STC SC-1001A User manual

World First handheld 4.3 inch Touch Screen
Display Portable Otoscope
SC-1001A/AR Quick Guide

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1. Safety and Declaration of Conformity ................ 02
1-1. Safety Considerations
1-2. Declaration of Conformity
2. Instruction ............................................................ 03
2-1. Intended Use
2-2. Intended User Profile
2-3. Intended Patient
2-4. Environments
2-5. Warnings and Precautions
3. Name and Function of Each Part ....................... 04
4. Operation and Maintenance .............................. 04
4-1. Quick Guide For Use
4-2. Pictures and Video Files Output by Connecting to a PC
4-3. Battery Charge
4-4. Care and Maintenance
5. Troubleshooting Section ..................................... 10
6. Specifications ..................................................... 11
7. Electromagnetic Compatibility (EMC) Tables ..... 12
8. Warranty and Service Program ........................... 13

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.
1. Safety and Declaration of Conformity
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 reminds the user should read instruction/manual carefully
before operating this device.
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.
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This symbol means the manufacturer.
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.
To identify the product’s serial number.
EC REP

SN
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

2. Instruction
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2-1. Intended Use
2-2. Intended User Profile
2-3. Intended Patient
2-4. Environment
The Portable 4.3” TP ENT Endoscope is primary designed for ease of use and portability, enabling
ENT (ear, nose, throat) medical inspection operations to be possible to be carried out in areas
where no fixed power source is available.
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.
This device is intended for a licensed professionals trained in ENT Scopy.
Intended operator: any operator (mild reading vision impairment or vision corrected to log MAR 0.2
(6/9.5 or 20/32)) with minimum of 8 years of education. Person diagnosed by a doctor with
unhealthy mental status is not allowed to use the device.
This product does not apply to children under 12 years old.
– Indoor use only
– Physical :
• Temperature range: 10 °C to +50 °C.
• Relative humidity range: 30 % to 80 %, noncondensing.
• Ambient pressure range: 700hPa~1060hPa.
• Warm-up Time not required particularly.
2-5. Warnings and Precautions
Do not use this device in explosive environments such as where flammable anesthetics exit or inside
an oxygen chamber with strong electronic and electromagnetic fields e.g., mobile phones.
• Use only provided AC 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.
• Do not use probe cover, battery other than it included with this device or replacement parts supplied by
the manufacturer.
• 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.
• No modification of this equipment is allowed.
• This device and accessories should not be used adjacent to or stacked with other equipment.
• Do not use this device while it is charging.
• Recharge the battery every 3 months to maintain the battery if this device is not likely to be used for
some time.
• Do not attempt to disinfect this device using glutaraldehyde products, ethylene oxide gas, steam
or any other liquid or gas disinfectant.
• If there is any other problem, please consult or return the device to your dealer/distributor. Do not try
to repair a defective device.
• This device is for medical practitioner or medical trained personnel use only.
• This device may seriously be damaged after the device is dropped and the probe end hits the ground.
• 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.
• To fully disengage the power, please disconnect the AC adaptor from the power outlet.
• Do not position the AC inlet to a position where it is difficult to disconnect the device.
• Follow national requirements to dispose of the device.
WARNING
CAUTION

3. Name and Function of Each Part
* Only compatible with the enclose type C cable.
*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.
1
2
3
4
5
6
7
8
Snap/ Record
Charger (Type C connector)
SD card slot/ Reset key
Power on/ off
1
2
3
4
Probe
Battery Cover
Reset key
SD card slot
5
6
7
8
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4. Operation and Maintenance
4-1. Quick Guide for Use
1. Before using the device, make sure the probe
cap is removed.
2. Make sure the lens in front of the end is clean.
* Clean the lens by using a soft cloth.
3. Attach the disposable probe cover by pushing
onto the probe end. Reverse procedure to
remove and discard after each use.

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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 will be pop up after Power on.
Power on/ off
Preview
1. Preview mode
2. Display
・Snapshot
・Battery capacity
・Zoom in/out (x1, x1.5, x2, x2.7 & x4)
・Playback
・Date/Time
Zoom in/out
Touch Zoom in/out icon to adjust the zoom
(x1, x1.5, x2, x2.7 & x4).
LED on/off
Touch the icon of LED on/off to switch LED on probe.
Video Record
・  Long press snap button on the handle for
video recording. Recording icon shown
on the left of screen.
・  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.
ON
OFF
Take Pictures
Press snap button on the handle once for still
image.
The flash once snapshot is ready.
ON
ON
ON
ON

Photo playback & delete
・When a picture is under playback mode, you can
scroll the picture up/down by touching the left
side of screen. You may see the page up/down
icon / shown up for selection.
・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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4. Operation and Maintenance
Playback
・Touch on the home page.
・Select folder by touching screen.
・Touch 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.
・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.
・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.
Page up
Page down








 
 
Set up
1. Saturation adjustment
2. Contrast adjustment
3. Sharpness adjustment
4. Language/ Date/ Time/ Battery Power Saving/ Reset
5. White Balance correction.
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Saturation
1. Select or to up or down level.
2. Enter
Sharpness
1. Select or to up or down level.
2. Enter
Backlight
1. Select or to up or down level.
2. Enter
Language/ Date/ Time
1. Battery Power saving mode
2. Date/ Time
3. Language Selection English/ Simplified Chinese)
4. Reset setting
White Balance
Select the white balance, will appear on the left
upper screen and indicate automatic correction is
on.
Power Saving Mode
1. Standby: The screen will be automatically off after
1min, 5min or 10min without any operation.
2. Shutdown : The device will be automatically
shutdown after 5min, 10min or 30min without any
operation.
3. Select "Off" for non "Power-Saving Mode"
* Touch the screen or press any button to wake up
the device. The default standby time is 5min.
AWB
SATURATION
SHARPNESS
BACKLIGHT
AWB
AWB


