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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 lancing device is CE (Conformité Européene) labelled, which means that the product meets the safety and normative requirements of those European directives. The European regulations are valid and recognised under mutual recognition agreements with many countries, including Canada, LATAM, APAC and Japan. The lancing device also complies with laws such as the US Needlestick Safety and Prevention Act, the TRBA 250 (Germany), the NR 32 (Brazil) and others.

Poland

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 sterilisation.

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

The lancets (needles surrounded by the sterility cap) of the device are sterilised in a process called gamma irradiation, which meets the international standards.

The lancing device should be disposed of in accordance with your facility’s procedures.

Yes. It is suitable for use children under 1 year of age and neonates.

No. The lancing device is not designed and intended to be used for AST.

No. The lancing device has a uniquely designed and engineered safety mechanism. The release button is depressed and locked in the housing after use.


Accu-Chek Safe-T-Pro Uno

Item Description

The Accu-Chek Safe-T-Pro Uno lancing device keeps up with increased safety and hygienic requirements by health authorities, legislators, and health institutions. At the same time, it provides ergonomic handling, lancing in just 3 milliseconds, and safety features that prevent accidental needle sticks. Its pre-set lancing depth makes it ready to use immediately.

SAFETY

Prevents accidental needle sticks

DEPTH

Pre-set, 1.5 mm

STERILITY

4 years after sterilisation

DISPOSAL

Single use

USE FOR

Adults, children <1 year, neonates

Benefits and features
  • Ready to use with a pre-set depth setting 
  • Safe-T-Technology ensures the needle is always safely stored away
  • Stored needle prevents accidental needle sticks
  • Ergonomic and easy to grip for safe handling 
  • Hygienic – each lancet can only be used once
  • Bevelled needle with small diameter for virtually pain-free blood sampling
  • Equally suitable for right- and left-handed use
  • After a single use, the complete lancing device is disposed of
Additional specifications
Pre-fixed depth setting:

Yes

Penetration depth:

1.5 mm

Needle diameter :

0.36 mm (28 G)

Special needle cut:

3-facet cut

Siliconized needle :

Yes

Sterility :

4 years after sterilisation

Single-use only:

Yes

Automatic retraction of needle:

Yes

Recognition of used device:

Yes

Intuitive handling:

Yes

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

Simple, 2-step lancing

  1. Twist the sterility cap one quarter turn and remove it.
  2. Hold the lancing device between your index finger, middle finger, and thumb. 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.

 

 

 

References

  1. Data on File. Accu-Chek Safe-T-Pro Uno Evaluation Summary 2015