Manufacturer > Merit Medical > Devices > SafeGuard® Pressure Assisted Device

SafeGuard® Pressure Assisted Device

Device-Type

Assisted Compression Devices

Targated Speciality

Hemostasis

Manufacturer

Merit Medical


12 cm PRESSURE ASSISTED DEVICE 

The SAFEGUARD 12 cm is a single use disposable device. SAFEGUARD has a clear medical grade polyurethane window and bladder, a clear medical grade PVC flexible fill tube, and a pressure sensitive, self-adhesive peel backing. A valve on the end of the fill tube enables a syringe to be connected to inflate the central bladder with air to provide pressure to the puncture site. The SAFEGUARD pressure assisted device has a sterile dressing with a clear window that facilitates visibility of the access site without removal or manipulation of the device.


INDICATIONS

The indications for use for the SAFEGUARD 12 cm pressure assisted device are to assist in obtaining and maintaining hemostasis.


24 CM PRESSURE ASSISTED DEVICE 

The SAFEGUARD 24 cm is a single use disposable device. SAFEGUARD has a clear medical grade polyurethane window and bladder, a clear medical grade PVC flexible fill tube, and a pressure sensitive, self-adhesive peel backing. A valve on the end of the fill tube enables a syringe to be connected to inflate the central bladder with air to provide pressure to the puncture site. The SAFEGUARD pressure assisted device has a sterile dressing with a clear window that facilitates visibility of the access site without removal or manipulation of the device.


INDICATIONS

The indications for use for the SAFEGUARD 24cm pressure assisted device are to assist in obtaining and maintaining hemostasis. The device is also indicated in the reduction of active compression time in femoral artery cannulation following diagnostic and interventional procedures with an ACT of 140 seconds or less, using a 6 Fr. and smaller sheath size.

Features and Benefits

Let Safeguard assist you in obtaining and maintaining hemostasis. The Safeguard pressure 24 cm assisted device is safe and effective in reducing active compression time in femoral artery cannulation following diagnostic and interventional procedures. Safeguard simplifies pre- and post-hemostasis management of the access site. It also reduces demands on staff, maximizes valuable resources and enhances patient comfort. Available in two sizes: 24 cm and 12 cm.


Real Pressure

Safeguard delivers adjustable active compression and enables immediate pressure adjustment, maintains consistent pressure on the site during patient recovery as well as patient positioning and transport, and provides site management control for non-compliant patients. Additionally, it facilitates site assessment through a clear window without removing the device.


Real Comfort

Safeguard adheres to the patient while inflated regardless of patient’s anatomy, preserving a high degree of comfort while also maintaining consistent pressure on the site when obtaining hemostasis with manual compression. In a clinical trial, 87% of patients who had undergone a catheterization procedure in the past indicated that Safeguard with the Safeguard Manual Assist Technique (MAT) was much more comfortable than any previous procedure.1

Safety informations

12 cm PRESSURE ASSISTED DEVICE 


CONTRAINDICATIONS

The adhesive portion of the SAFEGUARD device should not be used over excoriated skin.


PRECAUTIONS

• Use proper aseptic techniques while handling product.

• Do not use if package is damaged

• Inspect device prior to use to verify that no damage has occurred during shipping.


24 CM PRESSURE ASSISTED DEVICE 


CONTRAINDICATIONS

The adhesive portion of the SAFEGUARD device should not be used over excoriated skin.


REUSE PRECAUTION STATEMENT

For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.


PRECAUTIONS

• Use proper aseptic techniques while handling product.

• Do not use if package is damaged

• Inspect device prior to use to verify that no damage has occurred during shipping.



Potential adverse events

12 cm PRESSURE ASSISTED DEVICE 


Possible adverse effects that may result from the use of this device:

• Hematoma

• Local bleeding

• Arterio-venous fistula or pseudoaneurysm


24 CM PRESSURE ASSISTED DEVICE 


POTENTIAL ADVERSE EFFECTS

Possible adverse effects that may result from the use of this device:

• Hematoma

• Local bleeding

• Arterio-venous fistula or pseudoaneurysm

Device Documents

Related Device SKUs

* Select 2 or more (upto 4) SKUs to compare.
SKU Name Device SKUs Model Maximum Inflation Volume Band Length(cm)
SAFEGUARD®
82000 40ml 24
SAFEGUARD®
82050 7ml 12
device-thumbnail
SAFEGUARD®
  • Model : 82000
  • Procedure : -
  • Maximum Inflation Volume : 40ml
  • Band Length(cm) : 24
device-thumbnail
SAFEGUARD®
  • Model : 82050
  • Procedure : -
  • Maximum Inflation Volume : 7ml
  • Band Length(cm) : 12

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