BSi BSICare, User Manual

Page 1: ...User manual Telemedicine System for self testing of glucose ...

Page 2: ...s BSICare bolus application Calculation of the bolus suggestion General recommendations Warnings Bolus suggestion settings and changing the BSICare bolus settings Procedure for the calculation of the suggestion bolus BSICare bolus glycemic diary Care and maintenance Replacing the batteries Control solutions BSICare Warranty Error messages Technical features Symbols Warnings for the healthcare Tabl...

Page 3: ...lood consisting of BSICare application BSICare meter BSICare strips and a device smartphone or tablet Android or iOS In order to use the system correctly you should read carefully the USER MANUAL of the meter and the INSTRUCTION FOR USE of the strips The results are stored in the device s memory and they can be sent to a central server www bsicare it that allows you to manage your data and make it...

Page 4: ... N LOT 0000001 09 2012 X CR1620 BSI are 1 2 3 4 BSICare strips The proper use of the BSICare strips is very important to get accurate results Please observe the following points The strips are sensitive to light and moisture therefore store the strips only in their original vial Protect the vial from direct sunlight and store it at a temperature between 5 and 30 C 41 86 F ...

Page 5: ...trips with wet or dirty hands The BSICare system can use two different ap plications BSICare for the blood glucose measurement and for the management of the glycemic diary BSICare bolus for the blood glucose measure ment for the management of the glycemic diary and for the calculation of the bolus insulin sug gestion The applications WARNING IT IS RECOMMENDED TO DOWNLOAD AND USE ONLY ONE OF THE TW...

Page 6: ...Care applications can be used in two modes 1 OFFLINE Mode 2 OK Mode with login OK OFF LINE 1 OFFLINE Mode without login The OFFLINE mode allows you to perform the measurements and all the subsequent operations including storage in the glycemic diary but does not send any data to the server since it was not logged OFFLINE Warning It is necessary to register on the website www bsicare it in order to...

Page 7: ...ion User Registration Note 1 The first access when in OK mode requires a mandatory data connection 2 The OFFLINE mode is a connectionless mode therefore the processed data are not sent to the server but they remain on the database of the device you are using Such data cannot be exported but only consulted Only in the case of the BSICare bolus application the obtained OFFLINE database can be transf...

Page 8: ... is completely dry Prepare the lancing device contained in the BSICare kit by inserting the sterile lancet needle Carefully read the instruction for use of the lancing device contained within the BSICare kit How to get a drop of blood Use a new not damaged lancet for each blood sampling and use the lancing device only on yourself to prevent crosscontamina tion Before inserting please make sure tha...

Page 9: ...IP INTO THE BSICare fig 4 Take a strip out from the vial and insert it into the meter until it does not go any further with the printed or colored side facing up 7 The display of the smartphone will show the message PRICK A FINGER AND LET ASPIRATE THE BLOOD Figure 5 Prick your finger using the lancing device and the sterile lancet Bring the finger near the end of the strip Let the blood be automat...

Page 10: ...10 3 1 2 3 4 5 6 Start Result Bolus application display ...

Page 11: ...tronic waste IF YOU GET RESULTS WHICH DO NOT CORRESPOND TO YOUR HEALTH CONDITIONS AND TO YOUR FEELINGS RUN THE CHECK OF THE METER USING THE CONTROL SO LUTIONS AND ADVISE YOUR PHYSICIAN IF YOU GET EXTREME VALUES TOO HIGH HI OR TOO LOW LO CONTACT YOUR PHYSICIAN IMMEDIATELY Warnings In a laboratory and in a hospital biological safety procedures in handling potentially infected material must be follow...

Page 12: ...n the phone memory maximum 2000 results Procedure 1 Start the application 2 Click on DIARY 3 Once the list is shown it is possible to filter the performed measures by time slot 4 To go back press the button Glycemic diary 1 2 3 4 ...

Page 13: ...13 Start the application and enter the menu SETTINGS It is possible to change the following parameters Language Unit of measurement Changing the BSICare settings ...

Page 14: ...he bolus suggestion function is important to get a more accurate dose of insulin Calculation of the bolus suggestion Warning the bolus calculation is only a suggested quantity The function bolus suggestion displays automatically the amount of insulin bolus recommended according to the settings agreed together with the diabetologist To carry out the bolus suggestion please set along with your physi...

