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Components: |
Tubing |
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Plastic perforator, air inlet and filter. |
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Graduated chamber, injection portal, air filter and security gauge. |
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Drip-counting chamber: Drip counter and filter |
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Flow regulator. |
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Luer-lock connector and cap for connection to vascular system. |
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Tubing: |
Materials: supple PVC, medical grade. |
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Transparent (allows the detection of air bubbles), supple and resistant to kinking. |
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±150cm long (giving the set an overall length of 160-170cm) |
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ID: 3mm |
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OD: 4mm |
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Ends in a Luer-lock connector. |
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Perforator: |
Materials: polyacetate plastic. |
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Hollow device, ends in a piercing spike, situated at the proximal end of the set. |
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Allows connection to a fluid bottle or flexible bag. |
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Comprised of a tapering tube, mounted on a base, ensuring a good seal between the set and the fluid container. |
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Fitted with a protective cap. |
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Air inlet: |
Materials: ABS (Acrylonitrile Butadiene Styrene) |
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Incorporated in perforator base. |
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Fitted with a bacteriological filter. |
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Graduated chamber: |
Materials: polystyrene (without phthalate). |
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Connected to perforator or air inlet with a 15cm tube and clamp. |
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Chamber size 150ml, transparent, graduations every ml. |
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Air inlet with filter on top: |
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- Injection portal on top, with cap. The portal permits the slow intravenous administration of medication, in precise infusion volumes (e.g., quinine, antibiotics, Mg2Cl, KCl, etc.). |
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- The rubber security gauge inside the chamber stops the infusion automatically when the pre-set volume has been dispensed; this prevents air from entering the drip-counting chamber and/or tube. |
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Drip-counting chamber: |
Placed just under the graduated chamber. |
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Drip-counter, metal material, calibrated for 60 drops/ml. |
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Fitted to a 15-20µ polyamide filter (lower chamber end). |
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Flow regulator: |
Materials: ABS (Acrylonitrile Butadiene Styrene). |
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Small wheel, called a roller clamp, situated between the drip-counting chamber and the IV connector. |
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A good-quality roller clamp enables precise fluid regulation by narrowing the tube lumen through compression; it allows the drip to be stop when needed without damaging the tube. |
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Y injection site: |
Allows the injection of emergency drugs into the flow. The Y-site is located at +/- 20cm from IV connection. |
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A Y-shaped rigid plastic tube, with a minimum length of 40mm to avoid tube perforation when inserting a needle. |
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Closed with a tight, non-removable rubber membrane. |
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Terminal connection: |
Mobile Luer lock. |
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With purging filter 0.8µ. |
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Unit presentation: |
1 paediatric infusion set, single-use, sterile, in a peel pack. |
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Primary packaging: |
Labelling: Manufacturer’s name and/or trademark; product description and reference number, "sterile" and method, lot number, expiry date by year and month, "for single use", CE mark and reference number of notifying body, and instructions for use. Must be multilingual: English, French and Spanish, others when available. |
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Secondary packaging: |
Protected unit, one (1) box 25- or 50-unit presentation; labelling is the same as that of the 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.). |
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Storage: |
At temperatures below 30ºC. Protect from humidity. |
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Other requirements: |
Quality must comply with Medical Deice Directive 93/42/EEC (class risk IIa) or equivalent. |