Sol-Care Tip-Lock Safety IV Catheter



Intended use: SOL-CARE Tip-Lock Safety IV Catheter is intended to be inserted into a Patient’s peripheral vascular system for short term use to sample blood or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA devices are suitable for use with power injectors set to a maximum pressure of 300 psi when access ports not suitable for use with power injectors are removed.

Intended user: Healthcare professional.

Cautions:
1. For proper use, clinicians must be trained in the practice of venipuncture and follow the INSTRUCTIONS FOR USE.

2. Observe Standard Precautions on all patients.

3. Aseptic technique, proper skin preparation, and continued protection of the insertion site are essential.

4. Product is sterile, non-toxic and non-pyrogenic unless package has been opened or damaged.

5. This product is DEHP free. This product does not contain natural rubber latex.

6. Single use only. Do not re-use.

7. Do not bend the needle when using the catheter system.

8. Do not use scissors at or near the insertion site.

9. Do not attempt to override or defeat the needle shielding mechanism.

10. Report needle sticks immediately and follow established protocol.

11. Immediately dispose of any needles that fail to shield, keeping the needlepoint away from the body and fingers at all times.

12. Do not attempt to reinsert a partially or completely withdrawn needle back into the catheter.

13. Re-use may lead to infection or other illness/injury.

14. Connectors used in conjunction with the product must comply with ISO 80369-7.

15. Luer connections should not be left unattended due to potential of disconnection.

16. If the Disposable IV Catheter is indicated for power injection, catheter systems are suitable for use with power injectors set to a maximum pressure of 300 psi and within maximum flow rate recommendations (see table), when the vent plug is removed and a direct connection is made.

17. The patency of the catheter system must be assured immediately before power injecting.

18. Measures should be taken to avoid kinking or obstructing the catheter system during power injection to avoid product failure.

19. Use with power injector pressure greater than 300 psi may cause product leakage and/or damage to the product. Ensure that the injector is properly calibrated and will automatically stop at a pressure which exceeds 300 psi.

20. When power injecting through the device with a luer adapter with dual port, replace any needleless cap on the unused port with a dead-end cap and tighten.

21. Flush the device using sterile normal saline prior to and immediately following the completion of power injection.

22. It is recommended that the device be changed according to facility policy or if the integrity of the device has been compromised.

23. Follow current institutional policies and procedures for catheter insertion, maintenance and removal.

24. The device can be used in the MRI environment.

CE 0197

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