Infusuion set ( جهاز محلول )

Intravenous Device

Description:

The Intravenous Device is a sterile, single-use medical device designed to provide safe and reliable intravenous (iv) access for the administration of fluids, medications, blood products, and parenteral nutrition directly into the bloodstream. Commonly used in hospitals, emergency rooms, intensive care units, clinics, and home-care settings, this device is an essential component of modern intravenous therapy. It typically consists of a peripheral iv catheter (cannula) with an integrated needle, hub, and protective components, which is inserted into a peripheral vein, most often in the arm or hand. The Intravenous Device connects securely to iv tubing, infusion sets, or extension lines and may include a flow regulator, needleless connector, and securement features to ensure accurate dosing, minimize the risk of dislodgement, and reduce infection risk. It is intended for professional use by trained healthcare providers following strict aseptic technique to optimize patient safety and therapeutic outcomes.

Indications:

• Establishing peripheral intravenous access for administration of iv fluids (e.g., crystalloids, colloids) in dehydration, shock, or perioperative care.
• Continuous or intermittent infusion of intravenous medications such as antibiotics, analgesics, antiemetics, and vasoactive drugs.
• Administration of blood and blood products (e.g., packed red blood cells, plasma) under medical supervision.
• Delivery of parenteral nutrition in patients unable to meet nutritional needs orally or enterally.
• Rapid iv access in emergency situations such as trauma, sepsis, or acute cardiovascular events.
• Administration of chemotherapy and other specialized iv therapies as prescribed by an oncologist or specialist.
• Infusion of contrast agents for diagnostic imaging procedures when iv access is required.
• Management of electrolyte imbalances via controlled iv fluid and electrolyte therapy.
• Maintenance of iv access for patients requiring repeated or prolonged intravenous treatment.

Active Ingredients / Key Components:

• Active pharmaceutical ingredients: not applicable (device only; no active drug components).
• Key structural components (typical for an intravenous device; exact materials and dimensions may vary by manufacturer and model and are not specified by name here):
• Peripheral iv catheter (cannula) with introducer needle – typically made of medical-grade polymer (e.g., polyurethane or teflon) and stainless steel needle for vein puncture (exact gauge and length not specified).
• Catheter hub with luer lock or compatible connector – allows secure attachment to iv tubing, extension sets, or needleless connectors.
• Flow control/flow regulator (if included) – enables adjustment of infusion rate for accurate dosing (no specific flow range provided).
• Needleless connector or injection port (if included) – designed to reduce needle-stick injuries and contamination risk.
• Protective cap and/or safety mechanism – helps maintain sterility and may reduce accidental needle-stick risk (exact safety technology not specified).
• Securement interface – designed for use with adhesive dressings, tapes, or securement devices to stabilize the catheter.
• Materials and concentrations of any additives (e.g., lubricants, coatings, plasticizers) are not specified by the manufacturer in the provided information.

Dosage & Administration / How to Use:

• This product is a medical device and does not have a dosage. It must be used by trained healthcare professionals only.
• Preparation:
• Verify packaging integrity and expiry date. Do not use if the sterile pack is damaged, opened, or expired.
• Perform hand hygiene and wear appropriate personal protective equipment (ppe), including sterile gloves when indicated.
• Assemble all required supplies: Intravenous Device, iv fluids or medications, iv tubing/infusion set, antiseptic swabs, tourniquet, sterile dressings, and securement materials.
• Patient preparation:
• Identify patient using institutional protocols and explain the procedure.
• Position the patient comfortably and select an appropriate peripheral vein (usually in the forearm or hand, unless otherwise indicated).
• Apply a tourniquet above the insertion site to engorge the vein. Cleanse the skin with an appropriate antiseptic solution and allow to dry completely.
• Insertion:
• Open the sterile package and maintain aseptic technique.
• Hold the Intravenous Device at the correct angle (usually 15–30 degrees to the skin) and puncture the skin and vein with the introducer needle.
• Advance the catheter gently until blood return is observed in the flashback chamber, confirming venous entry.
• Advance the catheter further into the vein while withdrawing the needle according to the device’s instructions for use.
• Connection and securing:
• Connect the catheter hub to primed iv tubing, extension set, or needleless connector, ensuring a secure, leak-free luer connection.
• Release the tourniquet and open the flow regulator or clamp to confirm patency and appropriate flow.
• Secure the catheter with sterile adhesive dressing and/or a dedicated securement device to minimize movement and dislodgement.
• Monitoring and maintenance:
• Monitor the insertion site regularly for signs of infiltration, phlebitis, infection, or leakage.
• Check the infusion rate frequently and adjust using the flow regulator or infusion pump as prescribed.
• Flush the line according to institutional protocol to maintain patency (e.g., with sterile saline) when not in continuous use.
• Removal:
• Stop the infusion and clamp the iv line.
• Remove dressings carefully, withdraw the catheter smoothly, and apply pressure with sterile gauze until bleeding stops.
• Cover the site with a sterile dressing and dispose of the device and sharps in approved medical waste containers.
• Always follow the specific instructions for use provided by the device manufacturer and institutional guidelines.

