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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Publisher
Zhejiang POCTech Co., Ltd.
No.1633 Hongfeng Road, Building 11 & 12
Huzhou City 313000, Zhejiang, China
Version: 20220424
Document No.: A4-CGM14-004
Protective Note
Zhejiang POCTech Co., Ltd. reserves all rights to these operating instructions. Without the consent
of Zhejiang POCTech Co., Ltd. these operating instructions may neither be reproduced nor made
accessible to third parties. The same applies to individual parts or excerpts of these operating
instructions.
Violations give rise to a claim for damages and may have criminal consequences.
This User Manual is subject to change without notice. This User Manual may be changed without
prior notice, in which case a new version of the User Manual will be issued.
The device bears the CE mark indicating its conformity with the provisions of Council Directive (EU)
2017/745 concerning medical devices and meets the essential requirements of Annex I of this
regulation.
The CT3 series continuous glucose monitoring systems are manufactured by Zhejiang POCTech Co,
Ltd.

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Table of Contents
1. Introduction ..............................................................................................................1
2. Safety Statement.......................................................................................................2
3. Basic Product Information.........................................................................................6
4. Performance Characteristics .....................................................................................7
5. Operating Procedures ...............................................................................................8
6. Waste Disposal........................................................................................................27
7. Notifications and Troubleshooting..........................................................................27
8. EMC Declaration......................................................................................................28
9. Product code / batch number, manufacturing date and service life.......................33
10. Maintenance, Storage and Shipping .......................................................................33
11. Accessories, Peripherals and Consumables ............................................................34
12. Product Classification..............................................................................................34
13. EU Radio Equipment Directive (RED) ......................................................................34
14. Warranty .................................................................................................................34
15. Annex : AnytimeFollow setting-up guide ................................................................36

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1. Introduction
1.1 Foreword
Dear Users,
Please make sure that you carefully read the User Manual included with your CT3 series real time
continuous glucose monitoring (rtCGM) system before use to gain a full understanding of the instructions for use
and all indications, contraindications, warnings, precautions and cautions. Always keep the User Manual for future
reference. If you have any questions or difficulties regarding the use of your CT3 series, please do not hesitate to
contact us. You are encouraged to report any events of concern to us.
An "event of concern" refers to an event that directly or indirectly had, would have, could have, or may have
any of the following consequences:
•harm to the user or any other person;
•a serious public health hazard.
You will find our contact information in Imprint at the beginning of the User Manual.
1.2 What the User Manual is for?
The instructions described in the User Manual is for the use of POCTech’s CT3 series（contains CT3,CT3A,CT3C）
rtCGM. The contents of the User Manual are subject to change without notice.
1.3 Limits on POCTech’s liability obligations
POCTech shall not be liable for any personal injury or damage caused by failure to use the CT3 series rtCGM
System and its components according to the instructions for use and all indications, contraindications, warnings,
precautions, and cautions, including but not limited to:
improper use (e.g., use with protective covers removed, use without indications etc.)
improper maintenance (e.g., intentional damage to cables or electrodes, unauthorized repairs or
modifications etc.)
1.4 Label symbols
A WARNING provides important information about a potentially hazardous situation that, if not avoided, can
have serious consequences.
A CAUTION provides important information about a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury to the user or damage to the medical device or other property.
A NOTE contains additional information to avoid malfunctions during operation.
1.5 eIFU
You can get the latest version of User Manual at www.poctechcorp.com.
1.6 Software basic information
1.6.1Software name：AnytimeWell,AnytimeFollow
1.6.2 Software operating environment

