INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
Spark
™
Headlight
Spark
™
Headlight
4
5
Orascoptic
™
Spark
™
Headlight
Congratulations on your purchase of the Spark cordless LED headlight system!
Spark is designed to attach directly to a majority of through-the-lens (TTL) loupes as well as ophthalmic dress or safety
eyeglasses.
The Spark system contains these primary components:
• LED Headlight
• 2 Lithium-ion Rechargeable Battery Packs
Accessories include:
• Micro-USB Cable
• USB Power Adapter
• Curing Filter
• Screwdriver
• Storage Case
Indications for Use:
Spark 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 dental professionals, including,
but not limited to, dentists and dental hygienists, as well as medical doctors and/or professionals.
Contraindications:
None known.
Warnings:
1. The device must be used exclusively for the intended purpose described.
2. Do not disassemble or modify the device.
3. Do not use the device if the enclosure or electrical contacts/plugs are damaged.
4. Misuse of the batteries may cause them to become hot, explode, or ignite and may cause serious injury.
Be sure that the following safety precautions are expressly followed:
• Do not bring the battery into contact with fire.
• Maintain storage and operational temperature of 32° to 104°F (0°- 40° C).
• Do not short circuit the electrical contacts.
• Protect from fluids or damp environments.
• 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.
5. The use of power adapters and cords 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.
6. Before use, ensure all screws and removable components are secured to the device.
7. 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.
Precautions:
1. Do not remove product serial number labeling.
2. Avoid touching the electrical contacts on the bottom of the battery pack and top of the LED headlight.
3. To prolong the life of the battery packs, do not store battery packs in a fully charged or discharged state.
4. Do not hang or handle the device by the exposed cable or damage may result.
5. Do not rinse the device under running water or damage may result.
6. Do not submerge in any liquid or an ultrasonic cleaner or damage may result.
7. Do not use an autoclave or chemiclave.
8. Do not spray the device.
9. Do not pull on the exposed cable during cleaning.
10. Do not use glutaraldehyde or idophor.
11. Do not use a cleaner with alcohol concentration greater than 70%.
12. Do not begin a procedure while the battery indicator on the battery pack is illuminated or flashing SCARLET.
Adverse Reactions:
None known.
Disposal Instructions:
When you plan to dispose of the device, please return to Orascoptic for recycling. Contact customer support or
distributor for details. The European Union Waste Electrical and Electronic Equipment
(WEEE) Directive forbids the disposal of waste 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 migration of substances into the soil and
groundwater.
The Spark
™
battery packs contain lithium-ion cells. Recycle or dispose of the batteries accordingly to national,
state, and local regulations.
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