| Certification: | FDA, QS, CCC, ISO, CE |
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| Disinfection: | Disinfection |
| Color: | Transparent |
| Application: | Solving Periocular Issues, Eye |
| Material: | Hyaluronic Acid |
| Name: | Aeter Puri Eyes |
| Samples: |
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Audited Supplier AETER PURI EYES dermal filler Solving periocular issues
AETER PURI EYES CAUTIONS | General precaution | 1) Read the user manual carefully and thoroughly then apply AETER' PURI EYES as stipulated in the manual. 2) Make sure to maintain a state of sterilization throughout the duration of the procedure for application of AETERTPURI EYES. 3) Check the expiration date of AETER" PURI EYES and ensure that products with expired shelf life are not used. 4) Should there be signs of damages or traces of moisture in the container, or damages in the transparency or loss of viscoelasticity of the contents, do not use the product. 5) At the initial stage of the procedure, avoid exposure to high heat or extreme cold until edema and/or fever disappear. 6) Refrain from washing face, shaving and applying make-up up to 12 hours following injection and do not expose the area of application to sunlight, UV, sauna or steam bath for prolonged periods of time within 2 weeks following the injection. |
| Precautions in handling | 1) AETERT"' PURI EYES must be used by storing it at room temperature. 2)Protect from freezing. 3) AETER" PURI EYES must not be re-sterilized and reused as it is a sterilized disposable product. |
| Precautions in application | 1) AETER" PURI EYES must be applied by a doctor who has been sufficiently trained on the application procedure of the product. 2)The doctor must sufficiently explain the indications, prohibitions and potential side effects associated with AETERT PURI EYES to the patient prior to application. 3) Make sure to confirm that the state of sterilization has not been damaged prior to application. 4) Check the expiration date of AETERT' PURI EYES on the label. 5) Avoid applying AETER" PURI EYES to the blood vessel with the possibility of manifesting occlusion(and tissue necrosis as a result). 6) Because it may cause serious side effects including blindness. when it is injected into the blood vessel, injection to the middle of the forehead or around the eyes that has thin skin laver is prohibited. The operator should pay special attention during the injection. 7) Do not apply AETER" PURI EYES until infection or inflammation has been controlled or resolved. 8) Herpetiformis may recur if AETER" PURI EYES is injected into a patient with history of herpetic eruption. 9) Safety on patients with sensitivity towards formation of keloid, hyperpigment- ation and hypertrophic scar is yet to be established. 10) Safety and effectiveness of long-term usage other than the duration stipulated in the clinical study are yet to be established. 11) If needling is difficult, do not increase the pressure on the plunger rod, instead, apply into another site. 12) If the needle is blocked, do not increase the pressure on the plunger rod but stop the injection and replace the needle. 13) The amount injected will depend on the areas which are to be corrected. In particular, injection of an excessive volume can be at the origin of severe edema. |
| Prohibitions | Prohibitions 1)Do not inject into areas around the eyes. 2) Do not inject into the blood vessels. 3) Do not use in the following cases: Patient with the tendency of manifesting hypertrophic scar. Patient with past history of streptococcal diseases. Patient who displays hypersensitivity towards Polynucleotide. 4 Patient with past history of serious allergy and anaphylaxis. Patient with bleeding disorders. 6 Woman who is pregnant or breast-feeding. Minor 4) Do not inject into skin with inflammation or infection. |
| Warning | 1) Make sure to confirm that the state of sterilization has not been damaged prior to application. 2) Check the expiration date of AETERT" PURI EYES on the label. 3) Reusing the product is prohibited. Contamination due to the reuse of AETER" PURI EYES can cause inflammation, infection, edema, pains, etc. 4) AETER" PURI EYES must be applied by those who received training at a level higher than that of a medical expert or those with such qualification. 5) AETER" PURI EYES must be used in an operating room or designated location at which sterile environment is maintained. 6) Do not use AETERT" PURI EYES in an area where clinical safety and effectiveness has not been verified. 7) Do not use in combination with a non-standardized or non-approved medical device. |
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