Description
Accu-Flow UV Shield Infusion Set is a sterile, single-use device for controlled delivery of light-sensitive fluids. Its UV-protected tubing prevents degradation, while the built-in flow regulator ensures precise control. The purge filter enables smooth priming and prevents air entry for safe infusion.
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DESCRIPTION
SPM’s Infusion Sets Sets are used to administer Intravenous fluid and medicines into human circulating system by using The intravenous catheter or cannula. The I.V. Set is used in aseptic environment. The product is sterilized using EO (Ethylene fiod Oxide) gas. The use of the product is restricted to a qualified doctor or a paramedic.
INTENDED USE / INDICATION FOR USE
Infusion Set are intended for administer intravenous fluid and/or medication to a patient intravenously.
TARGET AGE GROUP:
Use All Age Groups
DURATION OF USE:
Short term Use (Less than 30 Days).
STORAGE CONDITIONS:
Store at specified temperature and humidity (Temperature in between 10°C to 40°C and Humidity in between 55%Rh to75%
Rh).
CONTRAINDICATIONSWARNINGS:
Device must not be used other than as indicated in intended use
Device should not be used for the administration of blood and blood components
Device should not be used in patients with known hypersensitivity to any of the materials used.
The instructions should be followed carefully before use.
DO NOT re-sterilize and /or reuse. CARE
Re use of single use device creates a potential risk for patient on use. It may lead to contamination and /or
impairment of functional capability. ミ
Do not use on injured or infected surface. QUALITY
Visually inspect and carefully check the product and packaging before use. ASSURANCE
NOIDA*
INDICATION/INTENDED APPLICATION:
To prevent or treat dehydration.
MODE OF ACTION:
This is a disposable IV Infusion Set of different variants. This device is supplied sterile in paper pouch. Based on stability
studies, the shelf life for sterile products is recommended to 5 years from the date of sterilization/manufacturing.
product life is mentioned on the product label. duct life is mentioned on the product label
HOW SUPPLIED:
IV Infusion Set is supplied sterile, packed in individual paper pouch. Hundred (100) such individuals a r e enclosed within is
a printed duplex box. The overall packing contains ten (10) duplex boxes and external identification stickers.
MATERIALS USED:
Polypropylene (PP), Acrylonitrile butadiene styrene (ABS), Poly Vinyl Chloride (PVC), Natural Latex, Stainless Steel (SS). Nylon.
CAUTIONS:
Store in a cool and dry place.
Discard after single use.
Do not use if package is open or damaged.
Do not store at extreme temperature and humidity.
Do not use with blood and blood components.
Do not use device after shelf life expires.
PRECAUTIONS
When handling the product care should be taken to avoid damage from handling. Avoid crushing and crimping damage to the product due to application of surgical instruments such as forceps etc.
INSTRUCTIONS FOR USE
eel open the pouch and take out the infusion set.
Remove protective cap from piercing spike.
Insert the piercing spike to its full length into the top of the container.
Open air vent of piercing spike.
Close flow regulator and squeeze drip chamber till it is half filled.
Open flow regulator & allow solution to pass till all air bubbles in the tube are
Close the flow regulator.
Remove the priming stop cap from luer lock connector.
Connect the set to intended device and regulate flow by using flow regulator.
Use Y-injection site for extra medicament.
For intermittent use put the prime stop cap back in luer connector.
DEVICE LIFE
removed.
GAREP
QUALITY
The expiration date of the product is the sterility expiration date. The product should not be use after the indicated sterility
expiration date. Recommended shelf life of the product is 05 years from the date of manufacturing.
INSTRUCTIONS FOR USE
Return the product in its original packing identified by the batch number, purchase information, your reference and
reason for return. Please contact your local distributor office regarding product return/exchange.
REPORTING
Adverse events and/or potentially sight-threatening complications that may reasonably be regarded as product related
were not previously expected in nature, severity or incidence must be report to SPM Medicare Pvt.Ltd. B-40,
Phase-II, Noida, Gautam Buddha Nagar, UP-201305. UP-201305
and that
DISPOSAL OF THE USED DEVICE
After use device should be disposed off in compliance with the local, state and country laws & regulations.
