Ambient Conditions; Users; Limitations Of Use; Contraindications - KLS Martin group Reconstruction de l'avant-bras IPS Implants Mode D'emploi

Instructions for Use
IPS® Implants Forearm Reconstruction
3.1.3

Ambient Conditions

The products may be used only in rooms intended for medical purposes under sterile operation conditions.
3.1.4

Users

The products may be used only by expert medical staff who are qualified to use the products based on their
specialized training, their knowledge and experience, as well as their knowledge of the relevant regulations.
Users must have adequate knowledge of the rules of medical practice, as well as the state of the art and
the contents of pertinent scientific articles published by medical authors.
The user must know and have mastered the surgical technique and the product as a whole.
The user bears the responsibility for:
• Thorough study of the complete product documentation
• Practical training in the handling of the product
• Selection and proper execution of the surgical procedure
• Compilation of the product components and their proper use
• Avoiding or minimizing the general risks posed by surgical interventions
• Obtaining informed consent from, instructing, and taking post-operative care of the patient
3.2

Limitations of Use

3.2.1

Contraindications

Non-compliance with the contraindications may result in serious or even fatal injury to the patient!
• Manifest infection in the vicinity of the location to be treated
• Material sensitivity or allergies to the implant materials used
• Quantitatively and/or qualitatively insufficient hard and/or soft tissue
• Patients who are unwilling or unable to follow instructions during the entire treatment including the
post-operative phase
• Use in areas that are exposed to inappropriate forces or weight loads
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