orangedental spot-on nxt User manual

Instructions for Use

1. DEAR CUSTOMER
1.1. Prologue
The product that you have purchased – spot–on
nxt
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.
These instructions contain an exact description and explain how to use the
spot–on
nxt
. If you have any additional questions or ideas, we would be
pleased to help you either by telephone or by email.
These instructions accompany the spot–on
nxt
. lease 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.
lease use these instructions to familiarize yourself with the product before
you use it during treatment.
1.1.1. Responsibility of the Manufacturer
The spot–on
nxt
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
carried out by persons authorized by orangedental,
the device is used in accordance with the instructions for use.

Instructions for Use | spot–on
nxt
age 2 of 24 Date: 18.05.2021 00.005.444-08 | EN
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 M BetreibV).
the operation.
the maintenance.
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 | spot–on
nxt
00.005.444-08 | EN Date: 18.05.2021 age 3 of 24
1.2. Content
1. De r Customer .............................................................................................. 1
1.1. rologue .......................................................................................................... 1
1.1.1. Responsibility of the Manufacturer ............................................................ 1
1.1.2. Responsibility of the Operator ................................................................... 2
1.2. Content ............................................................................................................ 3
1.3. Conventions, Symbols Used ............................................................................ 4
2. About the Product ......................................................................................... 6
2.1. Intended Use ................................................................................................... 6
2.2. Delivery scope ................................................................................................. 6
2.3. Spare arts and Accessories ........................................................................... 7
3. Inst ll tion ..................................................................................................... 8
4. Us ge ............................................................................................................ 10
5. Assembly of Sp re P rts nd Accessories ............................................... 12
5.1. Mounting the spot-on blue
nxt
......................................................................... 12
5.2. Mounting the orange filter ............................................................................. 13
6. S fety, H ndling nd M inten nce ........................................................... 14
6.1. General .......................................................................................................... 14
6.2. Hygiene ......................................................................................................... 14
6.2.1. Cleaning ................................................................................................... 15
6.2.2. Disinfection.............................................................................................. 15
6.2.3. Disinfection Agents for the spot-on
nxt
...................................................... 16
6.3. Servicing and Maintenance ........................................................................... 16
6.4. Disposal ......................................................................................................... 16
6.5. Warranty ........................................................................................................ 16
7. Specific tions, Conformity ......................................................................... 17
7.1. Requirements for the Environment of Use .................................................... 17
7.2. roduct labeling............................................................................................. 17
7.3. Technical Data ............................................................................................... 17
7.3.1. Dimensions .............................................................................................. 17
7.3.2. Electrical Characteristics ......................................................................... 18
7.3.3. Optical Characteristics ............................................................................ 18
7.3.4. roduct service life .................................................................................. 18
7.3.5. Conformity with Standards ...................................................................... 18
7.3.6. Ambient Conditions ................................................................................. 19
7.3.7. EMC-Classification ................................................................................... 19
7.3.8. Electromagnetic Compatibility ................................................................. 20

Instructions for Use | spot–on
nxt
age 4 of 24 Date: 18.05.2021 00.005.444-08 | EN
1.3. Conventions, Symbols Used
In these instructions, the conventions set out below indicate important
information:
W ARNING
: This symbol is used if deviating from the procedure described
can lead to physical injury or death.
C AUTION
: This symbol is used if deviating from the procedure described
can lead to damage to the product or to loss of data.
I M ORTANT : The usage of the term IM ORTANT
, formatted in bold capitals,
provides instructions about the use of the device or a
procedure.
Note: Notes are used to highlight important or unusual points.
The meaning of the symbols, which are used on this product, its packaging
or in these instructions, is listed below.
C HECK INSTRUCTIONS
This 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 TTENTION
This 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 ANUFACTURER
This symbol is used in order to display the name and address
of the manufacturer of the medical product.
D ATE OF MANUFACTURE
This symbol indicates the date of manufacture.
UDI-DI
This symbol indicates the UDI-DI number and the GTIN.
S ERIAL NUMBER
This symbol is used to indicate the serial number.

Instructions for Use | spot–on
nxt
00.005.444-08 | EN Date: 18.05.2021 age 5 of 24
M EDICAL D EVICE
This symbol is used to indicate that the product is a medical
device.
CE M ARKING
This symbol, attached by the manufacturer, indicates that the
medical product is in conformity with and fulfills all
requirements of the medical device regulation (EU)
2017/745.
D IS OSAL
This symbol means that the device labelled must not be
disposed of with normal household waste.

