EN
SealStream® is a hypertonic buffered solution, with hydrogel properties and a pleasant odor, for wound management and maintenance of wound moisture level. SealStream® is a clear, colorless solution, protected from microbial contamination by a low concentration of ionic silver and supplied in 100mL, 250mL and 500mL bottles
INTENDED USE AND INDICATIONS FOR USE
SealStream® is intended for use under the supervision of a healthcare professional for mechanical cleansing and removal of foreign material including micro-organisms and debris from wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second-degree burns, cuts abrasions and minor skin irritations
GENERAL DIRECTIONS FOR USE
SealStream® is designed for management and moisturizing of wounds.
Facilitate wound healing by applying the SealStream® solution directly from the bottle on the wound in one of the 4 ways:
(1) Applying by means of a syringe or bulb.
(2) Applying with device designed to allow for irrigation or lavage.
(3) Spraying onto the wound using a spray bottle.
(4) Pouring onto a gauze/dressing or sponge.
Apply 1-2 times daily, according to Medical Practitioner’s instruction.
Before removal of the gauze/dressing or sponge, moisten with SealStream® solution for easier removal.
Between dressing changes, wash the wound with water or soap and water.
DO NOT INJECT.
Note: The wound may be cleansed if SealStream® is applied with a 19G needle (application pressure of ~ 10 psi).
DO NOT wash the wound with Saline, Before or After using SealStream®.
INGREDIENTS
Ingredients include WFI (water for injection), glycerol (glycerin), sorbitan monolaurate (Tween-20), TRIS, menthol, and silver nitrate 0.01% (w/v).
Each mL contains ionic silver in the form of silver nitrate 0.01% (w/v)
PACKING
Each package contains twelve (12) bottles of 250mL or twenty-four (24) bottles of 100mL or twelve (12) bottles of 500mL and instructions for use leaflet, which is part of the bottle label.
⚠ CAUTIONS AND WARNINGS
- For external use only. Avoid contact with eyes.
- Use only undamaged bottle.
- Do not use in patients with history of hypersensitivity to any of the ingredients.
- Discontinue use if irritation develops.
- Avoid usage of turbid or colored solution.
- Protect bottle from direct contact with the wound.
- Bottle that comes in direct contact with the wound must be discarded after use.
- For single patient use only.
- If the bottle is closed immediately after use and the top of the bottle is protected from contamination, the solution may be reused within 28 days from first opening.
- Store between 10˚C-30°C (50˚F-86°F) in a dry place
- The empty bottle can be disposed to the regular trash can. A bottle that contains solution should be cleared off to an appropriate site.
- Do not apply more than 700 mL of SealStream® solution within a 24 hour period.
SYMBOLS
The following provides a description of the graphic symbols that appear on the SealStream® label:
DIRECTIONS FOR USE
Open the cap, insert
syringe with needle
into the bottle and
draw up the quantity
of SealStream®
solution as advised
by the Medical
Practitioner.
Rinse, by spraying the SealStream® solution on the wound.
Let the wound be exposed to the sprayed solution
for 5-10 minutes. DO NOT INJECT (The needle should
not touch the wound).
Wet a sterile cotton
gauze with
SealStreamm® solution.
Place the wet gauze
on the wound and
apply a secondary
non-antimicrobial
occlusive dressing as
directed by the
Medical Practitioner.
Before removal of the
gauze/dressing or
sponge, moisten
with SealStream®
solution for
easier removal.
SealStream® may remain on the wound until the next dressing change. The wound surface should be kept continuously moist with SealStream®. Maintaining moist environment has been shown to be conducive to wound healing. Between dressing with SealStream® changes, wash the wound with water or soap and water. Before removal of the gauze/dressing or sponge, moisten with SealStream® solution for easier removal.
