Spirit i-SENS TEE2 User manual

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
Scope
Operational and Clinical Directorate
Purpose
To ensure that the TEE2 Blood Glucose Monitors are used 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 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
®
TM
®
Spirit Healthcare Ltd.
Spirit 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

PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020
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Table of Contents
Information
Important Information: Read this First! --------------------------------------------- 4
Specifications 6
TEE2 Blood Glucose Monitoring System-------------------------------------------- 7
Inserting or Replacing the Batteries --------------------------------------------------- 8
Caring for Your System 9
TEE2 Blood GlucoseTest Strip 10
TEE2 Blood Glucose Meter 12
TEE2 Blood GlucoseMeter Display----------------------------------------------------13
Preparation
Setting up Your System 14
Adjusting the Date and Time 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 33
Transferring Test Results 34
Additional Functions
Meter Memory 35
Setting the Post-meal Alarm(PP2 alarm)--------------------------------------------38
Maintenance
Understanding Error and Other Messages------------------------------------------39
General Troubleshooting 41
Performance Characteristics 42
Warranty Information 44

PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020
Welcome to the TEE2
Blood Glucose Monitoring System
Thank you for choosing the TEE2 Blood Glucose
MonitoringSystem.Thesystem providesyou withsafe,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.
* No part of this document may be reproduced in any form or by any
means without the prior written consent of i-SENS.
* The information inthis manual iscorrect at the time of printing. However,
i-SENS reserves the right to make any necessary changes at any time
without notice as our policy is one of continuous improvement.

4 www.i-sens.com
www.spirit-healthcare.co.uk 5
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Important Information: Read this First!
To receive safe and optimum system benefits, please read the
entire manual contents before using the system. Please note the
following instructions:
The following chart explains the symbols you’ll find in the
TEE2 Owner’s Booklet, product packaging, and product inserts.
For in vitro diagnostic use
ThisproductfulfillstherequirementsforDirective98/79/
EC on in vitro diagnostic medical devices
Cautions for safety and optimum product use
Consult instruction for use
Do not discard this product with other household-type
waste
Use by (unopened or opened test strip vial)
Manufacturer Temperature limitations
Do not reuse Batch code
Serial number Authorised representative
Important Information
• The TEE2 Blood Glucose Monitoring System is intendedfor
self-testing outside the body (in vitro diagnostic use).
• The glucose in the blood sample mixes with special
chemicals on the test strip to produce a small electrical
current. The TEE2 meter detects this electrical current and
measures the amount of glucose in the blood sample.
• The TEE2 Blood Glucose Meter is designed to minimise
code 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 hypotensive
individuals or patients in shock. Inaccurate low results
may occur for individuals experiencing a hyperglycaemic-
hyperosmolar state, with or without ketosis. Critically ill
patients should not be tested with blood glucose meters.
• Inaccurate results may occur in patients undergoing oxygen
therapy.
Ifyouneedassistance, pleasecontacttheSpiritHealthcare24/7
Freephone Support Line at 0800 881 5423 or go to
www.spirit-healthcare.co.uk.
Intended use:
TEE2 Blood Glucose Monitoring System is used for the
quantitative measurement of the glucose level in capillary whole
blood as an aid in monitoring diabetes management effectively
at home or in clinical settings.
TEE2 Blood Glucose Monitoring System should be used only for
self-testing outside the body (in vitro diagnostic use only). A TEE2
Blood Glucose Monitoring System should not be used for the
diagnosis of diabetes or for testing newborns. Testing sites
include the traditional fingertip testing along with alternate sites
testing on forearm, palm, thigh and calf.