Caresite® Smbore Y Leg SpinLL 7 Inch OUS EU Box of 100

Caresite

Injection & Infusion

Smallbore Y-extension IV set / double extension set

CE Marked medical device for use within the European Economic Area (EEA), as indicated by manufacturer and EU distributors.
Designed and manufactured in accordance with applicable European medical device regulations and standards declared by B. Braun.
Latex Free construction as specified in manufacturer documentation.
DEHP Free tubing and components as specified for Caresite® extension sets.
Needle Free IV access system aligned with infusion therapy and infection prevention standards referenced by the manufacturer.

CE Marked medical device for use within the European Economic Area (EEA), as indicated by manufacturer and EU distributors.
Designed and manufactured in accordance with applicable European medical device regulations and standards declared by B. Braun.
Latex Free construction as specified in manufacturer documentation.
DEHP Free tubing and components as specified for Caresite® extension sets.
Needle Free IV access system aligned with infusion therapy and infection prevention standards referenced by the manufacturer.

Smallbore Y-extension IV set / double extension set

Description

Caresite® Smbore Y-Leg SpinLL (REF 470106-01) is a bifurcated smallbore Y-extension IV set equipped with two needle-free Caresite® membrane valves and Spin-Lock luer technology. It is designed for infusion therapy to extend IV lines and provide two closed, needle-free access points for aspiration, injection, transfusion and blood sampling. The set has 18 cm (7\) smallbore tubing with 1.3 mm inner diameter, a priming volume of 0.9 ml, flow rate of approximately 86.3 ml/min and a maximum working pressure of 2.0 bar (about 29 psi). The distal end has a male Luer-Lock (Spin-Lock) connector and the two proximal branches each terminate in a Caresite® needle-free valve. The device is supplied sterile in peel packs and is intended for single use.

Bnefits

Provides two needle-free Caresite® access ports to reduce needlestick injury risk and support closed-system infusion therapy.
Bifurcated smallbore Y design allows simultaneous or sequential connection of multiple infusions or intermittent injections via one catheter.
Low priming volume (0.9 ml) and 1.3 mm smallbore tubing help minimise dead space and fluid volume, beneficial for fluid-sensitive patients.
Spin-Lock luer connection at the distal end provides a secure, leak-resistant connection to the IV catheter or primary line.
Positive-displacement Caresite® valve design supports effective flushing and helps reduce catheter occlusion.
Latex- and DEHP-free tubing helps reduce the risk of hypersensitivity reactions and exposure to plasticisers.
Closed, swabbable valve surface facilitates disinfection and helps reduce microbial contamination of the IV line.
High-pressure-compatible Caresite® technology (per selected configurations) supports flexibility in infusion therapy when used according to IFU.
Sterile, single-use device reduces cross-contamination risk compared with reusable connectors.
Compatible with standard luer-lock syringes and IV administration sets used in hospital, clinic and veterinary environments.

Indications

Extension of intravenous infusion lines where two needle-free access points are required from a single catheter or primary line.
Use in infusion therapy for the administration of IV fluids, medications and compatible blood products via a luer-lock IV catheter.
Intermittent injection, aspiration and blood sampling through needle-free Caresite® valves in a closed IV system.
Use in general hospital, outpatient, intensive care and veterinary settings where smallbore extension sets with needle-free valves are clinically indicated.

Composition

Bifurcated smallbore extension tubing, approximate length 18 cm (7") with inner diameter 1.3 mm.
Two Caresite® needle-free membrane valves (luer-activated split septum, positive displacement).
Distal male Luer-Lock (Spin-Lock) connector for secure attachment to IV catheters or administration sets.
Latex-free, DEHP-free polymer tubing and connectors as specified by the manufacturer.
Sterile packaging materials (peel-pack pouches and outer carton).

Formulation

Single-use, sterile, bifurcated smallbore Y-extension IV set with two needle-free Caresite® valves and Spin-Lock male Luer-Lock connector.
Non-medicinal medical device (no active pharmaceutical ingredient).

Packaging

Individual sterile peel-pack pouches containing one Caresite® Smbore Y-Leg SpinLL extension set.
Box of 100 individually packed extension sets for the OUS-EU configuration.
Labelled with REF 470106-01, product description, sterility symbol, lot number and expiry date as per manufacturer labelling.

Usage

Verify the product reference (470106-01), integrity of the sterile peel pack and expiry date before use; do not use if the packaging is damaged or opened.
Using aseptic technique, open the peel pack immediately before use and remove the extension set without contaminating the connectors or valve surfaces.
Connect the distal male Luer-Lock (Spin-Lock) connector securely to the IV catheter hub or primary infusion line, ensuring a tight luer-lock connection.
Prime the extension set with the prescribed IV solution according to institutional protocol, removing all visible air from the tubing and valves.
Before each access, disinfect the Caresite® valve surface with an appropriate antiseptic swab and allow to dry as per local guidelines.
Connect syringes or secondary lines using standard luer connection and perform infusion, injection, aspiration or blood sampling according to clinical protocol.
After each use, flush the line per institutional policy (e.g., saline flush) to clear residual fluid and help maintain catheter patency.
Do not exceed the specified maximum working pressure of 2.0 bar (approximately 29 psi).
The device is intended for single use only; do not resterilize or reuse. Dispose of the used extension set according to local regulations for medical waste.
Follow all additional instructions for use (IFU) and institutional policies related to IV therapy and needle-free connectors.

Contraindications

Do not use in patients with known hypersensitivity to any materials used in the device (e.g., specific polymers) if such sensitivity is identified.
Do not use if the sterile packaging is damaged, opened or wet, or if the expiry date has passed.
Do not use if any component of the extension set appears damaged, discoloured, occluded or otherwise compromised.
Do not reuse or resterilize; single-use only.
Do not exceed the manufacturer-specified maximum working pressure (2.0 bar).

Adverse Effects

Potential catheter-related bloodstream infection if aseptic technique and valve disinfection protocols are not followed.
Local phlebitis, irritation or thrombosis at the catheter insertion site associated with IV therapy in general.
Catheter occlusion or impaired flow if flushing protocols are inadequate or if precipitates form in the line.
Leakage or disconnection-related complications if connections are not properly secured.
Rare hypersensitivity or allergic reactions to device materials in susceptible individuals.
Air embolism risk if the extension set and connected system are not fully primed and de-aired before use.

Storage Conditions

Store in the original packaging in a clean, dry environment.
Keep at room temperature away from direct sunlight and sources of heat or moisture, within the temperature range specified on the packaging.
Protect from mechanical damage, crushing or bending that could compromise tubing or connectors.
Do not freeze, and avoid exposure to extreme temperatures.
Keep out of reach of unauthorised persons to maintain sterility and product integrity.

Duration

Used for the duration of an IV infusion episode or as per institutional policy; replace the extension set when clinically indicated, when the IV line is changed, or if integrity is compromised.