beurer LD 04 Lancing Device Instruction Manual

beurer LD 04 Lancing Device Instruction Manual

| Symbols used
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| WARNING Warning notice indicating a risk of injury or damage to health.
| IMPORTANT Safety note on possible damage to the measuring device/ accessory.
| Warning, see accompanying documents.
| Observe the instructions for use.
| This product satisfies the requirements of the applicable European and national directives.
| Medical device.
| Manufacturer.
| Green dot (Der Grüne Punkt): German dual waste collection system.
| Dispose of packaging in an environmentally friendly manner.
| Item number.
| CE labelling This product satisfies the requirements of the applicable European and national directives.
| Batch code.
| Permissible storage and transport temperature and humidity (+25°C to +35°C, 0% to 90% relative humidity (non-condensing)).
| Biological risks.
| Separate the product and packaging elements and dispose of them in accordance with local regulations.
| Single patient multiple use.
| Unique Device Identifier (UDI) for unique product identification.
| Type number.
| Importer symbol.

Lancing device

Packaging contents

• 1 lancing device
• These instructions for use

WARNING

• The lancing device is suitable for self-testing. Never share the lancing device or lancet with others (risk of infection).
• Supervise children when using the device to ensure they do not play with it.
• Use a new, sterile lancet needle for each blood sample (for single use only).
• If you drop the lancing device with an inserted lancet needle, carefully pick it up and dispose of the lancet.
• Change the puncture area each time you take a measurement, e.g. use a different finger or the other hand. Repeatedly using the same area may cause inflammation, numbness or scarring.
• Make sure the puncture area is hygienically clean.

ATTENTION
Use the lancing device only with lancet needles from the same manufacturer. Using other lancet needles may permanently prevent the lancing device from working properly.
Intended Use
The lancing device, in combination with a separate lancet needle, is intended for taking a blood sample for measuring glucose levels in human capillary blood.
Use the lancing device only on the skin areas intended for taking the glucose measurement (fingertips).
Intended users
The device is suitable for domestic use by humans. This device is not suitable for use by people (including children) with restricted physical, sensory or mental abilities, or lack of experience and/or lack of knowledge, unless they are supervised by someone who is responsible for their safety, or have received instructions from this person on how to use the device. Do not allow children to play with the device.
Clinical benefits
Taking a blood sample to determine the glucose value in human capillary blood and any medical treatment that may be instructed as a result.
Indication
Applicable for diabetes mellitus to determine the glucose value in human capillary blood.
Contraindications
Use the lancing device only on the body parts listed in these instructions for use.
Never use the lancing device on injured, inflamed or scarred skin.
Never use the lancing device on areas already affected by a sensory disorder.
If you drop the lancing device with an inserted lancet needle, carefully pick it up and dispose of the lancet. Change the puncture area each time you take a measurement, e.g. use a different finger or the other hand. Repeatedly using the same area may cause inflammation, numbness or scarring. Make sure the puncture area is hygienically clean.

Risk of infection
All components of the measuring device and its accessories may come into contact with human blood and are therefore a possible source of infection.
Taking a blood sample
To take the blood sample, to measure blood glucose levels and to interpret the results, please read the instructions for use supplied with your measuring device
Disposal of lancing device and lancets
WARNING
It is essential to comply with the generally applicable safety precautions for handling blood when disposing of the lancing device and lancets. Carefully dispose of all blood samples and materials with which you have come into contact in order to prevent injury and infection of others.
Cleaning and maintenance
Clean the lancing device after each use.
Remove and dispose of the lancet as described in points 9-11 in these instructions for use.
For cleaning, use a soft cloth or cotton bud that can be moistened with disinfectant or 70% alcohol. To clean the entire device, please use a soft cloth slightly moistened with a mild soapy solution. Under no circumstances may liquid enter the device. Do not use the device again until it is completely dry.
Standards
This product complies with the Medical Device Regulation MDR (EU) 2017/745

Customer service address
Please contact our customer service if you have any questions. Please find the service address in the attached address insert.
OUR COMMITMENT TO YOU : We aim to satisfy customers by providing high- quality medical devices and the best customer service.
Please contact our customer service if you are not entirely satisfied with the product.

Lancing device Item no. 457.12

| Lancing device and lancet needles

1.  Cap
2. Protective lancet disc
3. Sterile lancet needle
4.  Lancet holder
5.  Lancet discharge
6.  Trigger with colour indicator
7.  Tensioning device

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1

| Undo the cap from the lancing device.
2

| Insert a sterile lancet needle into the lancing device and press it firmly into place.
3| Remove the protective disc of the lancet by turning it while holding the shaft of the lancet. Retain the protective disc for the safe disposal of the used lancet needle after taking a blood sample.
4

| Place the cap onto the lancing device and screw it tight.
5

|

• You can set nine different penetration depths on the lancing device. The penetration depth is displayed as a number.
• 1-3: for soft or thin skin
• 4-6: for normal skin
• 7-9: for thick or callused skin Turn the moving upper part of the cap until the desired penetration depth is displayed.

6

| Pull the tensioning device back until it audibly engages and the trigger turns yellow. Release the tensioning device. This automatically snaps back into the default position. The lancing device is now ready for use.

7

| You may now use the lancing device to take a blood sample. Make sure that the blood remains as a droplet and is not spread. Blood sample from the fingertip The best penetration areas are the middle finger and the ring finger. Firmly position the lancing device slightly to the side of the centre of the fingertip. Press the trigger. Remove the lancing device from the finger. A round drop of blood of at least 0.6 microlitres (corresponds to approx. 1.4 mm, original size:  ) must have formed.
8| If there is an insufficient amount of blood, repeat steps 1 to 7 with a greater penetration depth.
9 / 10

| Carefully undo the cap from the lancing
device and remove it.

Place the retained protective disc flat on a hard surface. Stick the tip of the needle into the protective disc so the needle is covered. Take care not to touch the used lancet.

11

| Actuate the side lancet discharge with a sliding movement. This causes the lancet to drop out of the holder.
Carefully dispose of all blood samples and materials with which you or your patient have come into contact. Dispose of the lancet in a puncture-proof container. This prevents injuries and the infection of others
12
| Replace the cap

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