INSTRUCTIONS FOR USE

PRODUCT INDICATON & DESCRIPTION

The Pocket Press is NON-STERILE. Do not open the Pocket Press within a sterile field. 

The Pocket Press is an external adhesive bandage made of polyurethane and acrylate adhesive intended to support and compress the surgical pocket following implantation of a pacemaker or defibrillator.  It is intended only for left or right-sided cardiac implantable electronic devices (CIED) implants in the pre-pectoral region. 

The Pocket Press is for use in adults after CIED placement.

The Pocket Press bandage is an elastic polyurethane fabric tape and a polyurethane foam pad[NR1] [AY2] .

CONTRAINDICATIONS

The Pocket Press is NOT indicated for use in the following situations:

·       Is not indicated for use as a sterile pressure bandage.

·       is not indicated for direct contact with the surgical incision.

PLACEMENT INSTRUCTIONS

Detailed placement instructions are located on the back of each peel pouch and carton.

Use clean gloves when handling the Pocket Press. 

Ensure the surgical pocket has achieved full hemostasis before applying the Pocket Press.

Dress the surgical pocket according to standard practice before applying the Pocket Press bandage.

Apply Pocket Press only after a primary dressing, thin film or skin adhesive has fully covered the surgical incision and completely dried.

For optimal results, remove as much hair as possible prior to application.

Thoroughly clean and dry application areas.

When applying the Pocket Press, ensure the tape does not come into contact and stick to itself[NR3] [AY4] [AY5] .

REMOVAL INSTRUCTIONS

1) Loosen the edge of the tape, 2) Stabilize the skin with one finger at the peel line, 3) As the tape is slowly removed, continue to support the skin at the peel line to avoid removal of the primary dressing underneath.

ADVERSE REACTIONS

As with any surgical procedure involving the implantation of a pacemaker/defibrillator, there may be complications, including but not limited to, bleeding, hematoma/seroma formation, inflammation, infections, skin tears, extrusion, fistula formation or death.  (See WARNINGS/PRECAUTIONS)

Report any Pocket Press pressure bandage related adverse events to Compress Innovations, LLC at (929) 444-9115.

WARNINGS / PRECAUTIONS

• The Pocket Press is a NON-sterile, elastic bandage.  Inspect the packaging to be sure it is intact and undamaged prior to use. 

• Do not open within a sterile field. 

• Patients with sensitivity to or history of allergy to polyurethane or acrylate adhesive should not use this tape. Discontinue immediately if sensitivity occurs.  Seek treatment per physician guidelines.

• The Pocket Press is not indicated for contaminated or infected wounds.

• The Pocket Press is not intended to be used as a prophylactic hemostatic agent. 

• The Pocket Press should only be applied to patients with healthy intact skin.

• The Pocket Press should not be allowed to be in direct contact with blood or other bodily fluids.

• This device is single-use only and should not be reapplied.  The Pocket Press should be used once the exterior peel pouch has been opened. 

• Limit wear time of this bandage to 24 hours or less.

• The Pocket Press should not be allowed to be in contact with water while in use.

• The surgical wound should be inspected periodically per normal guidelines, to assess for any erythema, edema or signs of an infection.