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Components: |
Tracheal tube: |
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Cuff and balloon: low pressure. |
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External pilot balloon and pressure cuff indicator. |
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Connector, standard size (external Ø 15mm). |
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Fixation flange. |
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Neck tape and band |
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Materials: |
Tracheotomy tube: siliconized polyurethane or polyvinyl chloride (PVC). |
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Neck tape and adjustable elastic band. |
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Tracheostomy tube made of thermo-sensitive PVC; provides sufficient rigidity for initial insertion, and then softens at body temperature to accommodate patient’s anatomy. |
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The tracheotomy tubes are standardized in terms of dimensions. |
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Tracheal tube. |
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Tube: angled +/- 90°, with open atraumatic end. |
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Tracheal cuff and balloon: located near the distal end:
- Prevents air leakage and stomach aspiration. |
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- Profile (high volume, low pressure) cuff. The cuff dynamically adjusts the pressure and points of contact during the breathing cycle, minimizing the potential for tracheal trauma. |
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- Connector: tube proximal end with standard connection (external Ø 15mm) |
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- Fixation flange: with all tube size indications. |
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- External pilot balloon: indicates cuff’s inflation status and is connected to a shut-off valve/ non-return valve to maintain the requested pressure in the trachea; connection for syringe: Luer tip. |
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- Built in X-ray radio-opaque line to confirm the tube’s position. |
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Attachment system: adjustable collar (cotton). |
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No inner cannula. |
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Tube size: Nr 6, length 64mm, ID 6.5mm, OD 8.7mm, cuff Ø 19mm |
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Tube size: Nr 7, length 70mm; ID 7.5mm, OD 10mm, cuff Ø 21mm |
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Tube size: Nr 8, length 81mm; ID 8.5mm, OD 11.3mm, cuff Ø 28mm |
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Tube size: Nr 9, length 87mm; ID 9.5mm, OD 12.7mm, cuff Ø 28mm |
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Individual sterilized peel packs made of paper and/or plastic. |
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Unit presentation: |
1 tube, sterile packed in a hard peel-pack container, single-use. |
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Packaging: |
Unit presentation: packed in a hard peel-pack container.
Labelling should mention: Manufacturer’s name and/or trademark, "sterile", batch/lot number, expiry date by year and month, "for single use", CE mark and reference number of notifying body, and product reference number and description. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: |
Protected unit, one (1) box with 5- or 10-unit presentation, labelling is the same as that of primary packaging. |
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Additional required information: Number of units per secondary packaging, information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.), and user instruction leaflet. Must be multilingual: English, French and Spanish, others when available. |
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Outer packaging: |
Packaging unit strong carton. |
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Quality requirements: |
Must comply with Medical Device Directive 93/42/EEC, risk class IIa requirement. |
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Meets norm EN 1282-1: 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 |