STC SC-2001L User manual

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SC-2001L/SC-2001R
Quick Guide

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Table of Contents
1. Safety and Declaration of Conformity
1-1 SafetyConsiderations ------------------------------------------------------------------------------------- 3
1-2 DeclarationofConformity --------------------------------------------------------------------------------- 3
2. Instruction
2-1 Intended Use -------------------------------------------------------------------------------------------------- 3
2-2 Intended User Profile ---------------------------------------------------------------------------------------- 4
2-3 Intended Patient ---------------------------------------------------------------------------------------------- 4
2-4 Warning and Precaution ------------------------------------------------------------------------------------ 4
3. Name and Function of Each Parts -------------------------------------------------- 5
4. Operation and Maintenance 7
4-1 Quick Guide For Use ---------------------------------------------------------------------------------------- 7
4-2 Pictures and Video Files Output by Connecting to a PC ---------------------------------------- 12
4-2 Battery Charge ------------------------------------------------------------------------------------------------ 13
4-4 Care and Maintenance -------------------------------------------------------------------------------------- 14
5. Troubleshooting Section --------------------------------------------------------------- 15
6. Specifications ------------------------------------------------------------------------------ 16
7. Electromagnetic Compatibility (EMC) Tables ----------------------------------- 17
8. Warranty and Service Program ------------------------------------------------------ 19

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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 interferenceto other devicesinthevicinity.
2. Instruction
2-1Intended 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 (includingAC
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 logMAR 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.

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lWarning
Use only providedAC adapter and Type C/USB cable to charge this device. Use of accessories
other than those specified above and the use of unapproved replacement components may
result in increased emissions or decreased immunity of this device.
lWarning
Do not use battery other than it included with this device or replacement parts supplied by the
manufacturer.
lWarning
Use a power cord that matches the voltage of the power outlet, which has been approved and
complies with the safety standard of your particular country.
lWarning
No modification of this equipment is allowed.
lWarning
This device and accessories should not be used adjacent to or stacked with other equipment.
lWarning
Do not use this device while it is charging.
lWarning
Remove the battery if this device is not likely to be used for some time.
lWarning
Do not attempt to disinfect this device using glutaraldehyde products, ethylene oxide gas,
steam or any other liquid or gas disinfectant.
lWarning
If there is any other problem, please consult or return the device to your dealer/distributor. Do
not try to repair a defective device.
lCaution
This device is for dentist or dental trained personnel use only.
lCaution
This device may seriously be damaged after the device is dropped and the probe end hits the
ground.
lCaution
The probe end will be slightly warm after the device has been operating continuously for a
period of time. The maximum temperature of the end complies with medical device regulations
and will not harm human skin.
lCaution
To fully disengage the power, please disconnect the AC adaptor from the power outlet.
lCaution
Do not position theAC inlet to a position where it is difficult to disconnect the device.
lCaution
Follow national requirements to dispose of the device.
2-3Intended Patient
inside an oxygen chamber with strong electronic and electromagnetic fields e.g., mobile phones.
This product does not apply to children under 12 years old.
2-4Warning and Precaution
Do not use this device in explosive environments such as where flammable anesthetics exit or

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3. Name and Function of each Parts
Dental Handpiece Cap

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✽The type C charger slot is compatible with the enclosed type C cable only.
✽✽The rechargeable battery is embedded and can only be replaced in authorized service center or
dealer or distributor.
✽✽✽Do not replace the battery yourself or it may cause device damage and no warranty.

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4. Operation and Maintenance
4-1 Quick Guide for Use
Make sure the lens infront of the probe end is clean.
Remove the Dental Handpiece Cap
Connect the Dental Handpiece with cable
Power on
-Press the Power button on the left side of top to
turn on the device one time to turn on the
device.
-LED on the distal tip of handpiece will be light up
after Power on.
Preview
1. Preview mode
2. Display
-Snapshot
-Battery capacity
-LED +/- adjustment (0~100)
-Zoom in/out (x1, x1.5, x2)
-Screen scale up (400x400 / 480x480)
-Playback
-Set up
LED +/-
Touch the icon of LED to adjust the LED light from
0, 10, 20 to 100.

