Description
EO STERILE
Accu-Site (Needle-Free Valve) is a closed-system vascular access device designed to enable safe and convenient IV therapy without the use of needles. It supports secure fluid administration, flushing, and medication delivery while helping reduce the risk of contamination, blood exposure, and needlestick injuries. Manufactured from high-quality medical-grade materials, Accu-Site ensures reliable flow performance, leak resistance, and compatibility with standard IV systems for routine and critical care applications.
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DESCRIPTION:
The SPM’s Extension line with/ without Needle-free Valve is a sterile, single-use,
Extension line with or without Needle-free Valve. The Extension line is available in
single or multi-Way. The multi-way extension line allows the administration of fluids or
medications. The extension line with/without needle-free valve is sterilized by ethylene
oxide.
INTENDED PURPOSE:
Extension line is used to extend the infusion line during administration of IV fluid. It
also provides a pressure monitoring aid and also enables multi-drug administration.
INDICATIONS FOR USE:
SPM’s Extension line with/without Needle-free connector is intended use to
connection and extension infusion or transfusion sets for administration liquids or
medications into the circulation system by using of intravenous catheter and
cannula.
INTENDED PATIENT POPULATIONS:
Extension line with/without Needle-free connector is intended to be used in patients
irrespective of age and gender.
INTENDED USERS:
Extension line with/without Needle-free connector is intended to be used by the trained
healthcare professionals including doctors, registered practitioners, and paramedics or
nursing staff.
INTENDED USE ENVIRONMENT:
Extension line with/without Needle-free connector is intended to use in healthcare
environments like hospitals and clinics.
CLINICAL BENEFITS:
• The transparent, smooth and kink-resistant PVC tube (latex-free) allows seamless
connection
• 6% taper in luer lock allows connection with a variety of medical devices.
• The needle free valve ensures the leak-proof drug administration.
PRINCIPLE OF OPERATION:
The Extension line with/without Needle-free connector allows the extension of the
vascular access device like infusion set, cannula, etc. It offers more flexibility and
convenience during treatments. The Needle-free/ Luer connector offers leak-proof
administration of more than one drug using a standard device like Luer lock/Luer slip
syringe.
PERFORMANCE CHARACTERSTICS:
• Interoperability with other vascular access devices like infusion set or IV cannula.
• Extension line with/without Needle-free valve which allows leak proof
administration of IV fluid or medications.
MATERIAL USED:
• Tube – PVC
• Luer Connector- Poly Carbonate
• Luer cap- Poly Propylene
• Slide Clamp – LDPP
• Needle free valve – Poly Carbonate
POTENTIAL COMPLICATIONS:
Fluid leakage and cross-contamination, Difficulty turning, Incompatibility with
medications, Blockage and obstruction, sterility breakdown, misalignment of ports,
Material deterioration, and limited durability in high-pressure.
INSTRUCTIONS FOR USE:
• Step 1. Insert the syringe tip into the valve.
• Step 2. For securing the connection:
o For Luer Slip syringe: Insert and rotate 1/4 turn
o For Luer lock syringe: turn syringe clockwise
• Step 3. Inject or Aspirate the fluid.
• Step 4. To Disconnect, Remove the luer from the valve by turning counter
clockwise.
HOW SUPPLIED
The Extension line with/without Needle-free valve is supplied in sterile, single-use
Paper pouch packaging, complete with instructions for use and necessary accessories (if
any).
WARNINGS
• For Professional Use Only: This device must be used only by trained healthcare
professionals
• Sterile Packaging: Do not use if the packaging is damaged or opened prior to
use.
• Single Use Only: The device is designed for single use. Do not reuse or resterilize.
• Proper Handling: Handle with care to avoid damage to the device, which could
compromise its sterility and functionality.
Allergic Reactions: Check patient history for allergies to materials in the
Extension line.
• Inspect Before Use: Ensure all components are present and undamaged before
use
• Follow Instructions: Carefully follow the included instructions for use to avoid
complications
• Dispose Properly: Dispose of the device in accordance with local regulations for
medical waste.
PRECAUTIONS:
• Check the integrity and functionality of the device before use. Do not use if the
package is open or damaged.
• Determine patient’s condition and vitals status during device application /
Operation.
• 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.
• Conduct procedure under strict surgical protocol and ensure complete asepsis.
• Do not Re-sterilize. Do not Re-use.
• Single use only.
• Do use after the Expiry Date
CAUTIONS:
• Store in a cool and dry place
• Discard after single uses
• Do not use if the package is open or damage
• Do not store at extreme temperature and humidity
• Do not use if the protective cap is detached.
• Always swab the top of the female connector with a sterile 70% IPA, wipe 1 or 2
second and allow to dry for 30 seconds.
• Do not leave slip luer syringe unattended.
STORAGE:
Stored at controlled temperature (10-40°C). Do not store at freezing temperature.
EXPIRATION PERIOD:
The device has a shelf life of 5 years from the date of manufacturing. The product should
not be used after the indicated sterility expiration date.
RETURN OF DAMAGED PRODUCT:
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.
DISPOSAL OF THE USED DEVICE:
• Disposal of the used product should be done according to hospital procedures,
State Regulations, National legislation.
• Device should be disposed after use on individual patient during a single
procedure.
• Disposal of the packaging material should be done as biomedical waste.
• Any open packaging should be done as biomedical waste.
• Leftover products should be disposed as biomedical waste.
REPORTING:
In case of any adverse events and/or potential threat/ complications that may
reasonably by regarded as product related and that were not previously expected in
nature, severity or occurrence, contact the manufacturer or authorized representative
and competent authority of the member state where the user and/or patient is
established.
