Beurer GL 50 evo User Manual

				instructions for use			mg/dL
							GL50 evo
							GB
	Codefree
3 IN 1 BLOOD GLUCOSE MONITOR
				step by step

germanlengineering

Beurer GmbH • Söfl inger Straße 218 • 89077 Ulm, Germany

www.beurer.com

Contents
1 Getting to know your instrument...................................................................................		4
Getting to know your instrument..................................................................................................		4
1.1	Delivery scope, replacements and accessories.....................................................................	5
1.2	Functions of the device...........................................................................................................	6
1.3	Signs and symbols.................................................................................................................	7
2 Warnings and safety notes................................................................................................		8
3 Description of units and accessories........................................................................		11
3.1	Blood glucose monitor.........................................................................................................	11
3.2	Lancing device and lancet needles......................................................................................	12
3.3	USB cover.............................................................................................................................	12
3.4	Display symbols....................................................................................................................	12
3.5	Test strips.............................................................................................................................	13
4 Initial use and basic settings..........................................................................................		14
4.1	Charging the rechargeable battery.......................................................................................	14
4.2	Making and changing basic settings....................................................................................	15
5 Taking measurements.......................................................................................................		18
5.1	Preparing to take a blood sample.........................................................................................	18
5.2	Preparing the lancing device for taking a sample.................................................................	19
5.4	Reading the result and labelling measurements...................................................................	23
5.5. Post-processing and disposal.............................................................................................		24
5.6	Evaluating measured blood glucose values.........................................................................	24
5.7	Functional check using control solution...............................................................................	26
6 Measurement memory......................................................................................................		29
6.1	Displaying individual values..................................................................................................	29
6.2	Displaying average blood glucose values............................................................................	30
6.3	Evaluating measured values on a PC...................................................................................	30
7 Storing, maintaining and disinfecting the device.................................................		31
7.1	Maintenance ........................................................................................................................	31
7.2	Disinfection...........................................................................................................................	31
8 What if there are problems?...........................................................................................		32
9 Technical specifications...................................................................................................		34
10 Comparison of measured values with laboratory value.................................		35
11 Usage limits for specialist personnel from the healthcare sector:...........		37
12 Guarantee and customer service..............................................................................		39
Beurer GL50 evo mg/dL		3

1 getting to knoW your instrument

Dear customer,

Thank you for choosing one of our products. Our name stands for high-quality, thoroughly tested products for applications in the areas of heat, weight, blood pressure, blood glucose measurement, body temperature, pulse, gentle therapy, massage and air.

Please read these Instructions for use carefully and keep them for later use, be sure to make them accessible to other users and observe the information they contain.

With kind regards, Your Beurer team.

Getting to know your instrument

The GL50 evo blood glucose monitor is intended for fast and simple blood glucose measurement of fresh capillary blood samples, either for self-testing or in a clinical environment by trained personnel. It enables you to measure your blood glucose quickly and easily, store the measured values and display the average of all measured values, thereby providing optimum assistance for monitoring your diabetes. The test is performed exclusively externally (IVD).

The backlit display shows measured values clearly. The user-friendly design that features handy test strips and is operated via a single scroll wheel guarantees simple yet reliable measurements.

The device can be connected directly to a PC using the integrated USB connection. You can evaluate the measured values on your PC using special software (in English and German) and use the results to monitor your blood glucose values.

Alternatively, you can transfer the measured values to your smartphone/tablet using the optional Bluetooth® adapter.

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1.1 Delivery scope, replacements and accessories

Check that the set packaging has not been tampered with and make sure that all contents are present. Before use, ensure that there is no visible damage to the device or accessories and that all packaging material has been removed. If you have any doubts, do not use the device and contact your retailer or the specifi ed Customer Services address.

A“3 in 1” monitor: Lancing device, plug-in USB and monitor

BAST cap for taking blood samples from alternative parts of the body

CUSB cover

D5 test strips

E5 sterile lancet needles

F1 practical case

These Instructions for use, additional information

•The blood glucose monitor (A), test strips (D) and additionally available control solutions have been specially designed to complement each other. For this reason, use only test strips (D) and control solutions that have been approved for this blood glucose monitor (A).

