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POCTech CT3 Series - User Manual

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CT3 Series Continuous Glucose Monitoring System
User Manual
for Serial Models: CT3, CT3A, and CT3C
Zhejiang POCTech Co., Ltd.
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Summary

1. Introduction

Manual Overview and Guidelines

Covers foreword, manual purpose, liability, eIFU, and software info.

1.4 Label Symbols

Explains various symbols used in the manual and on the device.

2. Safety Statement

2.1 Read the User Manual

Emphasizes reading the entire manual before system use for safety.

2.2 Label Symbols

Defines various symbols used on the device and packaging.

3. Basic Product Information

Product Name, Models, and Principle

States product name, lists models, and explains working principle.

3.4 Method of Calibration

Describes the factory calibration and optional user calibration process.

3.5 Product Components

Details the hardware and software components of the CT3 models.

4. Performance Characteristics

Performance Specifications

Details warm-up time, sensor life, glucose range, and operating conditions.

4.14 CT3 Clinical Data

Presents key performance data from clinical trials.

5. Operating Procedures

5.1 Prepare Your Transmitter

Outlines steps for preparing the transmitter for use.

5.1.1 Transmitter Cleaning

Instructions for cleaning the transmitter's contact pins.

5.1.2 Transmitter Charging

Details how to charge the transmitter before use.

5.2 Prepare Mobile Phone

Steps to prepare the mobile device for the system.

5.2.1 Application Login

Guide to logging into the AnytimeWell application.

5.2.2 Profile Setup

Instructions for setting up user profile information.

5.3 Connect Transmitter to Phone

Details the process of pairing the transmitter with the phone.

5.4 Sensor Warm-up

Explains the sensor warm-up process and QR code scanning.

5.5 Prepare Skin Site

Instructions for preparing the skin site for sensor application.

Sensor Site Preparation Details

Covers checking sensor package, selecting site, and cleaning.

5.6 Insert Sensor and Remove Applicator

Guides on inserting the sensor and removing the applicator.

5.7 Attach Transmitter to Sensor

Details how to attach the transmitter to the sensor.

5.8 AnytimeWell Main Interface

Introduces the main screen and data display of the application.

5.9 Sensor Calibration

Explains factory calibration and optional user calibration.

5.9.2 Start New Calibration

Guides on initiating a new calibration entry.

5.9.3 Enter Blood Glucose Value

Instructions for entering measured blood glucose values.

Calibration Warnings

Alerts about potential errors during calibration.

5.10 Log Events

Details how to record events like diet, medicine, and exercise.

5.11 End Monitoring Session

Explains automatic termination and confirmation at session end.

5.11.2 Sensor Removal Instructions

Instructions for safely removing the sensor.

5.11.3 Skin Check After Removal

Guidance on checking the skin after sensor removal.

5.11.5 Transmitter Reusability and Cleaning

Information on transmitter reusability and cleaning.

5.12 AnytimeWell Setup

How to configure high and low glucose alert thresholds.

5.12.2 Notification Settings

Instructions for customizing notification settings.

5.12.3 CGM Interface and Termination

Accessing CGM interface, viewing transmitter SN, and forced termination.

5.12.3.3 Unbound Device Status

Explains the "No device connected" status after unbinding.

5.13 View Glucose Report

How to view daily glucose readings and historical data.

5.13.2 Data Report Access

Instructions for accessing sensor session data reports.

5.13.2.1 Select Sensor Session

Guide on selecting the desired monitoring period.

5.13.2.2 Device Information

Details on viewing device-specific information.

Monitoring Results and Graphs

Presents monitoring results, panoramas, and trend graphs.

Highs and Lows Analysis

Displays daily highs/lows and time percentages.

Glucose Level Distribution

Shows the distribution of glucose levels across different ranges.

Sharing Data Reports

Instructions on sharing data reports and lists.

5.13.3 AGP Report

How to view and share the Ambulatory Glucose Profile report.

5.14 Other Sub-menus

How to access and edit personal profile information.

5.14.2 Help Center

Accessing help resources for followers.

5.14.3 Settings Overview

Overview of settings for app and account management.

5.14.4 Logout Procedure

Steps to log out of the current account.

5.14.5 Glucose Unit Settings

How to change the units for glucose readings.

5.14.6 Share Data with Followers

Instructions for sharing monitoring data with chosen followers.

5.14.6.1 Invite Followers

Guide on inviting new followers to share data.

5.14.6.2 Check Followers List

How to view lists of invited followers and notifications.

5.14.6.3 Follower Setup

Managing follower settings and sharing preferences.

6. Waste Disposal

Disposal Guidelines

Covers sensor and component disposal according to regulations.

7. Notifications and Troubleshooting

Alert Types and Troubleshooting

Covers alerts for current, battery, glucose levels, and connection issues.

Troubleshooting Caution

Critical advice for timely alerts and app operation.

8. EMC Declaration

Emissions and Interference Guidance

Explains emissions compliance, interference, and operating guidance.

Electromagnetic Immunity Guidance

Details immunity test levels and environmental guidance.

RF Immunity and Separation

Explains RF immunity levels and recommended separation distances.

Recommended Separation Distances

Provides guidelines for separation distances from RF equipment.

9. Product Information

Codes, Dates, and Service Life

Details product codes, dates, and service life for components.

10. Maintenance, Storage, and Shipping

Maintenance Procedures

General maintenance guidelines for device components.

Transport and Storage Conditions

Specifies environmental conditions for transport and storage.

11. Accessories and Consumables

12. Product Classification

12.1 Transmitter Classification

Classifies the transmitter based on safety and operation.

13. EU Radio Equipment Directive (RED)

14. Warranty

14.1 Contact and Service Info

Provides contact information for after-sales service.

14.2 Website Reference

Mentions the website for warranty information.

Warranty Details and Coverage

Covers warranty description, coverage, duration, and exclusions.

Making a Warranty Claim

Steps and requirements for submitting a warranty claim.

15. AnytimeFollow Setup Guide

1. Login to AnytimeFollow

Guide for users to log in to the AnytimeFollow application.

2. Add Sharer

Instructions for adding other users to share monitoring data.

3. Sharers List

Displays a list of shared users and their monitoring status.

4. Notifications List

Shows received and sent notifications regarding data sharing.

5.1 Real-time Follow View

How followers view real-time glucose monitoring results.

5.2 Daily View for Followers

How followers view daily glucose readings and charts.

5.3 Follower Settings

Accessing settings for followers, notes, and notifications.

5.3.1 Urgent Low Alert for Followers

Explanation of the urgent low alert for followers.

5.3.2 Low Alert for Followers

How followers can manage low glucose alerts.

5.3.3 High Alert for Followers

How followers can manage high glucose alerts.

6. Follower Profile Setup

Followers setting up their profile information.

7. Follower Unit Settings

How followers can adjust unit settings for glucose readings.

8. Follower Help Center

Accessing help resources for followers.

9. Follower About Information

Information on software updates and legal policies for followers.

10. Follower Account Management

Followers managing their account and password.

11. Follower Logout

How followers log out of their account.

POCTech CT3 Series Specifications

General IconGeneral
Sample TypeCapillary whole blood
Measuring Time5 seconds
Measuring Range1.1 mmol/L - 33.3 mmol/L (20 mg/dL - 600 mg/dL)
Operating Temperature10°C - 40°C
Operating Humidity10% - 90% RH
Hematocrit Range30% - 55%