ORASCOPTIC Spark Series Cordless Headlight Instruction Manual

ORASCOPTIC Spark Series Cordless Headlight

Getting Started With Your New Spark Series Headlight

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:

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 knew.
• Adverse Reactions: None knew.

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, headlights, 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.
5. IEC 62471 Risk Group 2

CAUTION: Possibly hazardous optical radiation is emitted from this product. Do not stare at the operating lamp. May be harmful to the eyes.

1. 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 an 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.

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 chemical ve, glutaraldehyde, iodophor, or any other sterilization method
• Do not use a cleaner with an 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 electrical 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 the migration of substances into the soil and groundwater. If you need assistance when disposing of 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

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 an ultrasonic cleaner
• Do not pull on the exposed cable during cleaning
• Do not use an autoclave, chemical ve, glutaraldehyde, iodophor, or any other sterilization method
• Do not use a cleaner with an 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™

Operating Your Spark Series

CAUTION: Point the headlight away from your eyes because the light beam is strong.

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 headlights 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 orangeM curing filter itself.

Troubleshooting

Mounting and Removing the Spark Series

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.

WARNING

• 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 a 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.

SYMBOLS

Specifications

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|  Class II and internally powered
Battery type| Lithium-ion / 3.7v / 425 mAh
Charge time (each battery pack)| 3 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

Technical Support

• Customer Care: 1.800.369.3698
• Outside the U.S. or Canada Call Your Local Distributor

References

• Surgical Loupes, Dental Loupes, Surgical Headlights | Orascoptic

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