olympus_4k_camera_head_ch-s400-xz-eb_operation_manu.pdf
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OPERATION MANUAL
INSTRUCTIONS
4K CAMERA HEAD
Labels and Symbols
1
Important Information — Please Read Before
Use
3
Chapter 1
Checking the Package Contents
13
Chapter 2
Instrument Nomenclature and
Functions
15
Chapter 3
Preparation and Inspection
17
Chapter 4
Operation
29
Chapter 5
Troubleshooting
37
OLYMPUS CH-S400-XZ-EB
Appendix
41
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Refer to the camera head’s companion manual, the “REPROCESSING MANUAL” with your
camera head model listed on the cover, for reprocessing information.
Page 3
Contents
Contents
Labels and Symbols .......................................................................................................... 1
Important Information — Please Read Before Use ......................................................... 3
Intended use .......................................................................................................................... 3
Contraindications ................................................................................................................... 3
Applicability of endoscopy and endoscopic treatment ........................................................... 3
Instruction manual ................................................................................................................. 4
User qualifications ................................................................................................................. 4
Instrument compatibility ......................................................................................................... 5
Reprocessing before the first use/reprocessing and storage after use ................................. 5
Spare equipment ................................................................................................................... 5
Maintenance management .................................................................................................... 5
Prohibition of improper repair and modification ..................................................................... 6
Classification of laser product ................................................................................................ 6
Signal words .......................................................................................................................... 6
Precautions ............................................................................................................................ 7
Precautions for disappeared endoscopic image ................................................................... 11
Chapter 1 Checking the Package Contents ....................................... 13
1.1
Checking the package contents ............................................................................ 13
Chapter 2 Instrument Nomenclature and Functions ......................... 15
2.1
Nomenclature and functions ................................................................................. 15
Chapter 3 Preparation and Inspection ................................................ 17
3.1
The workflow of preparation and inspection ....................................................... 17
3.2
Preparation of the equipment ................................................................................ 19
3.3
Inspection of the camera head .............................................................................. 20
3.4
Inspection of ancillary equipment ........................................................................ 21
3.5
Connection of the camera head and ancillary equipment .................................. 22
Connection to the camera control unit ................................................................................. 22
Connection to the endoscope .............................................................................................. 24
3.6
Functionality inspection of ancillary equipment connected to
the camera head ..................................................................................................... 25
Inspection of the ancillary equipment ..................................................................................
Inspection of the endoscopic image ....................................................................................
Inspection of the remote switches .......................................................................................
Inspection of the one touch auto focus ................................................................................
Inspection of the manual focus ............................................................................................
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25
26
26
28
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Contents
Chapter 4 Operation ............................................................................. 29
4.1
Precautions ............................................................................................................. 29
4.2
Focus adjustment ................................................................................................... 31
One touch auto focus adjustment ........................................................................................ 32
Manual focus adjustment ..................................................................................................... 32
4.3
Positioning the endoscopic image ....................................................................... 33
4.4
Color adjustment .................................................................................................... 33
4.5
Observation of the NBI image ............................................................................... 34
4.6
Disconnection from the endoscope ...................................................................... 35
4.7
Transporting outside the hospital ......................................................................... 36
Chapter 5 Troubleshooting .................................................................. 37
5.1
Troubleshooting ..................................................................................................... 37
5.2
Troubleshooting guide ........................................................................................... 38
5.3
Withdrawal when any irregularity is observed .................................................... 39
5.4
Returning the camera head for repair ................................................................... 40
Appendix ................................................................................................. 41
Combination equipment .................................................................................................. 41
System chart ........................................................................................................................ 41
Specifications ................................................................................................................... 44
Environment ........................................................................................................................ 44
Specifications ....................................................................................................................... 44
EMC information .............................................................................................................. 46
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Labels and Symbols
Labels and Symbols
Safety-related labels and symbols are attached to the camera head at the locations shown below. If
labels or symbols are missing or illegible, contact Olympus.
Symbol
Description
Refer to instructions.
Caution
Manufacturer
Authorized representative in the European Community
Serial number
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Labels and Symbols
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Model name plate
Caution
Caution related to drying the video connector is displayed.
Model name plate
Caution
7512345
Rear side
Refer to instructions.
