Abbott Ultiri 1015082 Operation Manual
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Abbott Ultiri 1015082 Operation Manual

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wi-bo
Ultiri
™
Measurement System
1015082
Operation Manual

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Summary of Contents for Abbott Ultiri 1015082

  • Page 1 wi-bo Ultiri ™ Measurement System 1015082 Operation Manual...
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  • Page 3: Table Of Contents

    Contents Symbols Glossary ........................................1 Labeling ............................................4 Ultiri™ Measurement System ....................................5 Safety Information ........................................6 Patient and Operator Safety ......................................... 6 Avoiding Electrical Hazards........................................... 7 Wireless Communication ..........................................9 Electromagnetic Interference ........................................11 Summary of Safety and Clinical Performance ................................... 11 Indications for Use ........................................12 Contraindications ........................................
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  • Page 5: Symbols Glossary

    Symbols Glossary Symbol Definition ON/OFF Measurement System Manufacturer Authorized representative in the European Community/European Union CE Mark UK Conformity Assessed Mark UK Responsible Person Consult instructions for use or consult electronic instructions for use Equipotentiality Direct current Computer network Intertek (Nationally Recognized Testing Laboratory) Universal Serial Bus (USB), port/plug Refer to instruction manual/booklet Non-ionizing electromagnetic radiation...
  • Page 6 Symbols Glossary (continued) Definition Symbol Video output Unique device identifier Date of manufacture Catalogue number Serial number Packaging unit Do not use if package is damaged and consult instructions for use Keep dry Excursion limits permitted to temperature Excursion limits permitted to humidity Importer in the European Community for Ultiri™...
  • Page 7 Symbols Glossary (continued) Definition Symbol For indoor use only Class II equipment TÜV Rheinland Certification Mark Alternating current PSE Mark Ultiri™ Measurement System Operation Manual – 600327583 Rev. A...

  • Page 8: Labeling

    Labeling Item Description Front Abbott Branding and Labeling UDI Label Main Label UDI Label Location Main Label Location Video Output port and symbol on Label Ultiri™ Measurement System Operation Manual – 600327583 Rev. A...

  • Page 9: Ultiri™ Measurement System

    Electronic versions of all Instructions for Use (IFU) are available at vascular.eIFU.abbott. Where paper copies are not provided, Instructions for Use are provided to the user via electronic media and / or Abbott Medical’s eIFU website. Paper copies may also be requested at no additional cost by reaching customer service using the contact information on the eIFU website.

  • Page 10: Safety Information

    Safety Information CAUTION: Before using the Ultiri™ Measurement System for the first time, be sure to read and understand all information in this chapter. Carefully read all instructions prior to use. Observe all warnings and precautions noted throughout these instructions; otherwise, complications and / or additional intervention may occur.

  • Page 11: Avoiding Electrical Hazards

    WARNING: Do not use the PressureWire™ X Guidewire if there are any signs of damage. CAUTION: Please note Abbott Medical makes no representation or warranty that use of the Ultiri Measurement System 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 Ultiri Measurement System.
  • Page 12 Safety Information Making Proper Electrical Connections Ensure that the electrical connection for the system is properly rated. Carefully follow the safety guidelines described in this section when connecting the system power cord to the hospital or laboratory AC outlet. WARNING: Failure to follow the electrical connection precautions detailed in this section 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, and may damage the equipment.

  • Page 13: Wireless Communication

    Safety Information Wireless Communication The Ultiri Measurement System utilizes radios to enable the wireless connectivity of the Wi-Box™ AO Transmitter, the PressureWire X Guidewire, and the tableside controller (TSC), as shown in this figure. The details of each wireless component are covered in the table below. Ultiri Measurement System Wireless Function...
  • Page 14 Pd button. Note: If an error message presents, select the appropriate error-message action to resolve the issue and contact Abbott Technical Service if error persists. Ultiri™ Measurement System Operation Manual – 600327583 Rev. A...

