Sometech TRUE EYE User manual

UM42L Rev.1 / Jan,2021
Before using the product, please read this user's manual carefully for
safety, and thoroughly learn how to install and operate before using
the product. ‘This product is a medical device.'

Table of contents
1. Overview................................................................................................................................................................1
2. Intended use.........................................................................................................................................................1
3. Indications..............................................................................................................................................................2
4. Contraindications................................................................................................................................................2
5. Intended user.......................................................................................................................................................2
6. Symbols information..........................................................................................................................................2
7. Warning, Caution, Note....................................................................................................................................4
8. Warnings................................................................................................................................................................4
9. Cautions.................................................................................................................................................................5
10. Electrical safety.................................................................................................................................................5
11. Product Description.........................................................................................................................................6
11.1 TrueEYE Laparoscope...........................................................................................................................6
11.2 Associated equipment.............................................................................................................................9
12. How to use....................................................................................................................................................... 11
13. Archive management method.................................................................................................................. 12
14. Instructions for Reprocessing................................................................................................................... 13
15. Environmental Conditions for Transport/Storage............................................................................. 18
16. Disposal............................................................................................................................................................ 18
17. Warranty and Service.................................................................................................................................. 19

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1. Overview
Sometech TureEYE rigid laparoscopy checks invisible body parts with real-time images at an
appropriate magnification.
It consists of an all-in-one type main unit (camera control unit + light source + recorder) and a 3D camera
head, which are used together to provide 3D images.
The TrueEYE rigid laparoscope should only be used with camera head sold by Sometech.
The TrueEYE rigid laparoscope can be used in Full-HD or UHD (4K) to deliver high-resolution images
depending on the camera head.
(Refer to the compatible product manual).
The TrueEYE Rigid Laparoscope is a tubular optical instrument used to view the internal anatomy of a
patient during laparoscopic procedure.
The TrueEYE rigid laparoscope is designed to provide an internal image of the patient using a
laparoscope, and the laparoscopic surgical procedure for this must be performed by a qualified person.
In all cases, it is best for physicians to use methods that, at their own skill and discretion, determine the
best fit for the patient. Please follow these instructions for proper operation of the machine.
⚫This manual does not describe how to perform actual procedures or teach proper surgical
techniques.
⚫Before performing any procedure, carefully inspect the instrument to ensure that it is properly
maintained, cleaned and sterilized, and is in full operation. If the inspection reveals damage,
do not use the device.
2. Intended use
The TrueEYE laparoscope is used to examine anomalies in organs or tissues in the body and perform
surgeries. The laparoscope is designed to be connected to the 3D camera head to check the image on
the display, and the light output from the light source device is irradiated to the tip of the laparoscope
through the light guide cable.
The TrueEYE Laparoscope is designed for use in general surgery, obstetrics and gynecology, thoracic
surgery, and urology, which clinicians deem appropriate for their patients.

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3. Indications
The laparoscope is designed for use in gynecological and general procedures that doctors deem
suitable for their patients.
The laparoscope is designed for use by surgeons in diagnostic and therapeutic procedures.
Laparoscopy uses include removal of the gallbladder and appendix, hernia correction, gastrointestinal
anastomosis, laparoscopic gastroscopy and examination of the abdominal cavity, appendix, gallbladder
and liver. Using a laparoscope, the surgeon can perform a procedure on the patient's highly obese area
4. Contraindications
There are no known contraindications.
5. Intended user
It should only be used by a medical doctor.
This device should not be used by unqualified personnel who are not trained in endoscopic or
laparoscopic surgery.
6. Symbols information
Symbol
Standard Designation
Number and Symbol
Reference Number
Symbol Title
ISO 7000 - 1641
ISO 15223-1 – 5.4.3
Consult Instructions
IEC 60601-2-18-101
Endoscope
ISO 7000 - 3082
ISO 15223-1 - 5.1.1.
Manufacturer
ISO 7000 - 2497
ISO 15223-1 - 5.1.3
Date of manufacture
ISO 7000-2492
ISO 15223-1-5.1.5
Batch code
ISO 7000-2498
ISO 15223-1 - 5.1.7
Serial Number

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Symbol
Standard Designation
Number and Symbol
Reference Number
Symbol Title
ISO 15223-1 - 5.1.2
Authorized representative in the European
Community
ISO 15223-1 5.2.7
Non-sterile
ISO 7000 - 0434A
ISO 15223-1 - 5.4.4
Caution
ISO 7010-W001
General warning
ISO 7000 0626
ISO 15223-1 – 53.4
Keep Dry
European Community
directive 2002/96/EC & RoHS
Directive 2002/95/EC
EN 50149 – 4.2
waste electrical and electronic equipment, WEEE
ISO 7000 – 0621
ISO 15223-1 – 5.3.1
Fragile, handle with care
ISO 7000 – 0632
ISO 15223-1 – 5.3.7
Temperature Limit
ISO 7000 – 2620
ISO 15223-1 5.3.8
Humidity Limitation
ISO 7000 – 2621
ISO 15223 – 5.3.9
Atmospherics Pressure Limitation
ISO 7000 - 2403
This way up
ISO 7010 – M001
General mandatory action
ISO 7010 – M002
Refer to Instruction Manual/Booklet
IEC TR 60878 – 5333
IEC 60417-5333
Type BF Applied Part

