Instruction for use

SilverStream®

Registration Number in the Register of
Ministry of Health, Medical Devices Department
11550401

Instruction for use

SilverStream® is a hypertonic buffered solution, with hydrogel properties and a pleasant odor, for wound management and maintenance of wound moisture level. SilverStream® is a clear, ranging from colorless to pale yellowish, 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

SilverStream is intended for use under the supervision of a healthcare professional for the management and moisturizing of 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

SilverStream is designed for management and moisturizing of wounds. Facilitate wound healing by applying the SilverStream 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 or foam bottle.
(4) Pouring onto a gauze/dressing or sponge.

Allow the wound to be exposed to the solution for 5-10 minutes. Do not rinse.
If necessary, use SilverStream-soaked gauze to gently clean the wound using a circular motion, starting from the center and moving outward.
Moisten sterile cotton gauze with SilverStream® solution and place the wet gauze on the wound according to the Medical Practitioner’s instruction.
Apply a secondary non-antimicrobial occlusive dressing as directed by the Medical Practitioner.

Apply 1-2 times daily, according to Medical Practitioner’s instruction.

The SilverStream solution may remain on the wound until the next dressing change.

It is recommended that the wound bed should be kept moist continuously with SilverStream®. Maintaining a moist wound environment has been shown to promote wound healing.

Between dressing changes, it is recommended to moisten the gauze, dressing, or sponge with SilverStream solution before removal for easier dressing removal.

Between dressing changes, you may wash the wound with water or soap and water.

DO NOT INJECT.

Note: The wound may be cleansed if SilverStream is applied with a 19-22G needle (application pressure of ~ 10 psi).

DO NOT wash the wound with Saline, Before or After using SilverStream as it may reduce the solution’s efficacy.

INTENDED USE AND INDICATIONS FOR USE

For external use only. Avoid contact with eyes.
Use only undamaged bottles.
Do not use in patients with a history of hypersensitivity
to any of the ingredients.
Discontinue use if irritation develops.
Avoid usage of turbid or intensely colored solution.
Protect the 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 the 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 a solution should be cleared off to an appropriate site.
Do not apply more than 700 mL of SilverStream® solution within a 24-hour period.

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).

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.

SYMBOLS

The following provides a description of the graphic symbols that appear on the SilverStream^® label: