Lutech LT-300 SD User manual

LT-300 SD and LT-300 HD
Digital Video Colposcope
Operator’s Manual
Lutech Industries, Inc.
Version 5.2 – 210423

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Table of Contents
Key Information....................................................................................................................................................4
1. Product Information .................................................................................................................................4
2. Manufacturer ............................................................................................................................................4
3. EU Representative....................................................................................................................................4
4. Version......................................................................................................................................................4
5. Markings...................................................................................................................................................4
6. Classification............................................................................................................................................5
7. Support and Maintenance.........................................................................................................................5
7.1 Warranty..................................................................................................................................................5
7.2 After Sales Service..................................................................................................................................6
8. Indication for Use.....................................................................................................................................6
9. Safety Terminology ..................................................................................................................................6
9.1 Hardware.................................................................................................................................................7
9.2 Software..................................................................................................................................................8
Chapter 1: Introduction......................................................................................................................................10
1.1 Scope........................................................................................................................................................10
1.2 Features....................................................................................................................................................10
1.3 System and Main Components ................................................................................................................10
1.4 Installation Preparation............................................................................................................................11
1.5 Unpacking and Inspecting........................................................................................................................12
1.6 Additional Information.............................................................................................................................12
Chapter 2: Camera and Stand Assembly............................................................................................................13
2.1 Camera Composition ...............................................................................................................................13
2.2 What’s included with the Colposcope......................................................................................................13
2.3 Pre-Assembly Check List ........................................................................................................................14
2.3.1 Vertical Stand Parts List.....................................................................................................................14
2.3.2 Swing Arm Stand Parts List...............................................................................................................14
2.4 Colposcope with Vertical Stand Assembly ..............................................................................................14
2.5 Colposcope with Swing Arm Stand Assembly .........................................................................................21
2.6 Troubleshooting ........................................................................................................................................26
2.6.1 Vertical Stand Assembly Troubleshooting .........................................................................................26
2.6.2 Swing Arm Stand Assembly Troubleshooting ...................................................................................28
2.7 Tips and Suggestions ...............................................................................................................................29
Chapter 3: Colposcope Adjustments..................................................................................................................31
3.1 Camera Angle Adjustment .......................................................................................................................31
3.2 Vertical Stand Adjustment........................................................................................................................31
3.3 Swing Arm Stand Adjustment..................................................................................................................32
3.4 Casters Adjustment ...................................................................................................................................32

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3.5 Remote Hanger ........................................................................................................................................33
Chapter 4: TV Screen or Workstation Setup......................................................................................................34
4.1 TV Screen Setup ......................................................................................................................................34
4.2 Computer Setup .......................................................................................................................................35
4.2.1 Connecting the Colposcope to a Computer........................................................................................35
4.3 Colposcope Workstation ...........................................................................................................................37
Chapter 5: Camera Operation ............................................................................................................................38
5.1 Preliminary Check List ............................................................................................................................38
5.2 Function Buttons......................................................................................................................................38
5.3 Tips for Achieving Optimal Image Clarity ..............................................................................................39
Chapter 6: Lutech Viewer ..................................................................................................................................41
6.1 Safety Safety Terminology.......................................................................................................................41
6.1.1 WARNING.........................................................................................................................................41
6.1.2 NOTE................................................................................................................................................41
6.1.3 Copyright ...........................................................................................................................................41
6.2 Installation ................................................................................................................................................41
6.2.1 Computer Specification Requirements ..............................................................................................41
6.2.2 Downloading the Software ................................................................................................................42
6.2.3 Installing the Software .......................................................................................................................42
6.3 Operation ..................................................................................................................................................44
6.3.1 Main Screen.......................................................................................................................................44
6.3.2 Session Window.................................................................................................................................46
6.3.3 Foot Pedal ..........................................................................................................................................46
6.3.4 Full Screen Mode...............................................................................................................................47
6.3.5 Picture Review...................................................................................................................................47
6.3.6 Video Review.....................................................................................................................................48
6.3.7 End Session........................................................................................................................................48
6.3.8 Test Session........................................................................................................................................48
6.4 Lutech Viewer Troubleshooting................................................................................................................48
6.4.1 Video Source Troubleshooting...........................................................................................................48
6.4.2 Foot Pedal Troubleshooting ...............................................................................................................49
6.4.3 Display Troubleshooting....................................................................................................................49
6.4.4 Saving Files Troubleshooting ............................................................................................................50
6.5 Folder Naming Structure...........................................................................................................................50
6.6 Picture and Video Naming Structure.........................................................................................................51
Chapter 7: Cleaning and Maintenance...............................................................................................................52
7.1 Cleaning...................................................................................................................................................52
7.1.1 Cleaning the colposcope enclosure and vertical stand .......................................................................52
7.1.2 Cleaning the colposcope cables .........................................................................................................52
7.1.3 Cleaning the lens, mini LCD screen, and the LED circular light.......................................................53