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7. Warning, Caution, Note
Please read this manual carefully and follow the instructions exactly. Words such as warnings,
cautions, and notices contain important content and should be reviewed carefully.
Warning: Indicates a risk to the safety of the patient or user. Failure to follow the warning
may result in injury to the patient or user.
Caution: Denotes a risk of damage to the equipment. Failure to follow the precautions may
damage the product. Note: clarify instructions or provide additional useful information
Note: Provides special information to clarify instructions or present additional useful information
8. Warnings
1.
This laparoscope is provided non-sterile. To prevent infection, clean and sterilize the
laparoscope prior to the first and every subsequent use.
2.
Laparoscopic surgery should only be performed by a person who is well trained in endoscopic
surgical techniques and knows how to use the laparoscope. Before proceeding with
laparoscopic surgery, refer to the medical literature regarding techniques, complications, and
risks involved.
3.
When used with a light source, the temperature around the endoscope light cable and the
distal tip should not exceed 41°C, as this can result in a risk of either burns to the patient or a
fire in the operating room.
How to reduce your risk:
⚫Never let the laparoscope come into direct contact with patient tissue or combustible
materials such as drape or gauze.
⚫Whenever possible, start the procedure with the light source at the lowest setting. If
necessary, gradually increase the light output to the lowest level to ensure adequate
lighting
⚫Turn off the light source and allow the laparoscope to cool before disconnecting.
4.
Do not use the laparoscope as a probe or press the surrounding tissue with the tip of the
laparoscope. The temperature and structure of the laparoscope can damage the patient's
tissue.
5.
Before each use, it is important to check if there are rough edges or protrusions on the outer
part of the laparoscope because, when inserted, these could inadvertently cut or damage the
patient's tissue.
6.
Contact with a rotating shaver or cutting instrument can sharpen the surface of the laparoscope
or cause parts of the laparoscope to break off as it enters the patient's body
7.
Use of laparoscopic equipment and laser equipment together may result in user injury, so users
must wear appropriate equipment for protection.
8.
Failure to use protective filters or suitable filtering spectacles during the activation of a surgical
laser beam may cause eye-damage to the user.
9.
Contact with a surgical laser beam may damage the endoscope surface and internal optics.
10.
During laparoscopic surgery, the image may become too bright and unclear due to the
activation wavelength of the surgical laser beam.

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9. Cautions
1.
This device is restricted and must only be sold by order of a doctor.
2.
Store the laparoscope in a clean, dry place when not in use. The exterior of the laparoscope
is stainless steel and is generally resistant to rust, however rusting cannot be completely
prevented.
3.
Shock, caused by bending or applying pressure to the laparoscope, can damage the lens and
render the laparoscope unusable.
4.
When the light source is on, look only at the distal end of the laparoscope as there is a risk of
eye injury from the light source.
5.
The laparoscope is a precision optical product, so careless handling may damage the product.
Be careful not to drop of heavily impact the laparoscope as this can also damage the
mechanism.
6.
Check instruction manual before each use for this product and any other equipment used with.
10. Electrical safety
1.
The applied part of the equipment used in interconnections conditions with this equipment
must be type BF or CF.
2.
If high-frequency electrosurgical instruments are used, keep the working element always
within the field of view to prevent accidental burns. Always ensure a sufficient distance from
the tip of the scope with conductive accessories before activating the HF output.
3
Avoid direct contact between the laparoscope and the conductive part of the high-frequency
electrode being used.
4
When used with electrodes, the product may be damaged by a high-frequency arc and
damaged fragments of the product may adversely affect the patient. Be careful when using
the laparoscope so as not to damage the laparoscope by keeping the distance between the
laparoscope and the electrode at least 10mm or more.
5
Temporary image interference or loss may occur in contact with or near active electrosurgical
instruments.
If high-frequency surgical interference is observed, adjust the distance between devices.
6
Electrosurgery with monopolar electrodes may interfere with the proper return path or cause
unintended burns as a result of capacitive coupling.
7
When setting the output level of the electrosurgical unit, first set it to a low level and slowly
increase it. If the output is set to a high level from the beginning, the endoscope may be
damaged and cause burns to the operator and patient.
8
Failure to remove the laproscope and laparoscopic accessories during a cardiac defibrillator
discharge may lead to punctured or injured patient tissue.
9
Consult literature for the safe use of electrosurgical equipment.

