Materials: |
Tube: Transparent polyvinyl chloride (PVC) or polyurethane. |
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Connector: PVC transparent or blue. |
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Pilot balloon: siliconized latex or siliconized PVC |
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Tracheal cuff: siliconized PVC or siliconized latex rubber |
Description: |
Endotracheal tube with cuff, pilot balloon and connector. |
Components: |
- Tube: Murphy type, curved. |
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- Nasal and oral, 37.5° angle. |
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- Continuous X-ray line. |
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- Graduated. |
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- A black position-indicator for correct tube placement, positioned above the pressure cuff. |
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- Patient end: open bevelled (obliquely cut). |
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Tracheal cuff and pilot balloon: |
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- The cuff, situated at the patient end of the tube, provides an airtight seal between the tube and the tracheal wall. It protects the patient’s airway from stomach aspiration. It also allows for effective ventilation during IPPV. |
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The cuff has a low pressure in order to avoid inadequate pressure on the tracheal mucous membrane to prevent damage or even necrosis. |
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The cuff is inflated via a small-bore inflation tube welded to the outside of the tracheal tube or built into its wall. |
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- Pilot balloon: The inflation tube is connected at the proximal end to a small pilot balloon designed to indicate cuff distension. It includes a device for maintaining a preset pressure in the circuit (plug, shut-off valve and non-return valve) with a Luer tip. |
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- Connector: straight, double-ended. |
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Machine end: standard male connector conical, straight, with outer Ø 15mm for connecting a breathing circuit or manual resuscitator. |
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Patient end: a long plain axis, length and diameter according to tube size to ensure a safe fitting. |
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Size: Tubes and connector part, patient end |
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- Nr 4: length +/-210mm, ID 4.0mm, OD +/-6.0mm, cuff Ø 10.5mm |
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Connector, patient end: length minimum 11mm |
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- Nr 5: length +/-250mm, ID 5.0mm, OD +/-6.7mm, cuff Ø 13 mm |
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Connector, patient side: length minimum 12mm |
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- Nr 6: length: +/-290mm, ID 6.0mm, OD +/-8.0mm, cuff Ø 18.5mm |
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Connector, patient end: length minimum 13mm |
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- Nr 7: length +/-320mm, ID 7.0mm, OD +/-93mm, cuff Ø 24mm |
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Connector, patient end: length minimum 16mm |
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- Nr 8: length +/-340mm, ID 8.0mm, OD +/-10.7mm, cuff Ø 26mm |
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Connector, patient end: length minimum 16mm |
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- Nr 9: length +/-350mm, ID 9mm, OD +/-12.0mm, cuff Ø 28mm |
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Connector, patient end: length minimum 16mm |
Unit presentation: |
1 endotracheal tube, sterile, single-use, peel pack. |
Packaging: |
Primary packaging: Sterile peel pack. |
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Labelling should indicate: Manufacturer’s name and trademark, "sterile", lot number, expiry date by year and month, "for single use", CE mark and reference number of notifying body, product description, and instructions for use. Must be multilingual: English, French and Spanish, others when available. |
Storage: |
Store in clean dry conditions; keep away from light and heat. |
Other requirements: |
Comply with Medical Device Directive 93/42/EEC, risk class IIa. |
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Meets following norms: |
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EN 1282-1 norm: Anaesthetic and Respiratory Equipment |
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Tracheostomy Tubes Part 1: Tubes for Use in Adults |
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EN ISO 5366-1:2004 Anaesthetic and respiratory equipment. |
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Tracheostomy tubes. Tubes and connectors for use in adults |