Note

• Use original manufacturer accessories only.

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Follow-up purchases

You can also obtain test strips, control solution and lancet needles without a prescription.

Item		REF
50 test strips		REF 464.15
Control solution LEVEL 3 and 4		REF 464.16
100 lancet needles		REF 457.01

1.2 Functions of the device

This device is intended for measuring the blood glucose content in human blood. It is also suitable for self-testing at home.

The blood glucose monitor enables you to quickly and simply:

•Measure your blood glucose level

•Display, label and save measured values

•Display the average measured blood glucose value from the last 7, 14, 30 and 90 days

•Display the average of the labelled measured blood glucose values from the last 7, 14, 30 and 90 days

•Set the time and date

•Evaluate the saved measured values on a PC using special software.

•The saved measured values can be transferred to a smartphone/tablet using the optional Bluetooth® adapter.

The blood glucose monitor also includes the following monitoring functions:

•Blood volume check

•Warning in the event of unsuitable temperatures

•Alarm function

•Ketone warning

•State of charge display when rechargeable battery is low.

Warning

•Do not use the device to diagnose diabetes; it is intended for regular monitoring only.

•Consult your GP with regard to insulin doses.

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1.3 Signs and symbols

The symbols on the packaging, type plate of the blood glucose monitor and accessories represent the following:

	In vitro diagnostics		Manufacturer
	Serial number		Please observe the Instructions
	Temperature limit		for use
	+2°C to +30°C		PCT: certification symbol for
	Not for re-use/For single use		products that are exported to the
			Russian Federation and mem-
	only
			bers of the CIS
	Use by		Green dot (Der Grüne Punkt):
	Maximum shelf life after		German dual waste collection
			system
	initial opening in months
			Contents sufficient for <n> tests
	Batch designation
	Sterilised by radiation (lancets)	/	Order number
		Art.-Nr.
	Warning, see accompanying
			Unit of measurement for blood
	documents		glucose value
	Rechargeable battery		Biohazard, risk of infection

In the Instructions for use, the symbols represent the following:

Warning

Warning instruction indicating a risk of injury or damage to your health/your patient’s health.

Important

Safety note indicating possible damage to the unit/accessory.

Note

Note on important information

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2 Warnings and safety notes

Risk of infection

All components of the blood glucose monitor and its accessories may come into contact with human blood and are therefore a possible source of infections.

Warning

•This blood glucose monitor must display the blood glucose content in mg/dL. The unit of measurement mg/dL accompanies each blood glucose value. Please contact Customer Services if the device does not display mg/dL. You risk damaging your health if you measure your blood glucose value using a unit of measurement with which you are not familiar, misinterpret the values and therefore take incorrect measures.

•When using the blood glucose monitor for various persons, observe the generally applicable regulations regarding disinfection, safety and contamination.

•Medical carers and others who use this system on several patients must be aware that all products or objects that come into contact with human blood must be handled, even after cleaning, as though they could transfer pathogens.

•The lancing device is suitable for self-testing. Do not share the lancing device or lancet needles with others or amongst various patients (risk of infection!).

•Use a new, sterile lancet needle for each blood sample (for single use only).

General notes

Warning

Do not use the device in the vicinity of strong electromagnetic fields and keep it away from radio systems or mobile telephones.

Measuring the blood glucose content

Warning

•The measurements taken by you are for your information only – they are no substitute for a medical examination! Consult your GP regularly regarding your measured values. Do not alter the procedures prescribed by your GP.

•The Beurer GL50 evo monitor provides a simple way of monitoring your own blood glucose levels, however, you may need to obtain information on how to use the system from your healthcare professional (for example, your GP, chemist or diabetes consultant). Only proper use will guarantee precise measurements.

•A lack of water, high fluid loss, for example perspiration, frequent passing of water, severe hypotension (low blood pressure), shock or hyperosmolar hyperglycaemic non-ketotic coma (HHNKC) may lead to incorrect measured results.

