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PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020

STANDARD OPERATING PROCEDURE DOCUMENT (SOP)

Title

Blood Glucose Monitoring (TEE2 Blood Glucose Monitors)

Doc.
No.

OP0274
/ CL072

Version

Supersedes

N/A

– New SOP

Approving Managers/Committee Clinical Directorate
Date Ratified

November 2020

Department of Originator

Medicines Management

Responsible Executive Director

Medical Director

Responsible Manager/Support

Head of Medicines Management

Date Issued

November 2020

Next Review Date

November 2021

Target Audience

Operational Clinical Directorate Staff

Version

Date

Control Reason

Accountable
Person for this
Version

November

2020

New SOP

Head of Medicines
Management

Reference documents

Electronic Locations

Locations for Hard Copies

Primary Care 24 Intranet /
Corporate Policies/ Current
SOPS/ ……

Standard Operating
Procedures File in the Call
Centre.

Document Status: This is a controlled document.
Whilst this document may be printed, the electronic version maintained on the PC24
Intranet is the controlled copy. Any printed copies of the document are not
controlled.

Summary of Contents for i-SENS TEE2

Page 1: ...d according the manufactures instructions Guidelines TTE2 manual PROCEDURE RESPONSIBILITY 1 TEE2 blood glucose meters should be used in accordance with the manufacturer s instructions attached 2 If the meter or test strips do not function properly or if you drop or damage the meter then you should undertake a control test Follow the manufacturer s guidance on undertaking the test and comparing the...

Page 2: ...t House Selbury Drive Oadby Leicester LE2 5NG CustomerSupportTel 08008815423 www spirit healthcare co uk i SENS Inc 27 36 Gwangun ro Nowon gu Seoul 139 845 Korea www i sens com Medical Technology Promedt Consulting GmbH Altenhofstrasse 80 D 66386 St Ingbert Germany 2015 i SENS Inc All Rights Reserved PGC8E3060 REV0 03 2015 ...

Page 3: ...e 14 Setting the Sound On OFF 17 Checking the System 18 Control Solution Testing 19 Comparing the Control Solution Test Results 21 Testing Using the Lancing Device 22 Preparing the Lancing Device 23 Preparing the Meter andTest Strip 25 Marking Post mealTest Results 25 Applying Blood Sample 26 Discarding Used Lancets 28 Alternative Site Testing 29 HI and Lo Messages 32 Target Blood Glucose Ranges 3...

Page 4: ...ood glucose in vitro i e outside the body diagnostic monitoring You can obtain accurate results in just 5 seconds with a small 0 5 μL blood sample No part of this document may be reproduced in any form or by any means without the prior written consent of i SENS Theinformationin this manualiscorrect atthetime of printing However i SENS reserves the right to make any necessary changes at any time wi...

Page 5: ...e related errors in monitoring by using the no coding function The TEE2 Blood Glucose Meter should be used only withthe TEE2 Strip An abnormally high or low red blood cell count hematocrit level over 60 or below 20 may produce inaccurate results If your test result is below 3 3 mmol L or above 13 3 mmol L consult a healthcare professional immediately Inaccurate results may occur in severely hypote...

Page 6: ...included depending on the place of purchase Check all the components after opening the TEE2 blood glucose monitoring system package The exact contents are listed on the mainbox Reported result range 1 1 33 3 mmol L Sample size Minimum 0 5 µL Test time 5 seconds Sample type Fresh capillary whole blood Calibration Plasma equivalent Assay method Electrochemical Battery life 5 000 tests Power Two 3 0 ...

Page 7: ... batteries are inserted firmly Step 3 Place the cover on the battery compartment Push down until you hear the tab click into place Caring for Your System Use a soft cloth or tissue to wipe the meter exterior If necessary the soft cloth or tissue might be dipped in a small amount of alcohol Do not use organic solvents such as benzene or acetone or household and industrial cleaners that may cause ir...

Page 8: ...ww spirit healthcare co uk 9 Downloaded from www Manualslib com manuals search engine Note Removing the meter batteries will not affect your stored result However you may need to reset your meter settings See pages 14 16 ...