Page 15: ...drates write 0 in the CHO field It is important not to write any values of carbohydrates if you do not plan to take any carbohydrates after the bolus intake corresponding to the insulin action time to avoid possible states of severe hypoglycemia Meals and doses of insulin taken previously should not be considered in the calculation of the bolus The bolus suggestion function cannot edit mistakes of...

Page 16: ...d select the desired unit of measurement Alarm thresholds the hypoglycemia and hyperglycemia thresholds should be set with your diabetologist The instrument will warn you when the values fall outside the thresholds Time slots Insulin needs vary during the day and the bolus calculation will take this into consideration It is possible to set up seven time slots pre breakfast post breakfast pre lunch...

Page 17: ...e consult your diabetologist to set the glicemy target values necessary for the calculation of the bolus Insulin on board this is the insulin which has already been provided but not yet fully used To calculate correctly the insulin on board it is necessary to set Action Time duration of insulin action and increase of blood glucose after a meal Latency time relative to the time that insulin require...

Page 18: ...value takes into account the preset CHO insulin ratio The bolus correction is the amount of insulin suggestion as a function of the measured blood glucose of the preset glicemy target interval and insulin sensitivity Therefore it is really important to set all the parameters correctly in order to use the bolus suggestion function After setting all the parameters it is possible to use the bolus sug...

Page 19: ...ary by pressing SAVE Carbohydrates The default unit of measurement in the meter is grams WARNING When using the BSICare Bolus application in the connected mode login the parameters for the calculation of the bolus suggestion must be set from the server and not on the device WARNING For the meaning of the configurable parameters please see chapter Bolus suggestion settings and consult your diabetol...

Page 20: ... filter the performed measures by time slot 3 Once the list is shown it is possible to view the details the averages the standard deviations and the related graphics of the measurements Values marked with an N refer to measurements performed with the neonatal blood function enabled 4 To go back press the button BSICare bolus glycemic diary ...

Page 21: ...eter after each measurement with a 70 alcohol solution before proceeding with the next measure ment Warnings If the BSICare meter is too cold or too hot eg after being stored in a car at very low or high temperature please allow it cooling down or heating up slowly at room temperature it takes about 20 minutes Care and maintenance Replacing the batteries The BSICare meter is equipped with a 3V lit...

Page 22: ...rear of the meter 1 Remove the old battery from the plastic support 2 Place the new battery so that the negative pole is facing up 3 Insert and close the battery compartment The battery should be properly disposed Full battery 0344 S N LOT 0000001 09 2012 X CR1620 BSI are Displayed icons Low battery Empty battery or compatibility problems of the smart phone Connection problems ...

Page 23: ...esult obtained must fall within the range printed on the label of the strips vial that you are using In this way it is possible to learn how to use the BSICare meter and at the same time to check if it is working properly Write down the opening date on the vial when the control solution is opened for the first time The control solution should be used within 90 days from the first opening Check if ...

Page 24: ...ement due to defects in some parts and handling Instruments that present defects due to damages caused from improper use alteration negligence technical assistance performed by not authorised personnel accident abuse or by using strips which are different from BSICare will not be replaced Biochemical Systems International Srl reserves the right to apply technical modifications to the BSICare meter...

Page 25: ...ading threshold Insufficient blood volume Solution Please replace the strip with a new one Please disconnect the BSICare meter and repeat the procedure If the error remains please contact the customer service Please check if the BSICare is correctly inserted Replace the battery If the error remains please check the compatibil ity of the device or contact the customer service If the result does not...

Page 26: ...tric and Electronic Waste Simboli Consult instrusctions for use Specifiche tecniche Model Sample volume Reactive strips Range of measurement Reading time Battery Temperature thresholds Humidity thresholds Storage Dimensions Weight BSICare meter 0 5 μL BSICare 20 600 mg dL 1 1 33 3 mmol L 5 seconds 1x3V mod CR1620 10 40 C 50 104 F 10 90 RH 5 30 C 41 86 F 43x30x14 mm 14 g including batteries ...

Page 27: ...e blood Thus they are not recommended for patients on dialysis http www fda gov MedicalDevices Safety AlertsandNotices PatientAlerts ucm177189 htm In the case of patients who are treated with a glucose solution to maintain the blood vessels pervious the measurement of blood glucose both from venipuncture and fingerpricking must be performed on the side opposite to the one where the glucose solutio...

Page 28: ...28 Biochemical Systems International S r l Via G Ferraris 220 52100 Arezzo Italia www biosys it biosys biosys it Tel 0039 0575 984164 Fax 39 0575 984238 0344 MBSIC IT ED2015 Maggio ...