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7.2 Maintenance.............................................................................................................................................53
7.3 Battery......................................................................................................................................................54
7.4 Storage .....................................................................................................................................................54
7.5 Transportation ..........................................................................................................................................55
7.6 Device Disposal .......................................................................................................................................55
Chapter 8: Troubleshooting................................................................................................................................56
8.1 Troubleshooting .......................................................................................................................................56
Appendix A– Specification.................................................................................................................................58
I. Power Supply/Adapter................................................................................................................................58
II. Battery.......................................................................................................................................................58
III. Grounding ................................................................................................................................................58
IV. Environmental Specifications ..................................................................................................................58
V. Colposcope Specifications.........................................................................................................................59
VI. Monitor....................................................................................................................................................60

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Key Information
NOTE: Unless specifically noted for one or the other, the following information is true for
both the LT-300 SD and the LT-300 HD digital video colposcopes.
1. Product Information
Model:
LT-300 SD
LT-300 HD
Product:
Digital Video colposcope
Digital Video colposcope
Applied
Part:
None. Product does not come
into contact with patient.
None. Product does not come into
contact with patient.
Electrical
Class
Class I
Class I
2. Manufacturer
Lutech Industries, Inc.
105 Remington Blvd., Suite C, Ronkonkoma, NY 11779, U.S.A.
T: (631) 676 – 7432
F: (631) 619 – 0723
www.lutechmedical.com
[email protected]
3. EU Representative
Arazy Group GmbH
The Squaire 12, Am Flughafen,
60549 Frankfurt am Main
Deutschland
Tel: [phone]
Fax: [phone]
4. Version
This instruction for use will update without notice.
Version: 5.1
Copyright: © 2021 Lutech Industries, Inc.
5. Markings
The following marks are included on the product:
Mar
k
Description

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Protect Against
Water
Fragile Contents
Manufacturer
Serial Number
Rx Only
6. Classification
The following is the classification information:
7. Support and Maintenance
7.1 Warranty
Lutech warrants The LT-300 SD and LT-300 HD digital video colposcopes, when new, to be free of defects
in material and workmanship and to perform in accordance with manufacturer's specifications for a period of
one year commencing on the date of purchase from Lutech or its authorized distributors. Extended warranty
is available. Please ask a Lutech representative or your representative for more information. Lutech, or its
authorized distributor, service center, or agents (collectively, “Repair Center”), will either repair or replace
any components found to be defective or operating outside of manufacturer's specifications within the
warranty period at no cost to the customer. It shall be the purchaser's responsibility to return the colposcope
to the Repair Center. This warranty does not cover breakage or failure due to improper use, modification,
neglect, accidents, or shipping damage. In Addition, this warranty is also void if the instrument is not used in
accordance with the instruction manual or if repaired by someone other than a Lutech Repair Center.
Purchase date determines warranty requirements. No other express warranty is given. Please keep the
packaging material for future transportation and/or storage needs.
WARRANTY LIMITATIONS: THE DURATION OF ANY IMPLIED WARRANTY OR CONDITION, OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR OTHERWISE, ON THIS PRODUCT
Classification Principle
Classification
Type of protection against electric
shock.
Class I
Degree of protection against electric
shock.
Type B
Mode of operation
Continuous operation
Degree of protection against ingress of
water.
Normal device.
Degree of safety in the presence of a
flammable anesthetic mixture with air,
oxygen or nitrous oxide.
Non AP or APG equipment
Type of management
Type II. Classification code 6822

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SHALL BE LIMITED TO THE DURATION OF THE EXPRESS WARRANTY SET FORTH ABOVE. IN NO
EVENT SHALL LUTECH BE LIABLE FOR ANY LOSS, INCONVENIENCE OR DAMAGE, WHETHER
DIRECT, INCIDENTAL, CONSEQUENTIAL OR OTHERWISE, RESULTING FROM BREACH OF ANY
EXPRESS OR IMPLIED WARRANTY OR CONDITION, OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR OTHERWISE WITH RESPECT TO THIS PRODUCT, EXCEPT AS SET
FORTH HEREIN.
7.2 After Sales Service
The standard warranty for the LT-300 SD and LT-300 HD colposcopes is 1 year from the date of purchase.
Warranties may vary from 1-3 years depending on purchase terms. Please ask your Lutech representative
or distributor for more details.
Please contact Lutech if you need technical support or service.
Lutech Industries, Inc.
105 Remington Blvd., Suite C
Ronkonkoma, NY 11779
[phone]
[email protected]
Service hours: 9:00 AM – 5:00 PM EST
Not including holidays or weekends.
Before calling the manufacturer, distributor or authorized service center, please have the following
information on hand:
•Product model number
•Product serial number
•Detailed issue with the product (including how to replicate the issue if available).
Alternatively, you can visit www.lutechmedical.com and fill out a service request form to obtain an RMA
number.
Warranty is not covered if:
•The colposcope frame has been opened or tampered with in any way.
•The damage is caused by misuse, physical damage, or carelessness.
•The damage is caused by lack of proper maintenance.
•The damage is caused by maintenance or repair made by unapproved persons or companies.
•The damage is done by unstable voltage.
•The damage is done by natural disasters.
8. Indication for Use
The LT-300 SD and LT-300 HD digital video colposcopes are intended for the magnified viewing of the
vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas
for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private
offices, and not intended for home use.
9. Safety Terminology
The terms “WARNING”, “CAUTION” and “NOTE” are used throughout this manual to point out hazards and
to designate a degree or level of seriousness. Familiarize yourself with their definitions and significance.
CONTRAINDICATIONS: Contraindications indicate a circumstance where the equipment is absolutely
forbidden for use.
WARNING: Warnings indicate a potential hazard or unsafe practice which, if not avoided, could result in
death or serious injury.