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Important Information — Please Read Before Use
Important Information — Please Read Before Use
Intended use
The camera head has been designed to be used with Olympus endoscopes, camera control unit, and
other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Contraindications
As a TYPE BF piece of electro-medical equipment, the endoscope attached to this camera head must
never be applied directly to the heart. Leakage current from TYPE BF equipment may be dangerous
and cause ventricular fibrillation or seriously affect the cardiac function of the patient. Accordingly,
always adhere to the following points:
Never apply the connected endoscope to the heart or an area near the heart.
Never allow an accessory or another endoscope, which is in contact with the heart (or an
area near the heart), to contact an endoscope connected to the camera head.
Applicability of endoscopy and endoscopic treatment
If there are official standards on the applicability of endoscopy and endoscopic treatment that are
defined by the hospital’s administrations or other official institutions, such as academic societies on
endoscopy, follow those standards. Before starting endoscopy and endoscopic treatment, thoroughly
evaluate its properties, purposes, effects, and possible risks (their nature, extent, and probability).
Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its
risks.
Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment
as well as any examination/treatment methods that can be performed in its place, and perform the
endoscopy and endoscopic treatment only after obtaining the consent of the patient.
Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential
benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the
risks to the patient become greater than the potential benefits.
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Important Information — Please Read Before Use
Instruction manual
This instruction manual contains essential information on using this instrument safely and effectively.
Before use, thoroughly review this manual and the manuals for all equipment that will be used during
the procedure and use the equipment as instructed.
Note that the complete instruction manual set for this camera head consists of this manual and the
“REPROCESSING MANUAL” with your camera head model listed on the cover. It also accompanied
the camera head at shipment.
Keep this and all related instruction manuals in a safe, accessible location.
If you have any questions or comments about any information in this manual, contact Olympus.
Terms used in this manual
NBI (Narrow Band Imaging) observation:
This is observation using narrowband light.
WLI (White Light Imaging) observation:
This is observation using white light.
Image sensor:
Image sensor is a device that converts light into electrical signals.
User qualifications
If there are official standards for user qualifications to perform endoscopy and endoscopic treatment
that are defined by the hospital’s medical administrators or other official institutions, such as academic
societies on endoscopy, follow those standards. If there are no official qualification standards, the
operator of this instrument must be a physician approved by the medical safety manager of the
hospital or person in charge of the department.
The physician should be capable of safely performing the planned endoscopy and endoscopic
treatment following guidelines set by the academic societies on endoscopy, etc., and considering the
difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic
procedures.
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Important Information — Please Read Before Use
Instrument compatibility
Refer to the “Combination equipment” on page 41 to confirm that this instrument is compatible with the
ancillary equipment being used. Using incompatible equipment can result in patient or operator injury
and/or equipment damage.
This instrument complies with the EMC standard for medical electrical equipment, edition 2
(IEC 60601-1-2: 2001) and edition 3 (IEC 60601-1-2: 2007).
Reprocessing before the first use/reprocessing and
storage after use
This instrument was not reprocessed before shipment. Before using this instrument for the first time,
reprocess it according to the instructions given in the camera head’s companion “REPROCESSING
MANUAL” with your camera head model listed on the cover.
After using this instrument, reprocess and store it according to the instructions given in the camera
head’s companion reprocessing manual. Improper and/or incomplete reprocessing or storage can
pose an infection control risk, cause equipment damage, or reduce performance.
Spare equipment
Be sure to prepare another camera head to avoid interruption of the examination due to equipment
failure or malfunction.
Maintenance management
The probability of failure of the camera head and ancillary equipment increases as the number of
procedures performed and/or the total operating hours increase. In addition to the inspection before
each procedure, the person in charge of medical equipment maintenance in each hospital should
inspect the items specified in this manual periodically following regulations, guidelines, etc. required of
you. A camera head with an observed irregularity should not be used, but should be inspected by
following Section 5.2, “Troubleshooting guide”. If the irregularity is still observed after inspection,
contact Olympus.
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Important Information — Please Read Before Use
Prohibition of improper repair and modification
This camera head does not contain any user-serviceable parts. Do not disassemble, modify, or attempt
to repair it; patient or operator injury and/or equipment damage may result.
Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than
Olympus’ own authorized service personnel is excluded from Olympus’ limited warranty and is not
warranted by Olympus in any manner.
Classification of laser product
This camera head is CLASS 1 LASER PRODUCT in combination use with the camera control unit
OTV-S400.
Signal words
The following signal words are used throughout this manual.
