orangedental spot-on nxt User manual

spot–onnxt
Instructions for Use

Instructions for Use | spot–onnxt
Page 2 of 17 Date: 10.11.2016 00.005.444-02 | EN
1. DEAR CUSTOMER
1.1. Prologue
The product that you have purchased –spot–onnxt 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–onnxt. 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–onnxt. 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.
You should use these instructions to familiarize yourself with the product before you use it
during treatment.
1.1.1. Copyright(s) and Trademark
Windows is a registered trademark or a brand of Microsoft Corporation in the USA and/or other
countries.
1.1.2. Responsibility of the Manufacturer
The spot–onnxt 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 authorised by orangedental,
The device is used in accordance with the instructions for use.
1.1.3. Responsibility of the Operator
Among other things, the operator is responsible for:
Adherence to the accident prevention regulations as well as regulation concerning the
installation, operation and use of active medical products –MPBetreibV).
The operation.
The maintenance.
The proper and safe condition of the product, and storing the instructions manual at
the location of use.
Following the safety instructions contained in these instructions (cf. section 1.3
Conventions, symbols used)

Instructions for Use | spot–onnxt
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1.2. Contents
1. Dear Customer ................................................................................................................................ 2
1.1. Prologue .........................................................................................................................................2
1.1.1. Copyright(s) and Trademark ............................................................................................................2
1.1.2. Responsibility of the Manufacturer.................................................................................................. 2
1.1.3. Responsibility of the Operator.........................................................................................................2
1.2. Contents.........................................................................................................................................3
1.3. Conventions, symbols used ............................................................................................................4
2. About the Product........................................................................................................................... 5
2.1. Intended Use ..................................................................................................................................5
2.1.1. Delivery Scope.................................................................................................................................5
2.1.2. Spare Parts and Accessories...........................................................................................................5
3. Installation....................................................................................................................................... 6
4. Use ................................................................................................................................................... 8
5. Safety, Handling and Maintenance.............................................................................................10
5.1. General.........................................................................................................................................10
5.2. Hygiene ........................................................................................................................................10
5.2.1. Cleaning.........................................................................................................................................10
5.2.2. Disinfection ...................................................................................................................................10
5.2.3. Disinfection agents for the spot-onnxt ............................................................................................11
5.3. Servicing and Maintenance...........................................................................................................11
5.4. Disposal........................................................................................................................................11
6. Specifications and Conformity....................................................................................................12
6.1. Requirements regarding the practice environment .......................................................................12
6.2. Product labeling............................................................................................................................12
6.3. Technical Data..............................................................................................................................12
6.3.1. Dimensions....................................................................................................................................12
6.3.2. Electrical characteristics ...............................................................................................................12
6.3.3. Optical characteristics...................................................................................................................12
6.3.4. Working life....................................................................................................................................13
6.3.5. Electromagnetic compatability ......................................................................................................13
6.3.6. Conformity with standards ............................................................................................................13
6.3.7. Ambient conditions........................................................................................................................13
6.3.8. Electromagnetic compatability ......................................................................................................14

Instructions for Use | spot–onnxt
Page 4 of 17 Date: 10.11.2016 00.005.444-02 | EN
1.3. Conventions, symbols used
In these instructions, the conventions set out below indicate important information:
WARNING: This symbol is used if deviating from the procedure described can lead to physical
injury or death.
CAUTION: This symbol is used if deviating from the procedure described can lead to damage
to the product or to loss of data.
IMPORTANT:Use of the term IMPORTANT in this formatting indicates advice on using the device
or on applying a certain procedure.
Note: Notes are used to make you aware of important or unusual points.
The significance of the symbols which are used on this product, its packaging or in these
instructions is listed below.
CHECK INSTRUCTIONS
By labeling the product with this symbol, the manufacturer is pointing out that the
instructions for use (i.e. this document) contain warnings and safety information
which should be observed when the product is used.
ATTENTION
indicates that there are warnings or regulations concerning the product which are
not specified on the label itself.
MANUFACTURER
This symbol is used in order to display the name and address of the manufacturer
of the medical product.
DATE OF MANUFACTURER
This symbol indicates the date of manufacture.
ORDER NUMBER
This symbol indicates the order number.
SERIAL NUMBER
This symbol is used to indicate the serial number.
CE MARKING
By attaching this symbol to the device, the manufacturer declares that the product
labeled complies with the EMC regulations 93/42 “Medical devices”.
DISPOSAL
This symbol means that the device labelled must not be disposed of with normal
household waste.

