Introduction; Indications; Contraindications; Precautions - Cardinal Health NPWT PRO Patient User Manual

1. Introduction

1.1 Indications

The Cardinal Health™ NPWT PRO/PRO to GO systems are an integrated wound management system, indicated for the
application of continual or intermittent negative pressure wound therapy to the wound as the device may promote
wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious
materials. The Cardinal Health™ NPWT PRO/PRO to GO systems are intended for patients with chronic, acute, traumatic,
subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The
Cardinal Health™ NPWT PRO/PRO to GO systems are intended for use in acute, extended and home care settings.

1.2 Contraindications

The Cardinal Health™ NPWT PRO / PRO to GO is contraindicated for patients with malignancy in the wound,
untreated osteomyelitis, non-enteric and unexplored fistulas, or necrotic tissue with eschar present. Do not place
the Cardinal Health™ NPWT foam dressing over exposed blood vessels or organs.

1.3 Precautions

Precautions should be taken for patients with infected wounds, active bleeding, difficult wound hemostasis, or who are
on anticoagulants. When placing the foam dressing in close proximity to blood vessels or organs, take care to ensure
that they are adequately protected with overlying fascia, tissue or other protective barriers. Exposed tendon, nerves or
blood vessels should be protected by moving available muscle or fascia over them or by a layer of synthetic material.
Greater care should be taken with respect to weakened, irradiated or sutured blood vessels or organs. Bone fragments or
sharp edges could puncture a dressing barrier, vessel or organ. Wounds with enteric fistula require special precautions in
order to optimize therapy.

1.4 Additional Precautions

• Defibrillation: Remove the Cardinal Health™ NPWT Dressing if defibrillation is required in the area of dressing
placement. Failure to remove the dressing may inhibit electrical current transmission and/or patient resuscitation.
• Magnetic Resonance Imaging (MRI): The Cardinal Health™ NPWT PRO family of devices is not MRI-compatible.
Do not take the device into the MRI area.
• Hyperbaric Oxygen Therapy (HBO): NEVER allow a device—whether on or off—inside a hyperbaric chamber.
The device must be disconnected from the patient prior to HBO treatment.
• Large Canisters: Use of Large Canisters (>500ml) may increase serious risks associated with excessive fluid loss.
Monitor patient status continually.
• DO NOT USE for infants or other patients with low fluid volume, nor for patients at high risk of major hemorrhage.
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