orangedental spot-on cordfree User manual

spot–on®
cordfree
Instructions for Use

Instructions for Use | spot–on®
cordfree
00.008.133-01 | EN Datum: 23.11.2018 Seite 1 von 30
1. DEAR CUSTOMER
1.1. Prologue
With spot–on®
cordfree
ou have acquired a product that represents the
latest state of the art and has been manufactured according to strict qualit
criteria. As we continue to develop our products, it is possible that the
images and drawings in this document ma differ slightl from the product
ou have acquired.
This manual contains a detailed description and instructions for use. If ou
have an further questions or suggestions, please do not hesitate to
contact us b telephone or e-mail.
These instructions for use are part of spot–on®
cordfree
. Please keep them
to hand for future reference. If ou pass this product on to third parties,
please also include this document as it contains important information on
commissioning and handling the product.
Use this manual to familiarize ourself with the product before using it
during part of an treatment.
1.1.1. Responsibilit of the Manufacturer
The spot–on®
cordfree
has been manufactured in accordance with the state
of the art and recognised safet regulations.
orangedental GmbH & Co. KG [hereinafter referred to as orangedental] onl
considers itself responsible for the effects on safet , reliabilit and
performance of the device if:
Assembl , add-ons, readjustments, alterations or repairs are carried
out b persons authorised b orangedental.
the device is used in accordance with the instructions for use.

Instructions for Use | spot–on®
cordfree
1.1.2. Responsibilit of the Operator
The operator is among other things responsible for:
compliance with accident prevention regulations and the Ordinance
on the Installation, Operation and Use of Medical Devices (German
regulation - MPBetreibV).
the operation.
maintenance.
the proper and safe condition of the product and the availabilit of
this manual at the place of use.
following the safet instructions contained in this manual (cf.
section 1.3 Conventions, S mbols used).

Instructions for Use | spot–on®
cordfree
00.008.133-01 | EN Datum: 23.11.2018 Seite 3 von 30
1. . Contents
1. Dear Customer .............................................................................................. 1
1.1. Prologue .......................................................................................................... 1
1.1.1. Responsibilit of the Manufacturer ............................................................ 1
1.1.2. Responsibilit of the Operator ................................................................... 2
1.2. Contents .......................................................................................................... 3
1.3. Conventions, S mbols used ............................................................................ 4
. About the Product ......................................................................................... 6
2.1. Intended Use ................................................................................................... 6
2.2. Scope of deliver ............................................................................................. 7
2.3. Accessories ..................................................................................................... 7
3. Installation ..................................................................................................... 8
4. Usage ............................................................................................................ 10
4.1. Settings ......................................................................................................... 12
4.1.1. Adjusting the brightness .......................................................................... 12
4.1.2. Automatic switch-off ................................................................................ 13
5. Assembly of spare parts and accessories ................................................ 16
5.1. Mounting the orange filter ............................................................................. 16
6. Safety, Handling and Maintenance ........................................................... 17
6.1. General .......................................................................................................... 17
6.2. H giene ......................................................................................................... 18
6.2.1. Cleaning ................................................................................................... 18
6.2.2. Disinfection.............................................................................................. 19
6.2.3. Disinfectants for spot–on®
cordfree
............................................................. 20
6.3. Maintenance and servicing ............................................................................ 21
6.4. Disposal ......................................................................................................... 21
7. Spezificatons, Conformity ..........................................................................
7.1. Requirements for the practical environment ................................................. 22
7.2. Product labelling ............................................................................................ 22
7.3. Technical data ............................................................................................... 23
7.3.1. Dimensions .............................................................................................. 23
7.3.2. Electrical characteristics ......................................................................... 23
7.3.3. Optische Eigenschaften ........................................................................... 23
7.3.4. Service life ............................................................................................... 23
7.3.5. EMC Classification ................................................................................... 24

Instructions for Use | spot–on®
cordfree
7.3.6. Compliance with standards ..................................................................... 24
7.3.7. Environmental conditions ........................................................................ 24
7.3.8. Electromagnetic compatibilit ................................................................. 25
1.3. Conventions, Symbols used
In these instructions, the conventions stated below indicate important
information:
W ARNING
: This s mbol is used if deviating from the procedure described
ma result in ph sical injur or death.
C AUTION
: This s mbol is used if deviating from the procedure described
ma result in damage to the product or loss of data.
I MPORTANT : The use of the term I MPORTANT
, formatted in bold capitals,
indicates advice for the use of the device or for the
application of a certain procedure.
Note: Notes are used to highlight important or unusual points.
S mbols used on the product, its packaging or in these instructions have
the following meanings.
C HECK INSTRUCTIONS
This s mbol indicates that this user manual contains
important, mandator instructions which must be followed to
compl with the safet standards for the medical product.
A TTENTION
This s mbol indicates that there are warnings or regulations
concerning the product which are not specified on the label.
It advises the reader to consult the accompan ing
documents.
M ANUFACTURER
This s mbol is used in order to displa the name and address
of the manufacturer of the medical device.

