INNOVATIVE Med Tech Instruction Manual

INNOVATIVE Med Tech

Product Information

Safety Winged Blood Collection Sets

Intended Use: UltraFlo-S Safety Winged Blood Collection Sets are used for the collection of venous blood. The winged needle comes with a safety shield that can be activated post-collection to prevent needlestick injuries.

Optional Package: Pre-attached Tube Holder included for protection against non-patient needle injury and blood splatter, enhancing working efficiency.

Product Description: Single-use, sterile winged needle bonded to flexible tubing with a luer adapter. Sterile and nonpyrogenic.

Specifications

Size| Item| Gauge x Needle Length x Needle Diameter x Needle Color| Tubing Length
---|---|---|---
Safety Winged Blood Collection Set| 21G x 3/4 x 12| 0.8 x 19mm x 305mm Green| 23G x 3/4 x 12
| | 0.6 x 19mm x 305mm Blue| 23G x 3/4 x 7
| | 0.6 x 19mm x 180mm Blue| 25G x 3/4 x 12
| | 0.5 x 19mm x 305mm Orange|

Product Usage Instructions

Storage

Store the device in a dry, ventilated place away from direct sunlight and heat sources.

Handling

Activation of Safety Mechanism: After blood collection, retract the needle by sliding the safety shield forward until locked. Gloves must be worn during handling to minimize exposure hazard.

Blood Collection Steps

1. Remove the protective sheath of the non-patient needle.
2. Secure the Luer adapter into the blood-collection tube holder.
3. Remove the protective sheath of the patient’s needle.
4. Perform venipuncture by holding wings.
5. Apply pressure to the site post-collection.
6. Safety Shield Activation: Use the one-hand technique to lock the safety shield over the needle tip.
7. Disposal: Dispose of all used materials in an appropriate container and wash your hands.

Safety Winged Blood Collection Sets

For use with UltraFlo®-S MFR #s: 281, 283, 285, 287, 292, 294, 296, 297, 298, 652, 653. 654, 655 and 656.

Instructions for Use

INTENDED USE
UltraFlo-S Safety Winged Blood Collection Sets and evacuated blood collection tube/ syringe are used together for the collection of venous blood.The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.
OPTIONAL PKG
 If included, the Pre-attached Tube Holder is designed to aid in protection against accidental non-patient needle injury and blood splatter. It also helps to improve the working efficiency as it eliminates the procedure of holder assembly to the blood collection set.

PRODUCT DESCRIPTION

UltraFlo-S Safety Winged Blood Collection Sets are single-use, sterile, winged needles bonded to flexible tubing with a luer adapter. It’s sterile and non- pyrogenic.

Specifications

Item

| Size|

Color

---|---|---
Gauge x Needle Length x Tubing Length| Needle Diameter x Needle Length x Tubing Length

Safety Winged Blood Collection Set

| 21G x 3/4″ x 12″| 0.8 x 19mmx 305mm| Green
23G x 3/4″ x 12″| 0.6 x 19mm x 305mm| Blue
23G x 3/4″ x 7″| 0.6 x 19mm x 180mm| Blue
25G x 3/4″ x 12″| 0.5 x 19mm x 305mm| Orange

PRECAUTIONS

• Handled by appropriately trained health care professionals.
• Handle all biologic samples and blood collection “sharps” (Lancets, needles, luer adapters and blood collection sets) in accordance with the policies and procedures of your facility.
• Obtain appropriate medical attention in the event of any exposure to biological samples (e.g. through a puncture injury) since samples may transmit viral hepatitis, HIV (AIDS) or other infectious diseases.
• Refrain from carelessly releasing the lock accidentally removing the rubber sleeve, or forcefully pulling the wings, as such actions might damage the integrity of the product.
• Do not forcefully release or re-activate the safety mechanism after it has been activated.
• Keep hands behind the needle at all times during the use and disposal of the device.

CAUTIONS

• Single-use only. Reuse of the product may cause harmful infections, injury or death.
• Gloves should be worn when handling blood collection sets and during venipuncture to minimize exposure hazards.
• Do not use if the package is opened or damaged, the needle is defective, or the safety shield is not firmly assembled.
• Discard all blood collection “sharps” in biohazard containers approved for their disposal.
• Before use, twist the protective plastic sheath covering the patient’s needle and pull it straight off to prevent an accidental needle stick or damage to the needlepoint.
• Before use, twist the protective plastic sheath covering the non-patient needle and pull it straight off to prevent any damage to the rubber sheath or needlepoint.