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11. Product Description
11.1 TrueEYE Laparoscope
Model Name
Direction of view
Working length
Insertion portion width
Tri-00 (10⌀)
0° ± 10°
375mm ± 10%
Ø 10mm ± 10%
Tri-30 (10⌀)
30° ± 10°
375mm ± 10%
Ø 10mm ± 10%

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Distal End
The direction of view is divided into 0° and 30° depending on the intended purpose.
1.
This is a window glass that protects two objective lenses.
2.
A bundle of fiber optics that illuminates light on a subject.

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Marking
1.
Sometech logo-indicates that it is manufactured by Sometech
2.
The marking of ‘TrueEYE’ is the top of the scope.
3.
Direction of view – It is marked as 0° or 30.
4.
Laparoscope eyepiece and camera fastener.
5.
Scope's serial number
6.
Product name
7.
Model name
Scope Eyepiece
1.
This is a window glass to protect the objective lens.
2.
The LED light is transmitted to the distal end through an optical fiber.
3.
It is a 3D camera head fastening part.

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11.2 Associated equipment
MiDAS I Camera control unit
The front panel of the main unit has a touch screen, which provides access to a variety of menus
including controls to adjust light level, zoom, white balance, and more.
*Technical Specifications
Item
Performance
Input Electrical
Ratings
100-240V AC 50/60Hz
Light source
60W White LED Lamp, more than 10x104 Lux
(Manufacturer measurement method)
Color temperature
5200˚K ± 5% (Manufacturer measurement method)
Light Distribution
Degree
65˚± 9˚ (Manufacturer measurement method)
Cooling method
FAN
Light Intensity
Adjustment Method
Step-by-step adjustment by GUI
Protection Type
and Protection Level
Regarding Electric
Shock
Class I, BF applied parts
Video output
HDMI, HD-SDI
Video storage
MPEG4/H.264
Interface
TFT touch LCD
Other interface
Foot switch

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Real endo VLS-200 Camera head
The camera head is connected to the main unit to create 3D images and transmit them to it.
There are several control functions that can be accessed through the button key pad on the top of the
camera head.
*Technical Specifications
Item
Performance
Rated operating
voltage
5V DC
Image sensor
CMOS Full-HD Color
Capture image
JPEG Format
Resolution
1920x1080/60p
Interface
5Key Button

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12. How to use
Precautions for use
1.
You must read carefully this manual and follow correctly the instruction before usage.
2.
This product must be handled by trained person.
3.
This product is not allowed to use any other purpose except original purpose of use.
4.
Clean and sterilize according to'Instructions for Reprocessing' in this product manual.
5.
You make sure that all products connection is firmly connected before inserting scope into
patients’ body.
6.
You should be careful not to exceed the usage time for treatment and diagnosis
7.
If the insufflation instrument is incorrectly positioned during laparoscopic surgery, gas may
penetrate into blood vessels or internal organs, resulting in gas embolism.
8.
As it may cause malfunction, you need to prepare a spare device or consider other procedures.
9.
Personnel responsible for equipment maintenance or safety inspections must have the
necessary qualifications.
10.
There is no guarantee that instruments selected solely using this maximum insertion portion
width and working length will be compatible in combination.
The way of Usage
1.
Correctly connecting the camera control unit and 3D camera Head etc.
2.
Screwing 3D camera and laparoscope on the camera head
3.
Turn on the camera control unit and monitor.
4.
Adjust the video source and the white balance.
5.
Adjust the target distance with 3D alignment jig before inserting the scope in the hole shown
below.
Insert a scope(30 or 0 degree) in the appropriate angle hole.
Control the horizontal & vertical axis with buttons on 3D align function to overlap two cross
lines..

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6.
Inject carbon dioxide (CO2) gas into the abdominal cavity to inflate the tummy (abdomen).
7.
Make an artificial path (hole) in the abdomen with an endoscopic trocar.
8.
Adjusts the light intensity. If possible, start from the lowest level and increase it gradually
9.
Insert the laparoscope connected to the camera head in the trocar.
10.
Focus the camera on the subject and observe the area.
11.
If the display is blurred or foreign bodies are spotted during a surgery, remove the scope from
the trocar, remove foreign substance, and re-insert the laparoscope.
12.
After finishing, slowly remove scope from the patient carefully.
Note
For detailed instructions on how to use the camera control unit and 3D camera head, be
sure to read the separate manual.
13. Archive management method
1.
Remove any residue by wiping with a soft, lint-free cloth or sponge..
2.
Separate the product from associated equipment.
3.
Clean and sterilize immediately after use accordingly to the reprocessing instructions.
4.
Put the product in a case when the product needs relocation.