Instructions for Use | spot–on®
cordfree
00.008.133-01 | EN Datum: 23.11.2018 Seite 5 von 30
O RDER NUMBER
This s mbol indicates the order number.
S ERIAL NUMBER
This s mbol is used to indicate the serial number.
CE M ARKING
This s mbol, attached b the manufacturer, indicates that the
medical device is in conformit with and fulfills all
requirements of the medical device directive 93/42/EEC.
D ISPOSAL
This s mbol means that the device labelled must not be
discarded with normal household waste.

Instructions for Use | spot–on®
cordfree
. ABOUT THE PRODUCT
The spot–on®
cordfree
is characterised b the fact that the batter is attached
directl to the lighting unit and therefore no cable is required.
Another special feature of spot–on®
cordfree
is the integration of a position
sensor and the associated automatic switch-off. The motion sensor
determines the current orientation of the lighting unit. If this corresponds
to the usual working position, the lamp is activated and the oral cavit can
be illuminated. When it is nearl horizontal, the lighting unit is deactivated.
This prevents, for example, our assistant from being blinded.
.1. Intended Use
The spot–on®
cordfree
is used for illumination of the oral cavit of a
patient using a binocular loupe s stem of the practitioner. The
spot–
on®
cordfree
is designed for use b dentists or qualified dental personnel
within a dental workspace.

Instructions for Use | spot–on®
cordfree
00.008.133-01 | EN Datum: 23.11.2018 Seite 7 von 30
. . Scope of delivery
.3. Accessories
The following parts below can be reordered from orangedental GmbH & Co
KG via our depot under the article number indicated.
1 batter unit ArtNr. zublup0499500
1 Orangefilter ArtNr. zublup0499440
Lighting unit
The magnetic adapter
is alread mounted on
it
.
2 batter units
Power suppl for
charging the
batter unit
Charging cable
for connection
between power
suppl unit and
charging unit
Charging unit
Allen ke

Instructions for Use | spot–on®
cordfree
3. INSTALLATION
Before using the spot–on®
cordfree
for the first time, ou should charge the
batter unit completel . After approx. one hour the batter is 80% charged;
after two hours it is full charged.
In order to charge, connect the charging cable with the supplied power
suppl unit and plug it into a suitable mains socket. Now plug the Micro-
USB plug of the charging cable into the socket of the charging unit. Insert
either one or both batter units into the recesses provided in the charging
unit. The magnets in the charging unit ensure correct positioning. As long
as the batter unit is charging, the respective LED lights up orange. When
it turns off completel , the corresponding batter is full charged. Now
remove the batter unit from the charging unit b pulling out the batter
unit while holding the charging station with our other hand.
C AUTION : If one of the LEDs lights up permanentl without a batter
being inserted, please disconnect the charging unit from the
mains plug and no longer use the charging unit. Get in touch
with orangedental.
Figure 1: charging batteries
Note: Do not use a USB port on our PC for charging. This cannot
provide the required power.

Instructions for Use | spot–on®
cordfree
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Now ou can insert the batter unit into the lighting unit. The magnetic
s stem ensures correct positioning.
Figure 2: Inserting the batter
Note: If no adapter is attached to the magnif ing glasses et,
please use the supplied Allen ke or contact orangedental if
necessar .

Instructions for Use | spot–on®
cordfree
4. USAGE
Switching on
Insert a batter into the lighting unit (see 3: Installation). The LED now lights
up for one second. During this time, the touch sensor is calibrated and
should therefore not be touched.
The LED then turns off automaticall . The spot–on®
cordfree
is now read for
use.
The spot–on®
cordfree
is operated b a touch sensor located in the centre of
the lighting unit. It is possible to feel a minimal elevation of the sensor.
Note: If ou have difficult feeling the touch sensor, swipe our
finger forward from the batter unit.
If ou touch the sensor with our finger briefl (less than one second), the
light switches on. This is alwa s the case, regardless of the orientation of
the spot–on®
cordfree
; the automatic switch-off function is still deactivated
here (see 4.1.2: Automatic switch-off). It is activated once the value has
fallen below the switch-off angle, unless the automatic switch-off function
is turned off (see section 4.1.2).

