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Quick Start Guide Quick Start Guide

Quick Start Guide

Get started with LinX quickly and

easily with this Quick Start Guide.

1034-PMTL-406.V02

READ THIS INSERT AND ALL OF

THE LABELLING PROVIDED WITH

THE CGM APP BEFORE

HANDLING THE SENSOR KIT.

Only MicroTech Medical consumables

should be used with the CGMS.

No modifications to the Continuous Glucose

Monitoring System are allowed. Unautho-

rized modification of the CGMS may cause

the product to malfunction and become

unusable.

Before using this product, you need to read

the Instruction Manual or be trained by a

professional. No doctor's prescription is

required for use at home.

The CGMS contains many small parts that

can be dangerous if swallowed.

During rapid changes in blood glucose

(more than 0. 1 mmol/L per minute), glucose

levels measured in interstitial fluid by the

CGMS may not be the same as blood

glucose levels. When blood glucose levels

drop rapidly, the sensor may produce a

higher reading than the blood glucose level;

Conversely, when blood glucose levels rise

rapidly, the sensor may produce a lower

reading than the blood glucose level. In

these cases, the sensor's reading is

checked by a fingertip blood test using a

glucose meter.

When it is necessary to confirm hypoglyce-

mia or near-hypoglycemia as measured by a

glucose sensor, a fingertip blood test should

be performed using a glucose meter.

Severe dehydration or excessive loss of

water may result in inaccurate results. When

you suspect you are dehydrated, consult a

healthcare professional immediately.

If you think the CGMS sensor reading is

inaccurate or inconsistent with the

symptoms, use a blood glucose meter to test

your blood glucose level or calibrate the

glucose sensor. If the problem persists,

remove and replace the sensor.

The performance of the CGMS has not been

evaluated when used with another implant-

able medical device, such as a pacemaker.

Details of what interferences may affect the

accuracy of the detection are given in

"Potential Interference information"

The sensor loosens or takes off may cause

the APP to have no readings.

If a sensor tip breaks, do not handle it

yourself. Please seek professional medical

help.

This product is waterproof and can be worn

during showers and swimming, but do not

bring sensors into the water more than 2.5

meters deep for longer than 2 hours.

CGMS readings should only be used as a

reference for the supplemental monitoring of

diabetes mellitus and should not be used as

a basis for clinical diagnosis.

While extensive user testing was done on

LinX CGMS in Type 1 and Type 2 diabetic

patients, the study groups did not include

women with gestational diabetes.

If the product is not working properly or has

been damaged, stop using the product.

For user safety, storage, disposal and

handling, plese refer to the system instruc-

tion for use.

Step 1

Select Insertion Area

Abdomen: Avoid the

waistband, abdominal wrinkle,

scars, insulin injection

induration, belt-wearing area,

and stretch marks. Also, make

sure that your insertion site is

at least 5cm away from your

navel.

Upper arm: the back of the

upper arm (Don’t insert into the

muscles on the outer side of

the upper arm.)

Step 2

Sterilize: Before the insertion,

clean the insertion site with an

alcohol wipe and let it dry

completely.

Step 3

Unscrew the cover from the

sensor applicator and set it

aside.

Step 4

Align the opening of the

applicator with the skin where

you want to apply it and press

it tightly on the skin. Then

press the implantation button

of the applicator, wait for a

few seconds after hearing the

sound of the spring retreating,

to make the sensor stick on

the skin, and the puncture

needle in the applicator will

automatically retreat.

Step 5

Gently pull the sensor

applicator away from the

body, and the sensor should

now be attached to the skin.

Step 6

After installing the sensor,

make sure that the sensor is

firmly in place. Put the cover

back on the sensor applicator.

Description：

The Sensor is located inside the Sensor

Applicator. Follow the instructions

to prepare and apply the Sensor on the

back of your upper arm. The Sensor

has a small, flexible tip that is inserted just

under the skin. The Sensor can

be worn for up to 15 days.

For more specific operations, please refer

to the user guide in the LinX app.

Symbols

Refer to Instruction Manual

Atmospheric pressure limitation

Type BF Applied Part

Single sterile barrier system with

protective packaging outside

using irradiation

Authorised Representative in the

European Community

Manufacturer

Do not use if package is

damaged and consult

instructions for use

Batch code

Importer

MR unsafe

Temperature limit

Humidity limitation

Do not re-use

Caution

Date of manufacture

Use-by date

Serial number

Unique device identifier

CE Mark

Instructions for use

Medical device

700hpa

1060hpa

2°C

25°C

10 %

90 %

The level of protection against

ingress of solid foreign objects is

6 (Protected against access to

hazardous parts with a wire)

The level of protection against

ingress of water with harmful

effects is 8 (Protected against the

effects of continuous immersion

in water)

Waste Electrical and Electronic

Equipment (WEEE) – Follow local

requirements for proper disposal

0197

图纸号

物料号

版本号

版本变

更描述

备注：

日期

设计

审核

批准

名称

生效日期发放范围生产（）采购（ √ ）计划（ √ ）其他:

1034-PMTL-406

传感器快操卡（CE版）

V02

内容、尺寸修改

186x285mm

四色印刷

105g铜版纸

For use with LinX App

LinX

Precautions

Indication for use:

The Continuous Glucose Monitoring

System sensor is a real time, continuous

glucose monitoring device. When the

system is used together with compatible

devices, it is indicated for the

management of diabetes in adult people

(age 18 and older). It is designed to

replace finger stick blood glucose testing

for diabetes treatment decisions.

Interpretation of the system results

should be based on the glucose trends

and several sequential readings over

time. The system also detects trends

and tracks patterns, and aids in the

detection of episodes of hyperglycemia

and hypoglycemia, facilitating both acute

and long-term therapy adjustment.

Contraindications:

The Continuous Glucose Monitoring

System must be removed prior to

Magnetic Resonance Imaging (MRI).

The Continuous Glucose Monitoring

System was not evaluated for the

Pregnant women.

Product name:

Continuous Glucose Monitoring

System Sensor

Product Model:

GX-01,GX-02,GX-01S,GX-02S

For use with:

RC2107, RC2108,

RC2109, RC2110 CGM app