Nipro 4Sure Smart Duo, Owner'S Manual

Page 1: ...Sure and Simple OWNER S MANUAL Blood Glucose Ketone Monitoring System IDEAL FOR...

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Page 3: ...tone Testing 9 7 Control Solution Testing 13 8 Reviewing Test Results 16 9 Transferring Data 17 10 Maintenance 18 11 Important Safety Instructions for Healthcare Professionals 20 12 Reference Values 2...

Page 4: ...he test Carry out all the quality control checks as directed Keep the device and testing supplies away from young children Small items such as the battery cover batteries test strips lancets and vial...

Page 5: ...re professional before use 3 Introduction Intended Use This system is intended for use outside the body in vitro diagnostic use by people with diabetes at home and by health care professionals in clin...

Page 6: ...ength of the current produced by the reaction depends on the amount of glucose or Ketone in the blood sample Product Overview 10 Bluetooth Indicator 4 Battery Compartment 5 Display Screen 6 Down Butto...

Page 7: ...The meter turns on automatically once a new battery is inserted 2 Start with the meter off no test strip inserted Press and hold and at the same time for five seconds Step 2 Configuring the Settings D...

Page 8: ...matically Absorbent Hole Apply a drop of blood here The blood will be automatically absorbed Confirmation Window This is where you confirm if enough blood has been applied to the absorbent hole in the...

Page 9: ...l the orange bar appears on the release button window Important To reduce the chance of infection Never share a lancet or a lancing device Always use a new sterile lancet Lancets are for single use on...

Page 10: ...owing times During a pre meal or fasting state more than 2 hours since the last meal Two hours or more after taking insulin Two hours or more after exercise To obtain a blood sample from the alternati...

Page 11: ...punctured area to obtain another drop of blood Be careful NOT to smear the blood sample The volume of blood sample must be at least 0 5 microliter L for blood glucose test 4 Apply the blood sample Mo...

Page 12: ...lancing device after you have finished testing Discard your used strip and lancet properly in a puncture resistant container Important The used lancet and test strip may be biohazards Please consult...

Page 13: ...cause in accurate results 3 Remove the code strip the display will show indicating the device has finished coding and is ready for Ketone testing Ketone Test Strip Appearance Absorbent Hole Apply a d...

Page 14: ...ow Important To reduce the chance of infection Never share a lancet or a lancing device Always use a new sterile lancet Lancets are for single use only Avoid getting hand lotion oils dirt or debris in...

Page 15: ...he pre set lancing device to puncture your desired site After penetration discard the first drop of blood with a clean tissue or cotton Gently squeeze the punctured area to obtain another drop of bloo...

Page 16: ...ure your meter and test strips are working correctly 2 4SURE Ketone control solution level 1 2 This solution contains a known amount of Ketone that reacts with the 4SURE Ketone test strips and is used...

Page 17: ...ange printed on the test strip vial and it should fall within this range If the test result is out of range read the instructions again and repeat the control solution test 6 5 8 8 4 The meter will de...

Page 18: ...n onto a strip 3 Read and compare the result After counting down to 0 the test result of the control solution will appear on the display Compare this result with the range printed on the individual fo...

Page 19: ...lts with and displayed on the screen Your 7 day average result measured in general mode will appear on the display 2 Press or to review 7 14 30 60 and 90 day average results stored in each measuring m...

Page 20: ...Bluetooth on your 4SURE meter will automatically deactivate after 2 minutes Note While the meter is in transmission mode it will be unable to perform a blood glucose or Ketone test Make sure your devi...

Page 21: ...attery does not affect the test results stored in memory Keep the battery away from small children If swallowed promptly seek medical assistance Battery may leak chemicals if unused for a long time Re...

Page 22: ...strips beyond the expiry date This may cause inaccurate results Do not bend cut or alter a test strip in any way Keep the strip vial away from children since the cap and the test strip may be a chokin...

Page 23: ...uideline Third Edition Clinical and Laboratory Standards Institute CLSI M29 A3 Control Solution Test Control solution tests shall be performed regularly between specific time intervals or after a cert...

Page 24: ...the test strip slot pointing down and wipe the area around the test slot but be careful not to allow excess liquid to get inside Use two or more wipes if necessary 4 Remove the wipe Allow the meter s...

Page 25: ...actice Recommendations Diabetes Care 35 Supplement 1 S1 100 Reference Value for Ketone test If you do a blood Ketone test lower than 0 6 mmol L is a normal reading 0 6 to 1 5 mmol L means you re at a...

Page 26: ...temperature limitation Use by CE Mark Batch code Manufacturer Serial number Dispose of the packaging properly after use Keep away from sunlight Caution consult accompanying documents Keep Dry Sterili...

Page 27: ...tivity for data sharing transfer 0 70 HCT Wide Haematocrit range of 0 70 for blood glucose testing ISO ENISO15197 2015 Device meets and exceeds current ISO standard EN ISO 15197 2015 Ketone Beta Keton...

Page 28: ...s below appear please call your local customer service Do not attempt to repair the device yourself and never try to disassemble the device under any circumstances Result Readings for blood glucose te...

Page 29: ...e test with a new strip If problem persists contact the local customer service for assistance You may have removed the strip after applying blood or insufficient blood volume Review the instructions a...

Page 30: ...evice is automatically turned off Repeat the test with a new test strip Apply sample only when flashing appears on the display Defective device Please contact customer service The control solution tes...

Page 31: ...ortation Condition Meter 20 C to 60 C 4 F to 140 F below 95 R H Test Strip 2 C to 30 C 35 6 F to 86 F below 85 R H Measurement Units Fixed mmol L Measurement Range 0 5 33 3 mmol L for glucose test and...

Page 32: ...dicated on the labeling ii any repairs alterations or other work has been performed by the buyer or others on such item other than work performed with Nipro Diagnostics UK Ltd authorisation and accord...

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Page 36: ...No GD87 For self testing and point of care testing of whole blood glucose and Ketone Distributed by Nipro Diagnostics UK Ltd Unit 12 14 South Point Ensign Way Hamble Southampton SO31 4RF United Kingd...