Orascoptic Spark Series Assembly instructions

Series INSTRUCTIONS
for Use and Care

INTENTIONALLY BLANK

INDEX
English...................................................................... 4
Български (Bulgarian)...............................................11
中國 (Chinese) .......................................................19
Ceština (Czech).........................................................27
Dansk (Danish)..........................................................35
Deutsch (German)......................................................43
Nederlands (Dutch) ...................................................51
Eesti (Estonian).........................................................59
Español (Spanish) .....................................................67
Français (French).......................................................75
Ελληνικά (Greek)........................................................83
Italiano (Italian)........................................................91
日本語(Japanese).................................................99
䚐ạ㛨G(Korean) .................................................107
Latvijas (Latvian).....................................................115
Lietuvos (Lithuanian)...............................................123
Magyar (Hungarian) .................................................131
Norsk (Norwegian)...................................................139
Polski (Polish) ........................................................147
Português (Portuguese) ...........................................155
Slovencina (Slovak).................................................163
Slovenščina (Slovenian)............................................171
Suomi (Finnish).......................................................179
Svenska (Swedish) ..................................................187

Orascoptic™Spark™Series
INSTRUCTIONS FOR USE AND CARE
Technical Support/Customer Care: 1.800.369.3698 | Outside the U.S. or Canada Call Your Local Distributor4
Spark series is designed to attach directly to a majority of through-the-lens (TTL) loupes as well as ophthalmic,
dress, or safety eyeglasses.
The Spark series system contains these primary components:
LED Headlight
Curing Filter
Mounting Clip
Mounting
Arms
(2) Lithium-ion Rechargeable Battery Packs
Accessories included
USB-to-Micro USB Cable, Power Adapter, Curing Filter, Optical Screwdriver
Please take special attention during unpacking to verify all components listed above are present. Please call
one of our Customer Care Specialists or your authorized Orascoptic distributor to order replacement parts.
Contraindications None known.
Adverse Reactions None known.
Indications for Use
Spark series is an illumination device attached to spectacles, worn as a visual aid, intended to illuminate oral
structures and operating areas. This device is intended to be used by qualified medical and healthcare professionals
including, but not limited to, dentists, dental hygienists, medical doctors and medical professionals.
Warnings
1. The device must be used exclusively for the intended purpose described.
2. Do not use the device if any component is damaged, loose, detached, or missing. This includes battery
packs, mounting clip, headlight, and electrical contacts/plugs. Parts that are broken, missing, distorted or
worn should be replaced immediately. Should such repair or replacement become necessary, ORASCOPTIC
OR AN AUTHORIZED SERVICE DEALER SHOULD PERFORM ALL REPAIRS TO THIS PRODUCT.
3. The use of power adapters and cables other than those provided for use with the device may result in
increased emissions or decreased immunity and may cause the system to be non-compliant with the
requirements of IEC60601-1-2. Only the power adapter and cable that ships with the device should be used
to power the Sparkseries.
4. This product maintains compliance with blue light testing standards for safety set by the International
Electrotechnical Commission (IEC). As with all lighting products, there are risks to staring directly into the light.
• IEC 62471 Risk Group 2 - CAUTION: Possibly hazardous optical radiation is emitted from this
product. Do not stare at operating lamp. May be harmful to the eyes.
5. Misuse of the batteries may cause them to become hot, explode, or ignite and may cause serious
injury. Be sure that the following safety warnings are expressly followed:
• Never open or modify the battery pack, mounting clip or power adapter.
• Do not use outside.
• Protect from fluids or damp environments.
• Maintain operational environment of 32° to 104°F (0° to 40°C).
• Do not short circuit the electrical contacts.
• Do not bring any part of the device into contact with fire or severe heat over 158°F (70°C)
• If you determine that the battery is hot, emits an odor, or changes color or shape, disconnect power
immediately. The battery must not be used again.
Getting Started With Your New Spark Series Headlight

