Carilex VT ONE - Contrain Ications; Recautions; Eneral Recautions for in Ication for Use; Arnin S

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Instructions for Use | Carilex® VT • One
Iortant notes for safe use
 Contrainications
Contraindicated for patients with the following conditions:
• Presence of necrotic tissue
•
Malignancy
• Untreated Osteomyelitis
• Untreated malnutrition
• Exposed arteries, veins, nerves, or organs
• Use over anastomotic sites
• Unexplored or non-enteric stulas
 recautions
The following statements describe medical conditions that may require special
care to be exercised by practitioner for the safe and effective use of the VT•One
NPWT device.
(1)Patients on anticoagulation medicine or who have active bleeding or who have
difcult wound hemostasis should be treated with caution. These patients are
at an increasing risk for bleeding and bleeding complications and should be
treated and monitored by properly trained medical caregivers in a controlled
setting.
(2)Close proximity of blood vessels, organs, muscle, and fascia. All blood vessels,
organs, muscles, and fascia that are in close proximity to the wound site and/
or are exposed and /or are near the skin surface should be properly protected
prior to initiating NPWT. Patient with infections in the wound and or other
parts of the body have to receive proper systemic treatment.
(3)Irradiated vessels and tissue. These patients are at an increasing risk for
bleeding and bleeding complications and should be treated and monitored by
properly trained medical caregivers in a controlled setting.
(4)Bony fragments. Sharp edges from bony fragment may puncture blood vessels,
organs, muscles, and fascia and may lead to bleeding. Proper care should be
taken to cover the bony fragments and protect the wound area and other areas
from bleeding.
 eneral recautions for inication for use
(1)It is important that a physician or other qualied healthcare provider evaluates
the patient to ensure that the use of the VT• One is an appropriate therapy.
(2)To reduce the risk of transmission of blood-borne pathogens, regardless of
their diagnosis or presumed infection status, all patients should take medical
standard operating procedure precautions against infection control.
(3)Caregiver should wear gloves, a gown, and goggles if there is the possibility of
contact with the patient’s body uids.
(4)Change dressing if the pump has stopped for more than 2 hours.
(5)Consider mode of therapy- intermittent versus continuous.
 arnins
The following Warning statements describe the potential for serious consequences
to the patient, such as death, injury, or adverse reactions. Failure to read and
follow all instructions in this manual prior to use may result in death or injury of
the patient.
(1)Physician should consider the patients’ size and weight when prescribing this
device.
(2)The device is not safe for use with an MRI or PET and must be disconnected
from the patient prior to MRI or PET.
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