PHILIPS OmniWire 89185 Pressure Guide Wire Instructions

PHILIPS OmniWire 89185 Pressure Guide Wire

Product Information

The OmniWire Pressure guide wire is a medical device used in interventional cardiology procedures. It is available in two models: 89185 and 89185J. The guide wire is designed to measure pressure within blood vessels and provide guidance during procedures. The device is manufactured in compliance with ISO 15223-1, ISO 7000, IEC 60878, and IEC 60601-1 standards. It is intended for use in accordance with EU Directives 90/385/EEC, 93/42/EEC, and 98/79/EC.

Important symbols and information displayed on the product and packaging include:

• Batch code: Indicates the manufacturer’s batch code for easy identification.
• Catalog number: Indicates the manufacturer’s catalog number for identification purposes.
• Serial number: Indicates the manufacturer’s serial number to uniquely identify each device.
• Manufacturer/Manufactured for: Indicates the medical device manufacturer as defined in EU Directives.
• Do not use if package damaged: Indicates that the device should not be used if the package has been damaged or opened.
• Sterilized using ethylene oxide : Indicates that the device has been sterilized using ethylene oxide.
• Keep dry: Indicates that the device needs to be protected from moisture.
• Keep away from sunlight: Indicates that the device needs protection from light sources.
• Do not re-use: Indicates that the device is intended for one-time use only.
• Do not desterilize: Indicates that the device should not be presterilized.
• Non-pyrogenic: Indicates that the device is non-pyrogenic.
• Authorized representative in the European community: Indicates the authorized representative in the European Community.
• Electronic instructions for use: Indicates that relevant information for product usage is available in electronic form.
• Use by date: Indicates the date after which the device should not be used.

Product Usage Instructions

• Check the package for any signs of damage or tampering. Do not use the device if the package is damaged or opened.
• Ensure that the device is within the specified use by date. Do not use the device if it has expired.
• Before use, carefully read and follow the electronic instructions for use provided with the device.
• Prepare the patient and equipment according to standard interventional cardiology procedures.
• Connect the pressure guide wire to the torque device and ensure a secure connection.
• Insert the guide wire into the blood vessel following the appropriate technique and guidance from medical professionals.
• Use the torque device to navigate and position the guide wire accurately.
• Monitor the pressure readings displayed by the guide wire during the procedure.
• After use, discard the guide wire and torque device as per local regulations for medical waste disposal. Do not attempt to re-use or re-sterilize the devices.

Note: It is important to consult with a physician or healthcare professional for specific guidance on using the OmniWire Pressure guide wire in different clinical scenarios.

Symbols

that the batch or lot can be identified.
| ISO 15223-1| 5.1.6| Catalog number| Indicates the manufacturer’s catalogue number so that the medical device can be identified.
| ISO 15223-1| 5.1.7| Serial number| Indicates the manufacturer’s serial number so that a specific medical device can be identified.
| ISO 15223-1| 5.1.1| Manufacturer/Manufactured for| Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
| ISO 15223-1| 5.2.8| Do not use if package damaged| Indicates a medical device that should not be used if the package has been damaged or opened.
| ISO 15223-1| 5.2.3| Sterilized using ethylene oxide| Indicates a medical device that has been sterilized using ethylene oxide.
| ISO 15223-1| 5.3.4| Keep dry| Indicates a medical device that needs to be protected from moisture.
| ISO 15223-1| 5.3.2| Keep away from sunlight| Indicates a medical device that needs protection from light sources.
| ISO 15223-1| 5.4.2| Do not re-use| Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure..
| ISO 15223-1| 5.2.6| Do not resterilize| Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
| ISO 15223-1| 5.6.3| Non-pyrogenic| Indicates a medical device that is non- pyrogenic.
| ISO 15223-1| 5.1.2| Authorized representative in the European community| Indicates the authorized representative in the European Community.
| ISO 7000| 3500| Electronic instructions for use| To indicate on product or product packaging that relevant information for use of the product is available in electronic form rather than, or in addition to, printed paper form.
| ISO 15223-1| 5.1.4| Use by date| Indicates the date after which the medical device is not to be used.
| IEC 60878| 2794| Package Contents:
Pressure guide wire with connector and torque device; One (1) Secondary Torque Device; One (1)| To indicate the package contents.
| IEC 60601-1| Table D.2, Symbol 10| Follow instructions for use| Refer to instruction manual/booklet.
| None| NA| Date of manufacture and country of origin (Costa Rica)| To identify the date of manufacture and country of origin.
| 21 CFR 801.15(c)(1)(i)F| NA| Prescription only| Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
| NA| NA| Not made with natural rubber latex| Not made with natural rubber latex.
| NA| NA| Part number| Part number
| NA| NA| Unique device identifier| Unique device identifier
| NA| NA| Medical device| Medical device
| ASTM-F2503-13| 7.3.3/3.1.14| MR unsafe| An item which poses unacceptable risks to the patient, medical staff or other persons within the MR (magnetic resonance) environment.
| NA| NA| Importer| Indicates the entity importing the medical device into the locale.
| NA| NA| Length| Length
| NA| NA| Outer diameter| Outer diameter
| NA| NA| Straight tip| Straight tip
| NA| NA| J-Tip| J-Tip