Orascoptic™Spark™Series
INSTRUCTIONS FOR USE AND CARE
Technical Support/Customer Care: 1.800.369.3698 | Outside the U.S. or Canada Call Your Local Distributor 5
Precautions
1. Before use, ensure all screws and removable components are secured to the device.
2. To prolong the life of the batteries, do not store in a fully charged or discharged state.
3. DO NOT
• Do not disassemble or modify the device
• Do not remove the product serial number labeling
• Do not touch exposed electrical contacts
• Do not begin a procedure while the low-battery indicator light is illuminated or flashing
• Do not hang or pull on exposed cables
• Do not spray directly onto the device
• Do not run any part of the device under water or submerge in any liquid or an ultrasonic cleaner
• Do not use an autoclave or chemiclave, glutaraldehyde, iodophor, or any other sterilization method
• Do not use a cleaner with alcohol concentration greater than 70%
Disposal Instructions
When you plan to dispose of the device, please return to Orascoptic for recycling. The European
Union Waste Electrical and Electronic Equipment (WEEE) directive forbids the disposal of elec-
trical and electronic equipment as unsorted municipal waste, requiring that it be collected and
recycled or disposed of separately. Hazardous substances are present in electrical and electronic
equipment and present potential risk to human health and environment if disposed of in municipal
landfills which are not designed to prevent migration of substances into the soil and groundwater.
If you need assistance when disposing the device, please call one of our Customer Care Specialists
or your authorized Orascoptic distributor.
This device contains lithium-ion cells. Recycle or dispose of the batteries accordingly to national,
state, and local regulations.
Transport and Storage
-4°F
(-20°C)
104°F
(+40°C)
85%
10%
0.5 atm
(500 hPa)
1.0 atm
(1060 hPa)
Cleaning and Disinfecting
The Spark series is a precision optical-electrical instrument manufactured from high quality components.
With proper care, it will provide a long and useful life. You must adhere to the following instructions for
proper cleaning and disinfecting, or damage may result.
DO NOT
• Do not spray directly onto the device
• Do not run any part of the device under water or submerge in any liquid or ultrasonic cleaner
• Do not pull on the exposed cable during cleaning
• Do not use an autoclave, chemiclave, glutaraldehyde, iodophor, or any other sterilization method
• Do not use a cleaner with alcohol concentration greater than 70%
Cleaning
You may use soap and water to clean all parts of the device. Dampen or spray a soft cloth and then wipe
the device. Squeeze excess fluid out of the cloth or wipe before using. If your eyewear is heavily soiled,
first remove the headlight and then clean your eyewear. Dry your eyewear thoroughly before reinstalling
the headlight.
Disinfecting
You may disinfect the device with a low-alcohol disinfectant. Apply the disinfectant to a soft cloth and
then wipe the device. Squeeze excess fluid out of the cloth or wipe before using.
Recommended Disinfectants
CaviCide™, CaviCide1™, CaviWipes™, or CaviWipes1™

Orascoptic™Spark™Series
INSTRUCTIONS FOR USE AND CARE
Technical Support/Customer Care: 1.800.369.3698 | Outside the U.S. or Canada Call Your Local Distributor6
Operating Your Spark Series
Filter Flips
Headlight Tilts
Capacitive Touch Control
Battery Indicator Light
Bezel Black Ring
Orange Filter
Power Adapter
Charging port
USB-to-Micro USB Cable
Electrical Outlet
Locking Tab
Point the headlight away from your eyes
because the light beam is strong.
!CAUTION

Orascoptic™Spark™Series
INSTRUCTIONS FOR USE AND CARE
Technical Support/Customer Care: 1.800.369.3698 | Outside the U.S. or Canada Call Your Local Distributor 7
Operating Your Spark Series
Operating the Headlight
The Spark series uses capacitive touch controls, making the light simple to operate during clinical procedures.
1. Install a battery pack onto the mounting clip.
2. Touch anywhere on the front or side beveled areas of the battery pack to turn the headlight on
and off.
3. Place your loupe and headlight on your head and adjust to a comfortable working position. Turn the
headlight on and tilt it to the appropriate angle to illuminate your visual field while looking through
the telescopes.
Charging the Battery Pack
Your Spark series comes with two battery packs so that one may be charging while the other is in use. Both
battery packs are partially charged when shipped and should be fully charged prior to use. To charge a
battery, plug the power adapter into an electrical outlet. Plug the USB-to-Micro USB cable into the
power adapter and into the charging port on the back of the battery pack.
• The battery indicator light will blink SCARLET when the battery pack is nearly depleted and needs
to be charged.
• The battery indicator light will illuminate AMBER while the battery pack is charging.
• The battery indicator light will illuminate GREEN when the battery pack is fully charged.
Installing and Removing the Battery Pack
The battery pack is secured to the mounting clip with locking tabs on each side of the battery pack.
Depress both locking tabs when installing or removing the battery pack. The locking tabs will ‘click’
into place when the battery pack is secure. After installing a battery pack, allow three seconds for it to
activate before attempting to turn the headlight on.
Using the Curing Filter
The curing filter should be used when working with light-cured composites. When applying these
materials, unfiltered light from the headlight can cause premature curing of the composite. The curing
filter is made up of two components; the black bezel ring that is secured to the end of the headlight and the
orange filter that can be flipped up and down as needed during procedures.
• If you don’t require the curing filter for your practice, you can remove it from the headlight. To
remove the curing filter, flip the orange filter to the UP-position and carefully pull the black bezel
ring off the headlight. Do not pull on the orange curing filter itself.
• To attach the curing filter, flip the orange filter to the UP-position and carefully push the black
bezel ring onto the headlight, making sure the hinge is at the top. Do not push on the orange
curing filter itself.
Troubleshooting
Problem Solution
Headlight does not turn on. Check that the battery pack is charged. Remove and reattach the battery pack, making sure both locking tabs are secure. Attach the other battery pack to determine
if the problem is in the headlight or battery pack.
Battery indicator light is blinking scarlet. Indicates the battery is low. Charge the battery.
Battery indicator light does not illuminate amber while charging. Check that the Micro-USB plug is secured in the charging port on the back of the battery pack. Check that the USB plug is secured in the power adapter. Check that the electrical
outlet is producing power.