DANGER
Indicates an imminently hazardous situation which, if not avoided, will result in
death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided, may result in
minor or moderate injury. It may also be used to alert against unsafe practices
or potential equipment damage.
NOTE
6
Indicates additional helpful information.
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Important Information — Please Read Before Use
Precautions
Follow the dangers, warnings, and cautions given below when handling this camera head. This
information is to be supplemented by the dangers, warnings, and cautions given in each chapter.
DANGER
• Failure to adhere to the following precautions may place the patient and medical
personnel in danger of an electric shock.
When this camera head is used to examine a patient, do not allow the metal
parts of the endoscope or its accessories to touch metal parts of other system
components. This camera head is electrically connected to metal parts of other
system components, and contact may cause unintended current flow to the
patient.
Do not prepare, inspect, or use this camera head with wet hands.
• Never install and/or operate the camera head under the following conditions. An
explosion or a fire could occur.
The concentration of oxygen is high.
Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere.
Flammable anesthetics are present in the atmosphere.
Flammable liquids are near.
WARNING
• After using this camera head, reprocess and store it according to the instructions
given in the camera head’s companion “REPROCESSING MANUAL” with your
camera head model listed on the cover. Using improperly or incompletely
reprocessed or stored instruments may cause patient cross-contamination and/or
infection.
• This camera head may interfere with other medical electronic equipment used in
combination with it. Before use, fully confirm the compatibility of this camera head
to all equipment with which it will be used.
• Do not insert the video connector while the electrical contacts or optical connecting
part are wet and/or dirty. This may result in an electric shock, causing severe
damage to the camera head and compromising patient and/or operator safety.
• Do not use this camera head in any place where it may be subject to strong
electromagnetic radiation (for example, in the vicinity of a microwave therapeutic
device, MRI, wireless set, short-wave therapeutic device, cellular/portable phone,
etc.). This may impair the performance of the product.
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Important Information — Please Read Before Use
WARNING
• For reasons described below, do not rely on the NBI*1 observation mode alone for
primary detection of lesions to make a decision regarding any potential diagnostic
or therapeutic intervention.
NBI has not been demonstrated to increase the yield or sensitivity of finding any
specific mucosal lesion.
NBI has not been demonstrated to aid in differentiating and establishing the
presence or absence of dysplasia or neoplastic changes within mucosa or
mucosal lesions.
*1 Narrow Band Imaging. For more details, refer to the instruction manual for the
camera control unit OTV-S400.
CAUTION
• Use the camera head within a range of ambient temperatures shown in
“Specifications” on page 44. When using the camera head at a higher than ambient
temperature in the operating environment, the external surface temperature of the
camera head may rise excessively.
• Do not strike the camera head. The camera head may be damaged.
• Do not hit or bend the electrical contacts and optical connecting part on the video
connector. The connection to the camera control unit may be impaired and faulty
contact can result.
• Do not coil the camera cable with a diameter of less than 20 cm. The camera cable
may be damaged.
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Important Information — Please Read Before Use
CAUTION
• Be careful not to twist the camera cable when it is coiled. The camera cable may be
damaged. The cable can be coiled without twists by piling loops that are made by
crossing the cable in front and back alternately.
A
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B
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Repeat Step A and B alternately.
• Never excessively bend, pull, twist, coil, squeeze, or crush the camera cable, which
could damage the camera cable.
• Turn the camera control unit ON only when the video connector is connected to the
camera control unit. In particular, confirm that the camera control unit is OFF before
connecting or disconnecting the video connector. Failure to do so can result in
equipment damage, including destruction of the electrical circuits inside the camera
head.
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Important Information — Please Read Before Use
CAUTION
• Electromagnetic interference may occur on this camera head near equipment
marked with the following symbol or other portable and mobile RF (Radio
Frequency) communications equipment, such as cellular phones. If
electromagnetic interference occurs, mitigation measures may be necessary, such
as reorienting or relocating this camera head, or shielding the location.
• Be sure that this camera head is not used adjacent to or stacked with other
equipment (other than the components of this camera head or system) to avoid
electromagnetic interference.
• Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous radiation exposure.
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Important Information — Please Read Before Use
Precautions for disappeared endoscopic image
WARNING
• If the endoscopic image disappears unexpectedly during an examination,
immediately stop using the camera head and withdraw the endoscope from the
patient according to Section 5.3, “Withdrawal when any irregularity is observed”.
Continued use of the endoscope under this condition could result in patient injury,
bleeding, and/or perforation.