Instructions for use

OmniWire pressure guide wire

Caution:

• U.S. Federal Law restricts this device to sale and use by or on the order of a physician.
• Prior to use, read this entire package insert.

Indications for use:
The OmniWire pressure guide wire is indicated for use to measure pressure in coronary blood vessels during diagnostic angiography and/or any interventional procedures. It can also be used to facilitate the placement of catheters as well as other interventional devices in coronary vessels.

Description:
The OmniWire pressure guide wire (hereafter referred to as the “pressure guide wire”) is a steerable guide wire with a pressure sensor mounted 3 cm proximal to the tip. The pressure guide wire measures pressure when used with the IntraSight and Core Series of systems and is intended to be used in adult patients eligible for endovascular procedures. The pressure guide wire has a diameter of 0.014″ (0.36 mm), a length of 185 cm and is available in straight or pre-shaped tips. It is coated with hydrophilic coating (39 cm length) on the distal portion to reduce surface friction and enhance lubricity. It is also coated with a hydrophobic coating (146 cm length) on the proximal portion to reduce surface friction. The pressure guide wire is packaged attached to the connector with an OmniWire-specific torque device to facilitate navigation through the vasculature.
The clinical application of OmniWire is to acquire the raw pressure data that can be used as an input to a compatible computer-system to generate FFR-iFR indices to assess the hemodynamic significance of stenoses. E.U. and U.S. society practice guidelines for myocardial revascularization support the use of FFR/iFR measurements to guide percutaneous treatment decisions when a determination of ischemia is warranted.1,2,3,4

Contraindications :
The OmniWire pressure guide wire is not intended for use with atherectomy devices or for crossing a total vessel occlusion.

Adverse effects:
As with all catheterization procedures, complications may be encountered with the use of the pressure guide wire. The major risks of coronary angiography and coronary angioplasty include: coronary vessel dissection, occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, serious arrhythmias, unplanned endovascular and/or surgical procedures, sterile inflammation or granulomas at the access site, pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, cerebral infarct, tissue necrosis and death. The major risks of peripheral angiography or peripheral angioplasty include: dissection, abrupt closure, perforation, embolus, spasm, unplanned endovascular and/or surgical procedures, sterile inflammation or granulomas at the access site, pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, cerebral infarct, tissue necrosis and death.
If a serious incident has occurred in relation to the device, it should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. A serious incident means any incident that directly or indirectly led, might have led or, in case of recurrence, could lead to any of the following: the death of a patient, user or other person; the temporary or permanent serious deterioration of a patient’s, user’s, fetus or other person’s state of health, or a serious public health threat.