  • Page 15: Electromagnetic Interference

    TSC to the host computer. Although security measures are incorporated in the protocol to authenticate the user and prevent unwanted intrusions, known vulnerabilities exist with the Bluetooth wireless communication protocol. ® Therefore, Abbott recommends that the user ensure control of third-party Bluetooth devices in the catheterization laboratory. ® Electromagnetic Interference The system uses digital signal processing techniques that operate in the radio frequency (RF) energy range.

  • Page 16: Indications For Use

    System. CAUTION: The Ultiri Measurement System is intended for use by medical personnel who are knowledgeable in 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 17: Potential Adverse Events

    Reporting Adverse Events Potential Adverse Events Potential complications which may be encountered during all catheterization procedures include, but are not limited to: • Angina • Arrhythmia • Bleeding • Coronary vascular injury • Death • Drug reactions to vasodilators (e.g., Adenosine or nitroglycerine) used ‡...

  • Page 18: Warnings, Precautions, And Limitations

    Warnings, Precautions, and Limitations Warnings • No modification of this equipment is allowed. • Prior to use, please review the installed software User Manual and the Instructions for Use supplied with the Ultiri™ Measurement System, Wi-Box™ AO Transmitter, and the PressureWire™ X Guidewire for more information on warnings, limitations, cautions, and set-up instructions.
  • Page 19 This can cause the user to be exposed to electric shock or loss of system function. Contact Abbott Technical Service for further instructions. •...

  • Page 20: Precautions

    To avoid this problem, Abbott Technical Service recommends verifying network settings in the system setup after each change.

  • Page 21: Limitations

    Only a qualified 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. Ultiri™ Measurement System Operation Manual – 600327583 Rev. A...

  • Page 22: System Overview

    Making such modifications may interfere with correct operation and will void system warranties. Contact an Abbott Technical Service representative for more information. CAUTION: Medical personnel who use the Ultiri Measurement System and the installed software must be aware of the system’s limitations.

  • Page 23: System Components

    System Overview System Components The following components are required for performing a physiological parameter procedure: • PressureWire X Guidewire • Aortic Pressure Transducer • Hemodynamic Recording System • Wi-Box AO Transmitter • Ultiri Measurement System • Adapter cable to connect the AO to the Wi-Box AO Transmitter •...

  • Page 24: Tableside Controller (Tsc)

    System Overview 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 turn on. • Improper handling of the USB connection can damage the port on the connector panel.

  • Page 25: Setting Up The System

    Setting Up the System Ensure that the power cord and all other connections to the Ultiri™ Measurement System are routed to prevent a tripping hazard. Ensure that the main power switch and power plug can be accessed at any time during the procedure.

  • Page 26: Mounting

    Setting Up the System Mounting Use the mounting bracket supplied separately by Abbott Medical (or an existing bracket compatible with standard Video Electronics Standards Association [VESA] 75 x 75 mm or 100 x 100 mm) to mount the unit. Follow the instructions provided with the mounting bracket to attach it to the back of the unit.

  • Page 27: Making Connections

    Setting Up the System Making Connections WARNING: All connections to the Ultiri Measurement System (except wireless connections to the TSC, PressureWire™ X Guidewire, and Wi-Box™ AO Transmitter) 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 28: Powering On

    Setting Up the System WARNING: External equipment intended for connection to the Ultiri Measurement System shall comply with relevant IEC standard (e.g., IEC 60601 series for medical electrical equipment). In addition, all such combinations of systems shall comply with the standard IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

  • Page 29: Cleaning And Maintenance

    Return the Ultiri Measurement System to Abbott Medical at the end of its operating life. Cleaning The following Ultiri Measurement System items require cleaning: •...

  • Page 30: 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. International customers, please contact your distributor or local Abbott Sales Representative.

  • Page 31: Troubleshooting

    USB drive to determine if drive plugged formatting. formatting is required. into the USB port. System Disposal Contact Abbott Technical Service for disposal instructions that are in accordance with local laws. Ultiri™ Measurement System Operation Manual – 600327583 Rev. A...

