ACCU-CHEK 4015630065578 Fastclix Finger Pricker and Lancet Instruction Manual

: June 4, 2024
: ACCU-CHEK

Table of Contents

Instructions for Use
Inserting the Lancet Drum
Setting the Penetration Depth
Obtaining a Blood Drop
Cleaning and Disinfecting the Finger Pricker and Cap
Disposing of the Finger Pricker
Documents / Resources

Finger pricker and lancet

ACCU CHEK 4015630065578 Fastclix Finger Pricker and Lancet -
Fig | ACCU CHEK 4015630065578
Fastclix Finger Pricker and Lancet - Fig 1
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ACCU CHEK 4015630065578 Fastclix Finger Pricker and
Lancet

Instructions for Use

Finger pricker
The Accu-Chek FastClix finger pricker is a device for a simple, virtually pain-free collection of capillary blood from the fingertips. The Accu-Chek FastClix finger pricker is intended for single-patient use only! It is only allowed to be used to obtain blood from one person. There is a risk of infections being transmitted if the finger pricker is used by other people, even by family members, or if healthcare professionals use this finger pricker to obtain blood from different people. This finger pricker is therefore not suitable for professional use in healthcare facilities and institutions. It is not a sterile product. People in the area of diabetes self-monitoring are considered a target group.
Lancet
Six Accu-Chek FastClix lancets are in a drum. The lancet drum is intended to be used with the Accu-Chek FastClix finger pricker. The lancet drum is a disposable part. Each lancet in it is intended to be used only once. The Accu- Chek FastClix lancet drum includes 6 lancets and is intended to be used with the Accu-Chek FastClix finger pricker for simple, virtually pain-free collection of capillary blood. The lancet drum is a disposable article with 6 lancets each intended to be used only once. Each lancet has a protective cap that guarantees sterile condition until its first use. The lancets are sterilized using irradiation. The used lancet drum is protected against re- use.
Features of the Finger Pricker
The finger pricker has 11 different penetration depths so that you can adjust the penetration depth to the texture of your skin. With the release button, you can prime the finger pricker and trigger a lancet in a single step. When a lancet is triggered, it penetrates the skin. You insert a lancet drum with 6 lancets into the finger pricker. You can obtain blood using a new, sterile lancet 6 times before the lancet drum needs changing.
Before You Get Started
Read these instructions for use before you obtain a blood drop from your fingertip. Information describing a situation for which there is a foreseeable serious hazard with the use of the device is preceded by the following heading:
WARNING
Information regarding any special care you should exercise for the safe and effective use of the device or to avoid damage to the device that could occur as a result of use, including misuse, is preceded by the following heading:
PRECAUTION
WARNING
Risk of suffocation This product contains small parts that can be swallowed. Keep this product away from people who might swallow small parts, for example, small children. Risk of infection
During obtaining a blood drop, the finger pricker may come into contact with blood. To prevent infections from being transmitted, the finger pricker must not be used by other people, even by family members. Healthcare professionals must not use finger prickers to obtain blood from different people.
Risk of infection
The finger pricker or lancet drum has come into contact with blood and has protruding sharps due to damage. To prevent infections from being transmitted, check the finger pricker and lancet drum for damages. Dispose of a damaged finger pricker or lancet drum as infectious material according to the regulations applicable in your country.
PRECAUTION
Risk of injury
Skin contact to the finger pricker, lancet drum or lancet may cause skin irritation. If your skin becomes irritated or inflamed, consult your healthcare professional.
Risk of injury
The needle of the lancet is damaged due to use on a hard surface. Only use the lancet to obtain a blood drop.
Risk of injury
Parts of the finger pricker, for example, the release button, may shoot away during use. Do not point the finger pricker at your face or other people. If the finger pricker or lancet drum was dropped or exposed to other mechanical stress, check them for damages, for example, cracks. Do not use them if they are damaged. Only insert Accu-Chek FastClix lancet drums into the Accu-Chek FastClix finger pricker. Other lancets or lancet drums may impair the operation of the finger pricker or damage it permanently.
Preparation
•Wash your hands with warm water and soap before you obtain blood (see 1 ). Dry your hands thoroughly. This reduces contamination of the puncture site and stimulates blood flow.

Inserting the Lancet Drum

You have to insert a lancet drum to be able to obtain blood with the finger pricker.
WARNING
Risk of infection Lancets in a damaged lancet drum may not be sterile anymore. If the lancet drum is damaged or shows cracks do not use it to obtain blood.