Warnings:

• Use of the OmniWire pressure guide wire should be restricted to specialists who are familiar with, and have been trained to perform, the procedures for which this device is intended.
• This product is supplied sterile. If the pouch is unintentionally opened before use or damaged, compromising the sterile barrier, please discard the product.
• The pressure guide wire is designed for single use only. This product cannot be re-sterilized or re-used. Re-use and/or re-sterilization of unused product may result in, but is not limited to the following risks:
  • Critical harm to patient due to device separation, material deformation or infection/sepsis;
  • Inaccurate pressure readings due to pressure sensor damage;
  • Decreased mechanical performance (including but not limited to torque ability and trackability).
• Do not use expired product. If the product is expired, discard.
• The safety and effectiveness of the device has not been established for use in the neurovascular region.
• Only use the OmniWire connector with the OmniWire pressure guide wire.
• Only use the OmniWire torque device provided with the OmniWire pressure guide wire.
• • Never advance, torque or withdraw a pressure guide wire that meets resistance.
  • This device is coated with a hydrophilic coating at the distal end of the device for a length of 39 cm, and coated with a hydrophobic coating at the proximal end of the device for a length of 146 cm. Please refer to the “Instructions for use” section for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.

Precautions:

• Do not use product that has been damaged in any way as this may result in vessel damage, inaccurate pressure measurements and/or poor mechanical performance.
• In order to minimize patient risk, exercise caution when using the pressure guide wire in a stented vessel. When advancing or withdrawing the pressure guide wire in a stented vessel, in the event that the stent is not fully apposed against the vessel wall, the pressure guide wire may become entangled in one or more stent struts. This may result in entrapment of the pressure guide wire, damage to the pressure guide wire and/or stent dislocation.
• Do not wipe the distal hydrophilic coated length of the pressure guide wire with dry gauze as this may damage the device coating.
• Do not use alcohol, antiseptic solutions, or other solvents to pretreat the pressure guide wire because this may cause unpredictable changes in the coating that could affect the device safety and performance.
• The use of an anticoagulant is recommended as per the local standard angiographic protocols and at the discretion of the physician to prevent thrombus formation.
• Simultaneous use of the pressure guidewire with electrosurgery devices is not recommended.
• Do not expose the device to a magnetic resonance environment. Device may not perform as intended and may present additional risks to patient.
• The pressure guide wire performance has been confirmed with 5 French guide catheters. When using any diagnostic or guide catheters, avoid side holes and take care to flush all residual contrast to ensure a reliable iFR/FFR.

Limitations:

• The pressure guide wire is only compatible with 0.014″ (0.36 mm) ancillary devices. Instructions for use:
  • Standard workflow
    Open the pressure guide wire pouch using sterile technique and place the tray on a flat surface in the sterile field.

Warning: If any portion of the device (wire, torque device, or connector) makes contact with the non-sterile field or non-sterile personnel, discard.

• Prepare the pressure guide wire for use following the numbers on the tray:

  • Flush wire: Flush the pressure guide wire with normal sterile heparinized saline (labeled #1) using the wire flush port on the spiral dispenser.

  • Zero wire: Lift the numbered tab to remove the compartment lid (labeled #2),
    

  • Remove product from tray: Lift the numbered tab to remove the compartment lid on the tray (labeled #3). Carefully slide the connector from the tray and slide the wire out of the spiral dispenser. Place wire and connector on the sterile field.
    Precaution: When withdrawing the wire from the spiral dispenser, keep the connector and wire in the same plane to avoid kinking the wire.
    Precaution: Do not grasp the tip of the pressure guide wire to remove it from the spiral dispenser. This may result in damage to the pressure sensor.

• At the physician’s discretion, the 1 cm shapeable pressure guide wire tip may be carefully shaped using standard tip shaping practices. For best results, shape the tip in the direction of the sensor housing opening. Do not use a shaping instrument with a sharp edge. Take care when shaping the tip. Do not grip the sensor housing as this may damage the pressure sensor.

• Insert the pressure guide wire through the appropriate introducer components and guiding catheter into the desired blood vessel. Slowly advance the pressure guide wire tip under fluoroscopy using contrast injections to verify location.

• Ensure that the tip is rotating freely and no resistance is felt when torque is applied.

