orangedental opt-on 2.7 User manual

Instructions for Use

Instructions for Use | opt–on
2.7
/opt–on
3.3
00.000.527-08 | EN Date: 11.10.2019 Page 1 of 15
1. DEAR CUSTOMER
1.1. Prolo ue
he product that you have purchased – the opt–on
2.7
/opt–on
3.3
is state-
of-the-art technology and has been produced in accordance with the
strictest quality criteria. As we are constantly developing our products
further, it is possible that the illustrations and drawings in this document
may differ slightly form the product that you have purchased.
hese instructions contain an exact description and explain how to use the
opt–on
2.7
/opt–on
3.3
. If you have any additional questions or ideas, we
would be pleased to help you by telephone or by email.
hese instructions accompany the opt–on
2.7
/opt–on
3.3
. Please keep them
to hand. If you pass this product on to a third party, please give them this
document too as it contains important information on commissioning and
handling the product.
Please use these instructions to familiarize yourself with the product before
you use it during treatment.
1.1.1. Responsibility of the Manufacturer
he opt–on
2.7
/opt–on
3.3
is manufactured in accordance with the state-of-
the-art technology and the recognized safety-related rules and regulations.
orangedental GmbH & Co. KG [hereafter referred to as orangedental] only
considers itself responsible for the effects on safety, reliability and
performance of the device, if:
Assembly, add-ons, readjustments, alterations or repairs are only
carried out by persons authorized by orangedental,
the device is used in accordance with the instructions for use.
1.1.2. Responsibility of the Operator
Among other things, the operator is responsible for:
adherence to the accident prevention regulations as well as the
regulation concerning the installation, operation and use of active
medical products (German regulation MPBetreibV).
the operation.
the maintenance.

Instructions for Use | opt–on
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/opt–on
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Page 2 of 15 Date: 11.10.2019 00.000.527-08 | EN
the proper and safe condition of the product.
the storage of the instruction manual at the location of use.
following the safety instructions contained in these instructions
(see chapter 1.3: Conventions, Symbols Used).

Instructions for Use | opt–on
2.7
/opt–on
3.3
00.000.527-08 | EN Date: 11.10.2019 Page 3 of 15
1.2. Contents
1. Dear Customer .............................................................................................. 1
1.1. Prologue .......................................................................................................... 1
1.1.1. Responsibility of the Manufacturer ............................................................ 1
1.1.2. Responsibility of the Operator ................................................................... 1
1.2. Contents .......................................................................................................... 3
1.3. Conventions, Symbols Used ............................................................................ 4
2. About the Product ......................................................................................... 6
2.1. Intended Use ................................................................................................... 6
2.2. System Components ....................................................................................... 6
2.3. Accessories/ Spare Parts ............................................................................... 6
2.3.1. Spare Parts Loupe Frame .......................................................................... 6
2.3.2. Accessories ............................................................................................... 7
3. Individual Fittin ........................................................................................... 8
3.1. Fitting of Nose Pads ........................................................................................ 8
3.2. Inclination ........................................................................................................ 8
3.3. Mounting of Lanyard ....................................................................................... 8
4. Installation of expendable Parts and Accessories .................................... 9
4.1. Change the emple ......................................................................................... 9
4.2. Change the Hinge .......................................................................................... 10
4.3. Change of Varioclips...................................................................................... 11
5. Safety, Servicin and Maintenance ........................................................... 12
5.1. Cleaning......................................................................................................... 12
5.2. Disinfection ................................................................................................... 12
5.2.1. Disinfection Agents for opt–on
2.7
/opt–on
3.3
........................................... 13
5.3. Disposal ......................................................................................................... 13
6. Specifications and Conformity .................................................................. 14
6.1. Requirements regarding the Practice Environment ....................................... 14
6.2. echnical Data ............................................................................................... 14
6.2.1. Loupe Data .............................................................................................. 14
6.2.2. Ambient Conditions ................................................................................. 14
6.2.3. Conformity with Standards ...................................................................... 15

