Safety And Declaration Of Conformity; Safety Considerations; Declaration Of Conformity; Instruction - STC SC-2001L Quick Manual

1. Safety and Declaration of Conformity

1-1 Safety Considerations

This symbol reminds the user should read instruction/manual carefully
before operating this device.
This symbol cautions the user that important information regarding the operation and /
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 denotes Type BF – Electrically connected to Patient but not directly to heart.
Recycling
Follow local governing ordinances and recycling plans regarding the recycling
or disposal of this equipment.
Safety Compliance
This product meets the requirements of EN-60601-1 so as to conform to the Medical
Device Directive 93/42/EEC and 2007/47/EC (general safety information).
This symbol means Medical Device.
This product meets or exceeds the safety requirements of Taiwan Bureau of Standards,
Metrology and Inspection (BSMI).
This product meets the requirements of Taiwan Food and Drug Administration
(TFDA) for medical device
This symbol means the manufacturer.
EC REP
This symbol means the manufacturer's European Community representative.
This symbol indicates the date on which a product was manufactured
To identify the manufacturer's batch or lot code.
SN
To identify the product's serial number.

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
simple to allow patients to visually understand your diagnosis.
This device is internally powered equipment to be used alone. The charging system (including AC
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
unit and ways to maintain it. Please read and retain this manual.

2-2 Intended User Profile

This device is intended for a licensed professionals trained in Dental Scopy.
Intended operator: any operator (mild reading vision impairment or vision corrected to log MAR 0.2
(6/9.5 or 20/32)) graduated from department of dentistry.
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