Beurer GL 44 User Manual

				instructions for use			mg/dL
							GL44
							GB
	Codefree
BLOOD GLUCOSE MONITOR
				Step by step

germanlengineering

Beurer GmbH  •  Söflinger Straße 218  •  89077 Ulm, Germany

www.beurer.com

Contents

1	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 aid and lancet needles............................................................................................	11
	3.3	Display symbols....................................................................................................................	12
	3.4	Test strips.............................................................................................................................	12
4	Initial use and basic settings .......................................................................................		14
	4.1	Removing the battery insulation strips, replacing the batteries............................................	14
	4.2	Making and changing basic settings....................................................................................	14
5	Measuring blood glucose values...............................................................................		16
	5.1	Preparing to take a blood sample.........................................................................................	16
	5.2	Taking a blood sample..........................................................................................................	17
	5.3	Reading out result and highlighting measurements .............................................................	20
	5.4	Post-processing and disposal..............................................................................................	21
	5.5	Evaluating measured blood glucose values .........................................................................	22
	5.6	Functional check with control solution .................................................................................	23
6 Measurement memory....................................................................................................			26
	6.1	Displaying individual values..................................................................................................	26
	6.2	Displaying average blood glucose values............................................................................	27
	6.3	Displaying average blood glucose values for highlighted values .........................................	27
	6.4	Deleting individual measured values from the memory........................................................	29
	6.5	Deleting the entire memory for measured values.................................................................	29
	6.6	Reset to basic settings .........................................................................................................	29
	6.7	Transferring measurements to a PC.....................................................................................	30
7	Storing, maintaining and disinfecting the device..............................................		31
	7.1	Cleaning................................................................................................................................	31
	7.2	Disinfection...........................................................................................................................	31
8	What if there are problems?.........................................................................................		32
9	Technical specifications.................................................................................................		33
10	Comparison of measured values with laboratory value.................................		35
11	Usage limits for specialist personnel from the healthcare sector............		36
12	Guarantee and customer service ..............................................................................		39
Beurer GL44 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 notes they contain.

With kind regards Your Beurer team.

Getting to know your instrument

The GL44 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 quick and easy blood glucose measurement, measured values to be stored and the average of all measured values to be displayed to ideally assist you in monitoring diabetes. The test is performed exclusively externally (IVD).

The large backlit display shows measured values clearly. The user-friendly design with handy test strips and a reduction in the controls to a few buttons guarantee simple, yet reliable measurements. The device can be connected directly to a PC using the USB cable provided. You can evaluate the measured values on your PC using blood glucose diary software and use the results to monitor your blood glucose values.

Beurer blood glucose software is available as a free download at www.beurer.com

4	Beurer GL44 mg/dL

1.1 Delivery scope, replacements and accessories

Check that the set packaging has not been tampered with and check the contents for completeness. Before use, ensure that all packaging materials are removed and that there is no visible damage to the unit or accessories. When in doubt, do not use the unit and contact your dealer or the customer service address provided.

A1 Blood glucose monitor

B1 Lancing device with AST cap to take blood samples from alternative body parts

C10 test strips

D10 sterile lancet needles

E2 button cell batteries, 3 V CR2032 (already inserted)

F1 practical case

G1 USB cable

These Instructions for use, additional information

•If the packaging has sustained considerable damage or the contents are incomplete, please return the system to your retailer.

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

Note

• Use original manufacturer accessories only.

Beurer GL44 mg/dL

5

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, highlight 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 highlighted measured blood glucose values from the last 7, 14, 30 and 90 days,

•Set the time and date,

•Transfer stored measured values to a PC for evaluation (additional accessories required).

The blood glucose monitor also includes the following monitoring functions:

•Warning in the event of unsuitable temperatures.

•Low battery display.

•Low test strips warning.

Warning

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

•Please consult your GP with regard to insulin doses.

6	Beurer GL44 mg/dL

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

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

Warning

Warning indicating a risk of injury or risk to your health/your patients’ health.

Important

Safety note indicating possible damage to the unit/accessory.

