Sterile 3 way stopcock :

General Description:

3-Way Stop Cock is made of medical – grade biocompatible polycarbonate.
Its fully transparent body allows visualization of flow of fluid. It is having universal 6% taper on luer which allow connection with a wide variety of standard medical devices.
3–Way Stop Cock facilitates multiple lines through single I.V. access.
The use of the product is restricted to a qualified doctor or a paramedic staff.
Stopcock systems for infusion therapy as channels.
Suitable for all current pressure infusion systems.
Continuous straight-flow channels for accurate pressure monitoring Axially and radially movable swivel lock for secure and speedy connection.
The device is required to be leak-proof, connect easily with the source(s) of IV fluids / drugs as well as with the venous access device and allow a continuous flow when in” on” position.
Additionally, the device should completely stop the fluid flow when in the “off ‘position. Further, the device should be sterile and associated with low risk of local and / or systemic infections.
Following claims are made related to the device:

STERILE, NON- PYROGENIC May be used to deliver simultaneous infusion of two different IV fluids

Intended Use:

3-Way Stop Cock- For infusion of more than one fluid at a single time. This device is lipid resistant.
3-way stop cock used with infusion sit not blood transfusion and don’t use with chemotherapy.
3 Way Stop Cock is an intended to be used for all patients.
It is not to be used in patients with known hypersensitivity to any of the materials.
This is device is to be used ambient conditions and should be used by a qualified doctor or a paramedic.
It has a two- fold function:

1) To serve as a protective stopper for any standard female luer.

2) To provide two additional ports for administration of any fluid.

INSTRUCTION FOR USE:

Inspect visually to ascertain that package is intact.
Remove SAFE-WAYS from sterile packing.
Connect one or two I.V. Infusion lines as required to the ports.
Remove protector from male portion & hold it upright.
Open clamps of I.V. Infusion lines & displace air entirely by rotating the tap to open position.
Rotate tap to close position.
Connect it to venipuncture device & secure it with rotating lock.
Rotate the tap to open position and adjust the flow of infusion set.

CONTRAINDICATIONS:

Product should not be used in patients with known hypersensitivity to any of the materials used.
Not to be Administration of high viscous fluids.
Not to be used Blood transfusion.
Do not use if package is open or damaged.
Not to be used on chemotherapy.

WARNINGS:

Product is single use only.
Re-use of the product can cause change in physical characteristics like handle loose, crack problem, Blockage, Infection & other blood diseases like HIV, AIDS & Hepatitis etc.
The use of this product is restricted to a qualified doctor or a Paramedic.
Do not re-sterile may increase the EO Residual in the product or physical property of the products may be change
The silicon oil used for lubricant should not be visual in the form of droplets
Read instructions before use.
The product should not be reprocessed.
Visually inspect and carefully check the product and packaging before use. Improper transport and handling may cause structural/functional damage
to device or packaging.
Transportation / Dispatch of the material should be done under covered & safe container to avoid any damage, rain & direct heat
The product is guaranteed non-toxic, sterile & non-pyrogenic if the package has not been opened or damaged.
Do not clean or resterilise. For single use only. Discard after use.
Store in cool & dry place.
Do not expose to heat or direct sunlight.
The product should be used immediately after opening the packaging.

Sterilization:

3WAY STOPCOCK is sterilized by Maramco for Medical Industries. EtO
Sterilization, biological indicator testing and aeration process are performed by Maramco for medical industries company.