Instructions for Use | spot–onnxt
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2. ABOUT THE PRODUCT
2.1. Intended Use
The spot–onnxt is used for illumination of the oral cavity of a patient using a binocular loupe
system of the practitioner. The spot–onnxt is designed for use by dentists or qualified dental
personnel within a dental workspace.
2.1.1. Delivery Scope
Innensechskantschlüssel
Art.no. 00.006.928
2.1.2. Spare Parts and Accessories
All parts displayed above can be reordered under the article number from your warehouse at
orangedental.
Two arm straps of
different lengths with
snap-on coupling
long Art.no. 00.005.387
short Art.no. 00.005.398
spot–onnxt lamp
This is normally
already mounted on
the glasses
Art.no. 00.005.343
Battery unit for
attachint to arm or
belt
Art.no. 00.005.365
Power supply unit
for charging the
battery unit
Art.no. 00.005.354
Charging cable for
connecting power
supply unit and
battery unit
Art.no. 00.005.591

Instructions for Use | spot–onnxt
Page 6 of 17 Date: 10.11.2016 00.005.444-02 | EN
3. INSTALLATION
Before you use the device for the first time, you should completely charge the battery unit of the
spot–onnxt. 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 comes on
underneath 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 refer to the separate
instructions for use regarding the mounting of the lamp. Now allow the magnetic plug on the lamp,
as shown in the illustration bellow, to snap into the battery casing coupling.
Illustration: Plug 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 projecting lug
on the lower part. Please remember that the device has a sensor key. Therefore, it should not be placed
where you place your arm when sitting. The key also works through clothing, providing it is not too thick.
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 bulkier arms) to the rear side of the casing underneath both of the
spring arms.

Instructions for Use | spot–onnxt
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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–onnxt
Page 8 of 17 Date: 10.11.2016 00.005.444-02 | EN
4. USE
The spot–onnxt 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 light intensity set 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 Lux1
2 lamps increased light capacity, approx. 30,000 Lux1
1 lamp normal light intensity, approx. 20,000 Lux1
1 measured at 25 cm working distance
Look at an even surface through the magnifiying 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 once again pressing the sensor area briefly with your finger, you can switch the lamp off
again. 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.

Instructions for Use | spot–onnxt
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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 on and off.
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 - 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. Do not use the USB connection of your PC to charge the device. The PC cannot
provide the required energy. Normally, the PC will switch off the USB interface due to overload. If, 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–onnxt
Page 10 of 17 Date: 10.11.2016 00.005.444-02 | EN
5. SAFETY, HANDLING AND MAINTENANCE
5.1. General
Remember that the spot–onnxt 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.
WARNING:The lamp on the spot–onnxt belongs to risk group 2 as per DIN EN 62471-1.
Danger of dazzling! Do not look directly into the ray of light.
The ray of light must not be directed towards the eye. The spot–onnxt is not to be
used for eye examinations (examination of pupils).
Increased danger of dazzling. Remember that the responsiveness of the eyes
diminishes when someone is under the influence of drugs, medication or alcohol.
Risk of injury to the retina.
The product emits blue light (400-780 nm). Do not look directly into the ray of
light.
CAUTION: Danger of heat build-up if the lamp is e.g. covered when in operation.
If spot–onnxt is used several times with highest light intensity, please note the heat generation
of the light.
5.2. Hygiene
CAUTION: The lamp and the battery unit are notautoclavable. The resulting temperatures
would destroy the plastics and electronics used.
Note: The spot–onnxt is sealed appropriately in order to protect it when it is cleaned /
disinfected with damp media / cloths.
The spot–onnxt should be cleaned immediately after use in order to prevent any
residual blood or protein from solidifying.
5.2.1. 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.
5.2.2. Disinfection
The spot–onnxt 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.

Instructions for Use | spot–onnxt
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Wipe the battery casing, the arm strap, the cable and the lamp several times with the
disinfecting cloth.
Allow the disinfecting agent to soak long enough in as per its instructions.
Now remove any residual disinfecting agent with damp, lint-free disposable cloths.
Now dry the spot–onnxt 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.
CAUTION: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.
5.2.3. Disinfection agents for the spot-onnxt
The following agents have been tested for cleaning and disinfecting the spot–onnxt:
Innocid DW-i Desinfektionstücher
PRISMAN Pharma International AG; Am Stalden 16; CH-4622 Egerkingen
Omnizid spray and wipe disinfection
OMNIDENT Dental-Handelsgesellschaft mbH; Gutenbergring 7-9; D-63110 Rodgau
5.3. Servicing and Maintenance
The device may only be repaired by a service point authorized by orangedental.
WARNING:Take the device out of operation if there are visible signs of damage or any
malfunctioning. Contact your orangedental service point in such cases.
5.4. Disposal
The spot–onnxt and the accessories contain a lithium polymer accumulator as well as
components which are not suitable for disposal with normal household refuse. Please contact
your dental stockist or enretec GmbH (www.enretec.de). Enquiries relating to disposal can be
sent to orangedental.

