ChemoSet is a piece of equipment or infusion line made of polyethylene, plasticizer DEHP free and with a 0.22 micrometers filter. This product is ideal for the infusion of chemotherapy paclitaxel.
Specification: The 0.22 µm ChemoSet filter is supplied by Pall Corporation, a global leader in the segment for high quality manufactured products. The ChemoSet IV infusion line is made of polyethylene internally and externally coated with PVC plasticized with TOTM [tris (2etilexil) trimellitate].
The polyvinyl chloride (PVC) is a plastic polymer commonly used in medical devices. When free of plasticizers, PVC is somewhat flexible and of easy fragmentation in ambient temperature. A plasticizer is usually employed to increase the flexibility of the polymer. The di (2-ethylhexyl) phthalate (DEHP) is used as plasticizer in PVC medical devices. However, DEHP can migrate from the plastic to the (parenteral) solutions in contact. The exposure to DEHP has produced various adverse effects in laboratory animals, but the ones of greatest impact are concerns related to the development of the male reproductive system, and abnormal sperm production in young animals.
Technical Specification: Product manufactured in polyethylene with a 0.22 µm filter. Sterilization by ethylene oxide.
Infusion Line: polyethylene (in contact with the drug). Outer portion (without contact with the drug): PVC-free DEHP. This device is compatible with paclitaxel, docetaxel, etoposide, teniposide.
Maximum flow rate: 12mL/minute, approximately.
This device is indicated for parenteral drug infusion, fulfilling the function of conducting fluid contained in the reservoir to the patient’s vascular access.
This product should be stored at room temperature in a cool place, protected from light and moisture. This product is sterile, of SINGLE use and should not be reprocessed.
INSTRUÇÕES DE USO
- 1. Close the roller clamp of the infusion line.
- 2. Fill the drip chamber with the solution to be administered.
- 3. Fill the infusion line slowly.
- 4. When the solution is near to the connector luer lock or the filter (on models equipped with this device), close the clamp-roller.
- 5. When the filter is present, hold it in the highest position and slowly fill it with the solution.
- 6. If air bubbles are observed, open the clamp-roller carefully to restore the flow, agitate the infusion line gently and filter and let it flow to remove the bubbles.
- 7. When the infusion line is free of bubbles, close the roller clamp, and connect the patient’s vascular access.
- 8. Open the roller clamp, and adjust the flow rate according to the necessity.
- Attention, single use. It is not possible to make the product sterile after use.
- Before use, check for leaks.
- Do not use the product if packaging is damaged or after the expiration date.
- The drilling of the equipment or infusion line can cause air embolism.
- Do not use with blood components or blood products.
- Before use, check the compatibility and the physical and chemical stability of drugs with the manufacturing materials of the device.