Note

Note on important information

Beurer GL44 mg/dL

7

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 our customer service 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, please 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 aid or the 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! Regularly consult your GP regarding your measured values. Do not alter the procedures prescribed by your GP.

•Despite the simple usage of the Beurer GL44 monitor for self-monitoring of blood glucose levels, you may possibly need to obtain instructions for using the system from your healthcare professional (for example, your GP, chemist or diabetes consultant). Only proper use will guarantee exact 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 may lead to incorrect measured results.

•A hematocrit value between 20% and 60% has no significant influence on the measurement results.

•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 glu-

8	Beurer GL44 mg/dL

cose value may be too low; in the event of a very low hematocrit value (below 20%), it may be too high. Please 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 measuring 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 GL44 mg/dL measuring system is intended to measure capillary whole blood.

Storage and maintenance

Warning

•Store the blood glucose monitor and its accessories out of the reach of small children and pets. Small parts, such as lancet needles, parts of the lancing device, batteries or test strips may be lifethreatening when swallowed. If swallowed, immediately seek medical attention.

•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, strong 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.

Batteries/Savingmeasured values

Warning

•Keep batteries out of the reach of children. Children may put batteries in their mouth and swallow them. This may severely damage their health. If affected, immediately seek medical attention!

•Normal batteries must not be charged, heated or thrown into an open fire (risk of explosion!).

Important

•Do not disassemble or short-circuit the batteries.

•Always replace all batteries at the same time and use batteries of the same type.

•Leaking batteries may damage the device. If you do not intend to use the device for longer periods, remove the batteries from the battery compartment.

Attention!

• Leaked or damaged batteries may burn the skin. In this case, use suitable protective gloves.

Beurer GL44 mg/dL

9

Note

•The stored blood glucose values are retained when the batteries are replaced. If applicable, the date and time must be reset after replacing the batteries.

•Use lithium-ion batteries only.

Repairs

Note

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

•Do not repair the device. Faultless functionality can no longer be guaranteed in this case.

•Do not dismantle the lancing device into individual parts, except in the steps described in these instructions.

•Please contact our customer service for repairs.

Disposal

Warning

•It is essential to comply with the generally applicable safety precautions for handling blood when disposing of materials of 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

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

The codes below are printed on batteries containing harmful substances:

•Pb = Battery contains lead,

•Cd = Battery contains cadmium,

• Hg = Battery contains mercury.

For environmental reasons, do not dispose of the device with the household waste at the end of its service life. Please dispose of the device 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.

10	Beurer GL44 mg/dL

		3 Description of units and accessories
	3.1 Blood glucose monitor
	Front					1
	1	Receptacle for test strips, illuminated
	2	Display
	3	Highlight button				2
	4	On/Off button
	5	PC port
	6	“+ –” rocker switch				3
		6

4

5

Rear			1
1	Battery compartment
	(bottom side)
2	Reset button
	CR2032	rese	CR2032
			2

	3.2 Lancing aid and lancet needles
	1	Cap
	2	AST Cap	1	6	7
	3	Protective lancet disc
				2
	4	Sterile lancet needles
				3	8
	5	Lancet holder
	6	Safety switch		4
	7	Trigger
				5
	8	Tensioning device

Beurer GL44 mg/dL

11

3.3 Display symbols

1Date

2Symbols for highlighting measurements

3Measured value display, HI, LO display, average blood glucose value, Err

4Blood droplet symbol

5Speaker symbol

6Hand symbol

7Test strip symbol

8Blood glucose unit mmol/L – not functional

9Blood glucose unit mg/dL

10Replace battery symbol

11Memory symbol

12Temperature symbol

13Time

	1	13
	2	12
		11
		10
	3
	4	9
	5
		8
	6
		7

Note

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

•Blood glucose unit: mg/dL

•Acoustic signal on

•Backlighting on

3.4 Test strips

Front Rear

1

2

	3
1	Gap for blood input							You can identify the rear by the contact tracks.
2	Handle
3	Contacts

12	Beurer GL44 mg/dL