Instructions for Use | spot–on®
cordfree
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Look through the magnif ing glasses onto a flat surface. You can optimall
adjust the illumination of our field of vision b pressing up or down the
lamp which is mounted on the glasses.
Switching off
With another short touch of the touch sensor, ou switch off the light again.
If the light is currentl deactivated due to the automatic switch-off function,
a short flash acknowledges the successful switch-off.
Note: If the spot–on®
cordfree
is no longer needed, remove the
batter to prevent it from deep discharging.
Charging
To charge the batteries, connect the charging cable to the supplied
charging unit and plug it into a suitable mains socket. Now plug the Micro-
USB plug of the charging cable into the socket of the charging unit. Then
insert either one or both batter units into the recesses provided in the
charging unit. The magnets in the charging unit ensure correct positioning.
As long as the batter unit is charging, the respective LED lights up orange.
When it turns off completel , the corresponding batter is full charged.
Now remove the batter unit from the charging unit b pulling out the
batter unit while holding the charging station with our other hand.
C AUTION : If one of the LEDs lights up permanentl without a batter
being inserted, please disconnect the charging unit from the
mains plug and no longer use the charging unit. Contact
orangedental.
Note: Do not use a USB port on our PC for charging. The USB port
cannot provide the required power. Normall the USB
interface in the computer switches off due to overload. If,
contrar to expectations, it does suppl power, the charging
process would take three to four times as long as with the
supplied USB power suppl unit.
The charging process is completed when the respective orange LED goes
out completel . After approx. one hour, the batter is 80% charged. The
batter is full charged after about two hours.
Power saving mode
If the light is not moved within approx. two minutes, the energ -saving
mode is automaticall activated and the light switches off b itself off. If the
lamp is moved again, it is automaticall switched on.

Instructions for Use | spot–on®
cordfree
4.1. Settings
4.1.1. Adjusting the brightness
The factor setting is a luminous intensit of 10,000 lux. To change the light
intensit , press the touch sensor six times when it is switched on (the light
is switched off and on again three times). Then each time ou press the
touch sensor, the light intensit of the light changes from the lowest level,
through the middle level to the highest and from the highest to the lowest.
Note: If the touch button is not pressed for three seconds, ou
leave the setting mode. Pressing the touch button again
switches the spot–on®
cordfree
off (see 4: Switching off).
Three different light intensities are possible:
normal light intensit approx. 10.000 Lux
1
increased light intensit approx. 15.000 Lux
1
maximum light intensit approx. 20.000 Lux
1
1
measured at a working distance of 25 cm
The selected value is saved and is active again after the next switch-on.
Note: If the touch button is pressed more than 20 times, pressing
the button again also exits the setting mode and switches off
the spot–on®
cordfree
.

Instructions for Use | spot–on®
cordfree
00.008.133-01 | EN Datum: 23.11.2018 Seite 13 von 30
4.1.2. Automatic switch-off
The spot–on®
cordfree
has a function that ensures that the lighting unit is
automaticall switched on or off depending on its orientation. This allows
ou to illuminate our working area in our working position with our head
slightl bent forward, while for an angle greater than α the lighting unit is
automaticall deactivated and therefore, for example, our assistant is not
dazzled. Another positive side effect is the extension of the batter life.
Figure 3: Switch-off angle undercut Figure 4: Switch-off angle exceeded
 the spot–on®
cordfree
lights up  the spot–on®
cordfree
is not lit
In order to satisf an individual working posture, one can choose between
three different angles α (small, medium and large).
It is also possible to deactivate the automatic switch-off function. In the
deliver state, it is activated and triggers at the medium angle. The selected
setting is saved and is active again after the next switch-on.
Note: The automatic switch-off triggers with a short time dela .
α

