POLYDENTIA Vista-Tec ilGrande User manual

Polydentia SA
via Cantonale 47 • 6805 Mezzovico-Vira • Switzerland
Phone [phone]2948 • Fax [phone]3203
polydentia.ch • [e-mail]
Made in Switzerland
Personal
protective
equipment
REV 03 10.2020
GPerformance obtained in technical examinations to verify the levels
or classes of protection of PPE
For analysis of the compliance of this PPE with the Essential Health and Safety Requirements, reference
was made to the European Standard EN166:2001 - Personal Eye Protection.
In particular:
General construction
Field of view
Optical requirements
Quality of material and surface
Increased robustness
Resistance to aging
Protection against droplets and liquid splashes
HReplacements
This PPE is designed to be used only with Vista-Tec ilGrande replacements.
IMarking
The CE marking affixed to the PPE states the compliance of the product with Regulation (EU) 2016/425 and with the
technical standard EN 166:2001. The identification of the production batch is clearly shown on the packaging by the
initials LOT.
JDeclaration of Conformity
The Declaration of Conformity is available on the website polydentia.ch
K Notified Body
Italcert Srl (NB 0426)
Viale Sarca, 336
20126 Milano - Italia
English •Vista-Tec ilGrande
Product REF Name Description
5663 Vista-Tec ilGrande 1 frame, 2 shields, 1 headband
5666 Vista-Tec ilGrande shields 5 shields
Frame marking
Identification Polydentia
Harmonized standard applied EN166
Field of use: liquids 3
Increased robustness S
Certification mark CE
Face shield marking
Identification Polydentia
Optical class 1
Increased robustness S
SWISS
MADE
Instruction
for use
for more
information

ADescription and field of application
Vista-Tec ilGrande is an EN166:2001 certified face shield for protection against liquid splashes.
Vista-Tec ilGrande can be used in dental, outpatient, hospital, laboratory or other professional settings that require
similar protection.
The face shields, made of polycarbonate, are resistant and do not yellow when exposed to light. They are reusable
and easy to clean (see Paragraph E).
Vista-Tec ilGrande is comfortable and light (about 42g), it can be worn comfortably for long periods as it does not
create distortions and visual fatigue, also ensuring a wide field of vision.
The protective face shields are easily attached through the clips integrated into the frame.
Vista-Tec ilGrande adapts stably to any type of face thanks to the headband.
Can be used with surgical masks.
This Personal Protective Equipment (PPE) is classified, according to Annex I of EU Regulation 2016/425, as Category
II Protective Equipment.
BComposition
Frame Vista-Tec ilGrande: Polysulfone
Headband: Silicone
Transparent protective shield: Polycarbonate
C Assembly
DWarnings
Vista-Tec ilGrande does not prevent the contagion of diseases or infections but reduces the risk of coming into
contact with liquid splashes aimed at the eyes, nose and mouth.
This PPE can only be used in dental, outpatient, hospital, laboratory or other professional contexts that require similar
protection where the user can directly evaluate the effectiveness against non-serious risks. The PPE must not be
used in case of risks that could lead to death or irreversible damage. In case of doubt regarding the effectiveness
against risks that are difficult to assess, the user must NOT use the PPE.
This PPE is not designed to protect the user from violent impacts against any obstacles; if ophthalmic glasses are
worn, this PPE can transmit the impact.
The PPE does not protect from sunlight, UV radiation, laser and BLUE light (used in photopolymerization in the dental
field). Do not expose the PPE to sunlight or UV lamps for long periods.
The materials constituting the PPE, in contact with the skin, can cause allergic reactions in people sensitive to these
types of materials (see Paragraph B).
The user is responsible for determining the suitability of the Vista-Tec ilGrande for the intended use.
Avoid exposing the PPE to chemicals, fumes, vapors or heat sources. Do not use solvents or organic liquids such as
petrol in contact with the PPE.
Scratched or damaged shields must be replaced.
As reported in paragraph 10, point P, of the EN166:2001 standard, if protection from high speed particles at extreme
temperatures is required, the face shields must be marked with the letter T immediately after the impact letter, i.e. FT,
BT or AT. If the impact letter is not followed by the letter T, the eye protector should only be used as protection from
high speed particles at room temperature.
EIndications for proper cleaning and maintenance
Cleaning
It is advisable to remove the shield from the frame for cleaning.
Protective face shields must be cleaned regularly after each use using warm water and neutral detergent. Use soft
microfiber cloths to dry the components.
The polycarbonate shields are characterized by high optical performance, so please pay special attention when
cleaning. The presence of particulate matter can cause scratches on the shield.
Surface disinfection of the frame and face shields Vista-Tec ilGrande can be carried out using alcohol-based
products. Never immerse the components completely in disinfectant solutions. Please always refer to the disinfectant
manufacturer’s instructions.
The frame and headband can be sterilized in an autoclave (up to 134 °C).
WARNING: Do not autoclave the face shield.
Maintenance
The PPE is designed to be reused multiple times if kept in good condition. It can be used for 3 years from its first
use.
Do not use the PPE if there are evident marks on the protective shield or if the frame is damaged.
Replace the damaged components if necessary.
FInformation for storage and transport
Store in a clean and dry place, away from sunlight and in an environment free of organic vapors. Vista-Tec ilGrande
must be transported and stored in its original packaging, at a temperature between +5 °C and +30 °C.
English •Vista-Tec ilGrandeEnglish •Vista-Tec ilGrande
1Remove the protective film on both sides
by the corners Z. The protective shield
has two pairs of openings, X and Y. The
openings called X act as a support into
which the temples of the frame will be
inserted, while the openings Y are the
attachment points of the clips present on
the frame.
2Insert the right temple arm of the frame
into hole X on the right side of the shield;
slide the shield onto the frame up to the
clip. Wrap the shield on the frame and
insert the left temple arm in the second
hole X on the left side of the shield.
3Insert the protective shield into the fixing
clip on the frame. Slide the shield into the
retaining clip until it locks in place.
Repeat the operations for fixing the left
side of the protective shield.
4Fix the two silicone bands on the specific
supports at the end of the temple arms of
the frame.
5The width of the band can be adjusted by
pulling the ends.
6Picture of the device correctly
assembled.
ZZ
YYXX
XX
X
X
Y
Y