Forge Medical VasoStat User manual

SP-001 Rev. 03 (2020-04) Page 1 of 2
VasoStat™ HEMOSTASIS DEVICE
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. Ensure the adhesive pads
completely contact the patient’s skin. Next, 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 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)
6. If bleeding is not controlled, apply additional pressure by
further depressing the plunger against the puncture site.
7. Ensure a pulse can still be felt beyond the device so that
an excessive amount of force is not being applied. If unsure,
loosen the device (see steps 8-9 below) and check for the
presence of a pulse before re-tightening the plunger.
8. After sufficient time to achieve hemostasis, release the
plunger by squeezing the wings on each side to disengage
them from the locking mechanism within the device.
9. Withdraw the central plunger until it no longer contacts
the skin and/or no longer produces pressure on the skin.
Verify hemostasis has occurred by visually inspecting the
puncture site underneath the plunger.
10. Remove the VasoStat™ Hemostasis Device and
SeeCure™ pad by gently peeling the adhesive surfaces free
from the patient's skin. Isopropyl alcohol swab(s) may also
be used to assist in removal. Discard the device in
appropriate receptacle. A sterile dressing may be applied to
the puncture site.
HOW SUPPLIED:
The VasoStat™ Hemostasis Device and SeeCure™ adhesive pad are supplied sterile in peel open packages,
intended for one time use. Sterile if package is unopened or undamaged.
Please report any defects or adverse events to 877-466-0109.
Forge Medical, Inc. MedQ Consultants B.V.
2436 Emrick Boulevard Baanstraat 110
Bethlehem, Pennsylvania, US, 18020 NL 6372 AH Landgraaf
+ 1 877 466 0109 + 31 45 303 0006
Do not resterilize Non Latex
Do not reuse Do not use if package or seal is damaged
Consult Instructions for Use Contents: 1 Device
Manufacturer Use by
Sterilized by gamma radiation CE Marking
Lot number Authorized Representative in the
European Community
Telephone number Facsimile number