e-nova Vizix User manual

ENGLISH (EN)
2023-03 F20484, Rev B www.goenova.com
Enova Vizix®
Custom Loupes
Instructions For Use

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Please read the instruction manual carefully before
using your Enova Loupes. Damages due to disregard
of the instructions within this manual are not covered
under the warranty policy of Enova Illumination.
• Improper use of oculars may result in damage
or failure of glue, resulting in loose or detached
ocular.
• DO NOT look directly into the sun or other
intense light while wearing loupes to avoid eye
damage.
• Avoid vibration or shaking of loupes. This may
result in loose or detached pieces.
• Proper use of the loupe and light system
requires parts from Enova or licensed suppliers
only.
• Avoid shock to product by keeping product in
approved composite carrying case when not in
use.
• Never spray disinfectant straight onto the
oculars.
• Never hold your loupes by the oculars.
• Please consult local regulations for proper
disposal.
2
Introduction
This Instructions For Use manual is the most
comprehensive source of information for the safe and
e󰀨ective use of your product. This manual may be used
by surgeons, dentists, veterinarians, or other healthcare
professionals.
Keep and consult this reference manual during the life
of the product.
The following conventions are used in this manual:
• A WARNING highlights a safety-related issue.
ALWAYS comply with this information to prevent
injury to patient, user, medical personnel, and/or
other persons and animals.
• A CAUTION highlights a product reliability issue.
ALWAYS comply with this information to prevent
product damage.
• A NOTE supplements and/or claries procedural
information.
If additional information, especially safety information,
or in-service training is required, contact your Enova
sales representative or call Enova customer service.
Trademarks not the property of Enova Illumination are
the property of their respective owners.
Indications for Use
Enova Loupes are designed to provide magnication
during dental or minor surgical procedures. Enova
loupes are tted for your head and crafted for your
eyes. Every pair is designed to consider ideal working
distance, individual facial features, custom lens
prescriptions, and the optimal declination angle.
Contraindications
None known.
Limitations of Use
None known.
For Use With
Safety & Care Instructions
NOTE: Proper usage of the products ensure their
lifespan. Misuse, disregard for instructions, or
improper care may result in breakage or deterioration
of your Enova products.
Axis Light System, Atom Wireless Light System,
Futudent microCam XS Systems, Futudent proCam XS
Systems, Futudent smartCam Systems.
WARNINGS:

F20484, Rev B (EN)
3
Accessories
This section describes components that may be
ordered to replace original equipment that is damaged,
worn, or must be replaced.
WARNINGS:
• DO NOT modify any component or accessory,
unless otherwise specied.
The following Enova-approved accessories can be sold
in conjunction with the Enova Loupe System.
DESCRIPTION REF
Classic Side Shield (L&R) 810003-001
Universal Side Shield (L&R) 810003-002
Airon Side Shield (L&R) 810003-003
Airon Radius Side Shield (L&R) 810003-004
Retainer Strap 800051-001
Chums Retainer Strap 800051-002
Enova Cleaning Cloth 810020-001
Enova Loupe Case 80034-006
Axis Light with Activ Battery Combo
Case 80034-008
Axis™ Light System with Activ™
Battery 90900-001
Axis™ Light System with Hip
Battery 90900-002
Axis™ Light System with Hip and
Activ™ Battery 90900-003
NOTE: For a complete list of accessories, contact
your Enova sales representative or call Enova
customer service.
Features
A
B
C
AMagnetic Adapter: Every Enova loupe
comes with a magnetic adapter to securely
attach optional clip-on lights or cameras.
BFlexible Temple Arms: Custom tted to
head for a comfortable and secure t.
C
Carrier Lens: High-quality TriVex lenses
provide high-resolution when not using
oculars. Option to use prescription.
D
Oculars: A series of high-quality glass
lenses and a custom eye-lens housed in
aircraft aluminum for clear magnication
and lasting durability.
E
Nose Pads: Made of comfortable materials
to support the user and the frame. May
be adjustable. See Instructions section for
details.
D
E
Instructions
1. Upon arrival, check product for damages and
report immediately.
2. Check packing slip to ensure all components
of your Enova Loupe System were properly
packaged and delivered.
3. Put on loupes and view a 3D object at your
working distance to make sure the image is
sharp.
4. If applicable to frame style, adjust nose pads to
desired comfort and t.
5. To secure frames, attach included retainer strap.
Pinch strap carefully to adjust.
NOTE: Oakley Frame nose pads are not
adjustable.
Figure 1