Instructions for Use | spot–on
nxt
age 6 of 24 Date: 18.05.2021 00.005.444-08 | EN
2. ABOUT THE PRODUCT
2.1. Intended Use
The spot–on
nxt
is used for illumination of the oral cavity of a patient using
a binocular loupe system of the practitioner. The spot–on
nxt
is designed for
use by dentists or qualified dental personnel within a dental workspace.
There are no known contraindications for the use of the lamp. There are no
restrictions regarding the intended patient group.
As an accessory to the spot-on cordfree, the spot–onblue
nxt
improves the
visibility of composites and composite residues as well as plastic residues
from orthodontic brackets by using a special spectral range. The spot–
onblue
nxt
is intended for use by orthodontists, dentists or dental
professionals in dental workplaces. There are no known contraindications
for the use of the spot–onblue
nxt
. There are no restrictions regarding the
intended patient group.
2.2. Delivery scope
Allen key
spot–on
nxt
lamp
This is normally
already mounted
on the glasses
Battery unit for
attachment to
arm or belt
ower supply
unit for charging
the battery unit
Charging cable for
connecting power
supply unit and
battery unit

Instructions for Use | spot–on
nxt
00.005.444-08 | EN Date: 18.05.2021 age 7 of 24
2.3. Sp re P rts nd Accessories
The following parts below can be reordered from orangedental GmbH & Co
KG via your depot under the article number indicated.
snap-on arm strap Art.Nr. zublup0499380 (long)
Art.Nr. zublup0499390 (short)
Battery unit ArtNr. zublup0499400
Orangefilter
ArtNr. zublup0499440
Endo bridge ArtNr. zublup0499910
Lighting unit
spot-on blue nxt
ArtNr. zublup0499900

Instructions for Use | spot–on
nxt
age 8 of 24 Date: 18.05.2021 00.005.444-08 | EN
3. INSTALLATION
Before you use the device for the first time, you should completely charge the battery
unit of the spot–on
nxt
. In order to do so, place the USB plug of the charging
cable into the socket of the charger. Now allow the plug on the other side of the
charging cable to snap into the socket of the battery unit. Since plug and socket are
magnetic, this happens almost automatically. Make sure that the plug is not at an
incline. Due to their shape and the magnetic forces, the plug and socket can only be
placed together in one direction. Then plug the power supply unit into a suitable
power socket. A small orange lamp lights up below the magnetic socket while the
battery unit is charging. The lamp has two lighting levels: bright, during the main
charging time and darker, in the precharge time and recharging time.
Note: If the lamp is not already attached to the magnifying glasses, please contact
orangedental if necessary. Now allow the magnetic plug on the lamp, as
shown in the illustration bellow, to snap into the battery casing coupling.
Illustration: lug for connecting the charging or lamp cable
If you want to use the battery unit in the traditional way, attach the battery now to
the clip on the rear side of your belt, your pocket or waistband. In order to insert
the clip more easily, there is a small protruding lug on the lower part. lease
remember that the device has a sensor key. Therefore, it should not be positioned
where you place your arm when sitting. The key also works through clothing, providing
that it is not too thick.

Instructions for Use | spot–on
nxt
00.005.444-08 | EN Date: 18.05.2021 age 9 of 24
Illustration: Installing the arm strap
In order to attach the device to the arm, you should first of all put the suitable arm
strap (shorter arm strap for delicate arms and longer one for larger arms) to the rear
side of the casing underneath both spring arms.
Now press the casing with the magnetic coupling
upwards on your upper arm. The straps snap
automatically around your arm. If not, apply light
pressure to the protruding strap. It is best to
hold the strap when both ends overlap on the
underside of the arm.
Illustration: Attaching the strap

Instructions for Use | spot–on
nxt
age 10 of 24 Date: 18.05.2021 00.005.444-08 | EN
4. USAGE
The spot–on
nxt
is operated by means of a sensor surface situated in the middle of
the battery casing and has some display elements which are not visible in normal
operation.
Switching on: When you touch the sensor surface with your finger (for less than a
second), the lamp switches on. During the contact time, the current battery charge
level and the set light intensity are displayed.
Battery charge level (green): 3 lamps 66-100%,
2 lamps 33-66%,
1 lamp 1-33% of a fully charged battery.
Light intensity (yellow): 3 lamps maximum light capacity, approx. 45,000 Lux
1
2 lamps increased light capacity, approx. 30,000 Lux
1
1 lamp normal light intensity, approx. 20,000 Lux
1
1
measured at 25 cm working distance
spot–on blue
nxt
irradiance (yellow): 3 lamps maximum light capacity, approx. 87 W/mW
2
2 lamps increased light capacity, approx. 58 W/mW
2
1 lamp normal light intensity, approx. 39 W/mW
2
2
measured at 20 cm working distance