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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 (55C) 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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difficulties in ensuring electromagnetic compatibility in other environments because of both conducted and
radiated disturbances.
•Electromagnetic fields may interfere with the normal function of the system. Therefore, make sure that the
external device complies with EMC requirements. X-ray machine or magnetic resonance devices may possibly
cause interference, because they can produce high intensity electromagnetic radiation.
CAUTION:
•Federal law restricts the sale of this device to, or by the order of, a physician or other licensed medical
professional.
•Without the written approval of the manufacturer, user shall not remove or modify the colposcope or any of its
attachments and accessories. Nor shall the user use any accessories which do not comply with the
manufacturer’s requirements.
•When not in use, the colposcope should be turned off and the camera should be covered to prevent dust
accumulation.
•To prevent accidental power failure and other potential accidents, use UPS (uninterruptible power source)
systems with the colposcope.
•Do not disconnect from AC power without first turning the camera and the power box off or you may damage the
camera or power box components.
•Do not disconnect any cables without first turning the camera and the power box off or you may damage the
camera or power box components.
•Do not use the device with other electrical devices.
•Keep cellular phones and other communication devices away from the colposcope.
•If the user suspects that the colposcope is not functioning properly, please contact Lutech for support.
•To ensure safe usage of this device, please follow all instructions contained within this manual. The information
contained is not a substitute for current medical requirements and/or regulations. The manual cannot replace
actual experience of a doctor or nurse.
•Always take notice of the warnings, cautions and notes provided throughout this manual.
•Do not use strong solvents such as acetone to clean any part of the colposcope.
•Do not use abrasive materials (such as steel wool) to clean the colposcope.
•Do not leave any solvent residue on the device. If residue is present, wipe it off quickly with a cloth damp with
distilled water. Then pat dry with a dry cloth.
•The outer shell of the colposcope may not be opened by anyone other than a trained Lutech technician/engineer
or a Lutech approved technician/engineer. Approval from Lutech must be obtained in writing and signed by the
Management. Opening the outer shell of the colposcope without proper training may put the person in risk of an
electrical shock.
NOTE:
•Video colposcope is not a treatment device. It is a non-contact examination device. Use only as directed.
•This manual should be placed near the device for easy user reference. Read the manual thoroughly before
using the device to ensure proper operation and safety.
•Assembly and disassembly of the colposcope should only be performed by trained and authorized personnel.
•The lens of the camera should always be covered when not in use.
•The LT-300 SD and LT-300 HD digital video colposcopes meet the requirements of the electromagnetic
compatibility in IEC60601-1-2.
•Portable and mobile RF communication devices should be kept away from The LT-300 SD and LT-300 HD digital
video colposcopes as it may influence performance.
•A colposcope examination is only a secondary means of examination and the results found through colposcopy
are not the end result. Other tests should be conducted to determine the result, ultimately confirming a diagnosis.
•Colposcope lenses are precision optical instruments and must be handled with care. Gently use the colposcope
and avoid collision with anything that may move the lens. Offsetting the lens would result in a deterioration of the
image quality.
•Avoid using the colposcope in bright environments as it will decrease image quality.
•When using the colposcope, stay away from RF lines whenever possible. This includes audio or video sources.
•If the power is suddenly turned off during normal use, it will not injure the operator or the patient. Please follow
the user manual to properly power off the device. When power is restored, operate the equipment normally in
accordance with the user manual.
•Removable power cables that are not part of the original system or additional extension cords should not be
used with the colposcope.
9.2 Software

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NOTE:
•The LT-300 SD and LT-300 HD digital video colposcopes can be used with various viewing or video editing
software. It is the end user’s responsibility to choose the software that works best for them as well as complies
with all regulatory requirements within their territory.
•The LT-300 SD and LT-300 HD may also be integrated into telemedicine and hospital EMR software systems as
an add on hardware device depending on their software. In most cases, the colposcopes will work with any
software that allows video input and file attachments.