Sol-Care Disposable IV Catheters Safety - Ported

Sol-Care™ Safety IV Catheter Closed System is single use indwelling device consists of medical plastics, stainless steel needle, wings and extension sets. The device can be single port and dual port with needle free port. It is used to insert into the human peripheral vascular system for
clinical infusion.
The device features passive safety mechanism that offers protection from needle stick injury after the needle is withdrawn from the patient.

Intended use: The device is intended for short term use in the peripheral vascular and subcutaneous system and provides access for the administration of intravenous fluids, medication, blood derivates or the withdrawal of blood samples. Closed peripheral venous catheter can stay inserted as long as clinically indicated for short term therapy but the only if there is no any sign of phlebitis or catheter occlusion or any signs of complications. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Intended user: Licensed healthcare professionals (HCP).

Cautions:
• Consult instruction for use before using this device
• Users must be trained by a healthcare professional and follow the Instructions For Use.
Failure to follow these instructions could result in serious injury to the patient and/or clinician.
• Sharp object. Risk of sharp injuries.
• Do not use if the unit package is damaged or opened.
• Device for single use only: do not sterilize and/or use again, in order not to compromise its performances or cause possible cross contamination by other patients.

CE0197

Distributed by Sol-Millennium Europe Sp. z o.o. Manufactured by Fujian Bestway Medical Polymer
Corporation, Room 02, 17th Floor, West District of Jinyuan Grand Plaza, No. 68 Guangda Road,
Taijiang District, Fuzhou, 350005 Fujian P.R.China

Sol-Care Safety Winged Infusion Sets are intended for short-term IV medication administration. Each infusion set is equipped with a sliding safety mechanism that is activated after the infusion has completed, helping to prevent needlestick injuries.

Intended use: The Safety Winged Infusion Set is a sterile winged infusion device with tubing and end cap. The device is used for infusion of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needle stick injuries.

Intended user: Licensed healthcare professionals (HCP).

Cautions:
• Mishandling of the device after use may result in blood contamination or a needle stick injury to the user, potentially resulting in blood-born infectious disease.
• Do not use the device within Magnetic Resonance (MR) environment.
• Sharp object. Risk of sharp injuries.

CE 2797

Sol-Care IV Dressing is specifically designed to provide secure catheter stabilization while ensuring patient comfort and clinical efficiency. It effectively holds peripheral venous catheters and other vascular access devices in place, minimizing the risk of dislodgement during movement. The transparent film enables continuous, non-invasive site visibility for early detection of complications such as infection or inflammation.

This dressing acts as a sterile barrier that is waterproof, breathable, and impervious to bacteria and viruses, supporting advanced protection in hospital and outpatient settings. Its skin-conforming material ensures reliable adhesion without causing discomfort, making it ideal for long-term wear. Healthcare professionals benefit from its easy application and removal, enhancing workflow while promoting a positive patient experience.

Key Benefits:

• Gentle, pain-free adhesion

• Ideal for device fixation, wound protection, and skin coverage

• Waterproof and breathable sterile barrier

Wear Time: Up to 7 Days

Indications: Sol-Care IV Dressing is designed to cover, fix and protect IV sites and Wounds from CRBSI (Catheter-related Bloodstream Infection) and related local complications.

Available in two options to meet different clinical needs:

• PU film dressing, a transparent dressing made from high-permeability polyurethane film, with a moisture-permeable medical-grade acrylic adhesive, available in both full film and pre-cut options.

• Non-Woven dressing, featuring an absorbent cotton pad laminated to a spunlaced non-woven material, with a medical-grade acrylic adhesive on glassine release paper.

CE0123

Sol-Care Prefilled Flush Syringes are developed to facilitate the flush procedures as they are ready-for-use which saves healthcare professionals time for preparation. Our unique labelling design provides all necessary information to facilitate easy identification and to help prevent the risk of medication errors. They are compatible with standard luers (ISO standard compliant)* and needle free connectors avoiding needlestick injuries. With its internal sterile fluid path, it is suitable for most of IV procedures that aim to keep the catheter patency. Our 3ml and 5ml products are presented with 10ml diameter barrel which enables a safe and low pressure when flushing the catheters. The stopper is designed in way to reduce blood reflux when in use. Our syringes plunger, flange, tip protection are designed for facilitate handling. Our products are Latex free, DEHP Free, PVC Free, BPA Free, PHT Free.

*EN ISO 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications  -- Part 1: General requirements

EN ISO 80369-7:2021 - Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

EN ISO 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

Indications: for flushing the catheters between intermittent infusions

Intended user: Trained doctors or nurses.

Precautions:

1. The use of the product must meet the requirements of relevant operational specifications and relevant regulations of medical department and be restricted to trained doctors or nurses.

2. Check for package integrity. It is strictly prohibited to use if product package is damaged, or the syringe breaks, leaks, disintegrates.