Orascoptic™Spark™Series
INSTRUCTIONS FOR USE AND CARE
Technical Support/Customer Care: 1.800.369.3698 | Outside the U.S. or Canada Call Your Local Distributor8
The Spark series is secured to a loupe frame by tightening the mounting screw which clamps your frame
between the mounting clip and mounting arms of the device. Access to the mounting screw is located
behind the LED headlight assembly. The headlight is designed to tilt down only enough to be parallel to the
battery pack to access the mounting screw and no further.
!DO NOT force the headlight down further than shown, or damage may result.
!DO NOT attempt to remove your Spark series without first loosening the mounting screw,
or damage may result.
When mounting the Spark series to a loupe
1. Tilt the LED headlight down. Use an optical screwdriver to loosen the mounting screw and open
the mounting arms.
2. Push the device over the top of your loupe frame with mounting clip in front of the carrier lenses and
mounting arms behind the carrier lenses.
3. Center the device over the bridge of your loupe frame and tighten the mounting screw until the
device is secure.
When removing the Spark series
1. Tilt the LED headlight down. Use an optical screwdriver to loosen the mounting screw and open
the mounting arms.
2. Pull the device straight up off your loupe frame.
Mounting and Removing the Spark Series
Mounting Arms
Mounting Clip
Mounting Screw
Moun
ti
ng
S
cr
ew
Mounting Arms

Orascoptic™Spark™Series
INSTRUCTIONS FOR USE AND CARE
Technical Support/Customer Care: 1.800.369.3698 | Outside the U.S. or Canada Call Your Local Distributor 9
Symbol Glossary
Medical Device Address of Manufacturer
Reference Number / Part Number Country of Manufacturer
Serial Number Date of Manufacture
Lot Number Phone number
Unique Device Identification Email address
Consult Instructions for Use Prescription Device
European Conformity EC REP European Union Representative
Waste Electrical and Electronic Equipment -4°F
(-20°C)
104°F
(+40°C) Temperature Limitations
Canadian Standards Association
85%
10%
Humidity Limitations
Address of Distributor 0.5 atm
(500 hPa)
1.0 atm
(1060 hPa) Pressure Limitations

Orascoptic™Spark™Series
INSTRUCTIONS FOR USE AND CARE
Technical Support/Customer Care: 1.800.369.3698 | Outside the U.S. or Canada Call Your Local Distributor10
Specications
Weight of headlight with filter 15.1 grams
Weight of battery pack 16.7 grams
Diameter of headlight .6 inches / 14 mm
Dimensions of battery pack Length = 1.7 inches / 43 mm
Width = 1.1 inches / 28 mm
Height = 0.5 inches / 13 mm
Electrical Internally Powered
Battery type Lithium-ion / 3.7v / 425 mAh
Charge time (each battery pack) 2 Hours
Run time (each battery pack) 3 Hours
Light Output 32 Lumens
LED Color Rendering Index (CRI) Standard = 70+
TruColor = 90+
LED Correlated Color Temperature (CCT) Standard = 6500K
TruColor = 5700K
Operation Mode Continuous
EMC Standard IEC 60601-1-2, EN55011
Safety Standard IEC 60601-1, IEC 62471
Operating Environment 32° to 104°F (0° to 40°C)
10% to 85% relative humidity (non-condensing)
0.5 atm to 1.0 atm (500 hPa to 1060 hPa) atmospheric pressure
Electromagnetic Compatibility Test
CISPR 11 - Emissions: Radiated RF Group 1, Class B
IEC 61000-4-2 - Immunity: Electrostatic Discharge ±8kV contact
±15kV air
IEC 61000-4-3 - Immunity: Radiated RF 3V/m, 80MHz – 2.7GHz, 80% 1kHz AM
IEC 61000-4-8 - Immunity: Power Frequency Magnetic Fields 30A/m, 50/60Hz
IEC 61000-4-3 - Immunity: Proximity Fields from RF Wireless Communications Equipment IEC 60601-1-2:2014, section 8.10