Intended Use; Intended Purpose; Users; Patient Selection - KLS Martin group Angulus2 Mode D'emploi

4

Intended Use

4.1

Intended Purpose

Surgical treatment of hard tissue.
4.2

Users

These products may only be used by competent medical staff who, due to their specialized
training, experience and knowledge of the relevant regulation have the necessary qualification
for using the system correctly.
Users must have adequate knowledge of the rules of medical practice, as well as state of the
art and the contents of pertinent scientific articles published by medical authors.
The user must be thoroughly familiar with the surgical technique as well as with the set of
instruments and accessories used.
The user bears the responsibility for
thoroughly study of the complete product documentation
•
selection and proper performance of the surgical procedure
•
avoiding or minimizing the general risks posed by surgical interventions
•
The angled screwdriver should only be prepared for use and maintained by staff who have
been trained in procedures for infection control, personal safety and patient safety.
4.3

Patient Selection

On the part of the manufacturer there are no restrictions regarding patient selection.
The final decision if the product can be used for a patient is by the user.
Restrictions on the use must be observed.
4.4

Environmental Conditions

Conditions for operation
Temperature:
Relative humidity:
Conditions for transport
Temperature:
Relative humidity:
38
+10 °C to +35 °C (+50 °F to +95 °F)
15 – 80 % (relative), non-condensing
-40 °C to +70 °C (-40 °F to 158 °F)
8 – 80 % (relative), non-condensing
Instructions for Use
Angulus2 Angled Screwdriver
Revision 04