3. It is strictly prohibited to use if protective tip cap is not installed correctly, loose or falls off.

4. Visual examination for clarity of solution, if solution discoloration, turbidity, precipitation or any form of suspended particulate matter material appears - DO NOT USE.

5. DO NOT RE-STERILIZE.

6. Please use the product within the validity period. The product batch number, production date and expiration date are shown on the product packaging label.

7. It is strictly prohibited to re-use. Single use only, and discard any unused remaining solution.

8. Check the compatibility of 0.9% sodium chloride solution with drugs. Direct contact with drugs incompatible with 0.9% sodium chloride injection is strictly prohibited.

9. It is strictly prohibited to be used for subcutaneous and intramuscular injection and dispensing. Only for flushing of intra-vascular catheters. It is not for medication dilutions, nor for dry product reconstitution.

10. DO NOT PLACE THE PRODUCT ON A STERILE FIELD.

11. Do not use if you are allergic to the sodium chloride solution

Safety - Straight

Sol-Care Safety IV Catheters are developed to provide a vascular access to patients and at the same time reduce the risk of needle stick injuries. They are single-use indwelling device consisting of medical plastics, stainless steel needle and passive safety needle tip protection. Available in two versions: straight with and without wings. Both versions are offered with soft polyurethane material, clear flashback chamber, anti-slips ribs and tab that helps on the catheter insertion and advancement with no technique change required by the user. They are designed to stand high pressure injection, up to 300psi. They are also color-code for easier catheter gauge identification, They are intended to be inserted into a patient’s peripheral vascular system for short term use of blood sampling or fluids administration.

They are compatible with ISO luers. Our products are Latex free, DEHP Free, non-toxic, non-pyrogenic and latex free

Indications: IV access to peripheral vascular system indicated for short term use to sample blood or administer fluid.

Intended user: Healthcare professional.

Precautions:

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/injur y.

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 fitting is removed, and a direct connection is made.

17. The patency of the catheter system must be assured immediately before power injecting. Measures should be taken to avoid kinking or obstructing the catheter system during power injection to avoid product failure.

18. Use with power injector pressure greater than 300 psi may cause product leakage and/or damage to the product.

19. 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.

Safety - Straight with wings

Sol-Care Safety IV Catheters are developed to provide a vascular access to patients and at the same time reduce the risk of needle stick injuries. They are single-use indwelling device consisting of medical plastics, stainless steel needle and passive safety needle tip protection. Available in two versions: straight with and without wings. Both versions are offered with soft polyurethane material, clear flashback chamber, anti-slips ribs and tab that helps on the catheter insertion and advancement with no technique change required by the user. They are designed to stand high pressure injection, up to 300psi. They are also color-code for easier catheter gauge identification, They are intended to be inserted into a patient’s peripheral vascular system for short term use of blood sampling or fluids administration.

They are compatible with ISO luers. Our products are Latex free, DEHP Free, non-toxic, non-pyrogenic and latex free

Indications: IV access to peripheral vascular system indicated for short term use to sample blood or administer fluid.

Intended user: Healthcare professional.

Precautions:

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 fitting is removed, and a direct connection is made.

*Please include "Notes - Table Straight"

17. The patency of the catheter system must be assured immediately before power injecting. Measures should be taken to avoid kinking or obstructing the catheter system during power injection to avoid product failure.

18. Use with power injector pressure greater than 300 psi may cause product leakage and/or damage to the product.

19. 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.

Sol-Care Safety IV Catheters are developed to provide a vascular access to patients and at the same time reduce the risk of needle stick injuries and blood exposure. They are single-use indwelling device consisting of medical plastics, stainless steel needle and passive safety needle tip protection. The notch presented in the needle enables a quick blood return visualization. Available in straight with wings version. They are offered in soft polyurethane material, clear flashback chamber, anti-slips ribs and tab that helps on the catheter insertion and advancement with no technique change required by the user. They are dsigned to stand high pressure injection, up to 300psi. They are also color-code for easier catheter gauge identification, It is intended to be inserted into a patient’s peripheral vascular system for short term use of blood sampling or fluids administration. Their blood control feature, will prevent blood exposure immediately upon needle removal reducing the risk of bloodborne pathogens contamination.

They are compatible with ISO luers. Our products are Latex free, DEHP Free, non-toxic, non-pyrogenic and latex free

Indications: IV access to peripheral vascular system indicated for short term use to sample blood or administer fluid.

Intended user: Healthcare professional.

Precautions:

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 fitting is removed, and a direct connection is made.

17. The patency of the catheter system must be assured immediately before power injecting. Measures should be taken to avoid kinking or obstructing the catheter system during power

injection to avoid product failure.

18. Use with power injector pressure greater than 300 psi may cause product leakage and/or damage to the product.

19. 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.