Abbott OPTIS 1014933 User Manual Download

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OPTIS

™

Integrated Next

Imaging System

1014933

Operation and Maintenance Manual

State: Released

Date: 2021.03.01 22:19 GMT

Effectivity: Upon Release

Summary of Contents for OPTIS 1014933

Page 1: ...OPTIS Integrated Next Imaging System 1014933 Operation and Maintenance Manual State Released Date 2021 03 01 22 19 GMT Effectivity Upon Release...

Page 2: ...State Released Date 2021 03 01 22 19 GMT Effectivity Upon Release...

Page 3: ...ectrical 17 Electronic Interference 18 Aortic Reference Pressure 18 Defibrillation 18 System Security 18 System Overview 19 System Features 19 System Components 20 System Setup 25 Positioning the Syst...

Page 4: ...State Released Date 2021 03 01 22 19 GMT Effectivity Upon Release...

Page 5: ...Mark Japanese RF identifier for the transmitter Australian Communications and Media Authority ACMA and New Zealand Radio Spectrum Management RSM Regulatory Compliance Mark RCM New Zealand Radio Spectr...

Page 6: ...tion 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...

Page 7: ...ation 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 Ag ncia N...

Page 8: ...State Released Date 2021 03 01 22 19 GMT Effectivity Upon Release...

Page 9: ...to the installed software User Manual Details of the imaging catheter are covered in the Dragonfly Imaging Catheter Instructions for Use provided with the catheter and are not covered in this manual...

Page 10: ...rmine if OPTIS Integrated Next use is appropriate An awareness of system limitations is essential to making that determination and ensuring safe operation for both operator and patient This section pr...

Page 11: ...on a catheter while it is in the patient WARNING Electrical Shock Hazard Do not remove OPTIS Integrated Next covers To avoid electrical shock use only the power cord supplied with the system and conne...

Page 12: ...established by 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...

Page 13: ...your joints in optimum positions with a balanced posture avoiding Static postures Exertion of force during repetitive motions Wrist flexion or deviation Position the keyboard and monitor to minimize...

Page 14: ...ircuits inside the housing could cause serious injury Making Proper Electrical Connections Ensure that the electrical connection for the system is properly rated figure below Carefully follow the safe...

Page 15: ...ions The OPTIS Integrated Next is intended for use by medical personnel who are knowledgeable in OCT and Physiology procedures To determine if system use is appropriate the user must be aware of syste...

Page 16: ...interference present if the system is moved to a different location in the facility Examples Placing the system close to an ECG cable can increase electromagnetic interference Moving the cable or othe...

Page 17: ...etation or diagnosis of recordings and makes no attempt to do so CAUTION All operators must be knowledgeable in performing OCT and physiological procedures prior to using the installed software OPTIS...

Page 18: ...ble angina Hypotension Warnings and Precautions Warnings Prior to use please review the installed software User Manual and the Instructions for Use supplied with the OPTIS Integrated Next Dragonfly Im...

Page 19: ...contrast media Instructions for Use for general warnings and precautions relating to use of contrast media Before creating an OCT recording review the installed software User Manual for additional war...

Page 20: ...idewire may be a potential biohazard Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations The system may place the point of index value at the wrong l...

Page 21: ...ted Next if it has been dropped or in another way exposed to mechanical or electrical damage or if liquids have penetrated the housing or the user or patient may be exposed to electrical shock or faul...

Page 22: ...rbances is high Aortic Reference Pressure CAUTION Check that the monitor cables and aortic pressure transducer AO adapter delivered with the OPTIS Integrated Next interface are compatible with the cat...

Page 23: ...ation laboratory so that OCT and Physiology are immediately available without the need to find connect position and power on a mobile console The system allows either the sterile operator or non steri...

Page 24: ...ansmitter installed in the catheterization laboratory Contact Abbott Service formore information CAUTION The above components are integral parts of the OPTIS Integrated Next The hardware and software...

Page 25: ...state and turn on the system indicator turns green A potential equalization conductor post located on the back of the system cabinet compliant to IEC 60601 1 2005 cl 8 6 7 provides a direct connectio...

Page 26: ...does not illuminate Improper handling of the USB connection can damage the port on the connector panel CAUTION A yellow no connection Wireless Connectivity Indicator LED means the tableside controlle...

Page 27: ...OCT imaging functions Refer to the installed software User Manual for Dragonfly Imaging Catheter connection details Figure 5 Drive Motor and Optical Controller DOC 3 4 5 6 2 1 7 1 Stop button 2 Enabl...