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IOS
Android
Typical hardware configuration:
CPU
2.5GHz
2.0GHz
Memory
3GB
4GB
Hard disk
64GB
64GB
Display
1792*828
1920*1080
Bluetooth
4.0
4.0
Typical sardware configuration:
OS IOS13 compatible version
OS Android7 compatible version
2. Safety Statement
2.1 Read the User Manual
Read the entire User Manual before you use your CT3 real time continuous glucose monitoring (rtCGM)
system. In case of any questions regarding the use of your CT3, please contact healthcare professionals (HCP). You
will be able to learn the instructions of use, and all indications, contraindications, warnings, precautions, cautions
and other important safety information by a careful read of the User Manual.
Warning
● CT3 is not a life sustaining device or a life support device. You may remove the sensor in case of device failure. If
you are feeling unwell that may be associated with abnormal glycemic levels, use a finger glucose meter to double
check. Failure to do so may result in severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
that leads to diabetic complications.
● Sensors are shipped and stored in sterile packages. Keep the sensor in sterile packaging until you are ready to
use it. Early opening may cause microbial contamination.
● Do not ignore hyper- or hypoglycemia symptoms. When experiencing low/high glucose symptoms, use your
blood glucose meter to confirm.
● Skin abnormalities such as wounds, scars, redness, swelling or infection may affect sensor attachment and
functioning.
● If you have anemia and abnormal hematocrit levels, fingertip blood glucose (BG) measurements may be
unreliable.
● When calibration is necessary, please use only authorized glucose meters.
● Entering wrong finger BG values for calibration will result in erroneous CGM readings.
● If a calibration is needed, do not calibrate when blood glucose is rapidly changing, as it may result in unreliable
readings.
● Carry your mobile phone at all times to maintain a smooth data communication. You won’t be able to receive
real time alerts when communication link is lost.
●The transmitter and sensor combined is IP58 certified (immersion in water at 2.5m for 1 hour). However，due to
variation in the adhesion level in different people, it is strongly recommended that you do not expose the

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transmitter-sensor in water for extended periods of time .
● Avoid vigorous physical activities or bumps. It may cause complete or partial detachment of the sensor, resulting
in unreliable readings.
●Remove the transmitter and sensor when you have to undergo MRI examinations.As it may cause interruptions
to other medical electrical equipment under extreme circumstances. Avoid strong magnetic field. See details in
the Electromagnetic Compatibility (EMC) Statement.
● Place the sensor not less than 5cm from your insulin pump infusion set or injection site.
● Do not misuse CT3 components with components of other systems. Do not connect your CT3 to other devices
or networks. Refer to manufacturer’s declaration of sensor compatibility.
● Used sensors should be handled according to local regulations for disposal of blood-contacting components to
avoid cross-infection.
● The transmitter, charger and power adapter are electronic devices. Do not wash with water. Do not use them in
humid environment or in strong electromagnetic field.
● Medical devices that do not comply with IEC 60601-1 standard should not be connected to the system.
● Do not let children have access to your CT3 without adult supervision. Do not swallow the small components
that may pose a choking hazard.
Note
● Read the User Manual before you use your CT3 real time continuous glucose monitoring (rtCGM) system. If you
have any questions, please contact HCP or our customer service.
● The transmitter must be fully charged before every use.
● Protect the sensor from coming off the skin. A few people may have skin conditions that tend to cause premature
peeling off of the adhesive, resulting in unreliable monitoring. Use an additional medical adhesive to protect the
sensor when necessary.
● Avoid excessive sweating as it may cause sensor failure. Poor contact, sweating and water ingress may lead to
abnormal readings. Remove the sensor if sustained abnormal readings are observed associated directly with
physical activities or sweating.
● There are no special requirements regarding the maintenance of the transmitter ,charger and power adapter.
Clean them with alcohol pads if the surface becomes dirty. Dry completely before use.
● Charge your transmitter using Type-C USB cable and either the adapter included with your CT3 or any IEC 60601-
1 certified adapters.
● The CT3 rtCGM system contains no parts that require user repair. Please contact the manufacturer or your agent
for any problem. Do not open the device, replace or modify parts.

