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Important information
Monitoring NPWT
Carefully monitor the patient, device, and dressing
frequently to determine if there are any signs of
bleeding, exudate accumulation (pooling), infection,
maceration, or loss of Negative Pressure Wound
Therapy (NPWT). The frequency should be determined
by the clinician based on individual characteristics of
the patient and wound. NPWT devices are not designed
to detect or issue an alarm condition based on the
presence of bleeding or pooling. These conditions may
only be detected by frequent monitoring.
Special attention to the risks of bleeding or loss of
NPWT should be considered when prescribing for
use in the Home Environment.
NPWT may be impacted by various conditions
related to system configuration, set-up and individual
characteristics of the patient and wound (e.g. exudate
characteristics, patient anatomy). Alignment of the
port to the opening in the drape, use of a bridging
technique and choice of dressing configuration based
on wound characteristics may impact NPWT vacuum
delivery over the course of therapy. Exudate volume,
viscosity and consistency may influence fluid removal
or occlusion formation. A full canister, incorrect canister
orientation and device/tubing height relative to the
wound can contribute to loss of NPWT and exudate
accumulation within the wound, which could lead to
maceration, infection, or unrecognized bleeding.
Monitor the wound for infection and ensure that all
wound filler is removed at each dressing change to
reduce the risk of infection.
Skin grafts should be closely monitored to ensure
NPWT is being delivered.
Review Contraindications, Warnings & Precautions
before use.
Indications for use
RENASYS™ GO is indicated for patients who would
benefit from a suction device (Negative Pressure
Wound Therapy), as it may promote wound healing via
removal of fluids, including irrigation and body fluids,
wound exudates and infectious materials.
Appropriate wound types include:
• Chronic
• Acute
• Traumatic
• Sub-Acute and dehisced wounds
• Ulcers (such as pressure or diabetic)
• Partial-thickness burns
• Flaps and grafts
Contraindications
Use of RENASYS GO is contraindicated in the presence
of:
• Untreated osteomyelitis
• Exposed arteries, veins, organs or nerves
• Necrotic tissue with eschar present
• Malignancy in wound (with exception of palliative
care to enhance quality of life)
• Non-enteric and unexplored fistulas
• Anastomotic sites
Warnings
1.
Carefully monitor patients for signs of bleeding,
which may lead to interruption in therapy and
hemodynamic instability. If such symptoms are
observed, immediately discontinue therapy, take
appropriate measures to control bleeding, and
contact treating clinician.
2.
Patients suffering from difficult hemostasis or
who are receiving anticoagulant therapy have an
increased risk of bleeding. During therapy, avoid
using hemostatic products that, if disrupted, may
increase the risk of bleeding.
3.
Do not use directly on exposed blood vessels or
organs. Sharp edges such as bone fragments must
be covered or removed prior to initiating therapy,
due to risk of puncturing organs or blood vessels
drawn closer under the action of negative pressure.
4.
NPWT has not been studied on pediatric patients.
Patient size and weight should be considered
when prescribing the device.
5.
Foam or gauze must not be tightly packed or forced
into any wound area. Over-packing may interfere
with distribution of NPWT evenly across the wound.
This may decrease the ability of the wound to
properly contract and permit exudate to remain in
wound.
6.
In the event defibrillation is required, disconnect
device from wound dressing prior to defibrillation.
Remove wound dressing only if its location will
interfere with defibrillation.
7.
Device is not MRI compatible. Do not bring
device into MRI suite. Prior to entering MRI suite,
disconnect device from dressing. Dressing can
remain intact on patient.
8.
Do not use the device in oxygen enriched
environment or in areas where there is danger of
explosion (e.g., hyperbaric oxygen unit).
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