STORAGE

Store the device in a dry, ventilated place. Avoid direct sunlight and away from the source of heat or ignition.

HANDLING

Activation of Safety Mechanism
After completion of blood collection, remove needle from vein, slide the translucent safety shield forward with the other hand, pulling the tubing backward until an audible click is heard indicating the needle is completely retracted and locked; the safety shield is in the correct place.
GLOVES SHOULD BE WORN WHEN HANDLING BLOOD COLLECTION SET AND DURING VEN IPUNCTURE TO MINIMIZE EXPOSURE HAZARD.

FOR BLOOD COLLECTION

1. Twist the protective plastic sheath of the non-patient needle and pull straight off.

2. Twist the conical fitting of the Luer adapter in a clockwise direction to ensure the Luer adapter is firmly fitted. Thread the Luer adapter completely into a blood-collection-tube holder.

3. Twist the protective sheath of the patient needle and pull straight off.

4. Perform venipuncture by holding wings.

5. After completion of blood collection, apply pressure to site using your fingers as shown.
   Withdraw blood collection set by grasping the translucent safety shield grip area with the thumb and index finger while at the same
   time grasping the tubing between the palm and other fingers.

6. Safety shield activation-one-hand technique: Grasp the translucent safety shield grip area with the thumb and index finger, while at the same time grasping the tubing between the palm and other fingers. Advance the safety shield with thumb and index finger until a click is heard indicating that the safety shield is locked in place over the needle tip.

7. Safety shield activation-modified one-hand technique withdrawal activation: Withdraw blood collection set by grasping the translucent safety shield grip area with the thumb and index finger. With opposite hand, grasp tubing between thumb and index finger while pushing safety shield forward until a click is heard indicating that the needle is completely covered and the safety shield is locked in place.

8. Dispose of all used materials in an appropriate container and wash hands.

FOR BLOOD COLLECTIONUSINGA SYRINGE

1. Remove Luer adapter and attach syringe.

2. Twist the protective plastic sheath of the non-patient needle and pull straight off.

3. Perform venipuncture by holding wings.

4. After completion of blood collection, apply pressure to site using your fingers as shown.
   • Withdraw blood collection set by grasping the translucent safety shield grip area with the thumb and index finger while at the same time grasping the tubing between the palm and other fingers.

5. Safety shield activation-one-hand technique. See step 6 under Blood Collection (above).

6. Safety shield activation-modified one-hand technique withdrawal activation. See step 7 under Blood Collection (above).

7. Dispose of all used materials in an appropriate container and wash hands.

8. Transfer blood specimen from syringe using a blood transfer device.

9. Dispose of all used materials in an appropriate container and wash hands.

FOR SHORT TERM IV ADMINISTRATION [UP TO 2 HOURS)

1.  Remove Luer adapter or Luer cap. Attach IV line or syringe to the Female Luer Adapter.

2. Twist the protective sheath of the patient needle and pull straight off. Prime set in accordance with recommended procedure.
   Gauge| Tubing (inch)| Volume (ml)
   ---|---|---
   21| 12| 0.503
   23| 12| 0.497
   25| 12| 0.496
   23| 7| 0.292

3. Perform venipuncture by holding wings. Administer medication. It is recommended that this device be changed per the institution’s procedures, but no longer than 2 hours.

4. After completion of blood collection, apply pressure to site using your fingers as shown.
   Withdraw blood collection set by grasping the translucent safety shield grip area with the thumb and index finger while at the same
   time grasping the tubing between the palm and other fingers.

5. Safety shield activation-One-hand technique. See Step 6 under Blood Collection (above).

6. Safety shield activation-Modified one-hand technique withdrawal activation. See Step 7 under Blood Collection (above).

7. Dispose of all used materials in an appropriate container and wash hands

Frequently Asked Questions (FAQ)

Q: How should I dispose of the used blood collection set?

A: Dispose of all used materials in an appropriate container following proper disposal guidelines.

Q: Can the Safety Winged Blood Collection Sets be reused?

A: No, the Safety Winged Blood Collection Sets are designed for single- use only to ensure safety and hygiene standards are met.

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