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There are 5 types of TINISOFT microneedles can be choosed: 34G 0.6mm,34G 0.8mm,34G 1.0mm,34G 1.2mm,34G 1.5mm.
INDICATIONS
The TINISOFT is intended for intradermal injections of any substance or drug approved for delivery by this delivery route.
CONTRAINDICATIONS
-The TINISOFT should not be used on skin abrasions, open wounds, cuts and scars.
-The TINISOFT should not be used on rashes, skin infections or any other area of damaged or diseased skin.
WARNINGS AND PRECAUTIONS
-The TINISOFT is intended for single use. by healthcare professionals
-Re-use may lead to infection or other illness/injury.
-Used or un-used devices should not be re-capped or removed from syringe unless there is no alternative or such action is required
by a specific medical procedure.
-The TINISOFT is not intended for aspiration of liquids.
-If the device appears to be damaged or broken, discard and use a new device.
ADVERSE EVENTS
Local adverse reactions, including edema, erythema and discoloration of skin at the injection site have been observed, most likely
related to the injected substance, and not to the TINISOFT.
Adverse reactions related to use of the TINISOFT include small risk of microbleeding (self-limiting blood dotting, ceasing within
normal clotting time). 0ther potential device related adverse events may rarely include local infection at the injection site.
STORAGE AND HANDLING
-TINISOFT should be stored at room temperature.
-The TINISOFT is individually packed in a soft blister, sterilized by ethylene oxide [EtO].
-Do not use the TINISOFT. in the event that the soft blister is either open and/or damaged.
-Dispose of all devices in accordance with national/institutional guidelines.and in their absence, discard in a sharps container.
SUPPLY METHOD
The device is supplied as a single sterile TINISOFT device, packed in a soft blister for single use.