Instructions FOr Use

  • Step 1

    Orient the compression pad over the surgical pocket area.

    Center the TOP tape 1 between the patient’s neck and shoulder.

    Position the axilla tape 2 beneath the patient’s underarm.

    Position the sternal tape 3 high on the opposite chest wall.

  • Step 2

    Holding the compression pad in place, remove liner 1A.

  • Step 3

    Holding the compression pad in place, apply the TOP tape to the patient.

    Remove liner segment 1B and apply.

  • Step 4

    Holding the compression pad in place, remove liner 2A.

  • Step 5

    Holding the compression pad in place, lightly stretch the axilla tape and apply.

    Remove liner 2B and apply.

  • Step 6

    Holding the compression pad in place, remove 3A liner.

    Lightly stretch the sternal tape and apply.

    Remove liner 3B and apply.

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 sterile primary dressing or skin glue 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.

  • Use the protective barrier wipe included in pouch and wipe any skin that will be taped prior to use. (The barrier wipe is manufactured by 3M)

Note: Do not allow the Pocket Press to come into direct contact with water.

REMOVAL AND DISPOSAL INSTRUCTIONS

  1. If available, use adhesive remover wipes to assist with removal.

  2. Loosen the edge of the tape,

  3. Stabilize the skin with one finger at the peel line, as the tape is slowly removed, continue to support the skin at the peel line to avoid removal of the primary dressing underneath. If patients will be removing the Pocket Press at home, then provide adhesive remover wipes with their discharge.

  4. Dispose of the Pocket Press in accordance with healthcare facility biohazardous waste protocols.

Federal Law (United States) restricts this device to sale by or on the order of a licensed healthcare provider.

PRODUCT DESCRIPTION

  • The Pocket Press is a non-sterile pressure bandage intended to be used over a sterile dressing following cardiac implant surgery.

  • 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 a non-sterile 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 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.

INTENDED USE

The Pocket Press is intended to be applied over a sterile dressing to apply compression to the surgical pocket, following pacemaker or defibrillator implantation surgery.

INTENDED USER

The Pocket Press is intended to be used by a healthcare professional or by the patient after instruction and under the supervision of a healthcare provider.

INDICATIONS

The Pocket Press is indicated for adult use following pacemaker or defibrillator implantation, which may reduce the incidence of hematomas.

CONTRAINDICATIONS

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

  • as a sterile pressure bandage.

  • direct contact with the surgical incision.

ADVERSE REACTIONS

Can cause allergic reactions in persons with skin sensitivity or history of dermatitis. Discontinue use if reaction occurs.

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. Contact the treating physician immediately should any of these things occur.

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 not be used once the exterior peel pouch has been opened.

  • Limit wear time of this bandage to 24 hours or less, unless instructed otherwise.

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

  • Excessive wear time or not using a skin protective barrier wipe or adhesive remover wipe may make removal more difficult.

Any serious incident that has occurred in relation to the Pocket Press should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Incidents may be reported to:

customerservice@compressinnovations.com or +1 (929) 444-9115