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Linx GX-01 - Page 2

Linx GX-01
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Quick Start Guide
Quick Start Guide
Get started with LinX quickly and
easily with this Quick Start Guide.
1034-PMTL-406.V02
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.
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
Precautions