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Thomas Select Tube Holder Adult

Thomas Select Tube Holder Adult

Thomas

Medical device / Airway management accessory
  • CE marked — conforms to EU Regulation 2017/745 (Medical Device Regulation)
  • Compliant with EN 1789:2007 (standard for ambulance equipment)
  • Compliant with ISO 13485 (quality management for medical devices), ISO 14971 (risk management), ISO 10993‑1 (biocompatibility)
  • REACH compliant
  • Latex‑free
  • Non‑sterile, single‑use disposable design
Endotracheal tube holder / Airway securing device

Description

The Thomas Select Tube Holder is a disposable airway‑securing device designed to hold and stabilise advanced airway devices (such as endotracheal tubes (ET), laryngeal mask airways (LMAs), and supraglottic airway devices) once inserted. It features a large mouthpiece opening to accommodate wide-bore devices or patients with missing dentures/facial trauma, a suction port for oral access, a wide padded hook-and-loop head strap for secure fit, and a pliable bite block to protect teeth and gums and prevent tube occlusion. It uses a push‑screw mechanism for quick adjustment and a screw clamp plus quick‑release button for secure fixation and easy removal. The product is latex‑free, non-sterile, single‑use (disposable, max 24 h), CE-marked under EU regulation for medical devices, compliant with standards including EN 1789:2007. :contentReference[oaicite:0]{index=0}

Bnefits

  • Secure fixation of advanced airway devices (ET tubes, LMAs, SGAs)
  • Large opening accommodates a wide range of tube diameters (≥ 6.5 mm ID to 42 mm OD)
  • Large mouthpiece surface area — suitable even for patients with removed dentures or facial trauma
  • Suction port allows easy oral access and visualisation of mouth/lip colour
  • Wide padded head strap ensures a stable, comfortable fit even when wet
  • Pliable bite block protects teeth and gums and reduces risk of tube occlusion due to biting
  • Quick‑set push‑screw mechanism and quick‑release clamp enable fast and secure application/release
  • Disposable single‑use design reduces risk of cross‑contamination

Indications

  • Securing endotracheal tubes (ET) after intubation
  • Securing laryngeal mask airways (LMAs) or other supraglottic airway devices (SGAs)
  • Use in patients aged 8 years and older requiring short‑term (less than 24 hours) airway tube fixation
  • Use in pre‑hospital, emergency, and transport settings (e.g. ambulances) compliant with EN 1789:2007

Composition

  • Mouthpiece: Polypropylene (PP)
  • Bite block / foam pads: Polyethylene foam (PE) or polyurethane foam components – see manufacturer materials listing
  • Head strap: Polyester / Nylon / hook-and-loop padded strap (material per manufacturer — typically textile + foam padding)
  • Other components: as per manufacturer specification (non‑latex materials)

Formulation

  • Medical device — single‑use disposable airway tube holder

Packaging

  • Single unit packaging (non-sterile)
  • Also available in 25‑pack cartons (pack code 600‑42500, 25/pkg)

Usage

  • Use only after insertion of the airway device (ET tube / LMA / SGA) into the trachea or supraglottic position.
  • Place the mouthpiece over the tube, adjust head strap to fit securely around patient’s head.
  • Use the push‑screw mechanism to roughly adjust clamp, then tighten screw clamp to secure tube.
  • Ensure bite block is positioned to prevent patient from biting or occluding the tube.
  • If necessary, use suction port for suctioning or oral care, and visualise lip colour / airway patency.
  • Use only in persons aged 8 years or older, limit use to a single patient and non‑reusable.
  • Remove and dispose of the holder within 24 hours of use.
  • Do not reuse, do not attempt sterilisation or disinfection before reuse.

Contraindications

  • Children under 8 years old (device not intended for use under 8 years) :contentReference[oaicite:1]{index=1}
  • Reuse of device (single‑use only)
  • Do not use if any part is damaged or defective
  • Do not over-tighten screw clamp (risk of tube occlusion / airflow restriction) :contentReference[oaicite:2]{index=2}

Adverse Effects

  • Potential risk of airway obstruction if clamp overtightened
  • Risk of pressure injury / skin irritation from head strap if incorrectly positioned or overly tight
  • Risk of oral or dental injury if bite block misaligned (though material is pliable to reduce this risk)

Storage Conditions

  • Storage temperature: −34 °C to +52 °C
  • Operating temperature (during use): −18 °C to +43 °C
  • Store in original packaging, avoid extreme temperatures, do not expose to direct sunlight or moisture before use

Duration

Single\u2011use, for airway tube securing up to 24 hours (short\u2011term airway management only)

Onset

Immediate \u2014 secures airway device upon application

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