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4
Cleaning
WARNINGS:
CAUTION: DO NOT use solvents, lubricants, or other chemicals, unless otherwise specied. Never spray
disinfectant directly onto loupes.
To Clean Loupes
1. To clean carrier lens, hold under running room temperature water for preliminary rinse. Apply a drop of mild soap
and rub into glasses. Rinse under running water.
2. After cleaning, wipe the area with a lint-free soft cloth moistened with water to remove any residue from cleaning
products.
3. To disinfect, use a small amount of non-alcohol disinfecting agents with a lint-free cloth or soft paper towel.
For further information on cleaning, care and handling of Enova surgical loupes, see Enova Loupe Customer Care Card
(F20003) provided.
Storage and Handling
CAUTION: ALWAYS store the equipment within the specied environmental conditions throughout its useful life.
To ensure the longevity, performance, and safety of this equipment, use of the composite carrying case or water tight
packaging is recommended for storage and transport.
Disposal / Recycle
WARNING: ALWAYS follow the current local recommendations and/or regulations governing environmental
protection and the risks associated with recycling or disposing of the equipment at the end of its useful life.
NOTE: Avoid scratching or striking the lenses as a reduction in visual clarity may occur.
NOTE: If any component must be discarded, see the Disposal / Recycle section.
Troubleshooting
Issue Additional Problem Indicators Troubleshooting
Image is blurry Image is clear at some point, but not the
desired distance.
Yes: Adjust working distance. Contact
Enova representative.
No: Prescription is incorrect or missing.
Contact Enova representative.
Image is doubled Draw a cross. If you’re seeing double
lines your oculars need to be adjusted.
Contact Enova representative for help
adjusting frames accordingly.
Shadowed Image
Seeing one directional shadow (top,
bottom, left or right).
Your nose pads need to be adjusted
opposite of the shadow appearing.
Example: if your image has a left side
shadow, adjust nose pads to the right.
Seeing split shadows or double outside
shadows. Contact Enova representative.
WARNING: DO NOT service this equipment, unless otherwise specied. If you require service, contact
your Enova sales representative or call Enova customer service.
If you are experiencing issues with your new loupes, follow the matrix to help customer service determine the
problem.

F20484, Rev B (EN)
5
Product Specications
Frame Specications
Frame
Weight (g)
w/o carriers
Material Lens Height
(mm)
Frame
Width (mm)
Bridge
Width (mm)
Temple
Length
Airon Radius 15.8 Aluminum 42.8 149.2 11.7 130.5
Airon Standard 17.9 Aluminum 43.0 149.3 12.2 142.0
Airon Small 15.1 Aluminum 40.7 137.7 8.8 136.0
Airon Sport 13.8 Aluminum 50.2 145.7 8.3 135.0
Oakley Flak
2.0 XL 16.5 Plastic 41.0 144.0 9.0 125.7
Oakley
Centerboard 12.9 Plastic 43.8 138.3 8.8 138.8
Ocular Weight Specications (g)
2.5x 3.0x 3.5x 4.5x 5.5x 6.5x
Galilean 28.8 34.4 36.4 - - -
P-Series Prism - - 44.6 50.4 55.8 TBD
Angled Prism - - 32.8 - - -
K-Series - - 42.4 47 - -
Symbol Denition
Symbol Denition
General Warning Sign (Yellow)
Catalog Number
Quantity
Lot Number
Medical Device
Keep Dry
Manufactured by
Recycle of Li-Ion Battery (in Accordance with Local Laws)
CE Mark indicating that the device complies with Regulation (EU) 2017/745 of the European Parliament
and of the Council of 5 April 2017 on medical devices
QTY

2023-03 F20484, Rev B www.goenova.com
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