• Follow the precautions given below. Otherwise, the endoscopic image may
disappear unexpectedly during the examination.
Never reprocess, or store this camera head with sharp-tipped instruments
(tweezers, forceps, knives, etc.). This could scratch or tear holes in the camera
cable, which could allow water to penetrate and damage electrical circuits inside
the camera head.
Do not drop the camera head or allow it to strike other objects. Strong impacts
could damage the electrical circuits inside the camera head.
Before connecting the video connector to the camera control unit, confirm that
the video connector, including the electrical contacts and optical connecting
part, is completely dry and clean. If the camera head is used with the electrical
contacts or optical connecting part wet and/or dirty, the camera head and
camera control unit may malfunction.
Never excessively pull the camera cable, but straighten it gradually when it is
coiled. The camera cable could be damaged.
Never excessively bend, pull, twist, coil, squeeze, or crush the camera cable.
The camera cable could be damaged.
Do not use excessive force when wiping the external surfaces of the camera
cable. The camera cable could be damaged.
Never attempt to lift the entire assembly by the camera cable while the camera
head is attached to the endoscope. The camera cable could be damaged.
Never use a clamp or forceps to attach the camera cable to another object. The
camera cable could be damaged.
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Important Information — Please Read Before Use
CAUTION
• Turn the camera control unit ON only when the video connector is connected to the
camera control unit. In particular, confirm that the camera control unit is OFF before
connecting or disconnecting the video connector. Failure to do so can result in
equipment damage, including destruction of the electrical circuits inside the camera
head.
• Do not hit or bend the electrical contacts on the video connector. The connection to
the camera control unit may be impaired and faulty contact can result.
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1.1 Checking the package contents
Chapter 1
1.1
Checking the Package
Contents
Ch.1
Checking the package contents
Match all items in the package with the components shown below. Inspect each item for damage. If the
instrument is damaged, a component is missing, or you have any questions, do not use the instrument;
immediately contact Olympus.
Camera head
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CH-S400-XZ-EB
Accessories
Operation manual
Reprocessing manual
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1.1 Checking the package contents
Ch.1
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2.1 Nomenclature and functions
Chapter 2
Instrument Nomenclature
and Functions
The instrument nomenclature and functions are described in this chapter.
2.1
Nomenclature and functions
1
Ch.2
2
3
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4
7
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5
12
6
8
9
11
No.
10
Nomenclature
Function
1
Endoscope lock
ring
This ring is moved to attach or detach the endoscope mount to the endoscope.
2
Endoscope mount
The endoscope is connected to this mount.
3
One touch auto
focus switch
The focus is automatically adjusted by pressing the switch.
4
Remote switch 1
The function of the switch is selected on the camera control unit. For more information
on selecting the functions, refer to the instruction manual for the camera control unit.
5
Remote switch 2
The function of the switch is selected on the camera control unit. For more information
on selecting the functions, refer to the instruction manual for the camera control unit.
6
Remote switch 3
The function of the switch is selected on the camera control unit. For more information
on selecting the functions, refer to the instruction manual for the camera control unit.
7
Focus ring
The focus is adjusted by turning the ring.
8
Camera cable
This cable connects the camera head to the camera control unit.
9
Video connector
This connector is connected to the video connector socket on the front panel of the
camera control unit.
10
UP mark
When the video connector is connected to the camera control unit, this mark should be
facing upward.
11
Electrical contacts
Connect the camera head and the camera control unit electrically.
12
Optical connecting
part
Connect the camera head and the camera control unit optically.
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2.1 Nomenclature and functions
Ch.2
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3.1 The workflow of preparation and inspection
Chapter 3
Preparation and Inspection
The equipment prepared before using this camera head and procedures for the inspection of the
camera head and equipment are described in this chapter.
The following inspection judges whether the device has exceeded its use life.
3.1
The workflow of preparation and inspection
The workflow of preparation and inspection is shown below.
Before each case, prepare and inspect this camera head as instructed below. Inspect other equipment
to be used with this camera head as instructed in their respective instruction manuals. Should any
irregularity be observed after inspection, follow the instructions as described in Chapter 5,
“Troubleshooting”.
If this camera head malfunctions, do not use it. Return it to Olympus for repair as described in
Section 5.4, “Returning the camera head for repair”.
WARNING
• Using a camera head that is not functioning properly may compromise patient or
operator safety and may result in more severe equipment damage.