Remove the cap from the finger pricker (see 2 ).
Insert a new lancet drum – white end first – into the finger pricker (see 3 ). Do not insert a lancet drum and press the release button at the same time. Do not insert a lancet drum with the release button resting on a surface, for example, a tabletop. This could release a lancet which could inadvertently prick you. The lancet drum is properly inserted when it is completely inside the finger pricker, and only the projecting edge protrudes from the finger pricker at the front (see 3 )
Place the cap back on again. The cut-out section at the edge of the cap must fit around the correspondingly shaped curvature with the penetration depth indicator (silver square) (see 4 ). The cap is on correctly when it is pushed back as far as it will go, and you hear and feel it click into place. The cap can only be correctly placed on up to the stop position when the lancet drum is completely inside the finger pricker. Do not use any force to place the cap on as this might damage the cap and the finger pricker. Correct the position of the lancet drum instead. Each lancet drum contains 6 lancets. The first lancet is now ready to be used. The window showing the number of available lancets shows 6; there are now 6 lancets available (see 5 ).
Tip
Do not remove the lancet drum before all 6 lancets have been used. The lancet drum cannot be re-inserted once it has been removed from the finger pricker.

Setting the Penetration Depth

You can set 11 penetration depths (0.5 to 5.5). The silver square (penetration depth indicator) on the finger pricker indicates the current penetration depth setting. The larger the number, the greater the penetration depth. If you have no experience with this finger pricker, we recommend setting a low penetration depth, such as penetration depth 2.
WARNING
Risk of injury If the penetration depth is too large, the puncture can injure children. Before using the finger pricker for the first time on children, ask your healthcare professional. Start with the lowest penetration depth. Rotate the cap until the desired penetration depth lines up with the indicator (see 6 ).

Obtaining a Blood Drop

**WARNING
Risk of infection The lancet was used several times to obtain blood. To prevent infections from being transmitted, use the lancet only once to obtain blood. Risk of infection In rare cases, the lancet is not pulled back into the finger pricker after you obtained blood. To prevent infections from being transmitted, check that the lancet does not protrude from the cap after you obtained blood. If the lancet protrudes from the cap, carefully set the finger pricker aside. Keep the finger pricker out of reach and contact customer support.
PRECAUTION
Risk of infection
The puncture site was not cleaned. Before obtaining blood clean the puncture site.
Risk of infection**
The use by date of the lancet has expired. Use only lancets that are within the use-by date. The use-by date is printed next to the E symbol on the packaging. In general, blood can be obtained from any finger. Certain fingers can be unsuitable if, for example, a skin or fingernail infection is present. We recommend obtaining capillary blood from the sides of the fingertips as these areas are the least sensitive to pain. Use a new lancet each time you obtain blood so that obtaining blood remains virtually pain-free. Only use the finger pricker when the cap is attached. Without the cap, the lancet penetrates too deeply and the puncture can become painful.

Press the finger pricker firmly against the selected puncture site (see 7 ).
Press the release button all the way down (see 8 ). The lancet is released and it penetrates the skin
Massage the finger in the direction of the fingertip to encourage a blood drop to form. The amount of blood that emerges depends on the penetration depth and the pressure used to hold the finger pricker against the skin. If not enough blood emerges, apply more pressure on the finger pricker when you next obtain blood. If that is not sufficient, increase the penetration depth progressively in addition. If too much blood emerges, decrease the penetration depth.
Test your blood glucose immediately after you obtained blood, according to the instructions for use for your blood glucose meter. We recommend protecting the puncture site from contamination afterward.

Loading a New Lancet
If you have already used the finger pricker to obtain blood, you will need a new lancet the next time you obtain blood.

Push the lever at the side of the finger pricker as far as it will go in direction A and then back in direction B (see 9 ). The next lancet is now ready to be used. The window next to the lever shows the new number of available lancets, which has decreased by one, for example, 5 instead of 6.
Proceed as in the previous step each time you need to change the lancet. Each time a new lancet is loaded, the number of available lancets shown in the window decreases by one, for example, from 4 to 3. When you have loaded the sixth and last lancet, the window shows 1.

Replacing a Used Lancet Drum
When you have used the sixth and last lancet, you need to replace the used lancet drum with a new one.

Remove the cap from the finger pricker (see 2 ).
Remove the lancet drum from the finger pricker (see 0 ). When a lancet drum has been used, a red stripe is visible on the white cylinder. A used lancet drum has a built-in lock that stops you from using it again. Used lancet drums can be disposed of in household waste if no other regulations apply in your country.
Insert a new lancet drum (see section Inserting the Lancet Drum).

