Contraindications - Opsens OptoWire Deux Mode D'emploi

D
eux
OptoWire
en: Instruction for Use
REF F1011 (with Gauge Factor Connector)
Content: One each

Non-sterile carton box (sealed)

Sterile pouch (sealed)

Sterile plastic tray
Specifications:
Operating pressure -30 to +300 mmHg
Zero drift <1 mmHg/h
Temperature range 15 - 42°C
Tip Straight
Carefully read all instructions prior to use. This device should only be used by physicians trained in angiography and percutaneous transluminal coronary angioplasty (PTCA), and / or
percutaneous transluminal angioplasty (PTA). Observe all warnings and precautions noted throughout these instructions. Failure to do so may result in complications.
INDICATION OF USE:
The OptoWire Deux pressure guidewire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography
and/or any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood
vessel disease.
DESCRIPTION:
The OptoWire Deux is a hybrid Nitinol/Stainless Steel pressure sensing guidewire that is a steerable guidewire with an optical pressure sensor mounted proximal to the 3.5 cm
long radio opaque tip. The OptoWire Deux is for use in combination with Opsens' OptoMonitor system for blood pressure measurement. The OptoWire Deux has a diameter of
0.014" (0.36 mm) and an effective length of 175 cm. The OptoWire
REF F1011 is supplied with an additional Gauge Factor Connector. The OptoWire cable and the Gauge Factor Connector for REF F1011 are unique to each OptoWire and it must be
used conjunctionally with the OptoWire supplied in the same tray.
OptoWire Deux is supplied sterile, non-pyrogenic and is intended for single use only.

CONTRAINDICATIONS:

This OptoWire is not intended for use in crossing a total vessel occlusion, in the cerebrovascular vessels and with atherectomy devices. Refer to the device label for any
additional product specific contraindications which may apply.
ADVERSE EVENTS:
Potential complications that may be encountered during coronary angiography and coronary angioplasties include but are not limited to: coronary vessel dissection, abrupt closure,
occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, myocardial infarction, serious arrhythmias, and death.
The physician should be familiar with the literature concerning the complications of angiography.
WARNINGS:

OptoWire should be manipulated only under fluoroscopy. Care should be taken when manipulating a guidewire inside a vessel during device placement and removal.

Observe OptoWire movement in the vessels. Before an OptoWire is moved or torqued, the tip movement should be examined under fluoroscopy. Do not torque an
OptoWire without observing corresponding movement of the tip; otherwise, vessel trauma may occur.

Never advance an OptoWire against resistance without first determining the reason for the resistance under fluoroscopy. Excessive force against resistance may result
in damage to the wire and/or to the vessel.

If resistance occurs and the cause of resistance cannot be determined, do not move or torque the OptoWire. Stop the procedure, determine the cause of resistance
under fluoroscopy and take appropriate action.

Do not resterilize and/or reuse this device. The OptoWire is intended for single use only. Reuse of single use devices creates a potential risk of patient or user infections.
Contamination of the device may lead to injury, illness or death of the patient. Reprocessing may compromise the integrity of the device and/or lead to device failure.

Do not use the OptoWire if any portion of the device or packaging appears damaged, if any portion of the sterile pouch has been opened or if product is expired. Return
damaged units to Opsens per the Return Policy.

Used of OptoWire in conjunction with interventional devices with a short monorail may result in folded or fracture guidewire.

Do not use OptoWire in the ventricles if the patient has a prosthetic mechanical or biological valve. It may result in damage to both the prosthesis and OptoWire, which
may cause injury or death.
PRECAUTIONS:

Use of an OptoWire with a different OptoWire Cable (in case of REF F1011, both OptoWire Cable and Gauge Factor Connector) than the one supplied would provide
inaccurate pressure information.

Do not use damaged OptoWire. Using a damaged OptoWire may cause vessel damage and/or inaccurate torque response and pressure reading.

When taking the OptoWire out of the dispenser hoop, do not handle the OptoWire roughly or pull it out abruptly as this can damage the OptoWire. Inspect the
OptoWire for bends, kinks or other damage prior to use.

Do not grasp the tip of the OptoWire in taking the OptoWire out of the dispenser hoop.

Avoid abrasion of the OptoWire coating. Do not withdraw or manipulate the coated wire in a metal cannula or sharp-edged object.

Do not bend or pull the tip section more than necessary or the OptoWire may be damaged.
2-v7 LBL-2005-07-v6 OW DEUX IFU F1011 Rev.2019 05

OptoWire Deux

Torque device

OptoWire Cable
is supplied preconnected to the OptoWire cable along with a torque device. The OptoWire Deux version
DEUX

Gauge factor connector
A
B
C
D
E
Gauge Factor Connector
FOIC Optical Connector
Torque Device
Handle
Pressure sensor
4