UniGuide™ CORE IFU
Intended Use
UniGuideTM CORE is a reusable device designed to assist trained ENT specialists in the precise local drug administration in the nose, mouth, and ears using flexible or rigid endoscopes. It enables multi-instrument procedures by allowing the operator additional control during interventions.
Device Description
- UniGuideTM COREhas a hollow titanium body that can accommodate a Braun Omnifix 3 mL syringe (length-compatible), but is also compatible with most other 3 mL syringes and some 2–2.5 mL syringes
- The device features a hand piece for improved operator control and a top rail guide, in which an endoscope up to 5 mm in circumference can be loosely inserted and supported. Pressure applied with the index finger allows controlled manipulation of the endoscope
- UniGuideTM CORE can be used for:
Local anesthesia procedures (e.g., SPG block)
Steroid injections and transtympanic procedures
Local drug delivery using needle or topical administration
Multi-site applications in ENT procedures
The device may accommodate standard accessories such as a suction hose for procedural setup and clinical workflow support
- No part of the device should contact the patient directly; users should wear gloves during handling
Contraindications
- Use only by trained medical professionals
- Do not use with syringes larger than 3 mL unless validated
- Do not use with endoscopes exceeding 5 mm in diameter
- Avoid use if the operator has known allergy to titanium or glove materials used; no patient contact is expected
Warnings and Precautions
- Inspect device and syringe/endoscope compatibility before use
- Do not use if device, syringe, or endoscope exceeds size specifications or is damaged
- Use only as described in the IFU
- Maintain aseptic technique during all procedures
- Follow all local infection control regulations
- Keep out of reach of unauthorized personnel
- Single patient use per handling cycle; device does not require full sterilization post-procedure but should be washed thoroughly
- UniGuideTM CORE is intended to facilitate needle-based or topical drug administration in ENT procedures. The device may additionally accommodate a standard suction hose for procedural setup and handling. Operators should follow standard clinical practice, including aseptic technique. Risks associated with drug administration are inherent to the procedure
- UniGuideTM CORE is made of titanium, a material with documented mechanical strength and corrosion resistance. Titanium can withstand washing and autoclaving up to 120°C without affecting its properties. Short-term contact with the operator’s gloved hands presents minimal risk. Full sterilization is not required post-procedure, but autoclaving may be used if desired
Instructions for Use
- Inspect device for damage and ensure all components are intact
- Insert a compatible syringe or other suitable device (Braun Omnifix 3 mL syringe is recommended; most 3 mL and some 2–2.5 mL syringes may also if within technical specs) into the hollow body
- Connect appropriate tool - such as a needle or a Weiss catheter - to the syringe
- Connect device to a flexible or rigid endoscope up to 5 mm in diameter using the top rail guide
- Apply controlled pressure on the endoscope using the index finger on the rail guide to manipulate and stabilize the scope
- Prepare the local anesthetic or drug according to clinical guidelines
- Insert device according to procedural protocol
- Deliver medication precisely as intended for the procedure
- Withdraw device carefully, maintaining aseptic technique and wearing gloves
Cleaning Instructions
- Wash device thoroughly after use with appropriate cleaning agents
- Full sterilization is not required post-procedure
- Inspect device for integrity before next use
Storage
- Store in a clean, dry place
- Protect from direct sunlight and extreme temperatures
- Keep in original packaging when not in use
Symbols
- CE Mark: Indicates conformity with EU MDR
- Lot: For traceability
Instructions for Use - UniGuideTM CORE
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