Page 1
Owner’s Booklet Spirit Healthcare Ltd. Unit 3, Dunn House, 15 Warren Park Way, Enderby, Leicester LE19 4SA, UK Customer Support Tel : 0800 881 5423 i-SENS, Inc. 465-6 Wolgye4-dong, Nowon-gu Seoul 139-845, Korea www.i-sens.com Medical Technology Promedt Consulting GmbH, Altenhofstrasse 80, D-66386 St.
Page 2
Welcome to the Blood Glucose Monitoring System Thank you for purchasing the Blood Glucose Monitoring System. The system provides you with safe, convenient and less painful blood glucose in vitro (i.e., outside the body) diagnostic monitoring. You can obtain accurate results in just 5 seconds with a small (0.5 ㎕...
Monitoring System Meter Memory CareSens N Blood GlucoseTest Strip Setting the Alarm Function CareSens N Blood Glucose Meter Maintenance CareSens N Blood Glucose Meter Display Replacing Batteries Preparation Caring for Your System Setting up Your System Understanding Error and Other Messages...
Important Information: Read this First! To receive safe and optimum system benefits, For in vitro diagnostic use please read the entire manual contents before This product fulfills the requirements using the system. Please note the following for Directive 98/79/EC on in vitro instructions: diagnostic medical devices.
Page 5
1. mmol/L may indicate hyperglycemia. • The glucose in the blood sample mixes with special chemicals on the test strip where to If you need assistance, please contact Spirit produce a small electrical current. meter detects this electrical Healthcare or Customer Support at 0800 881 542 for more information.
Weight 51.5 g (with batteries) depending on the place of purchase. Operating ranges • Please contact Spirit Healthcare at 0800 881 542 if any component is missing or damaged. Temperature 10 ~ 40˚C (50 ~ 104˚F) • The cable for data transmission can be ordered...
Blood Glucose Test Strip Blood Glucose Monitoring Warning! System measures blood glucose quickly and • The Test Strip should be accurately. It automatically absorbs the small used only with fresh capillary whole blood blood sample applied to the narrow edge of the samples.
S Button Turns the meter on/off and confirms menu selections Test Strip Port Insert test strip here • Note: The CareSens cable for data transmission to PC can be ordered separately. Please contact Spirit Healthcare at 0800 881 542...
Blood Glucose Meter Display unit for measuring blood glucose appears when test results stored in the memory are displayed appears when the post meal alarm has been set appears during post-meal testing and when postmeal test results are displayed indicates meter is ready for the application of a drop of blood or control solution Month Day Hour Minute appears when the time alarm has been set...
Setting up Your System Press and hold the S button for seconds to through the numbers quickly. After switch on the meter. After all settings are finished, setting the year, press the S button press and hold the S button for seconds to turn to confirm your selection and enter off the meter.
Step 5 Setting the Time Setting the Sound On/OFF The meter can be set in the AM/ Step 8 PM 12-hour or the 24-hour clock On pressing or , the screen format. Press or to select will display the On or OFF. Press a format.
Setting the ‘Test Result Reset’ • Note : (Deleting all the saved test results) At any stage, if the S button is pressed for Step 9 seconds, Time and Date setting mode In this mode all the test results stored in the meter will finish and the meter will be turned off.
Checking the System You may check your meter plus three months) in the space provided on and test strips using the the label. Control Solution. • Make sure your meter, test strips, and Control Solution control solution are at room temperature contains a known amount of before testing.
• Caution : If all the results you get on testing three times continuously are within the range printed on the test strip, the meter and test strips are working properly and you may use them for your blood glucose test. Control Solution Testing Step 1 Insert a test strip into the meter’s...
1. After your control solution work properly. Then, stop using the meter result appears on the display, and contact the Spirit Healthcare at 0800 press for seconds till the 881 542. ‘check’ icon appears on the •...
