OTV-S7ProH-HD-L08E CAMERA HEAD Instructions Nov 2011.pdf
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INSTRUCTIONS
HD CAMERA HEAD
OTV-S7ProH-HD-L08E
For PAL Type equipment
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Contents
Contents
HD CAMERA HEAD OTV-S7ProH-HD-L08E
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Contents
Labels and Symbols .....................................................................
1
Important Information — Please Read Before Use....................
3
Intended use ............................................................................................
3
Instruction manual ....................................................................................
3
User qualifications ....................................................................................
3
Instrument compatibility.............................................................................
4
Reprocessing and storage .......................................................................
4
Repair and modification ............................................................................
4
Spare equipment .......................................................................................
5
Signal words .............................................................................................
5
Dangers and warnings ..............................................................................
6
Cardiac applications .................................................................................
7
Precautions against frozen or lost endoscopic images .............................
8
Chapter 1
Checking the Package Contents ............................
10
Chapter 2
Nomenclature and Functions .................................
11
Chapter 3
Preparation and Inspection ....................................
13
3.1
Endoscope selection .......................................................................
13
3.2
Inspection of the camera head........................................................
14
3.3
Preparation of ancillary equipment..................................................
14
3.4
Connecting and disconnecting the camera head to the video system center
15
3.5
Connecting and disconnecting the endoscope ...............................
17
Operation..................................................................
19
4.1
Focus adjustment............................................................................
22
4.2
Positioning the endoscopic image...................................................
23
4.3
Color adjustment .............................................................................
24
4.4
Setting the brightness .....................................................................
24
4.5
Observation of the NBI image .........................................................
25
4.6
Setting the remote control switches ................................................
26
Reprocessing: General Policy................................
27
5.1
Instructions......................................................................................
27
5.2
Notes for cleaning, disinfection, and sterilization ............................
27
5.3
Precautions .....................................................................................
28
Chapter 4
Chapter 5
Chapter 6
ii
Compatible Reprocessing Methods and Chemical
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Contents
Agents .....................................................................30
6.1
Compatibility summary....................................................................
30
6.2
Detergent solution...........................................................................
32
6.3
Disinfectant solution........................................................................
33
6.4
Rinsing water ..................................................................................
33
6.5
Ethylene oxide gas sterilization.......................................................
34
Chapter 7
Cleaning, Disinfection, and Sterilization Procedures 35
7.1
Required reprocessing equipment ..................................................
35
7.2
Cleaning, disinfection, and sterilization procedures........................
36
7.3
Precleaning .....................................................................................
37
7.4
Manual cleaning..............................................................................
38
7.5
High-level disinfection .....................................................................
39
7.6
Rinsing after high-level disinfection ................................................
40
7.7
Sterilization .....................................................................................
41
Care, Storage, and Disposal...................................
42
8.1
Wiping the surface and cover glass ................................................
42
8.2
Storage ...........................................................................................
44
8.3
Disposal ..........................................................................................
44
Troubleshooting ......................................................
45
Returning the camera head for repair ......................................................
45
Appendix .......................................................................................
47
System chart ............................................................................................
47
Operating environment .............................................................................
50
Transportation and storage environment .................................................
50
Specifications ...........................................................................................
50
EMC information .......................................................................................
52
Chapter 8
Chapter 9
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Contents
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HD CAMERA HEAD OTV-S7ProH-HD-L08E
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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.
Caution, refer to instructions.
Type BF applied part.
Caution indication
Caution see below
Model name plate
Model name
HD CAMERA HEAD OTV-S7ProH-HD-L08E
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Labels and Symbols
Caution indication
Model name plate
Back cover of this instruction manual
Manufacturer
Authorized representative in the European Community
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HD CAMERA HEAD OTV-S7ProH-HD-L08E
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Important Information — Please Read Before Use
Important Information — Please Read
Before Use
Intended use
This camera head has been designed to be used with the CV-180 EVIS EXERA
II video system center or OTV-S7Pro VISERA Pro video system center1,
endoscope, light source, monitor, and other ancillary equipment for endoscopic
observation, diagnosis and treatment.