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Zoom in/out
Touch Zoom in/out icon to adjust the zoom (x1,
x1.5, x2) .
400x400
480x480
Screen scale up
1. Touch the scale up icon to scale up the image
400x400 or 480x480
2. Touch the screen to disappear the icons.
Take Pictures
Press snap button on the handle once for
still image.
The flash once snapshot is ready.
Video Record
-Long press snap button on the handle
for video recording. Recording icon
shown on the left of screen
-During recording, user may adjust zoom in/out
or LED light by pressing the icon on left side.
-Press snap button again or press the stop icon
on the screen to return to preview mode.
** The time display at the top of the screen
indicates the remaining recordable time.

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Playback
-Touch on the home page.
-Select folder by touching screen.
-Touch or double click the folder to enter
the folder to review the pictures or video.
-Touch or for page up and
down.
Playback Preview
-Touch can preview the last 9 pictures, and
for next 9 pictures.
( The file with icon is video file)
-Quick touch the picture for 2 times to enter full
screen playback.
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Touch to return to home page.
Video playback & delete
-Press the Video playback icon to play
video and press Pause icon to stop
playing video; Press the Playing button to
proceed the rest video or press to quit
from the playing mode
-Press Delete button to delete video file
-Press Return key to be back to file list.
-Press Return key to be back to folder
-Press the Return key again to be back to the
preview page
Photo playback & delete
-When a picture under playback mode, touch the
or for page up / down
-Press Delete button to delete current file.
-Press Return key to be back to the folder
-Press the Return key again to be back to
the preview page

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Set up:
1. Saturation adjustment
2. Contrast adjustment
3. Brightness adjustment
4. Language/Date/Time/Battery Saving/ Setting
Reset set up
5. White Balance correction.
Saturation:
1. Select or to up or down level.
2. Enter
Contrast:
1. Select or to up or down level.
2. Enter
Brightness:
1. Select or to up or down level.
2. Enter
White Balance:
Select the white balance, the upper left
screen appears and indicates that the
automatic correction.

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Language/Date/Time:
1. Battery Power saving mode
2. Date/Time
3. Language Selection (English/Simplified
Chinese)
4. Setting Reset
Power Saving Mode
1. Standby timing: After 1min or 5min or 10min
without any operation and then screen and
LED off automatically.
2. After 5min or 10min or 30min without any
operation and then device shut down
automatically.
3. Select “Off” for non-saving mode.
**Touch the screen or press any button to wake
up the device. The default set up is Standby
timing 5min.
Time Set Up
1. Select to set up Year/
Month/Date/Hour/Minute
2. Enter
3. Select to return.
Language Set Up:
Press or to select
language, English or Simplified Chinese.

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Setting Reset:
Press à to reset Saturation,
Contrast, Brightness and Battery Saving to default.
Turn off the device
-Long press “Power” button
-Power icon shown on the screen
-Press “Power” button again and "Goodbye"
displays on the LCD screen and release the
button to turn off the device.
4-2 Pictures and Video Files Output by Connecting to a PC
Turn on the device and connect to the computer by using the USB type C/A cable. Open
"Windows Explorer" and find "New Folder Name" folder under the "Devices with Removable
Storage". The pictures and videos in this folder can be copied, deleted and removed etc.
a. Connect to a monitor by using a TYPE C/USB cable
b. A new folder pop up on the PC screen
c. Read photo/video data from new folder

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4-3 Battery Charge
When low battery shows on the LCD screen, get USB type C/A cable and AC adaptor
plug in power outlet. An orange LED on the left top of the LCD screen will be lighted up after
the USB type C/A cable inserts to the device. The battery has reached full capacity oncethe
LEDlight turned off automatically.
a. Connect the device to USB port of PC by using USB type C/A cable.
b. An orange LED lights up while power is charged and the light will be off when power charge
is finished.
✽Make sure plugging the Type C plug into the type C socket is in same direction; otherwise, it is not
able to be plugged in or there is no image shown.
✽✽Adapter type: SINPRO, HPU26-102, INPUT 100-240V~47-63Hz, 0.7-0.4A
※NOTE：
Ask an authorized dealer to replace battery when the battery is always running low after have
been charged a few times.

