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Spirit i-SENS TEE2 - User Manual

Spirit i-SENS TEE2
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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
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
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

Questions and Answers

Summary

Welcome to the TEE2 Blood Glucose Monitoring System

Important Information: Read this First!

Intended Use

Details the system's purpose and limitations for blood glucose monitoring.

Important Information

Key operational and safety points for system use and potential issues.

Specifications

Product Specifications

Lists technical details of the TEE2 Blood Glucose Meter and its components.

Operating Ranges

Specifies the environmental conditions suitable for meter operation.

Inserting or Replacing the Batteries

Caring for Your System

TEE2 Blood Glucose Test Strip

TEE2 Blood Glucose Meter

TEE2 Blood Glucose Meter Display

Setting up Your System

Adjusting the Date and Time

Guide to setting the meter's date and time for accurate record-keeping.

Setting the Sound On;OFF

Checking the System

Control Solution Testing

Procedure for verifying meter and test strip accuracy with control solution.

Comparing the Control Solution Test Results

Using the Lancing Device

Preparing the Lancing Device

Steps to prepare the lancing device for blood sample collection.

Preparing the Meter and Test Strip

Marking Post-meal Test Results

Applying Blood Sample

Discarding Used Lancets

Alternative Site Testing

Alternative Site Blood Sampling

Guidance on collecting blood samples from sites other than fingertips.

Things to know when using AST

AST Precautions

HI and Lo Messages

HI Message

Explains the 'HI' message indicating high glucose levels.

Lo Message

Explains the 'Lo' message indicating low glucose levels.

Target Blood Glucose Ranges

Transferring Test Results

Meter Memory

Viewing Test Results Stored in the Meters Memory

How to access and review stored blood glucose test results.

Setting the Post-meal Alarm (PP2 alarm)

Understanding Error and Other Messages

General Troubleshooting

Performance Characteristics

Precision

Details on the precision studies performed on the TEE2 system.

Accuracy

Details on the accuracy studies comparing TEE2 to a lab instrument.

Warranty Information

Obtaining Warranty Service

Instructions on how to get warranty service for the meter.

Spirit i-SENS TEE2 Specifications

General IconGeneral
Measurement Range20-600 mg/dL
Sample Size0.5 μL
Test Time5 seconds
DisplayLCD
Blood SampleCapillary whole blood
Operating Temperature10-40°C
Operating Humidity10-90% RH
Hematocrit Range30 - 55%
Measurement MethodElectrochemical
Battery TypeCR2032
Battery LifeApproximately 1000 tests