• This camera head was not reprocessed before shipment. Before using this camera
head for the first time, reprocess it according to the instructions as described in the
camera head’s companion “REPROCESSING MANUAL” with your camera head
model listed on the cover.
CAUTION
Refer to “ Connection to the endoscope” on page 24 to check that the endoscope
is firmly fixed to the camera head, and refer to Section 4.2, “Focus adjustment” to
check that the endoscopic image is properly displayed on the monitor. Using the
camera head in combination with an incompatible endoscope may impair the
observation.
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Ch.3
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3.1 The workflow of preparation and inspection
Ch.3
1
Prepare the equipment to be used with the camera head.
2
Inspect the camera head.
3
Inspect the ancillary equipment.
4
Connect the ancillary equipment to the camera head.
5
Section 3.2 on page 19
Section 3.3 on page 20
Section 3.4 on page 21
Section 3.5 on page 22
Inspect the function of ancillary equipment to be connected to
the camera head.
Section 3.6 on page 25
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3.2 Preparation of the equipment
3.2
Preparation of the equipment
Prepare this camera head, equipment, and all personal protective equipment shown in Figure 3.1.
Prepare the equipment in “ System chart” on page 41 in accordance with the intended use.
Also, refer to the respective instruction manuals for each piece of equipment before use.
Camera head
Ch.3
Camera head*1
Ancillary equipment
Endoscope*2
Light guide cable
Light source
Camera control unit
Monitor
Personal protective equipment (for example)
Eyewear
Face mask
Moisture-resistant
clothing
Chemical-resistant gloves
Figure 3.1
*1 Prepare the camera head that has been reprocessed as described in the “REPROCESSING MANUAL” with
your camera head model listed on the cover.
*2 Prepare the endoscope that has been reprocessed as described in its manual.
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3.3 Inspection of the camera head
3.3
Inspection of the camera head
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Camera head’s
main body
Camera cable
Cover glass
Ch.3
Video connector
Figure 3.2
CAUTION
• A soiled cover glass will impede observation. Avoid leaving fingerprints or smudges
on the cover glass.
• To avoid scratching the cover glass, never use an abrasive cloth or material to
clean it.
• When wiping the camera head surfaces, wear chemical-resistant gloves that fit
properly and are long enough so that your skin is not exposed.
• Moisture adhering to the camera head surfaces will impede observation. Dry the
instruments thoroughly before use.
1
Confirm that the camera head does not have the following damages.
• The surface of the camera head’s main body is free from cracks, burrs, or other
damages.
• The camera cable is free from sagging, swelling, scratches, or holes.
• The surface of the video connector is free from cracks, burrs. The electrical
contacts and optical connecting part of the video connector are free from bends or
rust.
2
3
20
To remove dust, dirt, and other non-patient debris, use sterile lint-free cloths.
Make sure that the equipment is completely dry before use. Wipe the video connector,
including the electrical contacts and optical connecting part, using clean lint-free
cloths. Also, confirm that the electrical contacts and optical connecting part are
completely dry and clean.
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3.4 Inspection of ancillary equipment
3.4
Inspection of ancillary equipment
WARNING
• To ensure safety, securely connect the power cord of the camera control unit and
the light source to a hospital grade receptacle (wall mains outlet).
• When using a nonmedical monitor or other ancillary equipment, always connect
Olympus equipment via an isolation transformer.
Inspect the following equipment as described in their respective instruction manuals.
• Endoscope
• Light guide cable
• Light source
• Camera control unit
• Monitor
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3.5 Connection of the camera head and ancillary equipment
3.5
Connection of the camera head and ancillary
equipment
Connect the ancillary equipment to the camera head as described below.
Connection to the camera control unit
WARNING
• Before connecting the video connector to the camera control unit, confirm that the
video connector, including the electrical contacts and optical connecting part, is
completely dry and clean. If the camera head is used with the electrical contacts or
optical connecting part wet and/or dirty, the camera head and camera control unit
may malfunction.
Ch.3
• Push the video connector into the camera control unit until it clicks, then confirm
that the video connector is securely attached by pulling it gently. Improper
connection will damage the image sensor, so that no image could be displayed.
CAUTION
• Never excessively bend, pull, twist, coil, squeeze, or crush the camera cable. The
camera cable could be damaged.
• Do not pull out the video connector by pulling the camera cable. Equipment
damage may occur.
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