Page 28: ...ation laboratory between the hemodynamic recording system and the aortic pressure transducer AO The wireless connection to the Wi Box AO Transmitter is made during setup for the procedure Refer to the...

Page 29: ...onnection to the power mains must also be easily accessible Note USB ports are located on the keyboard Mount the TSC and DOC holster onto the procedure table rail in locations that are comfortable for...

Page 30: ...nd lift the grooved end of the clamp to release from the rail 3 Holding the clamp open gently pull the component from the rail To avoid damaging cables components or connections that may expose the us...

Page 31: ...ic shock to the patient or operator and damage to equipment For detailed information on electrical requirements refer to Making Proper Electrical Connections on page 10 1 Make sure the power cords are...

Page 32: ...ot recommended to shut down the system 1 Click the Shutdown button located at the top of the screen The system shutdown menu appears 2 Click Yes to begin the system shutdown or No to continue using th...

Page 33: ...chedule or at least every 30 days under normal use 1 Turn off or Standby all system components with accessible power controls and unplug the power cables 2 Clean system surfaces and the keyboard with...

Page 34: ...the installed software version Optical Connection Cleaning Procedure The optical connection between the DOC and the catheter should be cleaned whenever a loss of image quality occurs Image quality sho...

Page 35: ...DOC rotary motor stops and the laser source turns off 6 Remove the sizing cap from the end of the optical fiber connector cleaner figure below 7 Insert the cleaner into the center of the optical adapt...

Page 36: ...e sizing cap and place it on the end of the optical fiber connector cleaner figure below 12 Insert the cleaner into the optical connection in the catheter ensuring that it seats fully and press until...

Page 37: ...rs as this may damage them 1 If a catheter is connected to the DOC press the Unload button on the DOC and wait until the lock LED stops flashing When the lock LED is off remove the catheter 2 Click th...

Page 38: ...ible click is produced when the adapter seats Note If the carriage moves when you press on the adapter click the Exit button in the DOC Service section of the Service menu When it changes to Enter cli...

Page 39: ...ecure 3 Ensure that all other connectors are fully seated and properly secured Infection Control Follow the infection control procedures established in your institution for protection of both staff an...

Page 40: ...blank power indicator on monitor lit PC auto boot failed Turn off the main power switch and wait fifteen seconds Turn the main power switch back on and press the On Standby button on the right side of...

Page 41: ...eimagingcatheterfromDOC If background noise appears the imagingcatheteris defective Replacecatheter Dirty connection between DOCandimagingcatheter Referto Optical Connection Cleaning Procedure on page...

Page 42: ...ial performance IEC 60825 1 3rd Ed 2014 Safety of Laser Products Part 1 Equipment classification and requirements IEC60601 1 2 2014Ed 4Medical electrical equipment Part 1 2 General requirements for ba...

Page 43: ...ASK Radiated Power EffectiveRadiatedPower ERP 43 05dBm Tableside Controller TSC Bluetooth Module Frequency Range 2 400 2 4835GHz ISM band Type GFSK DQPSK 8 DPSK Radiated Power Bluetooth power Class 1...

Page 44: ...0825 1 Pullback Parameters Pullback Range 54 mm 75 mm Pullback Speed Settings 18 0mm sec 36 0mm sec General Scan Parameters A ScanRangein Air 7 0 mm A Scan Range in Contrast 4 83 mm DiameterMeasuremen...

Page 45: ...unity Table 7 Guidance and Manufacturer s Declaration Electromagnetic Immunity The device is intendedfor use in the electromagnetic environment specified below The customerorthe user of the device sho...

Page 46: ...in such an environment Immunity Test IEC 60601 Test Level ComplianceLevel ElectromagneticEnvironment Guidance Portable and mobile RF communications equipment should be used no closer to any part of t...

Page 47: ...ion Distances Table 9 Recommended separation distances between portable and mobile RF communications equipment and the OPTIS Integrated Next The OPTIS Integrated Next is intended for use in an electro...

Page 48: ...erence 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 th...

Page 49: ...State Released Date 2021 03 01 22 19 GMT Effectivity Upon Release...

Page 50: ...6 USA TEL 855 478 5833 Outside USA TEL 1 651 756 5833 Abbott Medical The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium TEL 32 2 774 68 11 2021 02 ARTEN600173796 A State Released Date...

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