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
