Specifications
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Specifications Table 3. System Electrical and Physical Specifications (continued) Parameter Specification Mechanical Specifications - DOC Weight 3.5 lbs (1.6 kg) Dimensions 24 x 9 x 10 cm Mechanical Specifications - TSC Weight 1.5 lbs (0.7 kg) Dimensions... -
Page 45: Electromagnetic Emissions
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Specifications Electromagnetic Emissions Table 6. Guidance and Manufacturer's Declaration - Electromagnetic Emissions The OPTIS Integrated Next is intended for use in the electromagnetic environment specified below. The customer or user of the OPTIS Integrated Next should ensure that it is used in such an environment. - Page 46 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Specifications Table 7 (continued). Guidance and Manufacturer's Declaration - Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment.
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Page 47: Recommended Separation Distances
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release System Specifications Table 8 (continued). Guidance and Manufacturer's Declaration - Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should ensure that it is used in such an environment. -
Page 48: Fcc Statement
Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Abbott Medical could void the user’s authority to operate the equipment. Essential Performance... - Page 49 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release...
- Page 50 State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release Abbott Medical Abbott Medical The Corporate Village 4 Robbins Road Da Vincilaan 11 Box F1 Westford, MA 01886 USA 1935 Zaventem TEL: (855) 478-5833 Belgium Outside USA TEL: +1 651-756-5833 TEL: +32 2 774 68 11...