Instructions for Use | spot–onnxt
Page 12 of 17 Date: 10.11.2016 00.005.444-02 | EN
6. SPECIFICATIONS AND CONFORMITY
orangedental GmbH & Co. KG
Aspachstrasse 11 | 88400 Biberach / Riss
6.1. Requirements regarding the practice environment
IMPORTANT:The spot–onnxt should only be operated by skilled and trained persons.
Position the device so that is not exposed to direct sunshine.
6.2. Product labeling
6.3. Technical Data
6.3.1. 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
6.3.2. Electrical characteristics
data
unit
supply voltage battery unit
5
V DC
max. power input
1500
mA
battery LiPo
9.6
Wh
6.3.3. Optical characteristics
data
unit
light intensity
normal/strong/maximum approx.
Measured at 25 cm working distance
20 / 30 / 45
x1000 Lux

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6.3.4. Working life
data
unit
life utility (except battery)
5
years
6.3.5. Electromagnetic compatability
data
EN 60601-1-2 group 1
HF energy used exclusively for its internal
function.
EN 60601-1-2 class B
Is suitable for use in all buildings including
domestic buildings and such that are
connected directly to a public supply network
which also supplies buildings which are used
for domestic purposes.
6.3.6. Conformity with standards
Data
Protection class
IP20
Classification according to 93/42/EEC
I
Electrical safety
EN 60601-1
6.3.7. Ambient conditions
Operation conditions
Use only in a normal climate
temperature: +10°C to +40°C
rel. humidity: 25 - 75%
air pressure: 800 hPa –1060 hPa
Transport conditions
temperature: -40°C to +60°C
rel. humidity: 10 - 90%
air pressure: 500 hPa to 1060 hPa
Storage conditions
temperature: +5°C to +50°C
rel. humidity: 10 - 75%
air pressure: 700 hPa to 1060 hPa

Instructions for Use | spot–onnxt
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6.3.8. Electromagnetic compatability
Guidance and manufacturer’s declaration –electromagnetic emissions
The spot–onnxt is intended for use in an environment as described below. The customer or the
user of the spot–onnxt should assure that it is used in such an environment.
Interference emission
measurements
Compliance
Electromagnetic environment –guidance
RF-emissions as per
CISPR 11
Group
1
The spot–onnxt uses RF energy only
for its internal function. Therefore its RF
emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
RF emissions as per
CISPR 11
Class
B
The spot–onnxt is suitable for use in all
establishments including domestic
premises and those directly connected
to the public power supply network that
supplies buildings used for domestic
purposes.
Harmonic emissions as
per IEC 61000-3-2
Not applicable
Voltage fluctuations / flicker
emissions IEC 61000-3-3
Not applicable

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Guidance and manufacturer’s declaration –electromagnetic immunity
The spot–onnxt is intended for use in the electromagnetic environment specified below. The
customer or the user of spot–onnxt should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
compliance
level
Electromagnetic environment –
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 6 kV
contact
± 8 kV
air
± 6 kV
contact
± 8 kV
air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical
fast
transient/burst
IEC
61000-4-4
± 2 kV for
power
supply lines
± 1 kV for input
/
output lines
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Surges
IEC 61000-4-5
± 1 kV line(s)
to
(line(s)
± 2 kV line(s)
to
(line(s)
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5 %
U
T
(>95 % dip in UT )
for 0,5 cycle
40 %
U
T
(60 % dip in UT )
for 5 cycles
70 %
U
T
(30 % dip in UT )
for 25 cycles
< 5 %
U
T
(>95 % dip in UT )
for 5 s
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
NOTE UT ist he a.c. mains voltage prior to application of the test.

Instructions for Use | spot–onnxt
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Guidance and manufacturer’s declaration –electromagnetic immunity
The spot–onnxt is intended for use in an environment as described below. The customer or the user of
the spot–onnxt should assure that it is used in such an environment.
Immunity test
IEC 60601-test
level
compliance level
Electromagnetic environment –
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Veff
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 Veff
3 V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of the
spot–onnxt including cables, then
the recommended separation
distance calculated from the
equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 1.17 √P
d= 1.17 √P for 80 MHz to 800 MHz
d = 2.3 √P for 800 MHz to 2.5 GHz
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey a should
be less than the compliance level in
each frequencyb
Interference may occur in the vicinity
of equipment marked with the
following symbol.
NOTE 1 at 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the spot–onnxt is used exceeds the applicable RF compliance level above, the spot–
onnxt should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the spot–onnxt.
b Over the frequency range 150 kHz to 80 MHz so field strengths should be less than 3 V/m.a

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Recommended separation distances between portable and mobile RF communications equipment and
the spot–onnxt
Die spot–onnxt is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the spot–onnxt can help prevent the electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the spot–onnxt –as recommended below, according to the maximum
output power of the communications equipment.
Rated
maximum
output power of
transmitter in
Watt
Separation distance according to frequency of transmitter [m]
150 kHz to 80
MHz
in the ISM bands
d = 1.17 √P
80 MHz to
800 MHz
d= 1.17 √P
800 MHz to
2.5 GHz
d= 2.3 √P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.