Page 9: ...y whole blood samples Do not reuse teststrips Do not use test strips past the expiration date Test strips in new unopened vials and test strips in vials that have been opened can be used up until the expiration date printed on the test strip box and vial label if the test strips are used and stored according to its storage and handling methods Store test strips in a cool and dry place at a tempera...

Page 10: ...toring TEE2 Blood Glucose Monitors v1 November 2020 Caution Keep the meter and testing supplies away from young children The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation ...

Page 11: ...are displayed Mute symbol appears only when the sound is set to OFF check appears when the control solution test results are saved or displayed Blood insertion M Button Turns the meter on off and confirms menu selections Test Strip Port Insertteststrip here C Button Selects or changes information meal testing and when post meal test results are displayed mmol L unit for measuring blood glucose Mon...

Page 12: ...ib com manuals search engine Note It is recommended to check if the display screen on the meter matches the illustration above every time the meter turns on Do not use the meter if the display screen does not exactly match the illustration as the meter may show incorrect results ...

Page 13: ...ar Press and release C button to adjust until the correct year appears Press and hold C button to scroll through the numbers quickly After setting the year press the M button to confirm your selection and progress to setting the month Step3SettingtheMonth A number indicating the month will be blinking on the left corner of the screen Press C button until the correct month appears PresstheMbuttonto...

Page 14: ... in the following instances if set to On When the test strip is inserted in the meter When the blood sample is absorbed into the test strip and the test starts When the test result is displayed When you push the M button or C button to turn on themeter When you push the C button to set the post meal PP2 alarm When it is time for a preset blood glucose test If the sound is set to OFF none of the so...

Page 15: ... clean Close the control solution bottle tightly and store at a temperature of 8 30 C 46 86 F You may do a control solution test When you want to practice the test procedure using thecontrol solution instead of blood When usingthe meterforthe first time Wheneveryouopen a new vialof test strips If the meteror test stripsdo not function properly If your symptoms are inconsistent with theblood glucos...

Page 16: ...tion bottlewas not shaken well When the meter test strip or the control solution were exposed to high or low temperatures When the first drop of the control solution was not discarded or the tipof the bottle was not wiped clean When the meter is notfunctioning properly Repeat the control solution test by referring to the Notes on page 18 When the control solution is past the expiration date printe...

Page 17: ... Button Sliding Barrel Step 2 The lancing device should not be used by more than one individual Ensure the lancing device is not shared among different users Use a soft cloth or tissue to wipe the lancingdevice If necessary a small amount of alcohol on a soft cloth or tissue may be used Unscrew and remove the lancing device tip Step 3 Firmly insert a new lancet into the lancet holder Hold the lanc...

Page 18: ...spirit healthcare co uk 23 Downloaded from www Manualslib com manuals search engine Note Repeated puncturing at the same sample site may cause pain or skin calluses thick hard skin Choose a different site each time you test ...

Page 19: ...Be careful not to bend the test strip The symbol will appear on the screen Step 7 If you want to attach a post meal mark to a test result press and hold C for 3 seconds after inserting the test strip The post meal mark and the symbol will appear on the screen The test result will also be displayed with the post meal mark If you do not want to save the result as a post meal test move on to step 8 a...

Page 20: ... filled in time because of abnormal viscosity thickness and stickiness or insufficient volume the Er4 message mayappear It is recommended that the application of blood sample to the test strip be performed virtually vertical to the sample site as shown in the diagram below Step 10 The test result will appear after the meter counts down from 5 to 1 The result will be automatically stored in the met...

Page 21: ...nt parts of the body is called Alternative Site Testing While AST may reduce the pain during testing it may not be simple for everyone and the following precautions should be observed during testing Alternative Site Blood Sampling forearm palm thigh calf Select a clean soft and fleshy sample site area free of visible veins and hair and away from bones Gently massage the sample site to help blood c...

