1 - Registration with Anvisa According to the Cold Network Manual issued by the Ministry of Health:"All products of health interest, national or imported, must be registered by the Ministry of Health, in order to be industrialized, exposed for sale. or delivered for consumption in the Brazilian market. Failure to comply with sanitary legislation characterizes violation of the Federal Sanitary Legislation ". Household refrigerators do not have temperature homogeneity, forced air circulation, alarms, software temperature control and encrypted data, and emergency power outages. The Cold Network Manual highlights: "In this sense, household refrigerators designed for the preservation of food and products that do not require precision in temperature adjustment are no longer suitable for the storage and preservation of immunobiologicals".
2 - About refrigeration equipment, Cold Network Manual (p. 53): "With regard to refrigeration equipment used in the cold chain, considering its intended purpose for the storage of liquids for administration or introduction into the body. according to Rule 2, Annex II of RDC 185/2001, as active product of Class II - Medium Risk. This resolution is reinforced by Normative Instruction IN 7, of June 7, 2010, which lists for use in health that do not fit the registration situation, remaining the obligation of registration, as follows: Item “188.8.131.52 Blood bag freezers and refrigerators, human biological tissues, organs intended for transplantation in humans and fluids to be administered in the It is important to note that registration, a simplified process, applies to equipment classified as: Class I - Low Risk and Class II - Medium Ri sco".
The innovation created by Biotecno is today a reality in the country, for every 10 calls for purchase of equipment for blood storage or vaccines, 9 request the emergency system, creation of Biotecno. Such expressive results have had a significant impact on the quality of the stored material, on the reduction of economic losses with products that are unusable due to poor conservation, on the effectiveness of immunization and, ultimately, our biggest cause, which is to benefit life. For this and other innovations, we are the most awarded medical and scientific refrigeration company in Brazil.
It is a management application that provides performance reports and graphs, including retroactive, allowing the camera management via internet, access via computer, tablet or mobile. Allows remote technical support for programming and configuration adjustments. The stored data is encrypted (tamper proof). The software is free of charge - it's free and always will be.
It allows to evaluate, configure and store temperature and electricity data;
Generates graphs and reports, in addition to sending alert messages to mobile phones and registered emails, if the variables do not meet the established standards;
Allows you to manage equipment parameters from anywhere in the world via the Internet;
It is totally secure (encrypted data transmission).
It is recommended that you purchase a computer close to the machine with the following minimum requirements: internet access and Windows. It also works on computers running the Apple IOS System, but you must virtualize the machine by creating a Windows directory for the program to run.
For external remote access via mobile and fixed devices, release ports 5001 and 5010 for the machine's IP.
Exclusive 10 amp, 110/127 or 220V outlet (depending on equipment voltage) should be provided on the new standard three-pin NBR5410. It is imperative that the outlet be grounded, in accordance with ABNT NBR 5410 electrical installation standard, in order to reduce the voltage variation of the mains, eliminate power leaks and protect users from possible electrical shock. Please be advised that the power cord plug of this equipment complies with the new standard established by NBR 14136 of the Brazilian Association of Technical Standards - ABNT, and by Conmetro Ordinance No. 02/2007. Therefore, if your outlet is still in the old standard, we recommend that you replace and match it with the new NBR 14136 standard. We recommend that the equipment be plugged into an exclusive outlet. Do not use extensions or T-connectors (benjamim).
Keep in a place protected from rain, direct sun and well ventilated. It is recommended that the room in which the equipment is located be heated to a temperature not exceeding 30ºC. It is not advisable to have high heat sources near the equipment such as heaters and greenhouses. If you have more than one camera, the minimum distance between equipment should be 10 cm, and the distance from the camera to the ceiling of the room should not be less than 50 cm. Also note that the cabin containing the cooling set has free air inlet and outlet, without blocking walls or other objects in general. It is also recommended that the floor on which the equipment is to be installed be level.
FIXED LINE PHONE DIALER
All Biotecno Cameras, except portable, are equipped with Fixed Line Telephone Dialer, this system has the function of making telephone calls to up to 6 pre-programmed numbers, whenever the equipment has the internal temperature in critical level (below 2 ° C or above 8 ° C). For fixed dialer installation, a dedicated telephone line or extension must be available on site with RJ11 connection for each equipment.