  • Page 32: Specifications

    EU MDR 2017/745 and RoHs Directive 2011/65/EU as amended by 2015/863/EU, and Radio Equipment Directive (RED) 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 33: Electromagnetic Compatibility (Emc)

    Specifications Electromagnetic Compatibility (EMC) General Specification Refer to “Electromagnetic IEC 60601-1-2: 2014 Ed.4, Medical electrical Emissions” and equipment - Part 1-2: General requirements for “Electromagnetic Immunity” basic safety and essential performance - for detailed specifications. Collateral standard: Electromagnetic compatibility - Requirements and tests – Group 1 Equipment, Class A Environmental Standards RoHs Directive 2011/65/EU as amended by 2015/863/EU...

  • Page 34: Electrical And Physical

    Specifications Electrical and Physical Parameter / Type Specification / Description Mains Classification Class II isolation Rated Input Voltage (Power 100–240 V~ 50–60 Hz Supply) Rated Input Current (Power 1.2–0.5 A Supply) Ultiri™ Measurement Adapter Technology Co., Ltd. System (Power Supply) Model ATM090T-A120 Tableside Controller (Power Tumbler Technologies + TRUMPower...

  • Page 35: Radio

    Specifications Radio Parameter / Category Specification IEEE 802.11ac/a/b/g/n (2T2R), Bluetooth V5.0, Standards ® V4.2, V4.0 LE, V3.0+HS, V2.1+EDR Data Rate 802.11b: 11 Mbps/802.11a/g: 54 Mbps/802.11n: MCS0~15/802.11ac: MCS0~9 Bluetooth : 1 Mbps, 2 Mbps, and up to 3 Mbps ® Operating Frequency IEEE 802.11 ac/a/b/g/n ISM Band, 2.412 GHz~2.484 GHz, 5.150 GHz~5.850 GHz.

  • Page 36: Electromagnetic Immunity

    Specifications Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should ensure that it is used in such an environment. Guidance and Manufacturer’s Declaration Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance...
  • Page 37 Specifications Guidance and Manufacturer’s Declaration (continued) Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the Transmitter.

  • Page 38: Recommended Separation Distances

    Specifications Recommended Separation Distances The Ultiri Measurement System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Ultiri Measurement System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Ultiri Measurement System as recommended below, according to the maximum output power of the communications equipment.

  • Page 39: Interfaces

    Specifications Interfaces Parameter Specification USB (version 2.0; supports Connector: Type A, receptacle high-speed communication) USB (version 3.0; supports Connector: Type A, receptacle high-speed communication) Ethernet 10 / 100 / 1000 Mbit / s Connector: RJ45 HDMI Screen resolution of main unit: 1920 x 1080 Output resolutions: (DVI Out): Auto, 1280 x 1024, 1600 x 1200, 1920 x 1080, 1920 x 1200 Frequency: 60 Hz...
  • Page 40 Specifications Interfaces (continued) Parameter Specification Frequency Range: WiFi wireless transmission IEEE 802.11 ac/a/b/g/n ISM Band, 2.412 GHz–2.484 GHz, 5.150 GHz–5.850 GHz Type: 802.11b: DSSS (DBPSK, DQPSK, CCK) 802.11a/g: OFDM (BPSK, QPSK, 16-QAM, 64-QAM) 802.11n: OFDM (BPSK, QPSK, 16-QAM, 64-QAM) 802.11ac: OFDM (BPSK, QPSK, 16-QAM, 64-QAM, 256-QAM) Radiated Power: 802.11b: 19dBm@11 Mbps...

  • Page 41: 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...
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  • Page 44 Abbott Medical Abbott Medical Abbott Medical UK Limited 4 Robbins Road The Corporate Village Elder House Westford, MA 01886 USA Da Vincilaan 11 Box F1 Central Boulevard USA TEL: (800) 227-9902 1935 Zaventem Blythe Valley Business Park , Belgium TEL: +1 951-914-4669...

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