Instructions for Use | opt–on
2.7
/opt–on
3.3
Page 4 of 15 Date: 11.10.2019 00.000.527-08 | EN
1.3. Conventions, Symbols Used
In these instructions, the conventions set out below indicate important
information:
W ARNING
: his symbol is used if deviating from the procedure described
can lead to physical injury or death.
C AU ION
: his symbol is used if deviating from the procedure described
can lead to damage to the product or to loss of data.
I MPOR AN : he usage of the term IMPOR AN
, formatted in bold capitals,
provides instructions about the use of the device or a
process.
Note: Notes are used to highlight important or unusual points.
he meaning of the symbols, which are used on this product, its packaging
or in these instructions, is listed below.
C HECK INS RUC IONS
his symbol indicates that this user manual contains
important, mandatory instructions which must be followed to
comply with the safety standards for the medical product.
A EN ION
his symbol indicates that there are warnings or regulations
concerning the product which are not specified on the label.
It advises the reader to consult the accompanying
documents.
M ANUFAC URER
his symbol is used in order to display the name and address
of the manufacturer of the medical product.
D A E OF MANUFAC URE
his symbol indicates the date of manufacture.
O RDER NUMBER
his symbol indicates the order number.
S ERIAL NUMBER
his symbol is used to indicate the serial number.

Instructions for Use | opt–on
2.7
/opt–on
3.3
00.000.527-08 | EN Date: 11.10.2019 Page 5 of 15
CE M ARKING
his symbol, attached by the manufacturer, indicates that the
medical product is in conformity with and fulfills all
requirements of the medical device directive 93/42/EWG.

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2.7
/opt–on
3.3
Page 6 of 15 Date: 11.10.2019 00.000.527-08 | EN
2. ABOUT THE PRODUCT
2.1. Intended Use
he loupe opt–on
2.7
/opt–on
3.3
is solely used to support the visual
inspection / to survey findings/ to aid in treatment by dental professionals
using optical magnification in a dental treatment room.
2.2. System Components
loupe
Incl. one pair of
Varioclips for the
needed working
distance
lup0499000
lanyard 00.001.934
micro fiber tissue zub0498210
Box zublup0499290
manual 00.000.527
2.3. Accessories/ Spare Parts
All parts can be ordered at your dealer or orangedental.
2.3.1. Spare Parts Loupe Frame
Frame No. frame No. right
temple
No. left
temple
No. frame
front
frame A (164) size : L; color: white
(6554) 00.002.013 00.002.283 00.002.327 00.002.248
frame A (165) size : S; color: white
(6554) 00.002.024 00.002.294 00.002.338 00.002.226
frame A (164) size : L; color: shiny
black (6550) 00.002.035 00.002.261 00.002.305 00.002.250
frame A (165) size : S; color: shiny
black (6550)
00.002.046 00.002.272 00.002.316 00.002.237
frame A (170) size : L; color: clear
(6053) 00.004.263 00.005.051 00.004.937 00.004.814
frame A (171) size : S; color: clear
(6053) 00.004.195 00.005.062 00.004.948 00.004.825