Clinical Benefits:

• Provides rapid and reliable intravenous access for life-saving therapies, including fluids, medications, and blood products.
• Enables precise control of infusion rate when used with a flow regulator or infusion pump, supporting accurate dosing and stable hemodynamic management.
• Supports effective treatment of dehydration, electrolyte imbalances, severe infections, and acute medical emergencies by delivering therapy directly into the bloodstream.
• Reduces delays in treatment initiation by facilitating quick iv access in emergency and critical care settings.
• Improves patient comfort compared to repeated needle injections by allowing multiple doses through a single iv access point.
• Designed to integrate with standard iv lines, infusion sets, and hospital systems, enhancing workflow efficiency for healthcare professionals.
• When used with proper aseptic technique and securement, helps minimize the risk of catheter-related complications such as dislodgement and contamination.

Warnings & Contraindications:

• For professional use only. Do not attempt to insert or manage an Intravenous Device without appropriate medical training and clinical supervision.
• Do not use if the sterile packaging is damaged, opened, or past the expiry date, as sterility may be compromised.
• Contraindicated in areas of active infection, severe skin damage, burns, or thrombosed veins at the intended insertion site.
• Use with extreme caution in patients with known bleeding disorders, severe peripheral vascular disease, or compromised venous access; follow specialist guidance.
• Strict aseptic technique must be followed during insertion, handling, and maintenance to reduce the risk of catheter-related bloodstream infections.
• Monitor closely for signs of infiltration, extravasation, phlebitis, thrombosis, or allergic reactions to any device materials; discontinue use and remove the device if complications occur.
• Do not reuse. This device is intended for single use only. Reuse may lead to infection, device failure, or serious patient harm.
• Consult your doctor before use if pregnant, nursing, taking medications, or having medical conditions that may affect venous access or coagulation (e.g., severe liver disease, uncontrolled diabetes, coagulopathies).
• Not intended to diagnose, treat, cure, or prevent any disease by itself; it is a delivery system for prescribed therapies.
• Keep out of reach of children and unauthorized individuals to prevent accidental injury or misuse.

Side Effects:

• Local reactions at the insertion site such as pain, tenderness, redness, or mild swelling.
• Bruising or minor bleeding at the puncture site, especially in patients on anticoagulant therapy.
• Phlebitis (inflammation of the vein), which may present with warmth, redness, and discomfort along the vein.
• Thrombophlebitis or venous thrombosis, potentially causing localized pain, swelling, or a palpable cord-like vein.
• Infiltration or extravasation, where infused fluid or medication leaks into surrounding tissues, leading to swelling, discomfort, or tissue damage (severity depends on the solution infused).
• Infection at the insertion site or catheter-related bloodstream infection, which may present with fever, chills, redness, pus, or systemic signs of sepsis; requires urgent medical evaluation.
• Allergic or hypersensitivity reactions to device materials (rare), potentially causing rash, itching, swelling, or more severe systemic reactions.
• Air embolism if air enters the line and is infused into the bloodstream; this is a medical emergency and requires immediate intervention.
• Nerve or tissue injury if insertion technique is improper or if the device is placed incorrectly.
• Patients or caregivers should seek immediate medical attention if they notice severe pain, sudden swelling, difficulty breathing, chest pain, high fever, or any rapidly worsening symptoms.

Storage Instructions:

Store in a clean, cool, and dry place away from direct sunlight, moisture, and extreme temperatures. Keep the product in its original, sealed packaging until time of use to maintain sterility. Do not expose to sharp objects or crushing forces that may damage the device or packaging. Keep out of reach of children and unauthorized persons.

Specifications:

• Product type: sterile, single-use intravenous access device (peripheral iv catheter with compatible connection).
• Intended use: establishment and maintenance of peripheral intravenous access for infusion of fluids, medications, blood products, and parenteral nutrition.
• Components: catheter with introducer needle, hub/connector, protective cap; may be used with iv tubing, flow regulator, and securement devices (not all components may be included in every configuration).
• Dimensions/gauge: specific catheter gauge, length, and flow characteristics are not provided in the available information (For full ingredient information, please check the product leaflet or the manufacturer’s official website.) and may vary by model.
• Material: medical-grade polymers and stainless steel needle; exact material composition and any coatings are not specified.
• Certifications and compliance: typical intravenous devices are manufactured under medical device regulations (e.g., ce or equivalent), but specific certifications for this product are not stated in the provided data.
• Manufacturer details, exact size, and model number are not available in the current information.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.