Do not use this camera head for any purpose other than its intended use.
1 This product is not available in some areas.
Instruction manual
This instruction manual contains essential information on using this camera head
safely and effectively. Before use, thoroughly review this manual and the
manuals of all equipment that will be used during the procedure and use the
instruments as instructed.
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, please
contact Olympus.
User qualifications
This manual does not explain or discuss clinical endoscopic procedures.
Therefore, the operator of this instrument must be a physician or medical
personnel under the supervision of a physician and must have received sufficient
training in clinical endoscopic technique.
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Important Information — Please Read Before Use
Instrument compatibility
Refer to the “System chart” in the Appendix to confirm that this camera head is
compatible with the ancillary equipment being used. Using incompatible
equipment can result in patient injury and/or equipment damage.
This instrument complies with the EMC standard for medical equipment, edition
2 (IEC 60601-1-2: 2001). However, when connected with an instrument that
complies with the EMC standard for medical equipment, edition 1 (IEC
60601-1-2: 1993), the whole system complies with edition 1.
Reprocessing and storage
This camera head was not disinfected or sterilized before shipment. Before
using this instrument for the first time, reprocess it according to the instructions
given in Chapter 5, “Reprocessing: General Policy” through Chapter 7,
“Cleaning, Disinfection, and Sterilization Procedures”.
After using this instrument, reprocess and store it according to the instructions
given in Chapter 5 through 8. Improper and/or incomplete reprocessing or
storage can present an infection-control risk, cause equipment damage or
reduce performance.
Repair and modification
This camera head does not contain any user-serviceable parts. Do not
disassemble, modify or attempt to repair it; patient or user injury and/or
equipment damage can result.
If problems appear to be malfunctions, contact Olympus.
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Important Information — Please Read Before Use
Spare equipment
Be sure to prepare another camera head to avoid interruption of the examination
due to failure or malfunction.
Signal words
The following signal words are used throughout this manual:
Indicates an imminently hazardous situation which, if not
avoided, will result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
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.
Indicates additional helpful information.
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Important Information — Please Read Before Use
Dangers and warnings
Follow the dangers and warnings given below when handling this camera head.
This information is to be supplemented by the dangers, warnings and cautions
given in each chapter.
•
Failure to adhere to the following precautions may place the
patient and medical personnel in danger of an electric shock.
When this equipment 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 equipment with wet
hands.
•
Never install and/or operate the camera head under the
following conditions. Otherwise, an explosion or a fire may
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.
6
•
Push the video plug until it clicks into the video system
center, then confirm that the video plug is securely attached
by pulling it gently, improper connection will damage the
CCD. A damaged CCD will display no image and make the
camera head hot, which could cause operator and/or patient
burns.
•
This product may interfere with other medical electronic
equipment used in combination with it. Before use, fully
confirm the compatibility of this camera head with all
equipment to be used.
•
Do not use this product 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
•
For reasons described below, do not rely on the NBI1
imaging modality alone for primary detection of lesions or to
make a decision regarding any potential diagnostic or
therapeutic intervention.
It has not been demonstrated to increase the yield or
sensitivity of finding any specific mucosal lesion.
It 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 NBI stands for Narrow Band Imaging. For more details,
refer to the instruction manual for the video system center.
•
Be sure that this instrument is not used adjacent to or
stacked with other equipment (other than the components of
this instrument or system) to avoid electromagnetic
interference.
•
Electromagnetic interference may occur on this instrument
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 instrument, or shielding
the location.
•
This product is prohibited to be applied to the heart (as the
equipment incorporating type-BF applied parts), never use it
for procedures aiming at observing or treating the heart.
Strictly observe the precautions below. Otherwise, an electric
shock will cause serious damage to the patient’s cardiac
function such as ventricular fibrillation.
Cardiac applications
Never bring the endoscope connected to this product into
contact with the heart and its surrounding tissues.
