Intrafix SafeSet LL – 180cm
Intrafix SafeSet
Medical deviceIV administration / giving set (pressure & gravity infusion)
Certifications
- CE Marked IV administration set under applicable EU/UK medical device regulations.
- Designed and tested in accordance with ISO 8536 8 for infusion administration sets and pressure resistance.
- Manufactured under an ISO 13485 Compliant medical device quality management system.
- Latex Free, DEHP Free materials in line with current IV safety standards.
- CE Marked IV administration set under applicable EU/UK medical device regulations.
- Designed and tested in accordance with ISO 8536 8 for infusion administration sets and pressure resistance.
- Manufactured under an ISO 13485 Compliant medical device quality management system.
- Latex Free, DEHP Free materials in line with current IV safety standards.
IV administration / giving set (pressure & gravity infusion)
Description
Intrafix SafeSet LL – 180cm is a premium IV administration (giving) set from B. Braun, designed for pressure and gravity infusions. The set features the Intrafix SafeSet safety concept with AirStop and PrimeStop technology to help prevent air infusion and maintain a closed system during priming. It includes a universal piercing spike for standard IV containers, a drip chamber with integrated filter, 180 cm tubing with a precision roller clamp and a screw-tight luer-lock patient connector. The pressure-rated set is suitable for use with compatible (non-dedicated) infusion pumps as well as gravity infusions in hospital and clinical environments.
Bnefits
- Pressure-rated administration set for both gravity and pressure infusions with compatible (non-dedicated) infusion pumps (up to approx. 2 bar).
- Intrafix SafeSet design with AirStop diaphragm in the drip chamber helps prevent air from entering the line, reducing air infusion risk.
- PrimeStop hydrophobic protective cap allows closed-system, drip-free priming and helps minimise contamination risk.
- 15 µm filter in the drip chamber helps retain particles and improves infusion safety.
- Highly transparent drip chamber dome and long drop former (approx. 20 drops ≈ 1 ml) allow easy visual control and accurate drop-rate adjustment.
- New ergonomic roller clamp design improves handling and provides more precise flow regulation.
- Screw-tight luer-lock connector provides secure connection to IV catheters and extension sets.
- Standard IV container spike (IV standard container connector) ensures compatibility with commonly used infusion bottles and bags.
Indications
- Intravenous administration of fluids (e.g. crystalloids, colloids) and medications via peripheral or central venous access.
- Gravity and pressure infusions in general wards, theatres, ICUs, emergency departments and outpatient clinics.
- Situations where closed-system priming, air-infusion prevention and reliable flow control are required in IV therapy.
Composition
- Tubing: medical-grade PVC (DEHP-free in current Intrafix SafeSet configurations).
- Drip chamber: transparent chamber with integrated AirStop filter diaphragm and 15 µm particle filter.
- Protective cap: PrimeStop cap with integrated hydrophobic membrane to prevent fluid leakage during priming.
- Universal piercing spike: medical-grade plastic spike for standard IV containers with bacteria-tight air vent and snap cap.
- Flow regulator: ergonomic roller clamp with integrated tube/spike dock.
- Patient connector: male luer-lock fitting in medical-grade plastic.
- Latex-free construction.
Formulation
- Device type: pressure IV administration set (Intrafix SafeSet LL).
- Application: infusion (administration set).
- Type of administration set: pressure (also suitable for gravity infusion).
- Container connector: IV standard universal piercing spike.
- Set length: 180 cm tubing (approx.).
- Drop factor: long drop former, approx. 20 drops ≈ 1 ml (typical for Intrafix SafeSet).
- Priming volume: approx. 23 ml (manufacturer value for 180 cm SafeSet).
- Pressure resistance: up to approx. 2 bar in accordance with ISO 8536-8.
Packaging
- Each Intrafix SafeSet LL 180 cm is individually packaged in a sterile, peel-open pouch.
- Standard presentation from B. Braun: box of 100 sets (REF 4063000).
- Medisave sells individual sets from manufacturer boxes with full product labelling (brand, REF 4063000, lot number, expiry date and sterile symbols).
- Packaging identifies the set as a pressure administration set with AirStop and PrimeStop safety features.
Usage
- Before use, check that the sterile pouch is intact and within the expiry date; do not use if packaging is damaged or expired.
- Using aseptic technique, open the pouch and remove the administration set.
- Close the roller clamp fully, then insert the universal spike into the IV container according to local protocol.
- If using rigid containers requiring venting, open the bacteria-tight air vent snap cap as directed; keep closed for non-vented use if appropriate.
- Prime the line: fill the drip chamber to the marked level, then open the roller clamp to allow solution to fill the tubing completely. AirStop and PrimeStop facilitate air-free, drip-free priming.
- Once the line is fully primed and free of visible air bubbles, close the roller clamp, then connect the luer-lock patient end to the IV cannula or extension set using aseptic technique.
- Adjust infusion rate by carefully regulating the roller clamp and, if applicable, by setting the compatible infusion pump according to prescribed flow rate.
- Monitor the infusion regularly for patency, fluid level, presence of air, leaks and patient reaction.
- At the end of infusion or when the set reaches its maximum recommended use duration per institutional policy, close the roller clamp, disconnect the set from the patient and container, and dispose of the entire set as clinical waste.
- Do not reuse or re-sterilise the administration set.
Contraindications
- Do not use if the sterile package is damaged, opened or past the expiry date.
- Not intended for arterial, epidural or non-approved routes of administration.
- Do not exceed the specified pressure limit (approx. 2 bar) or use with incompatible pumps or devices.
- Do not use in patients with known hypersensitivity to device materials, although the set is latex-free and DEHP-free.
- Single-use only; reuse or re-sterilisation is contraindicated due to increased risk of infection and device malfunction.
Adverse Effects
- Potential risk of local or systemic infection if aseptic technique and line-change intervals are not properly followed.
- Risk of air embolism if the set is not correctly primed or used contrary to instructions, although AirStop and PrimeStop are designed to minimise this risk.
- Possible infusion failure, occlusion or inaccurate flow if the tubing becomes kinked, the filter or clamp is misused, or if the set is used with an incompatible pump.
- Leakage or disconnection if luer-lock connections are not adequately tightened.
- Very rare hypersensitivity reactions to materials used in the device.
Storage Conditions
- Store in a clean, dry place at room temperature.
- Protect from direct sunlight, excessive heat, cold and moisture.
- Keep in the original packaging until immediately before use to maintain sterility.
- Do not use after the expiry date printed on the pouch and outer carton.
Duration
Used for the duration of one IV infusion episode and replaced according to hospital/clinic line-change and infection-control policies (commonly every 24 hours or as locally specified).
Onset
Immediate; once primed and connected, the set provides IV access for fluid and medication delivery as soon as the roller clamp or infusion pump is opened.
