FAQ Listing

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.

No.

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.

Yes.

No. The lancing device has a uniquely designed and engineered safety mechanism.

No. The Accu-Chek Safe-T-Pro Plus lancing device is not designed and intended to be used on alternative sites. 

Medium depth setting

Choose the low setting for soft, thin and delicate skin or use on average skin to obtain a smaller drop of blood. Choose the medium setting for normal skin or if a medium blood volume is required. Choose the high setting for calloused skin, to obtain a blood sample without pressing and squeezing, if a high blood sample is required or for multi-test situations. 

Different depth settings are required to accommodate different patient’s skin types. You do not require different single-use lancing devices with different penetration depths. This will save you time, costs and the need to stock a variety of lancing devices.