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4-4Care and Maintenance
a. No calibration is needed. Even components exceed the life limitation, there is no
aging problem.
b. Clean the Dental Handpiece
Putting the Dental Handpiece into “PBF” Sonacide Disinfectant (Glutaraldehyde 2%) for
10 minutes under 25℃room temperature and cleaning by distilled water. After then,
dipping the Dental Handpiece into 75% alcohol for 5 seconds. Then, wait the Dental
Handpiece for dry.
Step 1 Step 2
Step 3 Step 4
c. Do NOT immerse the device in any other liquid or subject to steam sterilization.
d. Always switch off thedevice when not use in for prolonged periods of time.
e. The device is not user-serviceable and should never be disassembled.
f. To order any replacement parts, contact the nearest dealer.
g. Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or
patient is established

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5. Troubleshooting Section
Problem Solution
5.1 Dental Handpiece does not connect with
the cable properly Make sure the direction red mark of cable and handpiece each is at same direction
5.2 Micro SD card does not insert into the
device properly No functions but Preview function only
5.3 Improper Operation Removing the SD card is not allowed during
snap or recording
5.4 Device shuts down or power off
automatically while in playback mode cause: Micro SD card may damage solution:
-connect the device to PC first
-check the SD card file from PC and delete
the bad file, which file capacity shows zero
"0"
-format the SD card before formatting the
SD card, please make sure to have files
backup
5.5 The device cannot be turned on - make sure the battery is full charged before
start up the device
- check and confirm the power button functional
well.
5.6 The image is fuzzy - make sure no dust or scratch in front of the
camera
- check LED light level has been adjusted to
suitable brightness
5.7 The function buttons can’t be controlled - check and confirm the buttons can be press
and depress easily
- restart the device and try the function buttons
again
5.8 The device is not charged after connecting
to USB adapter - try to unplug the USB adapter and re-connect it again to make sure if the plug was installed
properly
- try to charge device with USB adapter again
to check if the charging status LED will be pop
up
- switch on the device to see if the device is still
working
Note: If the above recommended solutions do not solve the problem, please contact your local
dealer for technical supports. Do not attempt to repair or open the device by yourself, as any
attempt to do so will render warranty invalid.

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6. Specifications
ITEM DESCRIPTION
Camera module
Camera resolution CMOS sensor, 400 x 400
Frame Rate 30fps
Light Source LED
Lens Fixed Focus
Field of View (FoV) 110°
Lens F/No F 5.0± 5%
Depth of Field (DoF) 5mm~50mm
Control system
Function Buttons Power / Snap / Record / Reset
Output Interface SD card slot / USB2.0 Mass Storage
Display 4.3” TFT-LCD + CTP
Display resolution RGB 800 x 480
Auto Exposure Control (AEC) Auto
White Balance Manual
Image Format JPEG
Video Format MOV.
Storage Built-in 16 GB Micro SD card
UI features Preview / Playback / LED / Zoom / Setting mode / Battery saving
Battery 3.6V, 3350mAh rechargeable lithium battery
Operating Temperature 10°C ~ +50°C (±10%) / 30% RH ~ 80% RH
Storage/Transportation environment -20°C ~ +60°C (±10%) / 20% RH ~ 90% RH
Atmospheric pressure 700-1060