• In the event that resistance is felt, exercise caution when removing the device, and exchange the device for a new one to complete the procedure.
  Precaution: The pressure guide wire should not be advanced or withdrawn if resistance is encountered. The wire should never be forcibly advanced into or withdrawn from a vessel. Any time that resistance is encountered, the wire should be slowly withdrawn under fluoroscopic guidance. In some instances, the wire may kink and must be removed.

• Position the pressure sensor (located 3 cm from tip) adjacent to the tip of the guide catheter and perform normalization procedure with the instrument. For system’s operations refer to the proper system “Operator’s manual”.

• In the event the pressure guide wire is “Not Recognized”, squeeze connector and realign the pressure guide wire (see “Attaching pressure guide wire to connector” section for further instruction).

• Advance the pressure sensor to desired measurement location, making sure the sensor is distal to the stenosis, and perform pressure measurements with the instrument. Refer to “Operator’s manual” for details on how to perform pressure measurements.

• After every procedure, slowly withdraw the pressure guide wire until the pressure sensor is just distal to the guide catheter tip. Verify that the pressures measured by the pressure guide wire and through the guide catheter are equal.

• If storing the wire for subsequent measurements, place the wire underneath a drape in the sterile field. Prior to reinsertion for multiple measurements, wipe wire with normal sterile heparinized saline using damp gauze.

• When the procedure is completed, withdraw the pressure guide wire and dispose of the pressure guide wire, torque device, and connector as biohazardous waste in accordance with local regulations.

Removing pressure guide wire from connector

• The pressure guide wire may be disconnected from the connector to facilitate wire maneuverability and to allow advancement of catheters and other ancillary devices over the proximal end of the wire.
  Note: If the plug remains connected to the instrument, it is not required to repeat zeroing and normalization.

• To remove the pressure guide wire, squeeze the connector and carefully lift the proximal end of the wire from the pressure guide wire channel.

Warning: Do not flex the proximal (electrical connector) end of the pressure guide wire when not inserted in the connector. Excessive flexing can damage or break the internal components.

• If desired, loosen the torque device and withdraw it from the proximal end of the pressure guide wire.
  Precaution: When unloading the torque device, use caution to prevent coating damage.

Catheter delivery

• Thread catheter over the pressure guide wire taking care not to kink the proximal conductive bands of the wire.
  Warning: When using the pressure guide wire with ancillary devices (e.g. stenting), incorrect device advancement/withdrawal can impact the mechanical performance of the pressure guide wire, damage its coating, or result in resistance.
  Warning: Take care not to deploy any interventional device over the pressure guide wire sensor as it could result in sensor damage and inaccurate pressure measurements.
  Precaution: When loading or unloading an ancillary device over the wire, use caution to prevent coating damage.

• For catheter delivery, refer to applicable catheter device’s “Instructions for use”. Attaching pressure guide wire to connector

• Install the included torque device over the proximal end of the pressure guide wire. The connector cannot be used to effectively torque the pressure guide wire as the wire rotates freely inside the body of the connector.
  Warning: Using a torque device other than the torque device provided will damage the wire. A secondary torque device is provided in the event the primary torque device is no longer available for use (e.g. compromised sterility).
  Precaution: When reloading the torque device, use caution to prevent coating damage. Warning: The connector provided in the package is unique to the individual pressure guide wire it is connected to and should not be used with any other pressure guide wires. Use of a different connector will result in inaccurate pressure measurement data.

• Clean the proximal end of the pressure guide wire with normal sterile heparinized saline. Prior to reconnecting, dry the proximal end of the pressure guide wire with a clean, dry cloth.
  Warning: Do not flex the proximal (electrical connector) end of the pressure guide wire when not inserted in the connector. Excessive flexing can damage or break the internal components.
  Precaution: Failure to dry the proximal end of the pressure guide wire will result in inaccurate pressure measurement data.

• Squeeze the connector to expose the pressure guide wire channel.
  Hold the pressure guide wire at a slight angle to the connector and place it in the channel with approximately 0.5 inches (1.3 cm) of the pressure guide wire protruding from the connector.

