Instructions for acupuncture needles
Description of the products concerned and the performance concerned
Single-use needles for acupuncture practice. Use for practitioners of acupuncture.
- Europa Marco Polo" references: MP E(5) and MP E(10)
- TRADITION Marco Polo" references: MP T (c / s / ct / st / Gold)
- FIVE Marco Polo" references: MP F
- ACUZEN" references: MP Z
- Gamma-sterilised needles in accordance with EN-ISO 11137 series standards.
- Special needles references : MPS / MPA / MP PN / MP SN
EC marking
Medical devices class IIa according to European Directive 93/42
Date of first application of CE marking: 1997
- Do not use if damaged packaging
- Expiry date YYYY-MM
- Single use – should not be reused
- Number of notified body which has validated the CE marking: 0197
- Manufacturer name
- Date of manufacture
- Medical device
- Product Reference (REF)
- Lot number (LOT)
- Store dry
- Keep safe from the sun
- Gamma sterilisation (R STERILE)
Conditions of use
- These needles should be used by qualified practitioners to exercise acupuncture.
- Before use, check the needle flexibility.
- Reject any twisted needle or needle with a tip defect.
Precautions for use
- Take the necessary hygiene precautions before puncture.
- To remove the needle, take precautions to use according to medical rules and pharmacopoeia principles.
- To dispose of the needle, use an approved container and follow existing standards for the recovery of medical waste.
Contraindications
- Avoid disinfecting the skin with products containing a coloured pigment.
- Within hours of punctuation, avoid makeup and colored bath products.
- The needle blade is made of AISI 304 / AFNOR Z7-CN18-Ni10 surgical steel, non-tractable, non-removable components.
- Avoid using needles in patients allergic to Nickel.
Materiality
No known side effects. Any incident, side effect or anomaly observed by the practitioner must be reported to us using the back of this document or any other means.