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•An excessively high or low hematocrit value (proportion of red blood cells) may lead to incorrect measurements. In the event of a very high hematocrit value (above 60%), the displayed blood glucose value may be too low; in the event of a very low hematocrit value (below 20%), it may be too high. Consult your GP if you do not know your hematocrit value.

•Do not use the test strips to measure blood glucose values on newborns.

•Do not use NaF or potassium oxalate anticoagulants to prepare for venous blood samples.

•Do not test any severely ill patients using this device.

•Use fresh capillary whole blood only. Do not use serum or plasma.

•Use capillary blood without squeezing the penetration area. If the area is squeezed, the blood is diluted with tissue fluid and this may lead to an incorrect result.

•Do not use the test strips above an altitude of 7010 m.

•Very high levels of humidity may influence the test results. Relative humidity of more than 90% may lead to inexact results.

Note

The Beurer GL50 evo mg/dL measuring system is intended for measuring capillary and venous whole blood.

Storage and maintenance

Warning

•Store the measuring device and its accessories out of the reach of small children and pets. Small parts, such as lancet needles, cover caps or test strips may be life-threatening when swallowed.

•The test strip box contains desiccant, which may irritate the skin or eyes when inhaled or swallowed. Keep the box out of the reach of children.

The blood glucose monitor is made from precision and electronic components. The accuracy of the measurements and service life of the device depend on its careful handling:

•Protect the device and its accessories from impacts, humidity, dirt, marked temperature fluctuations and direct sunlight. Do not store the device, test strips and control solution in your vehicle, in the bathroom or in a cooling appliance.

•Do not drop the device.

Repairs

Note

•Do not open the device. Failure to comply will result in voiding of the warranty.

•Do not repair the device. Proper operation can no longer be guaranteed in this case.

•Please contact Customer Services for repairs.

Beurer GL50 evo mg/dL

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Disposal

Warning

•It is essential to comply with the generally applicable safety precautions for handling blood when disposing of materials from the blood glucose monitor. Dispose of all blood samples and materials with which you or your patients come into contact correctly in order to prevent injury and infection of other persons.

•After use, dispose of test strips and lancets in a puncture-proof container.

Note

Rechargeable batteries must not be disposed of with household waste. As a consumer, you are required by law to recycle used rechargeable batteries. You can recycle your old rechargeable batteries at public collection points in your community or wherever rechargeable batteries of the relevant type are sold.

For environmental reasons, do not dispose of the device in the household waste at the end of its useful life. Please dispose of the unit in accordance with EC Directive WEEE (Waste Electrical and Electronic Equipment). If you have any questions, please contact the local authorities responsible for waste disposal.

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3 description of units and accessories

3.1 Blood glucose monitor

An overview of the monitor

					1	Lancing device
					2	Plug-in USB
					3	Monitor
	1	2		3
Front			2	Rear
				3		1
		1		4		2
1	Display			1	Scroll wheel
2	Slot for test strips			2	Sliding switch for on/off
3	Scroll wheel			3	Tensioning slider
4	Sliding switch for
	on/off					3

Beurer GL50 evo mg/dL	11

3.2Lancing device and lancet needles

1	AST cap (transparent)
2	Cap
3	Protective lancet disc	2
4	Sterile lancet needle
5	Lancet holder						8
6	Dial for setting		4	5	6	7
	different penetration depths	3
7	Tensioning slider
8	Trigger		1

3.3 USB cover

If you would like to use the blood glucose monitor without the integrated lancing device, you can use the supplied USB cover in place of the lancing device.

3.4 Display symbols

	1							1	Battery status
								2	Storage place
								3	Blood glucose unit mg/dL
							2
								4	Measurement Time
								5	Symbols for labelling measurements
7
							3
								6	Measurement Date
								7	Measured value display
6							4
								8	Blood glucose unit mg/dL
	5

Note

The blood glucose monitor is supplied with the following basic settings:

•Blood glucose unit: mg/dL

•Acoustic signal on

•Bluetooth® off

•Ketone warning on

•Language: German

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