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Instrumentation medical devices blood glucose meter system, pcba assembly ,electronics contract manufacturing ,OEM CEM EMS manufacturing service, a trust outsource china supplier.

Editor:adminTime:2017-10-23 13:04:50Views:732

Instrumentation medical devices blood glucose meter system, pcba assembly ,electronics contract manufacturing ,OEM CEM EMS  manufacturing service, a trust outsource china supplier with 20 years experience.
 
Topscom is an ISO 9001 & 13485 certified and FDA registered medical device contract manufacturing company. We have been a contract manufacturer of medical device for more than 20 years. We are committed to maintain full compliance in accordance with regulatory requirements.
 
A glucose meter (or glucometer) is a medical device for determining the approximate concentration of glucose in the blood. It can also be a strip of glucose paper dipped into a substance and measured to the glucose chart. It is a key element of home blood glucose monitoring (HBGM) by people with diabetes mellitus or hypoglycemia. A small drop of blood, obtained by pricking the skin with a lancet, is placed on a disposable test strip that the meter reads and uses to calculate the blood glucose level. The meter then displays the level in units of mg/dl or mmol/l.
 
Since approximately 1980, a primary goal of the management of type 1 diabetes and type 2 diabetes mellitus has been achieving closer-to-normal levels of glucose in the blood for as much of the time as possible, guided by HBGM several times a day. The benefits include a reduction in the occurrence rate and severity of long-term complications from hyperglycemia as well as a reduction in the short-term, potentially life-threatening complications of hypoglycemia.
 
There are several key characteristics of glucose meters which may differ from model to model:
 
Size: The average size is now approximately the size of the palm of the hand, although hospital meters can be the size of a remote control. They are battery-powered.
Test strips: A consumable element containing chemicals that react with glucose in the drop of blood is used for each measurement. For some models this element is a plastic test strip with a small spot impregnated with glucose oxidase and other components. Each strip is used once and then discarded. Instead of strips, some models use discs, drums, or cartridges that contain the consumable material for multiple tests.
Coding: Since test strips may vary from batch to batch, some models require the user to manually enter in a code found on the vial of test strips or on a chip that comes with the test strip. By entering the coding or chip into the glucose meter, the meter will be calibrated to that batch of test strips. However, if this process is carried out incorrectly, the meter reading can be up to 4 mmol/L (72 mg/dL) inaccurate. The implications of an incorrectly coded meter can be serious for patients actively managing their diabetes. This may place patients at increased risk of hypoglycemia. Alternatively, some test strips contain the code information in the strip; others have a microchip in the vial of strips that can be inserted into the meter. These last two methods reduce the possibility of user error. One Touch has standardized their test strips around a single code number, so that, once set, there is no need to further change the code in their older meters, and in some of their newer meters, there is no way to change the code.
Volume of blood sample: The size of the drop of blood needed by different models varies from 0.3 to 1 μl. (Older models required larger blood samples, usually defined as a "hanging drop" from the fingertip.) Smaller volume requirements reduce the frequency of unproductive pricks.
Alternative site testing: Smaller drop volumes have enabled "alternate site testing" — pricking the forearms or other less sensitive areas instead of the middle of the fingertips; pricking the sides of the fingertips is actually the least uncomfortable method of testing. Although less uncomfortable, readings obtained from forearm blood lag behind fingertip blood in reflecting rapidly changing glucose levels in the rest of the body.
Testing times: The times it takes to read a test strip may range from 3 to 60 seconds for different models.
Display: The glucose value in mg/dl or mmol/l is displayed on a digital display. The preferred measurement unit varies by country: mg/dl are preferred in the U.S., France, Japan, Israel, and India. mmol/l are used in Canada, Australia, China and the UK. Germany is the only country where medical professionals routinely operate in both units of measure. (To convert mmol/l to mg/dl, multiply by 18. To convert mg/dl to mmol/l, divide by 18.) Many meters can display either unit of measure; there have been a couple of published instances[citation needed] in which someone with diabetes has been misled into the wrong action by assuming that a reading in mmol/l was really a very low reading in mg/dl, or the converse. In general, if a value is presented with a decimal point, it is in mmol/l, without a decimal it is most likely mg/dl.
 
 
 

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