3
1. Safety and Declaration of Conformity
1-1 Safety Considerations
1-2 Declaration of Conformity
IEC:
This equipment has been tested and found to comply with the limits for medical devices to the IEC
60601-1-2. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to other devices in the vicinity.
2. Instruction
2-1 Intended Use
The Dental Root Canal Orifices Detector is a patented product. Built-in LED light, this tiny detector
enables dentist easily locate the root canal orifices. The compact and easy-to-hold design make it
This product meets the requirements of EN-60601-1 so as to conform to the Medical
or maintenance of this equipment has been included. Information preceded by this
symbol should be read carefully to avoid damage to the equipment or miss operation.
This symbol reminds the user should read instruction/manual carefully
before operating this device.
Recycling
Follow local governing ordinances and recycling plans regarding the recycling
or disposal of this equipment.
Safety Compliance
This symbol means Medical Device.
Device Directive 93/42/EEC and 2007/47/EC (general safety information).
This product meets or exceeds the safety requirements of Taiwan Bureau of Standards,
This symbol cautions the user that important information regarding the operation and /
This symbol denotes Type BF – Electrically connected to Patient but not directly to heart.
This product meets the requirements of Taiwan Food and Drug Administration
Metrology and Inspection (BSMI).
(TFDA) for medical device
This symbol means the manufacturer.
This symbol means the manufacturer’s European Community representative.
REP
This symbol indicates the date on which a product was manufactured
To identify the manufacturer's batch or lot code.
To identify the product’s serial number.
SN
EC
simple to allow patients to visually understand your diagnosis.
This device is internally powered equipment to be used alone. The charging system (including AC
unit and ways to maintain it. Please read and retain this manual.
adapter and Type C cable) is provided for charging the device while it is not in use.
Follow the instruction of the manual and some useful tips of how to experience performance of the
2-2 Intended User Profile
Intended operator: any operator (mild reading vision impairment or vision corrected to log MAR 0.2
This device is intended for a licensed professionals trained in Dental Scopy.
(6/9.5 or 20/32)) graduated from department of dentistry.