Instructions for Use | spot–on®
cordfree
Changing the switch-off angle or deactivating the automatic switch-off
function
If ou want to change the switch-off angle, put on the spot–on®
cordfree
and
switch it on. Within the next 15 seconds, tap twice from the side on one
of the temples with our index finger and middle finger ("double tap"). A
successful double-tap is acknowledged with a short blink.
Figure 5: Douple tap on temples
Immediatel afterwards, press the touch sensor six times (the light is
switched off and on again three times). Now ou are in the mode to change
the angle. Each time the touch button is pressed again, the angle is
increased and indicated b a short flashing signal from the lamp. After the
angle setting "large", the setting “automatic switch-off deactivated" follows.
Note: If the touch button is not pressed withing six seconds, ou
leave the setting mode. Pressing the touch button again
switches the spot–on®
cordfree
off.
Settings
Angle small 1x blinking
Angle medium 2x blinking
Angle large 3x blinking
Deactivated 4x blinking
The selected setting is saved and is active again after the next switch-on.

Instructions for Use | spot–on®
cordfree
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Note: If the double tap has not been registered b the motion
sensor, the spot–on®
cordfree
ma switch to the setting mode
"brightness". Set the desired brightness and then follow the
instructions again as described in Section 4.1.2: Changing
the switch-off angle.

Instructions for Use | spot–on®
cordfree
5. ASSEMBLY OF SPARE PARTS AND ACCESSORIES
5.1. Mounting the orange filter
1. Make sure that the pre-assembled grub screw does not protrude
into the inside of the orange filter.
2. Place the orange filter on the spot–on®
cordfree
and screw in the
grub screw using the Allen wrench.
3. If ou do not need the orange filter, lift it all the wa to the top.

Instructions for Use | spot–on®
cordfree
00.008.133-01 | EN Datum: 23.11.2018 Seite 17 von 30
6. SAFETY, HANDLING AND MAINTENANCE
6.1. General
Keep in mind that the spot–on®
cordfree
shines ver brightl and warms up
during operation. When using the spot–on®
cordfree
, make sure that ou do
not shine into the e es of the patient or our staff. Although the light output
is so low that the e elid closure reaction prevents damage to the retina, the
glare effect of the lamp is ver strong as soon as ou enter the light field
with our e es.
W ARNING : The spot–on®
cordfree
lighting unit corresponds to risk group
2 according to DIN EN 62471-1. Danger of glare! Do not look
directl into the light beam.
The light beam must not be directed towards the e es. Do not use the
spot–on®
cordfree
for e e examinations (examination of pupils).
Increased risk of glare. Note that the reaction of the e es decreases under
the influence of drugs, medications or alcohol.
Risk of injur to the retina.
The product emits blue light (400-780 nm). Do not look directl into the
light beam.
C AUTION
: Danger of heat accumulation, please do not cover during
operation.
W ARNING : The batter unit is a lithium-ion batter . Please observe the
following application instructions to avoid hazards:
- Do not use a defective or damaged batter .
- Do not short-circuit it. .
The lithium-ion batteries can easil be short-circuited if
the are placed on a conductive surface. Also be careful
when storing (do not store in a drawer or similar with
other metallic objects).
- Avoid subjecting the batteries to heat and mechanical
stress. Do not store them in direct sunlight.
- Do not open the batteries.

Instructions for Use | spot–on®
cordfree
- Onl use the supplied batter units and charging unit to
charge the batteries.
- Keep small cells and batteries that could be swallowed
out of the reach of children.
Ingestion ma result in burns, perforation of soft tissue
and death. Severe burns ma occur within two hours of
swallowing.
If a cell or batter is swallowed, seek immediate medical
attention.
- Store batteries clean and dr . If connections are dirt ,
clean with a dr , clean cloth.
- Do not charge batteries for long periods of time when
the are not needed.
- After prolonged storage it ma be necessar to charge
and discharge the cells or batteries several times to
achieve full performance.
- As far as possible, batteries should be removed from the
device when the are not in use
6. . Hygiene
C AUTION : The light, batter and charging unit are not autoclavable. The
resulting temperatures would destro the electronics.
Note: The spot–on®
cordfree
is appropriatel sealed for cleaning /
disinfection with moist media / wipes.
Cleaning should be done immediatel after using spot–on®
cordfree
to
prevent blood or protein residues from solidif ing.
6.2.1. Cleaning
Remove the spot–on®
cordfree
from the magnif ing glasses.
I MPORTANT : Carr out the cleaning on the assembled spot–on®
cordfree
. No
cleaning agent must enter the interior of the light or batter
unit.