Never bring the endoscope connected to this product into
contact with any tool or other endoscope which is in
contact with the heart and its surrounding tissues.
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Important Information — Please Read Before Use
Precautions against frozen or lost endoscopic images
•
If the endoscopic image unexpectedly disappears or a frozen
image cannot be restored during an examination,
immediately stop using the camera head and withdraw the
endoscope from the patient. Continued use of the endoscope
under these conditions may cause patient injury, bleeding
and/or perforation.
•
Follow the precautions given below. Otherwise, the
endoscopic image may disappear unexpectedly, or it may not
be possible to restore a frozen image.
Never clean, disinfect, sterilize or store this camera head
together with sharp-tipped instruments (tweezers,
forceps, knives, etc.). Doing so could scratch or tear holes
in the camera cable, that 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.
Make sure that the video plug and its electrical contacts
are completely dry before connecting the plug to the video
system center. Wet contacts could cause the equipment
to malfunction.
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Important Information — Please Read Before Use
While uncoiling the camera cable, a part of the cable may
form a loop of 10 cm or less in diameter. When such a
loop is observed, do not forcibly pull the camera cable, but
uncoil the loop and straighten it slowly, rotating the
camera head. Forcibly pulling the loop can damage the
camera cable.
Never excessively bend, pull, twist, coil, squeeze or crush
the camera cable. Doing so could damage the camera
cable.
Do not use excessive force when wiping the external
surfaces of the camera cable. Otherwise, the camera
cable could become damaged.
Never attempt to lift the entire assembly by the camera
cable while the camera head is attached to the
endoscope. Doing so could damage the cable.
Never use a clamp or forceps to attach the camera cable
to another object. Doing so could damage the cable.
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Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package
Contents
Match all items in the package with the components shown below. Inspect each
item for damage. If the camera head is damaged, a component is missing or you
have any questions, do not use the camera head; immediately contact Olympus.
This camera head was not disinfected or sterilized before shipment. Before
using this camera head for the first time, reprocess it according to the
instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter
7, “Cleaning, Disinfection, and Sterilization Procedures”.
Instruction manual
Camera head (OTV-S7ProH-HD-L08E)
10
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Chapter 2 Nomenclature and Functions
Chapter 2 Nomenclature and Functions
1. Endoscope mount lock
2. Endoscope mount
3. Endoscope lock button
4. Focus ring
5. Main body
6. Remote control switch SW1
6. Remote control switch SW2
6. Remote control switch SW3
9. UP mark
7. Camera cable
Electrical contacts
8. Video plug
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Chapter 2 Nomenclature and Functions
1. Endoscope mount lock
This lever is moved to lock and unlock the endoscope mount.
2. Endoscope mount
The endoscope is connected to this mount.
3. Endoscope lock button
This button is pressed to connect and disconnect the eyepiece of the
endoscope to and from the endoscope mount.
4. Focus ring
This ring is rotated for initial focus adjustment of the endoscopic image.
5. Main body
The image sensor (CCD), that converts the endoscopic image into electrical
signals, is located here.
6. Remote control switch SW1, SW2, and SW3
The function of the switch is selected on the video system center. For more
information on selecting the functions, refer to the instruction manual for the
video system center.
7. Camera cable
This cable connects the camera head to the video system center.
8. Video plug
This plug is connected to the video connector socket on the front panel of
the video system center.
9. UP mark
This mark is facing upward when the video plug is connected to the video
system center.
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Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection
•
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 the slightest irregularity be observed, do not
use the camera head; contact Olympus.
Damage or irregularity may compromise patient or user
safety and may result in more severe equipment damage.
•
This camera head was not disinfected or sterilized before
shipment. Before using this camera head for the first time,
reprocess it according to the instructions given in Chapter 5
through 7.
Prepare this camera head, other compatible equipment to be used with this
camera head (listed in the “System chart” in the Appendix), paper towels, basins,
lint-free cloths and personal protective equipment, such as eye wear, face mask,
moisture-resistant clothing and chemical-resistant gloves, for the procedure.