• Maintaining the angle, drag the pressure guide wire through the channel until the pressure guide wire alignment notch catches the locking clip in the connector. This will align the pressure guide wire.

• Lower the pressure guide wire into the channel.

• Release the connector to lock the pressure guide wire in place

• A pressure signal will now be present on the display instrument. It is not required to repeat zeroing and normalization as long as the modular connector has not been removed from the instrument.

• In the event the pressure guide wire is “Not Recognized”, squeeze connector and realign the pressure guide wire.

Technical specifications

Pressure accuracy

| ±3 mmHg, range of -30 to +100 mmHg
±3 %, range of +100 to +300 mmHg

Storage and handling:
Products should be stored indoors at room temperature in their original packaging.

Limited warranty

Subject to the conditions and limitations on liability stated herein, Philips warrants that the OmniWire pressure guide wire (the “wire”), shall materially conform to Philips’ then current specification for the wire at the time of shipment. Any liability of Philips with respect to the wire or the performance thereof under any warranty, negligence, strict liability or other theory will be limited exclusively to wire replacement or, if replacement is inadequate as a remedy or, in Philips’ opinion, impractical, to a credit of the purchase price paid for the wire. Except for the foregoing, the wire is provided “as is” without warranty of any kind, expressed or implied, including without limitation, any warranty of fitness, merchantability, and fitness for a particular purpose of noninfringement. Further, Philips does not warrant, guarantee, or make any representations regarding the use, or the results of the use, of the wire or written materials in terms of correctness, accuracy, reliability, or otherwise. Licensee understands that Philips is not responsible for and will have no liability for any items or any services provided by any persons other than Philips. Philips shall have no liability for delays or failures beyond its reasonable control. Additionally, this warranty does not apply if:

• The wire is used in other than a manner described by Philips in the “Instructions for use” supplied with the wire or the wire is subject to misuse, negligence or to an accident.
• The wire is used in a manner that is not in conformance with purchase specifications or specifications contained in the “Instructions for use”.
• The wire is re-used or re-sterilized.
• The wire is repaired, altered, or modified by other than Philips authorized personnel or without Philips authorization.
• The wire is not used by the stated “Use By” or “Expiration” date, or if the packaging is opened or damaged before use.

If claims under this warranty become necessary, contact Philips for instructions and issuance of a Return Material Authorization number if the wire is to be returned. Equipment will not be accepted for warranty purposes unless the return has been authorized by Philips.

Patent:
www.philips.com/patents
An electronic copy of these instructions can be found at: www.philips.com/IFU
The summary of safety and clinical performance will be available in the European database on medical devices (EUDAMED) at the following URL:
https://ec.europa.eu/tools/eudamed

REACH declaration:
REACH requires Philips Healthcare (PH) to provide chemical content information for “substances of Very High Concern (SVHC) if they are present above 0.1% of the product weight. The SVHC list is updated on a regular basis. Therefore, refer to the following Philips REACH website for the most up-to-date list of products containing SVHC above the threshold:
www.philips.com/REACH
This product is licensed to the customer for single use only.
Additional questions regarding this product should be directed to Philips in the U.S.A.:

Legal Manufacturer:
Volcano Corporation
3721 Valley Centre Drive, Suite 500 San Diego, CA 92130 USA
800-228-4728
IGTD.CustomerInquiry@philips.com

USA & Canada:
800-228-4728
IGTD.CustomerInquiry@philips.com

International:
vecomplaints@philips.com or
IGTD.CustomerInquiry@philips.com
European Authorized Representative: Volcano Europe SA/NV Excelsiorlaan 41
B-1930 Zaventem, Belgium
Telephone: +32.2.679.1076
Fax: +32.2.679.1079

Australian Sponsor:
Philips Electronics Australia Ltd
65 Epping Road
North Ryde, NSW Australia 2113

© 2022 Koninklijke Philips N.V. All rights reserved. Trademarks are the property of Koninklijke Philips N.V.

www.philips.com/IGTdevices
Revision date: 06/2022 300000256981_J

References

• Resource center | Philips
• Image-guided therapy | Philips
• Patent marking IP&S | Philips

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