Product Description; Indications For Use - Merit Medical Prelude IDeal Instrucciones De Uso

Hydrophilic Sheath Introducer

PRODUCT DESCRIPTION:

The Merit Prelude IDeal™ Hydrophilic Sheath Introducer consists of
some or all of the following components. These components may
be packaged together or separately.
• One (1) Sheath Introducer
• One (1) Vessel Dilator
• One (1) Mini Guide Wire
• One (1) Access Needle
• One (1) BowTie™ Guide Wire
Insertion Device
P X Only Federal (USA) law restricts this device to sale by or on the order of a physician.

INDICATIONS FOR USE:

The Merit Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous
introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while main-
taining hemostasis for a variety of diagnostic and therapeutic procedures.
The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for
placement of guide wires.
CONTRAINDICATIONS:
Radial access is contraindicated if there is an abnormal Allen's test, radial pulse, or insufficient dual arterial supply.
WARNINGS:
• Prior to beginning radial artery access, an assessment such as the Allen's test should be performed to assess
the presence/adequacy of dual arterial circulation to the hand.
• Do not use the Prelude IDeal hydrophilic sheath introducer in patients with an abnormal Allen's test or radial
pulse, or insufficient dual arterial supply.
• Do not advance the introducer and/or guide wire if resistance is met.
• Do not reinsert the inner metal needle into the plastic cannula at any time.
• Do not use device with a power injector.
• Appropriate flushing protocols should be utilized to prevent thrombus formation during procedural use.
CAUTIONS:
• Read instructions prior to use.
• Store in a cool, dry place.
• This device is intended for single use only. Do not reuse or resterilize.
• This device is sterile if package is unopened or undamaged.
• This device is non-pyrogenic.
• This device should be used by clinicians with adequate training in the use of the device.
• Utilize appropriate anticoagulant therapy for patient during procedure.
• Prior to use, ensure that the sheath and dilator are the appropriate size for the access vessel and devices to be use.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Caution: Consult accompanying documents.
Read instructions prior to use.
Single use.
Do not resterilize.
Non-pyrogenic.
Do not use if package is damaged.
Maximum diameter guide wire.
EtO sterilized.
I N S T R U C T I O N S F O R U S E
English