Instructions for Use | opt–on
2.7
/opt–on
3.3
00.000.527-08 | EN Date: 11.10.2019 Page 7 of 15
Frame No. frame No. right
temple
No. left
temple
No. frame
front
frame A (164) size : L; color:
brown (former copper matt)
(6051)
00.004.296 00.005.073 00.004.950 00.004.836
frame A (165) size : S; color:
brown (former copper matt)
(6051) 00.004.230 00.005.084 00.004.961 00.004.847
frame A (164) size : L; color: red
(6064) 00.004.285 00.005.095 00.004.972 00.004.858
frame A (165) size : S; color: red
(6064) 00.004.228 00.005.106 00.004.983 00.004.860
frame A (164) size : L; color: black
matt (6071) 00.004.274 00.005.117 00.004.994 00.004.871
frame A (165) size : S; color: black
matt (6071) 00.004.217 00.005.128 00.005.005 00.004.882
Description No.
hinge right 00.002.340
hinge left 00.002.351
Pads Euro (1pair) 00.002.362
Pads Asia (1 pair) 00.006.120
1 pair protection lenses with ocular individual
1 pair Varioclips working distance 250 mm=10 inch 00.000.966
1 pair Varioclips working distance 300 mm=12 inch zublup0499140
1 pair Varioclips working distance 350 mm=14 inch zublup0499150
1 pair Varioclips working distance 400 mm=16 inch zublup0499160
1 pair Varioclips working distance 450 mm=18 inch zublup0499170
1 pair Varioclips working distance 500 mm=20 inch zublup0499180
2.3.2. Accessories
Description No.
lanyard 00.001.934
box zublup0499290
micro fiber tissue zub0498210
clip in prescription adapter zublup0499100
clip in prescription adapter for long eye lashes zublup0499101
individual prescription lenses for clip in prescription
adapter
00.001.956

Instructions for Use | opt–on
2.7
/opt–on
3.3
Page 8 of 15 Date: 11.10.2019 00.000.527-08 | EN
3. INDIVIDUAL FITTING
Your opt–on
2.7
/opt–on
3.3
has been produced individually for your interpupillary and
working distance. You can take the following additional fittings:
3.1. Fittin of Nose Pads
here are two different nose pad positions:
>> click in: loupe position
high
>> click out: loupe position low
3.2. Inclination
here are three inclination positions.
You can change the inclination of your
loupe or compensate different height of
ears.
3.3. Mountin of Lanyard
You can use your loupe with or without
lanyard. he lanyard can be slid over
the earpiece. By tightening the lanyard
you achieve weight relief for your nose.

Instructions for Use | opt–on
2.7
/opt–on
3.3
00.000.527-08 | EN Date: 11.10.2019 Page 9 of 15
4. INSTALLATION OF EXPENDABLE PARTS AND ACCESSORIES
If your loupe needs to be repaired, you can send the loupe to your dealer or
orangedental. Often it is possible just to order the spare parts and mount the parts
on your own, to save time and money. You can also change the Varioclips to change
the working distance.
4.1. Chan e the Temple
Retract the temple and hold it as shown at the picture.
Push the temple.
o mount the new temple, just press it to the hinge.

Instructions for Use | opt–on
2.7
/opt–on
3.3
Page 10 of 15 Date: 11.10.2019 00.000.527-08 | EN
4.2. Chan e the Hin e
Remove the temple (see section 4.1: Change
the emple)
Push a solid, pointed tool (e.g. little screw
driver) against the small silver round area.
Push the part outside
Remove the broken hinge.
o mount the new hinge, do the same procedure in reverse order.
Important: he hinge for the right side is
marked with R, the hinge for the left side is
marked with L.
he right temple is placed at the right ear!
he letters R and L need to face inside the
loupe.

Instructions for Use | opt–on
2.7
/opt–on
3.3
00.000.527-08 | EN Date: 11.10.2019 Page 11 of 15
4.3. Chan e of Varioclips
If changing the working distance of your loupe is necessary, please contact
your dealer to order Varioclips for the needed working distance. Mounting
of the new Varioclips is easy. Just follow the written steps:
Remove the Varioclips. Just slide your fingernail
or the added enclosed tool between the white
and grey/black part.
Slide until your hear CLICK and the Varioclip
removes.
ake the Varioclip away.
Pose the new one at the bottom of the ocular.
Slightly push the orangedental logo on the upper
side of the clip until your hear CLICK.

