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 paper strips on the base of the VasoStat™
Hemostasis Device to expose the adhesive surfaces.
Ensure plunger of device is in the 'up' position. If needed,
gently squeeze the wings of the plunger together to move
plunger to the 'up' position.
2. Align central plunger of device above vascular puncture
site vascular sheath or catheter is still in place. If needed,
partially withdraw the vascular sheath or catheter to provide
sufficient room for positioning and securement of the device.
3. Secure adhesive wings of VasoStat™ device to patient's
skin with manual pressure.
completely contact the patient's skin.
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 VasoStat™ device
with thumb pressure until it is just contacting the patient's
skin.
5. Remove vascular sheath or catheter while simultaneously
depressing plunger of VasoStat™ to apply desired amount
of compression force to the puncture site.
SP-001 Rev. 03 (2020-04)
VasoStat™ HEMOSTASIS DEVICE
INSTRUCTIONS FOR USE
Ensure the adhesive pads
Next, remove the
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