Page 22: ...r healthcare professional Do not rely on the AST results for changing your treatment method The amount of glucose in alternative sites differsfrom person to person Before using AST please consult your healthcare professional When your glucose levels are unstable During the two 2 hours after a meal or exercise When sick or when glucose levels seem quite lower than test value When hypoglycaemia is n...

Page 23: ...ional Lo appears when a test result is less than 1 1 mmol L and indicates severe hypoglycaemia very low glucose levels If Lo symbol is displayed again on retesting please contact your healthcare professional immediately ExpectedValues Therangeofanormalfasting bloodglucose level for non diabetic adults isbetween 3 9 5 5 mmol L Two 2 hours after a meal the range of a normal blood glucose level for n...

Page 24: ...ate If the memory is full the oldest test result will be deleted and the latest test result will be stored The TEE2 Meter calculates and displays the averages of total test results pre meal test results and post meal test results from the last 1 7 14 30 and 90 days Viewing Test Results Stored in the Meter s Memory Step 1 Press the C or M button to turn the meter on The current date and time will b...

Page 25: ...reen for 2 seconds followed by the 1 day average value and the number for the last test period ofthetestresultssavedwithin the currentday Thenumberoftests withinthecurrentday Step5 Use the M button to scroll back through the averages seen previously Press the M button for 3 seconds to turn the meter off Step 2 UsetheMbutton to scrollthrough thetestresults startingfrom themostrecentandendingwith th...

Page 26: ...screen Step 2 Setting the PP2alarm OFF To turn off the PP2 alarm press and hold C for 3 seconds The PP2 character the alarm symbol and then the OFF character will appear on the screen Then the screen will change automatically to the memory check mode without the alarm symbol being displayed alarm disappears Understanding Error and Other Messages Message What It Means What To Do A used test strip w...

Page 27: ...trip Repeat test after inserting a TEE2 test strip There is a problem with the meter contact the Spirit Healthcare 24 7 Freephone Support Line at 0800 881 5423 or go to www spirit healthcare co uk Problem Troubleshooting The display is blank even after inserting a teststrip Check whether the test strip is inserted with the contact bars facing up Check if the strip has been inserted completely into...

Page 28: ...efficient r 0 992 Number of sample 122 Range tested 2 2 32 1 mmol L Precision The precision studies were performed in a laboratory using TEE2 BGM Systems Within Run Precision Blood avg 2 3 mmol L SD 0 1 mmol L Blood avg 4 4 mmol L SD 0 2 mmol L Blood avg 7 2 mmol L CV 2 6 Blood avg 11 2 mmol L CV 3 1 Blood avg 19 4 mmol L CV 2 7 Total Precision Control avg 2 0 mmol L SD 0 07 mmol L Control avg 6 5...

Page 29: ...ective meter or meter part that is covered by this warranty As a matter of warranty policy i SENS will not reimburse the consumer s purchase price To obtain warranty service you must return the defective meter or meter part along with proof of purchase to your nearest Spirit Healthcare Please contact Customer Support on 0800 881 5423 for further information ...

Page 30: ...PC24 SOP OP0274 CL072 Blood Glucose Monitoring TEE2 Blood Glucose Monitors v1 November 2020 MEMO MEMO ...

Page 31: ...PC24 SOP OP0274 CL072 Blood Glucose Monitoring TEE2 Blood Glucose Monitors v1 November 2020 MEMO MEMO ...

Page 32: ...PC24 SOP OP0274 CL072 Blood Glucose Monitoring TEE2 Blood Glucose Monitors v1 November 2020 M E M O ...

Page 33: ...ead of Medicines Management Date Issued 5th November 2020 Next Review Date November 2021 Target Audience Operational Clinical Directorate Staff Version Date Control Reason Accountable Person for this Version v1 November 2020 New SOP Head of Medicines Management Reference documents Electronic Locations Locations for Hard Copies Primary Care 24 Intranet Corporate Policies Current SOPS Standard Opera...

Page 34: ...PC24 SOP OP0274 CL072 Blood Glucose Monitoring TEE2 Blood Glucose Monitors v1 November 2020 ...

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