Remove the product from the sealed package.
Sterilize the sample location by wiping it with sterilized cotton, and then allow it to dry.
Hold the external case, and press the tip of the white inner case firmly against the fingertip.
Take the blood sample from the incision.
Where to take the sample: We recommend that the sample be taken from the center of the fingertip.
When you hear a “click,” the tip of the needle will protrude for just a moment, and then return to the case.
*Caution: If you do not hear a click, then the incision may not be complete.
Cautions during use
Important basic cautions
●When inserting the needle into a body part with thin tissue (e.g., the earlobe), do not use your finger to support the body part directly behind the insertion point.
[The needle could pass through the tissue, piercing the finger, and creating a risk of infection through blood contact. If there is a possibility of the needle passing through completely, please consider taking a sample from a different body part, with thicker tissue.]
● When taking a blood sample from a newborn child or infant, please take a sample from the thick tissue at the side of the heel.
● Guidance in taking blood samples should be provided by skilled medical staff.
● Please use the product immediately after opening the sealed package.
● Do not use the product if the package is damaged or stained, or if the product itself shows any sign of damage or other abnormality.
● Do not use the lancet after the “Use before” date has expired.
● Do not apply excessive force to the product. [This may damage the product.]
● The tip of the product is extremely sharp. Please handle with care, and store out of reach of children and animals.
● Swallowing hazard: If the product is swallowed accidentally, consult a physician immediately.
● Dispose of used lancets appropriately as “medical waste materials.”
Storage method and period of use
1. Storage method
● Store at room temperature, avoiding dampness, direct sunlight, high temperature, high humidity, and any locations that could result in contamination by chemical substances.
2. Period of use
● The period of use is printed on the external package.
(Verified in-house, using data obtained by Lightnix Inc.)
Shape, structure, and principles
1. Shape and structure
This product is a disposable blood sampling device used for blood tests and similar applications. By making a small incision in a fingertip or other body part, it allows a small amount of blood to be drawn easily. The product comprises a needle with a case that contains an internal spring mechanism. The entire device is sterilized and enclosed in a sealed package.
– Width: 0.25mm, 0.4mm, 0.6mm, 0.8mm
*Needle material: Polylactic acid
The user removes the device from the sealed package, presses the tip of the white inner case firmly against the sampling location (usually the fingertip), and then pushes down on the external case. This causes a spring inside the case to quickly contract and expand, so that a needle, also contained in the case, is pushed forward to pierce the skin. After use, the tip of the needle is pulled back inside the case. The inner and outer cases are then fixed in place so that the device cannot be reused.
Purpose, efficacy, and effects
This product is designed to make an incision to draw a small amount of blood from a fingertip or other body part, for use in blood tests. The product contains a needle to make the incision, as well as a spring mechanism, and so can be used quickly and easily, without the need for other devices.
Immediately after the incision is made, the needle is automatically pulled back inside of the case, so that the product can be disposed of safely and hygienically after use.
– Design of automatic lancet: The needle shall have a mechanism and structure such that the length from the base of the needle to the tip of the blade, and the effective dimension of the needle that is ejected from the protective container (the maximum dimension that enters the skin), is 4.5 mm or less. (JIS T 3257; 5.4)
Contraindications and prohibitions
1. Reuse is prohibited. Please dispose of the product immediately after use. Use a new product for each blood sample.
2. Do not use the product if the seal on the package is open or damaged before use. [Sterility is maintained as long as the package is sealed.]
3. Do not disassemble or modify the device, and do not use the device for any purpose other than drawing blood.
1. Always be sure to sterilize the fingertip or other sample location before drawing blood, as there is a risk of infection.
2. After drawing blood, use a bandage or other means to stop the bleeding.
3. If the incision is slow to heal, apply disinfectant on a regular basis.
4. Do not touch the needle after use. [There is a risk of infection.] Dispose of the device immediately after use.
5. Do not leave the device unprotected after opening the sealed package. [There is a risk that the needle will be ejected by mistake.]