IV administration / giving set (gravity and pressure infusion)
Certifications
CE Marked IV administration set under applicable EU/UK medical device regulations.
Designed and tested in accordance with DIN EN ISO 8536 8 for infusion administration sets and pressure resistance.
Manufactured under an ISO 13485 Compliant medical device quality management system.
DEHP Free tubing (and PVC Free Neutrapur variants available), in line with current safety recommendations for infusion devices.
CE Marked IV administration set under applicable EU/UK medical device regulations.
Designed and tested in accordance with DIN EN ISO 8536 8 for infusion administration sets and pressure resistance.
Manufactured under an ISO 13485 Compliant medical device quality management system.
DEHP Free tubing (and PVC Free Neutrapur variants available), in line with current safety recommendations for infusion devices.
IV administration / giving set (gravity and pressure infusion)
Description
The Intrafix SafeSet Infusion Set 180 cm is a high-quality IV administration (giving) set from B. Braun designed for safe and accurate gravity or pressure infusion of fluids and medications. It features a transparent drip chamber with integrated AirStop safety filter, PrimeStop hydrophobic protective cap for automatic priming, soft clear tubing (3 x 4.1 mm, 180 cm) with roller clamp for precise flow control, a sharp piercing spike with bacteria-tight air vent and a secure luer-lock patient connector. The system is intended to provide reliable, air-free, closed-system infusion in hospital, clinic and IV therapy settings.
Bnefits
Universal IV administration set suitable for gravity infusion and for use with compatible (non-dedicated) infusion pumps up to 2 bar.
AirStop safety filter in the drip chamber helps prevent air from entering the line, reducing the risk of air infusion.
PrimeStop hydrophobic protective cap allows automatic priming and prevents fluid dripping, maintaining a closed system during set-up.
Soft, clear tubing (standard lumen 3 x 4.1 mm, 180 cm length) improves handling and allows visual detection of air bubbles.
Highly transparent drip chamber dome and long drop former (20 drops ≈ 1 ml) enable easy monitoring and accurate flow-rate adjustment.
Bacteria-tight air vent with snap cap and 15 µm particle filter help reduce contamination and particle infusion.
Roller clamp with integrated spike dock supports safe disposal of the spike and fine, flexible flow regulation.
Secure screw-tight luer-lock connector ensures safe connection to standard IV cannulas and extension lines.
Indications
Intravenous administration of fluids (e.g. crystalloids, colloids) and medications via a peripheral or central venous access.
Use in gravity infusions and in pressure infusions with compatible non-dedicated infusion pumps (pressure-resistant up to approx. 2 bar).
General hospital, theatre, emergency, outpatient and clinical IV therapy where a closed, needle-free administration set is required.
Use in adult, paediatric and neonatal patients where infusion therapy is prescribed, according to clinical judgement and local protocols.
Tubing: medical-grade PVC, DEHP-free (Neutrapur PVC-free variants also available depending on configuration).
Drip chamber: PVC-free highly transparent chamber with integrated AirStop filter membrane and 15 µm particle filter.
Protective cap: PrimeStop cap with integrated hydrophobic membrane to prevent fluid leakage and allow automatic priming.
Air vent: bacteria-tight air vent with closable snap cap (Euro lid, typically green).
Connectors: universal clear ISO piercing spike and screw-tight luer-lock patient connector made of medical-grade polymers.
Roller clamp: orange DIN safety colour roller clamp with integrated spike dock for safe spike retention during disposal.
Formulation
Device type: premium IV administration (giving) set with safety features AirStop and PrimeStop.
Standard tubing dimensions: lumen 3 x 4.1 mm; length 180 cm.
Drop factor: long drop former, approximately 20 drops ≈ 1 ml in aqueous solutions.
Integrated safety and filtration: AirStop diaphragm in drip chamber, hydrophobic PrimeStop cap, 15 µm infusion filter and bacteria-tight air vent.
Pressure capability: suitable for gravity and for pressure infusions with compatible pumps up to approx. 2 bar, per ISO 8536-8.
Connection standard: universal spike for infusion containers and male luer-lock patient connector.
Packaging
Each Intrafix SafeSet Infusion Set is individually packaged in a sterile, peel-open pouch.
Standard sales unit from manufacturer: box of 100 pieces (configuration may vary by distributor).
Outer carton labelled with product name, brand (B. Braun Intrafix SafeSet), product code (e.g. 4063000 for 180 cm set), lot number, sterile symbol and expiry date.
The Crystal Pharmacy clearance listing refers to units with short expiry (October 2023).
Usage
Check the packaging before use; do not use if the sterile pouch is opened, damaged or past the expiry date.
Using aseptic technique, remove the infusion set from its pouch.
Close the roller clamp, then insert the universal spike into the infusion container as per local protocol.
Open the bacteria-tight air vent snap cap if vented infusion from rigid containers is required; keep closed for non-vented use if appropriate.
Prime the line: allow solution to fill the drip chamber to the marked level, then open the roller clamp so that fluid fills the tubing. AirStop and PrimeStop assist in maintaining a constant fluid level and preventing air entry and dripping during priming.
Once fully primed and air-free, close the roller clamp and connect the luer-lock patient connector to the IV cannula or extension set using aseptic technique.
Adjust the flow rate by carefully regulating the roller clamp and, if applicable, according to infusion pump settings.
Monitor the infusion site and line regularly for patency, air, leaks and patient comfort.
At the end of infusion or when changing sets according to local policy, close the roller clamp, disconnect from the patient, remove from the container and dispose of the entire set as clinical waste. Do not reuse or re-sterilise.
Contraindications
Do not use if the sterile packaging is damaged, opened or if the product is beyond its expiry date.
Not intended for arterial or other non-approved routes of administration.
Do not use with incompatible fluids, medications or infusion pressures outside the manufacturer’s specifications (e.g. > 2 bar).
Do not use in patients with known hypersensitivity to any material used in the device, although the set is DEHP-free and typically latex-free.
Single-use only; do not reuse or re-sterilise, as this may increase the risk of infection, device malfunction or patient harm.
Adverse Effects
Potential risk of local or systemic infection if aseptic technique is not strictly followed or if the set is used beyond recommended duration.
Risk of air embolism if improperly primed or used contrary to instructions, although AirStop and PrimeStop significantly reduce this risk.
Possible occlusion, backflow or inadequate flow if the line is kinked, the filter becomes blocked or clamps/pump settings are incorrect.
Mechanical complications such as leakage or disconnection if connectors are not securely tightened.
Very rare risk of hypersensitivity reactions to device materials.
Storage Conditions
Store in a clean, dry environment at room temperature.
Protect from excessive heat, cold, moisture and direct sunlight.
Keep in original packaging until immediately before use to maintain sterility.
Do not use after the expiry date indicated on the pouch and outer carton.
Duration
Not fixed; the infusion set is used for the duration of an IV infusion episode and should be replaced according to institutional policies and infection-prevention guidelines (e.g. typically every 24 hours or as specified by local protocols).
Onset
Immediate mechanical function once the set is primed, connected and the roller clamp or infusion pump is opened to start infusion.