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2.7
/opt–on
3.3
Page 12 of 15 Date: 11.10.2019 00.000.527-08 | EN
5. SAFETY, SERVICING AND MAINTENANCE
I MPOR AN : Please read safety instruction opt–on
2.7
/opt–on
3.3
I MPOR AN : Please read manual attentively.
A EN ION
: When wearing the loupes do not look directly at the sun or
any other bright light source to avoid injuries of your eyes.
A EN ION
: Do not leave the loupe where it is exposed to direct sunlight
as this could lead to a fire.
A EN ION
: Do not use that loupe when working with laser light.
I MPOR AN : Do not use the loupe when the working area needs to be
sterile.
I MPOR AN : Check that the loupe strap is fastened carefully before use.
I MPOR AN : Please note that your field of vision is restricted, while
wearing the loupe and walking around.
5.1. Cleanin
Clean the loupes and eyepieces carefully using a micro fiber cloth. For
coarse dirt, moisten the cloth with alcohol or water, and scrub the dirt off
gently.
Note: Please clean the opt–on
2.7
/opt–on
3.3
immediately after use
to prevent that blood or protein residues coagulate.
C AU ION
: Only clean the loupe if the Varioclips are installed. Do not
expose the plastic lens to any liquid as it could scratch the
lens when drying it.
C AU ION
: Only use soft cloths for cleaning and disinfecting. Do not use
sharp or scratching objects.
5.2. Disinfection
C AU ION : Do not submerge the loupe opt–on
2.7
/opt–on
3.3
in water,
sterilization, or other cleaning liquids. he loupe opt–
on
2.7
/opt–on
3.3
is not waterproof.
C AU ION : Do not use aggressive solvents.

Instructions for Use | opt–on
2.7
/opt–on
3.3
00.000.527-08 | EN Date: 11.10.2019 Page 13 of 15
C AU ION : Any sterilization (autoclave/chemical clave procedures,
iodinated agents or other proceedings) is not possible.
5.2.1. Disinfection Agents for opt–on
2.7
/opt–on
3.3
he best way to disinfect your opt–on
2.7
/opt–on
3.3
is using a medically
approved disinfection wipes, offering a broad spectrum of activity against
bacteria, fungi and viruses e.g. disinfection wipes:
- Schülke kodan wipes [100g agent solution contain 30g Propan-2-
ol and 30g Propan-1-ol]
- Schülke mikrozid AF wipes [100g agent solution contain 25g
Ethanol and 35g Propan-1-ol]
5.3. Disposal
Die opt–on
2.7
/opt–on
3.3
can be disposed with the normal waste.

Instructions for Use | opt–on
2.7
/opt–on
3.3
Page 14 of 15 Date: 11.10.2019 00.000.527-08 | EN
6. SPECIFICATIONS AND CONFORMITY
orangedental GmbH & Co. KG
Aspachstrasse 11 | 88400 Biberach / Riss
6.1. Requirements re ardin the Practice Environment
Important: he loupe opt–on
2.7
/opt–on
3.3
is solely used to support the
visual inspection / to survey findings / to aid in treatment by
dental professionals using optical magnification in a dental
treatment room.
6.2. Technical Data
6.2.1. Loupe Data
magnification 2,7x / 3,3x
Working
distance
25 cm 30 cm 35 cm 40 cm 45 cm 50 cm
10 inch 12 inch 14 inch 16 inch 18 inch 20 inch
he working distance of your loupe is written on your loupe ID
card
Ocular
distance
he distance between the oculars has been calculated for your
pupil and working distance
weight 32 gram
6.2.2. Ambient Conditions
Operation and Storage:
emperature: +10°C to +40°C
Rel. humidity: 25 to 75%
Air pressure: 700 hPa to 1060 hPa

Instructions for Use | opt–on
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/opt–on
3.3
00.000.527-08 | EN Date: 11.10.2019 Page 15 of 15
ransport
emperature: -40°C to +60°C
Rel. humidity: 10 to 90%
Air pressure: 500 hPa to 1060 hPa
6.2.3. Conformity with Standards
Classification according to 93/42/EEC I