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7. Electromagnetic Compatibility (EMC) Tables
All medical electronic devices must conform to the requirements of IEC 60601-1-2.
Precautions, adherences to the EMC guideline information provided in this manual and
verification of all medical devices in simultaneous operation are required to ensure the
electromagnetic compatibility and co-existenceofallothermedicaldevices.
nGuidance and manufacturer’s declaration – electromagnetic immunity
The Dental Root Canal Orifices Detector is intended for use in the electromagnetic environment specified below.
The customer or the user of The Dental Root Canal Orifices Detector should assure that it is used in such an
environment.
Immunity test IEC 60601 test
level
Compliance
level Electromagnetic environment – guidance
Radiated,
Radio-frequency,
electromagnetic field
IEC 61000-4-3:2010
80MHz-2.7GHz
3V/m
80%, 1kHz AM
3V/m, 9V/m,
27V/m, 28V/m
Portable and mobile RF communications equipment should be
used no closer to any part of The Dental Root Canal Orifices
Detector, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 1,2
d = 1,2 80 MHz to 800 MHz
d = 2,3 800 MHz to 2,5 GHz
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, a should be less than the compliance
level in each frequency range b.
Interference may occur in the vicinity of equipment marked with
the following symbol:
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3:2010
PASS
Immunity to conducted
disturbances, induced by
radio-frequency fields
IEC 61000-4-6:2013
0.15-80MHz
3V, 6V
0.15-80MHz
3V, 6V
NOTE 1 Applicable Limits: For radiated emissions at frequencies up to 1GHz (Class A, Group 1/2) & up to 1GHz (Class B, Group
1/2)
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which The Dental Root Canal Orifices Detector is used exceeds the applicable RF
compliance level above, The Dental Root Canal Orifices Detector should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating The Dental Root
Canal Orifices Detector.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and manufacturer’s declaration – electromagnetic immunity
The Dental Root Canal Orifices Detector is intended for use in the electromagnetic environment specified below. The
customer or the user of The Dental Root Canal Orifices Detector should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment –
guidance

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Electrostatic discharge
IEC 61000-4-2:2008 Contact: ±8kV
Air: ±2kV, ±4kV,±8kV, ±15kV Contact: ±8kV Air: ±8kV, ±15kV
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Electrical fast transient/ burst
IEC 61000-4-4:2012 Input AC power ports: ±2kV Input AC power ports:
0.5kV, 1kV, 2kV
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5:2014 Input AC power ports:
±0.5kV, ±1kV, ±2kV Input AC power ports:
0.5kV, 1kV
Mains power quality should be that of a
typical commercial or hospital
environment.
Power frequency magnetic
field
IEC 61000-4-8:2009
50Hz or 60Hz
30A/m (rms) 50Hz or 60Hz 30A/m (rms)
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Voltage dips
Voltage interruptions
IEC 61000-4-11:2004 +A1:
2017
PASS
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of The Dental
Root Canal Orifices Detector requires
continued operation during power mains
interruptions, it is recommended that The
Dental Root Canal Orifices Detector
be powered from an uninterruptible power
supply or a battery.
NOTE UT is the a.c. mains voltage prior to application of the test level.

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8. Warranty and Service Program
The Dental Root Canal Orifices Detector is warranted against any defects in materials and
workmanship under normal use and service as follows:
1. Warranty extends to the originalretail purchaser.
2. The Dental Root Canal Orifices Detector is warranted one (1) year from date of purchase.
3. Except in case of misuse, negligence, obvious abuse or accidental damage, if a material or
manufacturing defect is discovered during the warranty period, repairs will be made without
charge upon the return of the instrument to our distributor.
Model No. SC-2001L/R
Name: Address: __________________________________
Dealer’s Name: _______________________ Date of Purchase: _____________
SHINCHI TECHNOLOGY CORP.
11F., No.37, Sec. 3, Minquan E. Rd.,
Chungshan Dist.,
Taipei City 104, Taiwan
Tel: [phone]
Email: [e-mail]