GIMA Professional Medical Products

Product Specifications

Product Main Structure

The safety lancet is made up of a needle core, an elastic device, a launching device and a casing.

Key components include: Cover, Firing spring, Slot, Lancet sea, Lancet, Protective cap, Return Spring, Shell.

Intended Use

The safety lancets are intended for capillary blood sampling to obtain a small blood sample for various tests. They are designed for use by both healthcare professionals and lay users, providing a safe and convenient method for blood specimen collection in clinical and home healthcare settings.

Contraindication

Use with caution in individuals with coagulation mechanism disorders.

Operating Procedure

1. Please read the instructions before use.
2. Wash hands before use. Dry thoroughly.
3. Scrub and disinfect the complete skin surface of the blood collection site with medical disinfectants such as iodine or alcohol etc. Healthcare Professionals should wear gloves prior to disinfecting the lancing site and completing the lancing procedure.
4. Use the safety lancet immediately after opening the primary package.
5. Follow the steps to use the safety lancet to draw blood.
6. Dispose of any used safety lancet to a biohazard waste container. Wash hands after use.

Instructions for Use

1. Wash hands before use. Scrub and disinfect the complete skin surface of the blood collection site with medical disinfectants such as iodine or alcohol etc. Healthcare Professionals wear gloves prior to disinfecting the lancing site and completing the lancing procedure.
2. Twist the protective cap off.
3. Hold the safety lancet against the patient's fingertip and press down gently to draw blood.
4. Push the cap into the used safety lancet reversely until the cap is fully secured and then dispose of it to a proper waste container.
5. Wash hands after use.
6. For paediatric and neonatal patients, first immobilize the child by asking the parent to:
   • Sit on the phlebotomy chair with the child on the parent's lap.
   • Immobilize the child's lower extremities by positioning their legs around the child in a cross-leg pattern.
   • Extend an arm across the child's chest and secure the child's free arm by firmly tucking it under their own.
   • Grasp the child's elbow and hold it securely.
   • Use his or her other arm to firmly grasp the child's wrist, holding it palm up.

Indications for Use

• The safety lancet is a single-use device indicated for capillary blood sampling.
• For single use only. Not to be used on more than one patient. The device is deactivated after single use.

Waring

• For single use only. Not intended for more than one use. Not to be used on more than one patient. The device is deactivated after single use and cannot be used more than once.
• Improper use of safety lancets can increase the risk of inadvertent transmission of blood-borne pathogens, particularly in settings where multiple patients are tested.
• Expiration time is 5 years; using the product beyond the expiration is strictly prohibited.
• The product has no therapeutic or diagnostic function.
• If the lancet protective cap is damaged or lost, please do not use it.
• Use with caution for those with coagulation mechanism disorders.
• For obese users or individuals who require larger blood volumes, it is recommended to choose products with a small "G" value or large puncture depth for blood collection.

Storage and Transportation

1. The device shall be stored in an environment where the temperature is between -20°C and 40°C and the relative humidity is less than 80%. The storage environment shall be free of corrosive gases, dry, away from sunlight, well-ventilated conditions, and clean.
2. The device shall be taken care of during transportation and handling.

Shelf Life

Valid period of product is 5 years.

Clinical Benefit

Helps medical staff and patients complete capillary blood sampling in order to obtain a small blood sample for various tests.

Adverse Events

A search for adverse events and state-of-the-art literature on equivalent and similar devices in the market was conducted. No adverse events were found for equivalent and similar products, indicating compliance with the current technical standards.

If any adverse events occur during the use of the product, please contact Gima S.p.A. to resolve the relevant issues as soon as possible. Additionally, any serious incidents related to the device should be reported to the manufacturer and the competent authority of the Member State where the user and/or patient is established.

Disposal

• The product must be disposed of after use.
• Products contaminated with blood must be disposed of in accordance with the valid regulations for hazardous materials.
• The product must not be used after the expiry date.
• Safe disposal is carried out in accordance with current national regulations.

Warranty

The Gima 12-month standard B2B warranty applies.

Key Symbols and Compliance

• CE 0197: CE Mark with Notified Body number.
• MD: Medical Device.
• ℹ️ [Information]: Indicates important information.
• Temperature/Humidity: Storage conditions specify temperature range (-20°C to 40°C) and relative humidity (<80%).
• STERILE R [Sterilized by Radiation]: Indicates the product is sterilized using radiation.
• [Single Use Device] ??: The device is for single use only and must not be reused.
• ❄️?️ [Store in a cool, dry place]: Recommended storage conditions.
• ? [Humidity Limit]: Indicates the maximum allowed humidity.
• ?️ [Temperature Limit]: Indicates the allowed temperature range.
• ? [Consult Instructions]: Advises users to read the instructions for use.
• ? [Unique Device Identifier]: A unique identifier for the device.
• ? [Lot Number]: Batch or lot number for traceability.
• ?️ [Product Code]: The manufacturer's product code.
• ⚠️ [Do Not Use If Package Damaged]: Warning against using the product if the packaging is compromised.
• ?? [EU Authorized Representative]: Indicates the authorized representative within the European Union.
• ? [Imported By]: Indicates the importer.
• ?️ [Single Sterile Barrier System]: The product uses a single sterile barrier system.
• ✅ [Non-Pyrogenic]: The product is non-pyrogenic.