Ultiri™ Measurement System

INDICATIONS

The Ultiri™ Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment, to determine if therapeutic intervention is indicated.

CONTRAINDICATIONS

There are no known contraindications for the Ultiri™ Measurement System.

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 to induce hyperemia during FFR determination such as bronchospasm, dyspnea, bradycardia, coronary artery spasm
• Hypotension
• Infection
• Ischemia
• Potential allergic reactions to drugs administered for the procedure
• Stenosis

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, precautions / cautions, and set-up instructions.
• Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
• The operator should not touch Ultiri™ Measurement System non-CF connectors (or other non-medical equipment) and the patient or patient leads at the same time. Conductive connection may cause leakage currents to induce ventricular fibrillation.
• High frequency surgical equipment must not be used on a patient at the same time as the PressureWire™ X Guidewire and the Ultiri™ Measurement System.
• Do not use this device for any conditions contraindicated for use of compatible guide wires.
• 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.
• External equipment intended for connection to signal output or other connectors 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. Any person who connects external equipment to signal output, or other connectors, has formed a system and is therefore responsible for compliance of the system with the requirements of IEC 60601-1. If in doubt contact a qualified technician. Only the PressureWire™ X Guidewire and the Wi-Box™ AO Transmitter are intended to be used with the Ultiri™ Measurement System wireless receivers.
• Connecting to External Equipment - When used in the patient environment, all equipment connected to the Ultiri™ Measurement System must meet the requirements for medical isolation according to the IEC 60601 safety standards. Connection of equipment that does not follow relevant IEC standards (e.g., IEC 60601 series for medical electrical equipment) may lead to patient injury or death.
• The HDMI output is not isolated. External equipment which is connected to this output must provide isolation against leakage current. The user is responsible for compliance with the requirements of standard IEC 60601- 1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• Electrical Shock Hazard - Do not remove Ultiri™ Measurement System covers. To avoid electrical shock, use only the power supply and power cord supplied with the system. Refer to “Setting Up the System” and “Safety Information” for electrical safety information.
• The main power remains switched on when the system is in Standby mode. Avoid direct or indirect (e.g., via the operator) conductive connection between other electrical equipment and the Ultiri™ Measurement System. Conductive connection may cause leakage currents to induce ventricular fibrillation. High frequency surgical equipment must not be used on a patient at the same time as PressureWire™ X Guidewire and the Ultiri™ Measurement System.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the Ultiri™ Measurement System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• Do not use the Ultiri™ Measurement System if it has been dropped, or in any other way exposed to mechanical or electrical damage, or if liquids are suspected to have penetrated the casing or the power supply unit. This can cause the user to be exposed to electric shock or loss of system function. Contact Abbott Technical Service for further instructions.
• Do not sterilize the Ultiri™ Measurement System or any of its parts. Do not use this system or any of its parts if it has been sterilized.
• The Ultiri™ Measurement System contains a lithium battery for the system real-time clock. Danger of explosion. Battery is not intended to be replaced.
• To prevent possible patient or operator injury and damage to the system, make sure the equipment is securely mounted.
• Make sure the unit is dry before connecting it to the power supply.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. If abnormal performance is observed, it is necessary to increase distance between equipment.
• To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access-controlled environment. Do not use the Ultiri™ Measurement System if there is reason to believe the system’s security has been compromised or if the system was unaccounted for during a period of time (i.e., misappropriated, modified, or tampered with).
• The system has no patient alarm functions. Do not use for cardiac monitoring.
• Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

PRECAUTIONS

• Patients with potential microvascular dysfunction and borderline index values should be interpreted with caution, and management strategies should be guided not only by pressure measurement, but also by possible supplementary clinical risk stratification and other tests.
• Before performing a physiological parameter procedure or creating a physiological parameter recording, review the installed software User Manual for additional warnings and cautions.
• To connect to the correct Wi-Box™ AO Transmitter, you must select the room where the system is being used. The first time you connect to a room, you must enter the room’s information into the system. Refer to the installed software User Manual for more information.
• Do not unplug from AC power or turn off main power until the shutdown is complete and the screen turns black. Disconnecting from AC power before the shutdown is complete may damage the system.
• The power switch shuts down the Ultiri™ Measurement System, but power remains in the mains cable and power supply unit. To fully disconnect from mains power, remove the mains power plug from the wall socket.
• Output sensitivity changes should be performed by a qualified technician. Incorrect settings may result in discrepancies between monitor system and Ultiri™ Measurement System values.
• Direct connection to a non-secure network (e.g., the internet) may interfere with correct operation and / or result in inappropriate access to patient information. Furthermore, it should be noted that reconfiguring a used network may lead to inability to import or export patient examination data, ultimately leading to a risk of loss of patient and examination data. To avoid this problem, Abbott Technical Service recommends verifying network settings in the system setup after each change.
• No connections to other systems or components are to be made to the Ultiri™ Measurement System except through the Connector Panel. No connections are to be made through the Connector Panel except as described in this manual. 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. Any person who connects external equipment to the Ultiri™ Measurement System has formed a medical system and is therefore responsible for compliance of the system with the requirements of IEC 60601-1. If in doubt contact a qualified technician. Only the PressureWire™ X Guidewire and the Wi-Box™ AO Transmitter are intended to be used with the Ultiri™ Measurement System.
• PressureWire™ X Guidewire readings may be affected by defibrillation. After defibrillation, restart the procedure. Re-zero and re-equalize the PressureWire™ X Guidewire.
• Radio transmitting equipment, cellular phones, and strong emission sources such as high frequency surgical equipment shall not be used in close proximity to the Ultiri™ Measurement System since this could influence the performance of the device.
  
  Note: The device should be used in a hospital environment except for near active high frequency (HF) surgical equipment and the radio frequency (RF) shielded room of a medical equipment system for magnetic resonance imaging, where the intensity of electromagnetic (EM) disturbances is high.
• Check that the monitor cables and aortic pressure transducer (AO) adapter used with the Ultiri™ Measurement System interface are compatible with the catheterization laboratory system to be used. The AO should be in accordance with ANSI / AAMI BP22-1994. After the laboratory monitor system has been zeroed, use only the Ultiri™ Measurement System to calibrate the AO and PressureWire™ X Guidewire.
• Do not immerse in liquid: Do not use the Ultiri™ Measurement System if it has been immersed in liquid.