Instructions for Use | spot–on
nxt
00.005.444-08 | EN Date: 18.05.2021 age 11 of 24
Look at an even surface through the magnifying glasses. By pressing the lamp on the
glasses up or down, you can adjust the way your field of vision is illuminated.
Switching off: By briefly pressing the sensor surface with your finger again, you can
switch the lamp off. When the lamp is switched off, only the charge level of the battery
is displayed.
Adjusting the brightness: In order to alter the light intensity, touch the sensor area of
the battery casing for more than one second. After this period, the light begins to
become brighter and dimmer at three levels. For control purposes the three yellow
lights also display the current light intensity. Let go of the sensor area again when the
desired level has been reached.
This value is stored and becomes active again the next time the device is switched
on. One exception is the maximum contrast level which can only be activated for 5
minutes. In order to prevent the lamp from becoming unpleasantly warm, the highest
illumination level is switched down to the middle level after 5 minutes. It is likewise
switched down to the middle illumination level after the device is switched off and
on.
Charging: When the sensory area is touched, one to three small green lamps light up.
These show the battery’s state of charge. If only one lamp is lit, this means that the
battery has only one third of its capacity remaining and should be charged before the
lamp is used again.
In order to charge the device, connect the charging cable - instead of the lamp’s cable
- to the battery unit and connect the USB plug of the charging cable to the charging
device. Now plug the charging device into a suitable mains socket.
Note: Only use the supplied charger for charging.
Note: Do not use the USB connection of your C to charge the device. The
C cannot provide the required energy. Normally, the C will switch
off the USB interface due to overload. If it, contrary to expectation,
supplies a current, the charging procedure would take 3-4 times longer
than with the charging device.
The charging procedure is completed when the orange LED beneath the magnetic
plug completely goes out. It takes 2 – 3.5 hours.

Instructions for Use | spot–on
nxt
age 12 of 24 Date: 18.05.2021 00.005.444-08 | EN
Note: To avoid a deep discharge of the battery, please charge the
battery every three months - even when not in use.
5. ASSEMBLY OF SPARE PARTS AND ACCESSORIES
5.1. Mounting the spot-on blue
nxt
1. Disconnect the cable connection from the spot–on
nxt
battery.
2. Remove the spot–on
nxt
from your magnifying glasses.
3. Attach the spot–on blue
nxt
to your magnifying glasses using the
adapter.
Note: It is recommended to use a magnetic adapter when using
spot–on
nxt
and spot–on blue
nxt
alternately.
4. Connect the cable of the spot–on blue
nxt
light unit to the battery
unit.

Instructions for Use | spot–on
nxt
00.005.444-08 | EN Date: 18.05.2021 age 13 of 24
5.2. Mounting the or nge filter
1. Make sure that the pre-assembled grub screw does not protrude
into the inside of the orange filter.
2. lace the orange filter on the spot–on
nxt
and screw in the grub
screw using the Allen key.
3. If you do not need the orange filter, flip it all the way up.

Instructions for Use | spot–on
nxt
age 14 of 24 Date: 18.05.2021 00.005.444-08 | EN
6. SAFETY, HANDLING AND MAINTENANCE
6.1. Gener l
Remember that the spot–on
nxt
illuminates very brightly when in
operation. When using it, make sure that you do not shine the device into
the eyes of patients or staff. Although the light capacity is low enough for
the blinking reflex of the eye to prevent damage to the retina, the dazzling
effect of the lamp is very strong as soon as the light shines towards eyes.
W ARNING : The spot–on
nxt
(including spot–on blue
nxt
) lighting unit
corresponds to risk group 2 according to DIN EN 62471-1.
The products emit blue light. Danger of glare! Risk of injury
to the retina. Do not look directly into the light beam.
The light beam must not be directed towards the eyes. Do not use the
spot–on®
cordfree
for eye examinations (examination of pupils).
Increased risk of glare. Note that the reaction of the eyes decreases under
the influence of drugs, medications or alcohol.
spot–on
nxt
/spot–on blue
nxt
:
The limit value <1 W/m² is undercut at the following distance:
≥ 1250 / 1530 / 1875 mm (normal / increased / maximum intensity)
C AUTION : Danger of heat build-up, e.g. if the lamp is covered when in
operation.
If spot–on
nxt
is used several times with highest light intensity, please note
the heat generation of the light.
After prolonged storage it may be necessary to charge and discharge the
battery several times to achieve full performance.
6.2. Hygiene
C AUTION
: The lamp and the battery unit are not autoclavable. The
resulting temperatures would destroy the plastics and
electronics used.
Note: The spot–on
nxt
is sealed appropriately in order to protect
it when it is cleaned / disinfected with damp media / cloths.

