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STANDARD OPERATING PROCEDURE DOCUMENT (SOP)
Title
Blood Glucose Monitoring (TEE2 Blood
Glucose Monitors)
Operational and Clinical Directorate
Scope
Purpose
To ensure that the TEE2 Blood Glucose Monitors are used according the
manufactures instructions.
Guidelines TTE2 manual
PROCEDURE
TEE2 blood glucose meters should be used in accordance with the manufacturer's
1
instructions (attached)
If the meter or test strips do not function properly or if you
2
drop or damage the meter then you should undertake a
control test.
Follow the manufacturer's guidance on undertaking the test
and comparing the results.
3
Control tests can be found at Wavertree PC24 Headquarters or at the Litherland
site for the Sefton practices.
PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020
Doc. No. OP0274
/ CL072
RESPONSIBILITY
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Summary of Contents for Spirit i-SENS TEE2
- Page 1 STANDARD OPERATING PROCEDURE DOCUMENT (SOP) Doc. No. OP0274 Title Blood Glucose Monitoring (TEE2 Blood / CL072 Glucose Monitors) Operational and Clinical Directorate Scope Purpose To ensure that the TEE2 Blood Glucose Monitors are used according the manufactures instructions. Guidelines TTE2 manual PROCEDURE RESPONSIBILITY TEE2 blood glucose meters should be used in accordance with the manufacturer’s...
- Page 2 ® ® Spirit Healthcare Ltd. Spirit House, Selbury Drive, Oadby, Leicester, LE2 5NG Customer Support Tel : 0800 881 5423 www.spirit-healthcare.co.uk Medical Technology Promedt i-SENS, Inc. Consulting GmbH 27-36, Gwangun-ro, Nowon-gu Altenhofstrasse 80, D-66386 Seoul 139-845, Korea St. Ingbert, Germany www.i-sens.com...
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Page 3: Table Of Contents
Table of Contents Information Important Information: Read this First! --------------------------------------------- 4 ----- Specifications ---- TEE2 Blood Glucose Monitoring System-------------------------------------------- 7 Inserting or Replacing the Batteries --------------------------------------------------- 8 ---- Caring for Your System ---- TEE2 Blood Glucose Test Strip TEE2 Blood Glucose Meter TEE2 Blood Glucose Meter Display ---------------------------------------------------- 13 ---- Preparation... - Page 4 Welcome to the TEE2 Blood Glucose Monitoring System Thank you for choosing the TEE2 Blood Glucose Monitoring System. The system provides you with safe, fast, and convenient 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 μL) blood sample.
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Page 5: Important Information: Read This First
Use by (unopened or opened test strip vial) Manufacturer Temperature limitations If you need assistance, please contact the Spirit Healthcare 24/7 Do not reuse Batch code Freephone Support Line at 0800 881 5423 or go to Serial number Authorised representative www.spirit-healthcare.co.uk. -
Page 6: Specifications
• Certain components may not be included depending on the place of purchase. Hematocrit 20-60% • Check all the components after opening the TEE2 blood glucose monitoring system package. The exact contents are listed on the main box. 6 www.i-sens.com www.spirit-healthcare.co.uk 7 Downloaded from www.Manualslib.com manuals search engine... -
Page 7: Inserting Or Replacing The Batteries
• Store all the meter components in the portable case to Step 3 prevent loss and help keep the meter clean. Place the cover on the battery compartment. Push down until you hear the tab click into place. 8 www.i-sens.com www.spirit-healthcare.co.uk 9 Downloaded from www.Manualslib.com manuals search engine... - Page 8 Note: • Removing the meter batteries will not affect your stored result. However, you may need to reset your meter settings. See pages 14-16 . 8 www.i-sens.com www.spirit-healthcare.co.uk 9 Downloaded from www.Manualslib.com manuals search engine...
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Page 9: Tee2 Blood Glucose Test Strip
TEE2 Blood Glucose Test Strip The TEE2 blood glucose monitoring system measures Warning! blood glucose quickly and accurately. It automatically absorbs • The TEE2 Test Strip should be used only with fresh capillary the small blood sample applied to the narrow edge of the strip. whole blood samples. - Page 10 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. PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020...
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Page 11: Tee2 Blood Glucose Meter
The cable for data management software can be ordered separately. Please contact your authorised i-SENS sales representative. • The unit of measurement is fixed and it cannot be changed by the user. 12 www.i-sens.com www.spirit-healthcare.co.uk 13 Downloaded from www.Manualslib.com manuals search engine... - Page 12 Do not use the meter if the display screen does not exactly match the illustration as the meter may show incorrect results. 12 www.i-sens.com www.spirit-healthcare.co.uk 13 Downloaded from www.Manualslib.com manuals search engine...
