INTENDED USE OF THE DENACAM SYSTEM
DENACAM System | User Manual | REF M1000-1001 I Version 1.2 3
Intended medical contraindication
All contraindications for dental implants apply as well as
a contraindication for this navigation system.
Dental implants contraindications
General:
Serious internal medical problems, bone metabolism
disturbances, uncontrolled bleeding disorders,
inadequate wound healing capacity, poor oral hygiene,
maxillary and mandibular growth not completed, poor
general state of health, uncooperative, unmotivated
patient, drug or alcohol abuse, psychoses, prolonged
therapy-resistant functional disorders, xerostomia,
weakened immune system, illness requiring periodic use
of steroids, titanium allergy, uncontrollable endocrine
disorders.
Relative contraindications:
Previously irritated bone, diabetes mellitus,
anticoagulation drugs/hemorrhagic diatheses, bruxism,
parafunctional habits, unfavorable anatomic bone
conditions, tobacco abuse, uncontrolled periodontitis,
temporomandibular joint disorders, treatable pathologic
diseases of the jaw and changes in the oral mucosa,
pregnancy, inadequate oral hygiene.
Local contraindications:
Inadequate bone volume or quality, local root remnants.
Navigation system contraindications
Heavy artefacts in region of marker, preventing
unambiguous detection.
Electromagnetic compatibility (EMC)
The DENACAM System is a medical device that requires
special safety precautions and must be installed and
placed in operation in accordance with the attached EMC
information.
mininavident only guarantees compliance of the
DENACAM System with the EMC directives when it is
used with original spare parts, consumables, and
accessories. The use of spare parts, consumables, and
accessories that have not been approved by mininavident
may lead to increased emission of electromagnetic
interference or to reduced resistance to electromagnetic
interference.
For more information about the EMC manufacturer’s declaration,
see "EMC manufacturer’s declaration for the DENACAM System" on
page 94