Standby ( Turn off LED & LCD )
1min 5min 10min off
Shutdow
5min 10min 30min off

Turn off the device
Long press " Power " button until " Goodbye " shown
on the LCD screen and release the button to turn off
the device.
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.
简

 
 
 
 
Setting Reset
Press to reset Saturation, Contrast,
Brightness and Battery Saving to default.
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4. Operation and Maintenance
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
To PC

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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 once the LED light 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.
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.
4-4. Care and Maintenance
a. No calibration is needed. Even components exceed the life limitation, there is no
aging problem.
b. The device requests routine cleaning and inspection.
c. Use a dry cloth to clean the device. Do NOT use any organic solvent (for example:
antiseptic solution, etc.) to clean the device.
d. Do NOT immerse the device in any liquid or subject to steam sterilization.
e. Use a 75% alcohol cotton to clean the tip of probe or attach the included disposable
probe cover before operating the device.
f. Always switch off the device when not use it in short period of time.
g. The device is not user-serviceable and should never be disassembled.
h. To order any replacement parts, contact the nearest dealer.
i. 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
type C type A
AC outlet

5.7
5.1
5.2
5.3
5.4
5.5
5.6
5. Troubleshooting Section
Micro SD card is not inserted into the
device properly.
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Problem Solution
No Snap and record functions. Preview
function only.
Improper Operation. It is NOT allowed to remove the SD
card during snapping or recording
Device shuts down or power off
automatically while in playback
mode.
Cause: Micro SD card might be damaged
Solution:
・Connect the device to PC first.
・Check the SD card files from PC and
delete the bad files which show zero file
capacity.
・Format the SD card, please be sure to
backup files before formatting.
The device cannot be turned on
・Make sure the battery is fully charged
before starting up the device.
・Check and confirm.
The image is fuzzy
・Make sure no dust or scratch in front
of the camera.
・Check if LED light level has been
adjusted to the suitable brightness.
The function buttons can’t be
controlled
・Check and confirm the buttons can
be pressed and depressed easily.
・Restart the device and try the function
buttons again.
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 the device with USB
adapter again to check if the
charging status LED is on or not.
・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.

6. Specifications
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ITEM
Camera resolution
Frame Rate
Light Source
Lens
Field of View (FoV)
Lens F/No
Depth of Field (DoF)
Control system
Function Buttons
Output Interface
Display
Display resolution
Auto Exposure Control (AEC)
White Balance
Image Format
Video Format
Storage
Battery
Operating Temperature / Humidity
Storage / Transportation environment
Atmospheric pressure
DESCRIPTION
720P CMOS sensor, default 960 x 720
30fps
LED x 4pcs
Fixed Focus
85°
F 4.0± 5%
5mm~50mm
Power / Snap / Record / Reset
SD card slot / USB2.0 Mass Storage
4.3” TFT-LCD + CTP
RGB 800 x 480
Auto
Manual
JPEG
MOV
Built-in 16 GB Micro SD card
3.6V, 3350mAh rechargeable lithium battery
10°C ~ +50°C (±10%) / 30% RH ~ 80% RH
-20°C ~ +60°C (±10%) / 20% RH ~ 90% RH
700-1060
UI features Preview / Playback / LED / Zoom /
Setting mode / Battery saving

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-existence of all other medical devices.
The Portable 4.3” TP ENT Endoscope series is intended for use in the electromagnetic environment
specified below. The customer or the user of the Portable 4.3” TP ENT Endoscope series should assure
that it is used in such an environment.
・
Guidance and manufacturer’s declaration – electromagnetic immunity
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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
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
Portable and mobile RF communications equipment
should be used no closer to any part of the Portable
4.3” TP ENT Endoscope series, 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 is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommend-
ed 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 :
*Note1 : Applicable Limits: For radiated emissions at frequencies up to 1GHz (Class A, Group 1/2) & up
to 1GHz (Class B, Group 1/2).
*Note2 : 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 Portable 4.3” TP ENT Endoscope series is used exceeds the applicable RF
compliance level above, the Portable 4.3” TP ENT Endoscope series should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the Portable 4.3” TP ENT Endoscope series.
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 Portable 4.3” TP ENT Endoscope series is intended for use in the electromagnetic environment
specified below. The customer or the user of the Portable 4.3” TP ENT Endoscope series should assure
that it is used in such an environment.

8. Warranty and Service Program
The Portable 4.3” TP ENT Endoscope series is warranted against any defects in materials and
workmanship under normal use and service as follows:
1. Warranty extends to the original retail purchaser.
2. The entire Portable 4.3” TP ENT Endoscope series 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-1001A/AR
Name: _______________________ Address: __________________________________
Dealer’s Name: _______________________ Date of Purchase: _____________
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Immunity test IEC 60601 test level Compliance level Electromagnetic environment –
guidance
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 %.
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 Portable
4.3” TP ENT Endoscope series requires
continued operation during power mains
interruptions, it is recommended that the
Portable 4.3” TP ENT.
Endoscope series be powered from an
uninterruptible power supply or abattery.
*NOTE UT is the a.c. mains voltage prior to application of the test level.
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.

SHINCHI TECHNOLOGY CORP.
11F., No.37, Sec.3, Minquan E. Rd.,
Chungshan Dist., Taipei City 104, Taiwan
TEL : [phone]
FAX : [phone]
E-mail : [email protected]
www.shinchitech.com