Safe-T Pro Plus Support | CAC
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Frequently Asked Questions

General questions

Roche Diabetes Care, as a manufacturer of medical devices, certified to European standards, complies with all applicable European directives. The device is CE (Conformité Européene) labeled, which means that the product meets the safety and normative requirements of those European directives. The European regulations are valid and recognized under mutual recognition agreements with many countries, including Canada, LATAM, APAC and Japan. The device also complies with laws such as the US Needlestick Safety and Prevention Act, the TRBA 250 (Germany) or the NR 32 (Brazil) and others.

The Accu-Chek Safe-T-Pro Plus lancing device is manufactured in Poland and Japan.

200 units.

No. (For a list of materials please contact Roche Diabetes Care, Mannheim, Germany.)

If stored properly, the lancing device remains functional for 4 years after sterilization.

If stored properly, the lancets remain sterile for 4 years after sterilization.

The lancet (= needle surrounded by the sterility cap) of the Accu-Chek Safe-T-Pro Plus lancing device is sterilized in a process called gamma irradiation which meets the international standards.

The device should be disposed in accordance with you facility’s disposable procedures.

With children younger than 1 year of age, the capillary blood must be obtained from the heel. Obtaining blood must occur from the lateral areas of the sole.

The puncture must occur vertically to the sole. While obtaining blood, the child should be held with its foot vertically facing the floor. A site which has already been punctured must not be punctured a second time.

To improve blood flow at the heel before obtaining blood, you can carefully warm the heel, for example by wrapping it in a warm, moist cloth of a maximum 42 °C.

The heel must be disinfected and then dried completely.

To obtain capillary blood from the heel of children under 1 year, use only the low or medium penetration depth. If the high penetration depth is used, the calcaneus (heel bone) is at risk of being injured.

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Accu-Chek Safe-T Pro Plus

Item Description

Multiple safety features combined with customized settings make the Accu-Chek

Safe-T-Pro Plus lancing device especially advantageous. This single use lancing device supports patient safety and ease of use. It also complies with the safety requirements demanded by health authorities, legislators, and health institutions.

 

Intended use

Single use, obtaining capillary blood from the fingertip or, if the patient is a child under 1 year from the heel.

 

Disposal

Entire device is for single use only.

Disposal of used single-use lancing devices always in accordance with the local / facility’s disposal procedures and country’s sanitary regulations.

LANCING

In 3 milliseconds

DEPTH

1.3, 1.8 and 2.3 millimeters

STERILITY

4 years after sterilization

DISPOSAL

Entire device is for single use only.

Disposal of used single-use lancing devices

always in accordance with the local / facility’s disposal procedures

Intended Use

Single use, obtaining capillary blood from the fingertip or, if the patient is a child under 1 year, from the heel.

Benefits and Features
  • 3 adjustable depth settings allow the sampling of blood according to the skin condition of the patient
  • Each depth setting clicks into place and cannot slip out of position once selected
  • Special beveled needle cut and needle diameter for virtually pain-free blood sampling
  • Use with adults, children under 1 year and neonates
  • Save space and costs by using one type of lancet
  • Designed for single use, to avoid cross contamination
  • The Safe-T-technology ensures that the needle is always safely stored in the housing, preventing accidental needle sticks
  • Automatic needle retraction after single use eliminates risk of injury and cross contamination
  • After the single use the complete lancing device is disposed of
Additional Specifications
Use :

Single use only

Adjustable depth setting:

Yes

Penetration depths:

Low (short marking) – 1.3mm
Medium (middle marking) – 1.8mm
High (long marking) – 2.3mm

Special needle cut:

3-facet cut

Siliconized needle :

Yes

Needle diameter:

0.63 mm (23 G)

Automatic retraction of needle :

Yes

Single-use only:

Yes

Recognition of used device :

Yes

Sterility:

4 years after sterilization

How to use the Accu-Chek Safe-T-Pro Plus lancing device

Simple, 3-step testing:

  1. Twist the sterility cap and remove it.
  2. The penetration depth adjuster is pre-set at medium. Turn the penetration depth adjuster to the desired penetration depth. The 3 penetration depths are easy to identify by their short, medium, or long markings.
  3. Hold the lancing device between your index finger, middle finger, and thumb. You will find that it fits comfortably and securely between fingers, right or left-handed. Press the lancing device firmly against the chosen puncture site.  Using your thumb, press the release button down completely. Move the lancing device away from the puncture site and discard it.