• Note : Ejection Lancet Adjustable System Control Solution can be Holder purchased separately. Please Contact Spirit Healthcare at 0800 881 542. Sliding Barrel Release Button • The lancing device should be used by one individual. • Use a soft cloth or tissue to wipe the lancing device.
• Caution : To avoid infection when drawing a sample, Step 3 use a lancet only onetime, and: Firmly insert new lancet into • Do not use a lancet that has been used by lancet holder. Hold lancet others. firmly. Gently twist to pull off •...
Step 7 • Note : If you want to attach an post-meal The skin depth to retrieve samples will vary flag ( ) to a test result, press for various people at different sample sites. and hold for seconds after The lance’s adjustable tip allows the best inserting the test strip.
Page 19
Step 9 Step 10 After the symbol appears on the screen, The test result will appear apply the blood sample to the narrow end of the after the meter counts down test strip till the meter beeps. If the confirmation from 5 to 1.
Alternative Site Testing Discarding Used Lancets What is AST(Alternative Site Testing)? Step 1 Usually, when someone tests their glucose, they take Unscrew general lancing the blood sample from the tip of the finger. However, device tip. since there are many nerve endings distributed there, it is quite painful.
Page 21
Things to know when using AST AST Precautions Please understand the following things before testing • Do not ignore the symptoms of hyperglycemia or outside of the fingertip (arms, thighs, calves). hypoglycemia. The capillary blood of the fingertip shows the change •...
Try puncturing again in a smoother area. displayed again on retesting, please contact your healthcare professional immediately. • Note : Please contact Spirit Healthcare Customer Support at 0800 881 542 if such messages are displayed even though you do not have hyperglycemia or hypoglycemia.
Target Blood Glucose Ranges Meter Memory meter can save up to 250 glucose Reminders test results with time and date. If the memory is full, Your target ranges the oldest test result will be deleted and the latest test Time of day from your healthcare expert result will be stored.
Setting the Alarm Function Step 2 Four types of alarms can be set in the Press to view the average value and the meter: one post-meal alarm (PP2 alarm) and three number of tests performed before eating a meal time set alarms (alarm1 ~ ).
Page 25
Setting the Time Alarms (alarm1 ~ ) Step 2 Setting the PP2 alarm OFF Step 1 To turn off the PP2 alarm, press and hold for Without inserting a test strip, seconds. The ‘PP2’character, the bell ( press and the S button icon and then the ‘OFF’...
Replacing Batteries meter comes with two .0 V Step 4 lithium batteries. When the icon appears on On pressing , the number indicating the minute will start the display for the first time, the battery should be replaced as soon as possible. The test results might blinking.
Caring for Your System Use a soft cloth or tissue to wipe the meter exterior. If Step 3 necessary, the soft cloth or tissue might be dipped in a Place the cover on the small amount of alcohol. battery compartment. Do not use organic solvents such as benzene, or Push down until you hear the acetone, or household and industrial cleaners that may...
• Move to an area where the temperature is within the operating range (10 ~ 40˚C/50 ~ 104˚F) and • Note : repeat the test after 0 minutes. If the error messages persist, contact Spirit Healthcare Customer Support at 0800 881 542.
• Repeat the test after inserting the blood a new test strip. sample on the strip. • Note : If the problem is not resolved, please contact Spirit Healthcare Customer Support at 0800 881 542.
Performance Characteristics Accuracy results for glucose concentration≥4.2mmol/L Within ± 5% 45/9 (48%) The performance of Blood Glucose Within ± 10% 88/9 (96%) Monitoring System Strips has been evaluated in laboratory and in clinical tests. Within ± 15% 9/9 (100%) Accuracy: The accuracy of the Within ±...
As a matter of warranty policy, i- SENS will not reimburse the consumer’s purchase price. Obtaining Warranty Service To obtain warranty service, you must return the defective meter or meter part to Spirit Heathcare. Please contact Customer Support on 0800 881 542 for further information.