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Indications for Use
This device is intended to illuminate and magnify oral structures and operating areas and is to be used by
qualified health professionals including, but not limited to, dentists, dental hygienists, medical doctors
and medical professionals.
This device is suitable in professional healthcare facility environments, specifically physician/dental offices
and clinics, limited care facilities, freestanding surgical centers, and hospitals (emergency rooms, patient
rooms, intensive care rooms, and surgery rooms), except near high frequency surgical equipment outside
the radio frequency shielded room for magnetic resonance imaging (MRI).
Intended Purpose: This device is intended to Illuminate oral structures and operating areas.
Intended Users: 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.
Intended Patient Population: This device is intended for use on patients during general dental and
surgical procedures.
Clinical Benefits: When attached to loupes or other eyewear, this device illuminates the field of view of
the wearer to improve visibility during procedures.
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INSTRUCTIONS FOR USE AND CARE
Orascoptic ™ Dragonfly ™ Powered Loupe
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.
DO NOT
• Do not disassemble or modify the device
• Do not remove the product serial number labeling
• 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 tightly bend or wrap the headlight cable
• 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%
Contraindications
Adverse Reactions
None known.
None known.
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