Forge Medical VasoStat Instructions For Use

CAUTION: Rx only: U.S. federal law restricts this device to sale to or on the order of a licensed health
care practitioner.
DEVICE DESCRIPTION: The VasoStat™ Hemostasis Device is used to augment hemostasis through a
ratcheting pressure mechanism.
INTENDED USE: The VasoStat™ Hemostasis Device is indicated for use by medical professionals to
promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or
lower leg, including radial artery catheterization, pedal or tibial artery catheterization, arterial or venous
line removal, hemodialysis, and in patients on anticoagulation therapy.
CONTRAINDICATIONS: Allergy to medical adhesives.

PRECAUTIONS:


The device is intended for single use only. Do not sterilize and/or reuse this device.

Do not use this product if there is doubt as to whether the product is sterile.

Store in a dark, dry, cool place. Avoid extended exposure to light.

Upon removal of the product from packaging, inspect product to ensure no damage has occurred.

POTENTIAL ADVERSE EVENTS:


Undesired bleeding at the puncture site could occur if care is not used when securing the device at
puncture site

Hematoma

Radial artery or tibial artery thrombosis if the device is tightened excessively without checking for the
presence of a pulse and/or hand/foot perfusion distal to the site of device application

Vascular thrombosis if the device is tightened excessively over a hemodialysis access without
checking for the presence of a thrill

As in common with skin adhesives, slight irritation of the skin may occur with prolonged use
INSTRUCTIONS FOR USE:
1. Remove the paper strips on the adhesive
wings of the VasoStat™ Hemostasis Device to
expose the adhesive surfaces on the base of
the device. Ensure the plunger of the device is
in the up position. If needed, gently squeeze
the wings of the plunger together to move the
plunger to the 'up' position.
2. Align the central plunger of the device above
the vascular puncture site of the patient's skin
while the vascular sheath or needle is still in
place. If needed, partially withdraw the
vascular sheath or needle to provide sufficient
room for positioning and securement of the
device.
3. Secure the adhesive wings of the VasoStat™
device to the patient's skin with manual
pressure. Ensure
completely contact the patient's skin.
remove the paper strips and apply the
SeeCure™ adhesive pad over the wings of the
VasoStat™ device and surrounding skin.
4. While stabilizing the base of the device with
index and middle fingers, depress the plunger
of the VasoStat™ device with gentle thumb
pressure until it is just contacting the patient's
skin.
VasoStat™ HEMOSTASIS DEVICE
INSTRUCTIONS FOR USE
the adhesive pads
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