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Page 13: Setting Up Your System
24-hour format. M button to confirm your selection and After selecting the format, press the M progress to setting the month. button to progress to setting the hour. 14 www.i-sens.com www.spirit-healthcare.co.uk 15 Downloaded from www.Manualslib.com manuals search engine... -
Page 14: Setting The Sound On/Off
At any stage, if the M button is pressed for 3 seconds, Time and Date setting mode will finish and the meter will be turned off. Press and hold C to scroll through numbers quickly. 16 www.i-sens.com www.spirit-healthcare.co.uk 17 Downloaded from www.Manualslib.com manuals search engine... -
Page 15: Checking The System
If the meter turns off, remove the strip, reinsert, • If the meter or test strips do not function properly, and start from step 1. • If your symptoms are inconsistent with the blood glucose test 18 www.i-sens.com www.spirit-healthcare.co.uk 19 Downloaded from www.Manualslib.com manuals search engine... -
Page 16: Comparing The Control Solution Test Results
If results continue to fall outside the range printed on the test strip vial, the TEE2 Test Strip and Meter may not be working Note: properly. Do not use your system and contact Spirit Healthcare • The TEE2 Control Solution can be purchased separately. -
Page 17: Using The Lancing Device
• Do not use a lancet that has been used by others. Save disk to recap lancet after use. • Always use a new sterile lancet. Replace lancing device tip. • Keep the lancing device clean. 22 www.i-sens.com www.spirit-healthcare.co.uk 23 Downloaded from www.Manualslib.com manuals search engine... - Page 18 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. 22 www.i-sens.com www.spirit-healthcare.co.uk 23 Downloaded from www.Manualslib.com manuals search engine...
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Page 19: Preparing The Meter And Test Strip
The test result will also be displayed with the recommended. post-meal mark ( ). If you do not want to save the result as a post-meal test, move on to step 8 after step 6. 24 www.i-sens.com www.spirit-healthcare.co.uk 25 Downloaded from www.Manualslib.com manuals search engine... -
Page 20: Applying Blood Sample
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. Good Sample Insufficient Sample 26 www.i-sens.com www.spirit-healthcare.co.uk 27 Downloaded from www.Manualslib.com manuals search engine... -
Page 21: Discarding Used Lancets
Keep holding the lancing device against your skin until sufficient (at least 0.5 μL, actual size: ) blood is drawn. Carefully lift the lancing device away from your skin. 28 www.i-sens.com www.spirit-healthcare.co.uk 29 Downloaded from www.Manualslib.com manuals search engine... - Page 22 If the sample drop of blood runs or spreads due to contact with hair or with a line in your palm, do not use that sample. Two (2) hours after an insulin injection Try puncturing again in a smoother area. 30 www.i-sens.com www.spirit-healthcare.co.uk 31 Downloaded from www.Manualslib.com manuals search engine...
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Page 23: Hi And Lo Messages
Diabetes – 2012.” Diabetes Care. January 2012; 35(1):S11-S63. Note: • Please contact the Spirit Healthcare 24/7 Freephone Support Line at 0800 881 5423 or go to www.spirit-healthcare.co.uk, if such messages are displayed even if you do not have hyperglycaemia or hypoglycaemia. 32 www.i-sens.com www.spirit-healthcare.co.uk 33... -
Page 24: Transferring Test Results
For more from the last 1, 7, 14, 30 and 90 days. information, contact the Spirit Healthcare 24/7 Freephone Support Line at 0800 881 5423 or Viewing Test Results Stored in the Meter’s Memory go to www.spirit-healthcare.co.uk. - Page 25 After checking the stored test result, press the S button to turn off the meter. Step 5 Use the M button to scroll back through the averages seen previously. Press the M button for 3 seconds to turn the meter off. 36 www.i-sens.com www.spirit-healthcare.co.uk 37 Downloaded from www.Manualslib.com manuals search engine...
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Page 26: Setting The Post-Meal Alarm (Pp2 Alarm)
122˚F) and repeat the test after the meter and test strips have reached a temperature within the operating range. PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020 38 www.i-sens.com www.spirit-healthcare.co.uk 39... -
Page 27: General Troubleshooting
• Perform control solution test. Note: Note: • If the problem is not resolved, please contact the Spirit • If the error messages persist, contact the Spirit Healthcare Healthcare 24/7 Freephone Support Line at 0800 881 5423 24/7 Freephone Support Line at 0800 881 5423 or go to or go to www.spirit-healthcare.co.uk. -
Page 28: Performance Characteristics
Performance Characteristics Precision: The precision studies were performed in a laboratory The performance of TEE2 Blood Glucose Monitoring System has been evaluated in laboratory and in clinical tests. using TEE2 BGM Systems. Accuracy: The accuracy of the TEE2 BGM System (Model Within Run Precision GM505KAB, GM505KBB) was assessed by comparing blood Blood avg. - Page 29 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. PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020...
- Page 30 MEMO MEMO PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020...
- Page 31 MEMO MEMO PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020...
- Page 32 PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020...
- Page 33 STANDARD OPERATING PROCEDURE DOCUMENT (SOP) Doc. Title Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) OP0274 / CL072 Version N/A – New SOP Supersedes 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...
- Page 34 PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020...