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14. Instructions for Reprocessing
Sometech has validated that the device can be reprocessed and re-use. However, it is the responsibility of
the person performing the work to ensure that the reprocessing operation is performed using the equipment,
materials, and personnel from the reprocessing facility to achieve the desired results.
This normally requires validation and routine monitoring of the process.
Warnings
⚫This device must be cleaned and sterilized prior to the first use and after every subsequent use.
⚫Use only the sterilization cycles outlined in this manual. Using unspecified sterilization cycles may
damage the device or result in incomplete sterilization and may result in patient cross-
contamination and infection.
⚫Improper cleaning causes device malfunctions, and potential for patient injury
⚫Before cleaning or sterilizing, remove any protective packaging used to protect the laparoscope
during transportation.
⚫Separate the camera head before cleaning or sterilizing. When cleaning, disinfecting, or sterilizing
in the assembled state, the sterility of the product may decrease as the product is separated.
⚫When reprocessing all medical devices, wear appropriate protective equipment such as gloves
and eye protection, etc.
Cautions
⚫Do not use brushes or pads that contain metal or abrasive materials during the manual cleaning
process, as permanent scratches or damage may occur.
⚫To minimize galvanic corrosion, do not wash with other devices.
Limitations on Reprocessing
⚫Using multiple sterilization methods is not recommended as it can significantly reduce the
instrument's performance.
⚫Proper processing has a minimal effect on this device. End of life is normally determined by wear
and damage due to use.
⚫Damage incurred by improper processing will not be covered by the warranty.
⚫Laparoscope is not autoclavable. The autoclave will result in product damage.

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Cleaning procedure
1. Clean for 1 minute under tap water
2. Soak the rigid Laparoscope in detergent1) for 15 minutes.
While submersing, obtain a softbristled brush, dip brush head into solution. Brush debris from the tip until
visibly clean.
3. Rinse thoroughly the device with tap water for 1 minute.
- Check for foreign substances.
(Repeat the cleaning step 2 and step 3 in case there is foreign substanceremain.)
4. Rinse in a purified water for 1 minute.
5. Wipe with a clean dry gauze or lintfree cloth.
1) CIDEZYME Enzymatic Cleaner has proven efficient cleaning agent
Maintenance
⚫Inspect the device on a continual basis. If a problem is observed or suspected, the device should
be returned for repair
⚫Check the laparoscopic insert for cracks, dents, protrusions, or deformations by sweeping your
fingers all the way.
⚫Inspect all components for cleanliness. If liquid or tissue residue remains, repeat the cleaning
procedure above.
⚫Check the tip of the laparoscope for scratches, cracks, stains, or deformation.
[Normal]
[Scratch]
[Crack]

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[Stain]
[Deformation]
⚫Observe the written document at a distance of the working distance from the distal end of the
laparoscope to ensure it is clearly visible, in good focus, and not dark or blurry
Condition of Use (X)
Condition of Use (O)
⚫Inspect the optical surfaces of the laparoscope for clarity. If deposits that need to be removed on
optical surfaces, remove it with a cotton swab soaked in acetone or alcohol.

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⚫Check the equipment used together according to each instruction manual.
1) Check the video image quality through the Test object.
2) As shown in the figure, the image quality inspection is completed only when the two
crosshairs are completely aligned.
Note
When adjusting the alignment, proceed without using 3D glasses (polarizing
glasses).

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Sterilization
Ethylene Oxide (EtO)
After following the cleaning instructions above, perform the following sterilization procedure.
Before sterilization, each device must be double wrapped2) and follow the following criteria.
Preconditioning
Time: 2 hours
Minimum product temperature at chamber: Not less than 10℃
Chamber temperature & Humidity: 55±10℃ , 40 ± 20 % R.H.
Conditioning
Conditioning time: 13 min ± 3 min
Maximum vacuum level: 0.15 bar ± 0.05 bar
Vaporizer temp: 80 ± 5
EO gas/Steam injection pressure: 0.10 bar ~ 2.10 bar
EO gas concentration: 618.97 mg/L (EO: CO2 = 20:80)
Chamber temperature & Humidity: 55±10℃ , 50 ± 20 % R.H.
Exposure
Exposure time: 6 hours
Chamber temperature & Humidity: 55±10℃ , 60 ± 20 % R.H.
Pressure: 2.05bar ± 0.1 bar
Flushing & Aeration
Time: 3 hours
Vacuum Level: 0.2bar ± 1.0bar
2) Sterilization wrap

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15. Environmental Conditions for Transport/Storage
Observe the following environmental conditions fo transport and storage:
⚫Temperature: -20°C to + 60°C
⚫Humidity: 10% to 95%
⚫Pressure: 50kPa to 106kPa
16. Disposal
Disposal of this medical device requires no special measures. Dispose of the device following relevant
national regulations and in accordance with hospital procedures. This device does not contain any
hazardous substances.