Operating Conditions
Use the finger pricker including accessories under the following operating conditions:

Temperature range: +5 to +45 °C
Relative humidity range: 5 to 90 %

Storing the Finger Pricker and Lancet Drums
Do not store the finger pricker and lancet drums at extreme temperatures, for example, in a hot car. This can impair the operation of the finger pricker and lancet drums.

Cleaning and Disinfecting the Finger Pricker and Cap

PRECAUTION
Risk of infection The finger pricker and cap may have come into contact with blood. To prevent infections from being transmitted, clean and disinfect the finger pricker and cap always before someone else handles them, for example, to assist you. To prevent infections from being transmitted, you must clean and disinfect the finger pricker and cap regularly:

At least once a week
When there is blood on the finger pricker or cap
Always before someone else handles the finger pricker, for example, to assist you. You need lint-free cloths in which you can wrap the whole finger pricker, water, and 70 % isopropanol. Before you disinfect the finger pricker and the cap, you first have to clean them to remove the blood and other dirt. To avoid damaging the finger pricker and the cap
Do not dip the finger pricker and the cap in the fluids.
Use only water for cleaning and only 70 % isopropanol for disinfecting
Remove the cap from the finger pricker (see 2 ).
Remove the lancet drum from the finger pricker (see 0 ). Cleaning
Moisten a cloth with water.
Wipe the finger pricker and the cap thoroughly. Wipe the finger pricker from the outside only (see q ) and the cap from the outside and the inside (see w ).
Dry the finger pricker and the cap with a dry cloth. Disinfecting
Dampen a cloth with 70 % isopropanol.
Wipe the finger pricker and the cap thoroughly for 2 minutes each. Wipe the finger pricker from the outside only and the cap from the outside and the inside.
Place the cap back on again.
Wrap the whole finger pricker in the cloth.
Leave the finger pricker wrapped for 8 minutes.
Unwrap the finger pricker and let it dry in the air.

Disposing of the Finger Pricker

PRECAUTION
Risk of infection
The finger pricker has come into contact with blood and is disposed of improperly. To prevent infections from being transmitted, dispose of the used finger pricker as infectious material according to the regulations applicable in your country. During obtaining a blood drop, the finger pricker may come into contact with blood. A used finger pricker, therefore, carries a risk of infection. Dispose of an unused finger pricker as plastic waste. For information about correct disposal, contact your
local council or authority.
Alternative Sites for Obtaining Blood You can obtain capillary blood for blood glucose testing not only from the fingertips but also from other sites (palm, forearm, upper arm, calf or thigh), so-called alternative site testing (abbreviated as AST). To be able to obtain capillary blood from other sites, you have to replace the regular cap by a special cap, the Accu-Chek FastClix AST cap.
Ordering Information
If you want to order an Accu-Chek FastClix finger pricker, Accu-Chek FastClix lancet drums or an Accu-Chek FastClix AST cap, contact the Accu-Chek Customer Careline (see section Customer Support ). Reporting of Serious Incidents For a patient/user/third party in the European Union and in countries with identical regulatory regimes; if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority.
Last Update
2021-03
Customer Support
United Kingdom
Roche Diabetes Care Limited
Charles Avenue, Burgess Hill
West Sussex, RH15 9RY, United Kingdom
Accu-Chek Customer Careline

UK Freephone number: 0800 701 000
ROI Freephone number: 1 800 709 600
calls may be recorded for training purposes Some mobile operators may charge for calls to these numbers.
www.accu-chek.co.uk
www.Accu-chek.ie
Malta Vivian Corporation
29, Sanitas Building
Tower Street
Msida MSD1824
Freephone: 80073102

| Consult instructions for use or consult electronic instructions for use
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| Caution, refer to safety-related notes in the instructions for use accompanying this product.
| Use by
| Sterilized using irradiation
| Use only once
| Single patient multiple uses
| Medical device
| Manufacturer
| Unique device identifier
| Catalog number
| Batch code
| Complies with the provisions of the applicable EU Legislation

0123
ACCU-CHEK and FASTCLIX
are trademarks of Roche.
© 2021 Roche Diabetes Care
Roche Diabetes Care GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
www.Accu-chek.com DE 09245693001(02) – US 09245693002

Documents / Resources

| ACCU-CHEK 4015630065578 Fastclix Finger Pricker and Lancet [pdf] Instruction Manual
4015630065578, Fastclix Finger Pricker and Lancet, 4015630065578 Fastclix Finger Pricker and Lancet
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