SECURITY

As a manufacturer of medical devices we must satisfy all essential safety and health requirements of the Medical Device Directive EEC/93/42 and the requirements listed in the Appendix I of the Fifth Book (b) of the French Public Health Act. HE.COSTOP is recorded in the EUDAMED file concerning the persons responsible for the marketing of medical devices under the number fr/CA01/0306175V, delivered by the AFSSAPS, Direction of Medical Devices (French Sanitary Body of Ministry of Health). The company HE.COSTOP has at your disposal all declarations of CE conformity as stated in the regulations of the R.665.36 article of the the Fifth Book (b) of the French Public Health Act. These medical devices can be put on the market under the conditions as explained in the articles R.665.7 and R.665.8 of the above mentioned book.

Security advise
When using our products, it is very much recommended to read all instructions for use in order to prevent accidents and this in particular for products as instant cold packs, instant hot packs, reusable cold/hot packs, stop bleeding spray and the nasal plugs. However, all these items have been registered at the 4 anti-poison centers in France (Paris, Lyon, Marseille and Strasbourg.

TECHNICAL CHARACTERISTICS


Composition :  
Ammonium nitrate and water. Activate the instant cold pack by firm squeezing of the pack for pain relief, contusions and distorsions; it is advised not to put in direct contact with the skin in order to prevent from burning. Keep out of reach of children, do not pierce the pack and in case of contact with the eyes or the skin rinse abundantly with water. In case of swallowing it is advised to cause vomiting and to prevent the nearest anti-poison center. In all these cases it is recommended to consult a doctor.


Composition :  
Thiosulphate Sodium, dextrose, water. Activate the instant hot pack by firm squeezing of the pack for pain relief, contractions, tensed muscles and rhumatisms. It is advised not to put in direct contact with the skin in order to prevent from burning. Keep out of reach of children, do not pierce the pack and in case of contact with the eyes or the skin rinse abundantly with water. In case of swallowing it is advised to cause vomiting and to prevent the nearest anti-poison center. In all these cases it is recommended to consult a doctor.


Composition :  
Methyl cellulose , propylene glycol and water. The reusable cold-hot pack is used after storage in freezer as a cold pack for blows, shocks, hematomes and distorsions and as a hot pack after microwave heating or heating in boiled water in case of pain relief, tensed muscles and rheumatisms. It is advised not to put in direct contact with the skin in order to prevent from burning. Keep out of reach of children, do not pierce the pack and in case of contact with the eyes or the skin rinse abundantly with water. In case of swallowing it is advised to cause vomiting and to prevent the nearest anti-poison center. In all these cases it is recommended to consult a doctor.


Active ingredients:  
Calcium salt – sodium extracted from oxidized cellulose – m.doc – 2,5 gr. The spray will stop bleedings very quick. For small cuts spray directly on the cleaned wound. The spray will deposit a fine powder layer that will absorb the blood. In case the bleeding persists, apply some product on a gauze and carry out a light pressure on the wound. Keep out of reach of children and avoid spraying in eyes. In case of contact with eyes rinse abundantly and consult a doctor. Keep out of reach of sun, excessive heat and never apply the spray nearby a flame or smoke. Do not pierce or burn the emptied can.

Stop bleeding nasal plugs
Description :  
PVA foam impregnated with m.doc (microdispersed and oxidized cellulose). The nasal plugs will stop nasal bleedings quickly. The plug will become soft when absorbing blood. Withdraw carefully some minutes after stopping of the bleeding. When applying to children, cut the plug in the desired size with a pair of scissors Warning !!! Do not apply the plugs to children under the age of five. Do not keep the plug longer than one hour in the nose. Consult your doctor in case of prolonged bleeding.