Instructions for Use | spot–on
nxt
00.005.444-08 | EN Date: 18.05.2021 age 15 of 24
The spot–on
nxt
should be cleaned immediately after use in order to
prevent any residual blood or protein from solidifying.
6.2.1. Cleaning
Take the lamp off the battery unit and pull the arm strap out of the holder.
First of all, remove any residue by wiping with a mild cleaning agent.
Remove any residual detergent with a damp, lint-free disposable cloth.
6.2.2. Disinfection
The spot–on
nxt
is disinfected by way of wipe disinfection.
A cloth moistened (not soaked) with disinfecting agent should be used for
this purpose.
Note: The products listed in the following section have been
tested positively with regard to their compatibility with the plastics used.
We cannot guarantee that other agents will not affect the surfaces of the
battery unit.
Wipe the battery casing, the arm strap, the cable and the lamp several
times with the disinfecting cloth.
Allow the disinfecting agent to take effect long enough as per its
instructions.
Now remove any residual disinfecting agent with damp, lint-free disposable
cloths.
Now dry the spot–on
nxt
with a sterile, lint-free disposable cloth and then
allow it to dry properly. Make sure that the glass lens on the lamp is
clean. Dirt on the lens can affect the light intensity.
C AUTION : When cleaning, please pay attention that the disinfecting
agent and liquid detergents used do not gain access to the
plug or the area behind the lens.
Only use soft cloths for cleaning and disinfecting and no sharp or abrasive
objects.

Instructions for Use | spot–on
nxt
age 16 of 24 Date: 18.05.2021 00.005.444-08 | EN
6.2.3. Disinfection Agents for the spot-on
nxt
The following agents have been tested for cleaning and disinfecting the
spot–on
nxt
:
Innocid DW-i Desinfektionstücher
RISMAN harma International AG; Am Stalden 16; CH-4622
Egerkingen
Omnizid spray and wipe disinfection
OMNIDENT Dental-Handelsgesellschaft mbH; Gutenbergring 7-9;
D-63110 Rodgau
6.3. Servicing nd M inten nce
The device may only be repaired by a service point authorized by
orangedental.
W ARNING : Take the device out of operation if there are visible
signs of damage or any malfunctioning. Contact your
orangedental service point in such cases.
6.4. Dispos l
The spot–on
nxt
and the accessories contain a lithium polymer accumulator
as well as components which are not suitable for disposal with normal
household refuse. lease contact your dental stockist or enretec GmbH
(www.enretec.de). Enquiries relating to disposal can be sent to
orangedental.
6.5. W rr nty
1 year, (6 months only for the battery)

Instructions for Use | spot–on
nxt
00.005.444-08 | EN Date: 18.05.2021 age 17 of 24
7. SPECIFICATIONS, CONFORMITY
orangedental GmbH & Co. KG
Aspachstrasse 11 | 88400 Biberach / Riss
7.1. Requirements for the Environment of Use
I M ORTANT : The spot–on
nxt
should only be operated by skilled and
trained persons.
lace the device so that is not exposed to direct sunlight.
7.2. Product l beling
7.3. Technic l D t
7.3.1. Dimensions
data unit
casing battery unit 75 x 63 x 25 mm
lamp 29 x 15
⌀
mm
length of cable lamp 1100 mm
weight battery unit 85 g
weight lamp 7 g

Instructions for Use | spot–on
nxt
age 18 of 24 Date: 18.05.2021 00.005.444-08 | EN
7.3.2. Electrical Characteristics
data unit
supply voltage battery unit 5 V DC
max. power input 1500 mA
battery Li o 9.6 Wh
7.3.3. Optical Characteristics
d
ata
u
nit
Light intensity spot–on
nxt
normal/amplified/maximum approx.
measured at a working distance of 25
cm
20 / 30 / 45 x1000 Lux
Irradiance spot–on blue
nxt
normal/amplified/maximum approx.
measured at a working distance of 20 cm
39 / 58 / 87
W/m²
7.3.4. roduct service life
data unit
roduct service life (except battery) 5 years
7.3.5. Conformity with Standards
Data
rotection class I 20
Classification according to regulation
(EU) 2017/745
I
Electrical safety EN 60601-1
hotobiological safety of lamps and lamp systems DIN EN 62471