Technolas Victus, User Manual

Page: 44 / 207

5.2 Patient selection criteria
Danger of injury due to the failure to observe the patient selection criteria!
Failure to observe the contraindications may result in serious permanent
patient injury.
– Observe the contraindications in
Ä
Chapter 5.2.1 ‘Contraindications’
on page 5 - 2 .
5.2.1
Contraindications
Limitations for usage of the laser system correspond to the exclusion criteria
known to be associated with such applications.
Patients with pacemakers
The cover of the laser is designed in a way that electromagnetic fields are minimized.
Nevertheless, special precaution must be taken when treating patients with pace‐
makers. Patients with pacemakers should only be treated in the presence of an
anesthetist and after consultation with their cardiologist.
n Corneal opacity that would interfere with the laser beam.
n
Pediatric surgery, patients under the age of 18 years or legal age.
n
All valid exclusion criteria for the intended treatment like:
– glaucoma and suspected glaucoma
– diabetes mellitus
– retinal disorders
– rheumatic diseases
– occlusion of retinal vessels
– pellucid marginal degeneration
– herpes zoster or herpes simplex keratitis
– heavy vascularization of the ocular tissue
– epilepsy
– recurrent corneal erosion
– severe basement membrane disease
– patients who suffer from severe wound-healing disorders such as con‐
nective tissue disease, autoimmune illnesses, immunodeficiency illnesses,
endocrine diseases, lupus, rheumatoid arthritis, collagenosis, or clinically
significant atopy
– patients suffering from AIDS or HIV.
n Valid exclusion criteria that complicate the docking procedure like:
– chemosis
– significant loss of stability of the conjunctiva
– nystagmus
– On a keratometric map of the cornea, the minimum and maximum K-
values of the central 3 mm zone must not differ by more than 5 D.
– The maximum K-values must not exceed 60 D. The minimum value must
not be smaller than 37 D.
n
Patients who are pregnant or nursing.
L
WARNING
The following criteria apply
to all procedures:
CLINICAL APPLICATIONS
5
SKU: 70005780TPV * Version 6 * UM-100010770 GB
5 - 2
TPV Controlled Document / Status: Effective / Effective Date: Jun 14, 2017 2:38:46 PM
UM-100010770 / Version 6 / Page 44 of 207