Refer to the respective instruction manuals for each piece of equipment.
3.1
Endoscope selection
Refer to Section 3.5, “Connecting and disconnecting the
endoscope” on page 17 to check that the endoscope is firmly
connected to the camera head, and refer to Section 4.1,
“Focus adjustment” on page 22 to check that the endoscopic
image is properly displayed on the monitor.
Select an endoscope according to type of camera head to be used.
Camera head type
OTV-S7ProH-HD-L08E
Endoscope mount type
Eyepiece type
Compatible endoscopes
Rigid endoscopes and
fiberscopes
Table 3.1
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Chapter 3 Preparation and Inspection
Selection of the endoscope’s mount design
Select an endoscope with a mount design that matches the camera head being
used (see Figure 3.1).
Eyepiece
Figure 3.1
3.2
Inspection of the camera head
Inspect the camera head and video plug for cracks or other damage. If any
damage or deterioration is observed, stop using the camera head and send to
Olympus for inspection and repair. The camera cable surface may deteriorate
after multiple sterilization cycles in specific models of STERRAD sterilization
systems. Please consult ASP or Olympus for more specific information. Inspect
the camera cable for damage and other irregularities.
A sticky camera cable surface has no influence on the
product performance or on the safety.
3.3
14
Preparation of ancillary equipment
•
To ensure safety, securely connect the power cord of the
video system center and the light source to a hospital grade
receptacle (wall mains outlet).
•
When using a non-medical monitor or other ancillary
equipment, always connect Olympus equipment via an
isolation transformer.
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Chapter 3 Preparation and Inspection
Setup the video system center, monitor and other ancillary equipment as
described in the video system center instruction manual and the respective
instruction manual for each piece of equipment.
3.4
Connecting and disconnecting the camera head
to the video system center
•
Never excessively bend, pull, twist, coil, squeeze or crush the
camera cable. Doing so could damage the camera cable.
•
Make sure that the video plug and its electrical contacts are
completely dry before connecting the plug to the video
system center. Wet contacts could cause the equipment to
malfunction.
Do not connect or disconnect the video plug while the video
system center is ON. Doing so may damage the electrical
circuits inside the camera head.
Connecting
1.
Confirm that the video plug and its electrical contacts are dry (see Figure
3.2). If the video plug is wet, wipe it dry with a clean, lint-free cloth.
UP mark
Video plug
Electrical contacts
Figure 3.2
2.
Turn the video system center OFF.
3.
Hold the video plug so that the UP mark is facing upward (see Figures 3.2
and 3.3).
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Chapter 3 Preparation and Inspection
4.
Hold the video system center stationary with one hand. With the other hand,
push the video plug into the video connector socket until it clicks (see Figure
3.3).
UP mark
Locking lever
Video connector socket
Video plug
Figure 3.3
Disconnecting
Do not pull out the video plug by pulling the camera cable.
Otherwise, equipment damage may occur.
1.
Turn the video system center OFF.
2.
Hold the video system center stationary with one hand. With the other hand,
press the video connector socket’s locking lever and pull the video plug
straight out (see Figure 3.4).
Locking lever
Video plug
Figure 3.4
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HD CAMERA HEAD OTV-S7ProH-HD-L08E
Video connector socket
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Chapter 3 Preparation and Inspection
3.5
Connecting and disconnecting the endoscope
•
Be sure to hold the endoscope securely when disconnecting.
Otherwise, the endoscope may fall and become damaged.
•
To remove the endoscope, pull it carefully from the
endoscope mount, while keeping the endoscope lock button
pressed. Forcibly removing the endoscope without pressing
the endoscope lock button may damage the endoscope and
camera head.
•
After the connection, ensure that the endoscope is firmly
connected to the camera head, without any looseness. A
loose connection of endoscope and camera head may cause
interference on the endoscopic image.
•
The use of OTV-S7ProH-HD-L08E in conjunction with laser
equipment is not guaranteed. If a filter for laser equipment is
used, operate the instruments carefully, as the connection
between the endoscope and the endoscope mount could be
weakened.
