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CAUTION: Cautions indicate a potential hazard or unsafe practice which, if not avoided, could result in
minor personal injury or product damage.
NOTE: Notes provide application tips or other useful information to assure the best possible user
experience.
9.1 Hardware
CONTRAINDICATIONS:
There are no known contraindications.
WARNING:
• Please confirm the imaging system is in normal working condition before operation.
• Check all cables before use. Take notice to avoid cables intertwining on the neck of patient and replace any bad
cables and connectors immediately.
• The device can only be used on one patient at a time.
• The device must be grounded to avoid short circuiting the system.
• The device should only be used in the correct patient environment.
• Colposcope must be powered off and disconnected from AC power before cleaning.
• Keep the camera away from extreme humidity. During operation, avoid splashing any liquid near the colposcope.
If liquid is splashed onto the colposcope, it may cause the device to malfunction.
• Never place the camera in an environment where the temperature is higher than 131°F (55C) or under direct
high temperature radiation of thermal therapeutic or microwave devices.
• This device is not meant to be in contact with the patient. Please avoid contact between the device and the
patient during use.
• Make sure the power cord is properly plugged into a power socket with proper ground protection.
• Any peripheral electronics attached to the video colposcope (i.e. monitor, computer, etc.) should comply with IEC
60601-1 (General Requirements for Safety, Medical Electrical Equipment) or other relevant IEC standards
depending on the type of peripheral device used.
• The device should only be connected to parts and accessories that are supplied by Lutech. Lutech cannot
assure the safety of the device when used in conjunction with an unapproved part or accessory. Lutech cannot
assure the safety of the unapproved device that is being connected to The LT-300 SD and LT-300 HD digital
video colposcopes.
• Always turn the colposcope off first before plugging in or unplugging the video cable.
• Never stare at the lights around the lens.
• At any point during the use of the colposcope, if any liquid gets splashed onto the outer casing or the lens of the
colposcope, immediately stop using the device and wipe the liquid off. Please follow the instructions set forth in
chapter 6 of the manual under Cleaning and Maintenance.
• At any point during the use of the colposcope, if any liquid gets splashed onto the colposcope and gets inside the
casing, please turn off the colposcope right away and call your technician or the manufacturer. The device
should be checked by an authorized technician to make certain it is working accurately before being put back to
use.
• Do not attempt to immerse any part of the equipment in cleaning solutions.
• Do not let any liquid enter the inner casing of the camera. If water enters the inner casing of the camera, call
your technician or service center for assistance.
• Do not immerse the cable into any liquid or let any liquid touch or enter the electrical connection portions of the
cable.
• Always disconnect the colposcope from any power source before disassembling any
components or parts.
• The colposcope should always be operated by trained and authorized medical personnel
and according to the requirements of the Operator’s Manual. For any questions or
concerns, please contact the manufacturer or authorized repair/service center.
• Do not use product in anesthetic, flammable and explosive environments due to potential
fires or explosions.
• The LT-300 SD and LT-300 HD digital video colposcopes should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the user must be alert and monitor The LT-300 SD and LT-
300 HD digital video colposcopes to verify it is operating within the manufacturer standards.
• The LT-300 SD and LT-300 HD digital video colposcopes are class I equipment and is intended for use in a
hospital or medical office environment. The LT-300 SD and LT-300 HD digital video colposcopes can encounter
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