KCI ABThera, Инструкция по эксплуатации

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Dressing Removal: The ABThera
™
Dressing components are not bioabsorbable. Always
remove all dressing components from the abdomen at every dressing change.
Keep Negative Pressure On : Never leave the ABThera
™
Dressing in place without active
negative pressure for more than two hours. If negative pressure is off for more than two
hours, change dressing as shown in these instructions for use. Either apply a new ABThera
™
Dressing from an unopened sterile package and restart negative pressure; or apply an
alternative dressing.
Defibrillation: Remove adhesive drape from area of defibrillation to prevent inhibition of
electrical energy transmission.
Acrylic Adhesive:
The ABThera ™ Drape has an acrylic adhesive coating, which may
present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic
adhesives. If a patient has a known allergy or hypersensitivity to such adhesives, donot
use the ABThera
™ Dressing. If any signs of allergic reaction or hypersensitivity develop,
such as redness, swelling, rash, urticaria or significant pruritus, discontinue use and ensure
appropriate emergency medical treatment. If bronchospasm or more serious signs of allergic
reaction appear, remove dressing and ensure appropriate emergency medical intervention.
Magnetic Resonance Imaging (MRI) – Therapy Unit: The ABThera
™
(NPT) Unit is MR
unsafe. Do not take the device into the MR environment.
Magnetic Resonance Imaging (MRI) – ABThera™ Dressing: The ABThera
™
Dressing can
remain on the patient with minimal risk in an MR environment, assuming that use of the
ABThera
™
(NPT) System is not interrupted for more than two hours; please refer to Keep
Negative Pressure On .
Hyperbaric Oxygen Therapy (HBO): Do not take the ABThera
™
(NPT) Unit into a
hyperbaric oxygen chamber. The ABThera
™
(NPT) Unit is not designed for this environment,
and should be considered a fire hazard. After disconnecting the ABThera
™
(NPT) Unit,
either (i) replace the ABThera
™
Dressing with another HBO compatible material during the
hyperbaric treatment, or (ii) cover the unclamped end of the ABThera
™
Dressing tubing
with moist cotton gauze. For HBO therapy, the tubing must not be clamped. Never leave
an ABThera
™
Dressing in place without active negative pressure for more than two hours;
please refer to the Keep Negative Pressure On section.
Application Setting: ABThera
™
Dressing applications and changes should be performed
under strict sterile conditions in the surgical suite. If dressing change is performed outside
the surgical suite, it must be performed in an environment equipped to address the onset of
critical complications (refer to
WARNINGS section) and where strict aseptic technique can
be utilized.
PRECAUTIONS
Standard Precautions: To reduce the risk of transmission of bloodborne pathogens,
apply standard precautions for infection control with all patients, per institutional protocol,
regardless of their diagnosis or presumed infection status. In addition to gloves, use gown
and goggles if exposure to body fluids is likely.
Intra-abdominal Packing: When using intra-abdominal packing with the ABThera
™
(NPT) System, packing material may be drier than anticipated. Evaluate packing material
prior to removal and rehydrate if necessary to prevent adherence or damage to adjacent
structures.
Monitor Fluid Output: The ABThera
™
Dressing is designed to efficiently remove fluid
from the abdominal compartment and to evenly distribute negative pressure. When
treating patients with the ABThera
™
(NPT) System, the volume of exudate in the canister
and tubing should be frequently examined.
Patient Size and Weight:
The size and weight of the patient should be considered
when prescribing the ABThera ™ (NPT) System. Initial lower negative pressure should
be considered for certain small or elderly patients who are at risk of fluid depletion or
dehydration. Monitor fluid output including the volume of exudate in both the tubing
and canister. This therapy has the potential to remove and collect large volumes of fluid.
Tubing volume = approximately 25 mL from dressing to canister.
Spinal Cord Injury:
In the event a patient experiences autonomic dysreflexia (sudden
changes in blood pressure or heart rate in response to stimulation of the sympathetic
nervous system), discontinue negative pressure therapy to help minimize sensory
stimulation.
Bradycardia: To minimize the risk of bradycardia, the ABThera
™
(NPT) System must not be
placed in proximity to the vagus nerve.
Enteric Fistula or Leak: When treating an open abdomen where enteric fistulas are
present, clinicians should consider the potential for abdominal contamination if effluent is
not appropriately isolated or managed.
Protect Periwound Skin: Consider use of a skin preparation product to protect
periwound skin. Do not allow foam to overlap onto intact skin. Protect fragile / friable
periwound skin with additional drape, hydrocolloid or other transparent film.
• Multiple layers of the drape may decrease the moisture vapor transmission rate, which
may increase the risk of maceration.
• If any signs of irritation or sensitivity to the drape, foam or tubing assembly appear,
discontinue use and consult a physician.
• To avoid trauma to the periwound skin, do not pull or stretch the drape over the foam
dressing during drape application.
If there are any questions regarding the proper placement or usage of the ABThera ™ (NPT)
System, please contact your local KCI Clinical Representative.
ABThera
™
DRESSING APPLICATION INSTRUCTIONS
ABThera
™
Dressing Components
Visceral Protective
Layer (1)
Drape (4) Perforated Foam (2) Tubing Set with
Interface Pad (1)