PressureWire Receiver
VASCULAR
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The PressureWire Receiver is a wireless receiver used with the PressureWire X guidewire to provide accurate assessment of fractional flow reserve (FFR) measurements.

 

The PressureWire Receiver connects directly to the standard pressure transducer input on any cardiac cath lab recording system. This receiver—which can be attached easily to the cath lab table —uses advanced “frequency hopping” to ensure a secure radio signal with the PressureWire X guidewire.

The secure, wireless connection between the PressureWire X guidewire and the PressureWire Receiver eliminates the possibility of cables crossing the sterile field.

PressureWire Transmitter, PressureWire Receiver, and hemodynamic recording

PressureWire Transmitter, PressureWire Receiver, and hemodynamic recording

PressureWire Transmitter, PressureWire Receiver, and hemodynamic recording

FEATURES OF THE PRESSUREWIRE RECEIVER

The PressureWire Receiver ensures secure communication for accurate fractional flow reserve (FFR) results.

  • The PressureWire transmitter and receiving system lock to each other at calibration using a unique identification code. The receiver cannot receive pressure from any other PressureWire X guidewire being used in the vicinity.
  • The system uses advanced frequency-hopping spread spectrum (FHSS) technology and very low radio power to avoid interfering with or being disturbed by other systems in the cardiac cath lab.
  • The system changes radio frequency 400 times per second so that even if there are several interfering radio sources it will always locate other available frequencies.
  • Mobile phones, computer networks or x-ray equipment will not disturb the radio signal.
  • If a power failure occurs, the receiving system stores the last connected PressureWire X guidewire in its memory for automatic reconnection.

PressureWire Receiver

INTUITIVE FUNCTIONALITY

The “Plus” button:

  • Increases pressure offset by +1 mmHg or
  • Increases reference level output in Refout mode

The “Connect” button is:

  • Pressed once to connect to PressureWire X guidewire
  • Pressed and held > 3 second to enter Refout mode
  • (While in Refout mode) Pressed once to exit

The “Minus” button:

  • Decreases pressure offset by -1 mmHg or
  • Decreases reference level output in Refout mode


PERFORMANCE IN A HEMODYNAMIC RECORDING SYSTEM

The PressureWire X guidewire is a key component of an FFR-enabled hemodynamic recording system. When the PressureWire Receiver is plugged directly into the recording system front end, users can count on:

  • FFR presented in real time on existing monitor screens
  • Recording and analysis of FFR recordings on screens inside the cardiac cath lab and control room
  • Configurable beat- or time-based pressure averaging
  • Easy software equalization of Pa and Pd pressures*
  • Complete documentation of FFR measurements

FFR Compatible Recording Systems

Siemens AXIOM Sensis‡ Merge HeartSuite‡
GE Mac-Lab‡ Ortivus CoroNet PCI‡
Philips Xper Flex Cardio‡ CathMed Picasso‡
McKesson Horizon Cardiology‡ Fysicon QynetiQ CVIS‡
Mennen Horizon XVu‡  


* Pa: proximal coronary pressure; Pd: distal coronary pressure
‡ Indicates a third party trademark, which is property of its respective owner

ORDERING INFORMATION

The PressureWire Receiver, which comes with a Table Mount (1 unit per box), requires a Monitor Cable for connection.

REORDER NUMBER DESCRIPTION
C17040 PressureWire Receiver

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INDICATIONS AND IMPORTANT SAFETY INFORMATION

rx-only-logo PressureWireTM X Guidewire

INDICATIONS

The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.

CONTRAINDICATIONS

This guidewire is contraindicated for use in the cerebral vasculature.

WARNINGS

  • No modification of this device is allowed.
  • The PressureWire™ X guidewire is supplied sterile. Discard the guidewire if the pouch is opened or damaged, compromising the sterile barrier. The guidewire is designed for single use only and shall not be reused or resterilized. Adverse effects of using a non-sterile or resterilized guidewire may include, but are not limited to:
    • Local and/or systemic infection
    • Mechanical damage
    • Inaccurate readings
  • Observe all guidewire movements. Whenever the guidewire is moved or torqued, the tip movement should be examined under fluoroscopy. Never push, withdraw, or torque the guidewire if it meets resistance or without observing corresponding movement of the tip, otherwise vessel/ventricle trauma may occur.
  • Torquing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may:
    • Cause dissection or perforation of blood vessels
    • Cause vessel spasm
    • Damage and/or fracture the guidewire
  • When introducing the guidewire, flush the catheter and administer anticoagulation as for a standard catheterization procedure or clotting may occur.
  • Do not use the guidewire in the ventricles if the patient has a prosthetic mechanical or biological valve. It may result in damage to both the prosthesis and the guidewire, which may cause injury or death.
  • Use of the PressureWire™ X guidewire in conjunction with interventional devices with a short rapid exchange may result in a folded or fractured guidewire.
  • High frequency surgical devices must not be used on a patient at the same time as the guidewire.

PRECAUTIONS

  • The PressureWire™ X guidewire is a delicate instrument and should be handled carefully.
  • Make sure that the transmitter is kept dry to ensure accurate pressure and/or temperature readings. Inaccurate readings may necessitate device replacement.
  • Do not use the guidewire in conjunction with atherectomy catheters. It may damage the guidewire.
  • Do not withdraw or manipulate the guidewire in a sharp-edged object. It may result in abrasion of the guidewire coating.
  • Factors that may affect the accuracy of the diagnostic information include, but are not limited to:
    • Improper placement of the aortic pressure sensor.
    • Failure to achieve maximum coronary and myocardial hyperemia.
    • Blood flow affected by the position of interventional devices, such as balloon catheters.
  • Guidewire readings may be affected by defibrillation. Rezero the guidewire after defibrillation use.
  • Do not measure pressure when the guidewire sensor element is in a sharp bend or in contact with atrial or ventricular walls. It might result in pressure artifacts.
  • Do not use the PressureWire™ X guidewire together with another guidewire, for so called jailed wire technique, due to difficulty in guidewire withdrawal and possible guidewire entrapment.
  • Store at room temperature in a dry and dark place.

POTENTIAL ADVERSE EVENTS

Potential complications which may be encountered during all catheterization procedures include, but are not limited to: vessel dissection or occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, congestive heart failure, myocardial infarction, hypotension, chest pain, renal insufficiency, serious arrhythmias, or death.

AP2946268-WBU Rev. A

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