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2.2 Label symbols
Figure or Symbol
Definition
Figure or Symbol
Definition
Consult instructions
Type BF applied part
Refer to instruction
manual
DC current
Sterilized using
Irradiation
Non-ionizing irradiation
Do not re-use
Do not dispose in unsorted municipal
waste stream
Do not use if package
is damaged
Temperature limits (2 ~ 30 ℃)
IP58
Water proof level
IP58
USB port
Do not re-sterilize
Class II equipment
Keep away from
sunlight
Keep dry
This side up
Transmitter stacking limit
Date of manufacture
Warning
Use-by date
Batch code
Manufacturer
Authorized representative in the
European Community/European
Union

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Figure or Symbol
Definition
Figure or Symbol
Definition
Single sterile
barrier system with
protective packaging
outside

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2.3 Intended Use
The CT3 real time continuous glucose monitoring (rtCGM) system is intended for use in persons age 14 years
and older by providing real-time continuous readings, graphs and alerts of interstitial fluid glucose levels.
Interpretation of the CT3 rtCGM System results should be based on the glucose trends and several
sequential readings over time. It is intended for single patient use.
2.4 Indications
T2D or T1D patients 14 years and older or other patients in need of glucose trend monitoring.
2.5 Contraindications
Remove the system for magnetic resonance imaging (MRI)
If you are at risk of bleeding or skin ulcers, allergic to disinfectants or medical adhesives, or have sensitive
skin, talk with your physician and use your CT3 under his or her guidance.
3. Basic Product Information
3.1 Product Name
Continuous Glucose Monitoring System
3.2 Models
CT3/CT3A/CT3C
3.3 Working Principle
Glucose in the interstitial fluid reacts with glucose oxidase in the sensor membrane, producing hydrogen
peroxide which in turn reacts at the sensor electrode to generate electrochemical current signal. The current is
proportional to the tissue glucose concentration. The electric signal is converted to numerical values to represent
glucose levels.
3.4 Method of Calibration
The CT3 series sensors feature factory calibration. The factory calibration information is coded in the QR code
which is printed on the sensor base (visible after opening the sterile packaging).
User calibrations are generally not required. However, user calibration using finger blood glucose is available
during monitoring if so desired.
3.5 Product Components
Table 1. Components for CT3 serial Models
Model
Hardware
Components
App-Software
Components
Accessories
CT3
Sensor CT-302
Transmitter CT-300D
AnytimeWell
AnytimeFollow
Transmitter Charger
Type-C USB Cable
Power Adapter
(optional)）
User Manual
CT3A
Sensor CT-312
Transmitter CT-301D
CT3C
Sensor CT-312C
Transmitter CT-301DC

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See Figure1 for details of CT3 components
No.
Name
1
Charging indicator
2
Applicator
3
Safety button
4
Release button
Figure 1 CT3 Components
4. Performance Characteristics
4.1 Warm Up Time: 1 hour.
4.2 Sensor Use Life: 14 days.
4.3 Effective Glucose Range: 1.7 - 27.8mmol/L.
4.4 Number of 24 -hour glucose data points: 480 (1 data point / 3 minutes).
4.5 The senor is a single-use medical device, sterilized by E-beam irradiation.
4.6 Laboratory test accuracy: (linear deviation): within ± 20%
4.7 The sensor can automatically monitor and correct electrochemical interference. Lab test recovery ranges 80%
- 120% (n = 12, with 20mg / L acetaminophen and 60mg / L ascorbic acid).
4.8 Transmitter Power Supply: DC 3.7V rechargeable battery. Use power adapter provided or specified by the
manufacturer for charging.
Adapter Input: 100-240VAC, 50 / 60Hz, 0.35A, Output: 5.0V, 1.0A
4.9 Operating Conditions
4.10 Transmitter, charger and power adapter operate at temperatures between 5℃ to 40℃，humidity ≤93% RH.
If the transmitter has been stored at a temperature lower than 5℃, warm up to room temperature before
using.