Connecting
1.
Hold the endoscope mount with one hand and press both endoscope lock
buttons (see Figure 3.5).
2.
While keeping the endoscope lock buttons pressed, press the eyepiece of
the endoscope gently into the endoscope mount then release the
endoscope lock button (see Figure 3.5).
Endoscope
Endoscope mount
Endoscope lock button
Figure 3.5
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Chapter 3 Preparation and Inspection
•
Before attaching the endoscope, make sure that its eyepiece
is attached firmly. If the eyepiece is loose, the endoscopic
image may be out of focus or may fluctuate.
•
Only rigid endoscopes or fiberscopes with a rigid
endoscope-type eyepiece can be connected to this
endoscope mount.
Inspection of the endoscopic image
1.
Turn ON the monitor, the video system center and the light source.
2.
Place your hand over the distal end of the endoscope. Confirm that the
illumination light is emitted and that the image is free from noise, blur, fog or
other irregularities.
3.
Shake the camera cable and confirm that the endoscopic image is free from
irregularities such as momentarily disappearing or flickering.
Inspection of the brightness setting
According to Section 4.4, “Setting the brightness”, confirm that the
recommended brightness setting can be set.
Inspection of the special light observation function
According to Section 4.5, “Observation of the NBI image”, confirm that the image
of the special light observation can be displayed correctly.
Inspection of the remote control switch
Inspect all remote control switches and confirm that they
work properly even if you do not plan on using them during
the procedure. A malfunctioning switch could cause the
endoscopic image to freeze and/or cause other irregularities
during the procedure that could lead to patient injury,
bleeding and/or perforation.
Press each remote control switch and confirm that the
programmed functions work properly.
Disconnecting
Hold the endoscope mount with one hand, press both endoscope lock buttons,
and gently remove the endoscope from the endoscope mount.
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Chapter 4 Operation
Chapter 4 Operation
This manual does not explain or discuss clinical endoscopic procedures. It only
describes basic operation and precautions related to the operation of this
camera head, the operator of this camera head must be a physician or medical
personnel under the supervision of a physician and must have received sufficient
training in clinical endoscopic technique.
•
If an abnormal endoscopic image/function occurs and returns
to its normal condition by itself, the equipment has
malfunctioned. In this case, immediately stop the use and
slowly withdraw the endoscope from the patient. Continued
use of such equipment may cause more severe damage to
the equipment and/or patient injury, such as bleeding and/or
perforation.
•
If the endoscopic image unexpectedly disappears or a frozen
image and cannot be restored during an examination, turn
the video system center OFF and then ON again. If the
image still does not appear, immediately turn the video
system center OFF. Disconnect the camera head from the
endoscope and carefully withdraw the endoscope from the
patient, while viewing the endoscopic image through the
endoscope’s eyepiece.
•
Intense endoscopic illumination may cause mucosal burns.
When endoscopes are used with high intensity (e.g., xenon)
light sources, they can concentrate intense light on a
relatively small area of the mucosal surface. Always use the
minimum level of illumination necessary for adequate
viewing. Whenever possible, avoid close, stationary viewing
and do not leave the distal end of the endoscope close to
mucous membranes for a long time.
•
When you are using an endoscope or ancillary equipment
without automatic brightness control, adjust the brightness
manually to maintain the minimum level of illumination
necessary for adequate viewing.
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Chapter 4 Operation
•
The risk of thermal injury increases under the following
conditions:
Prolonged contact with or close, stationary viewing of the
mucosa.
Passing the endoscope through a narrow lumen (e.g.,
esophagus, pharynx).
Using high-intensity light sources (e.g., CLV-180,
CLV-S20, CLV-S30, CLV-S40) at their maximum output
settings.
•
Take the following precautions to reduce the risk of mucosal
burns:
Always use the minimum level of illumination necessary
for adequate viewing. The filter supplied with
high-intensity (e.g., xenon) light sources may be used to
reduce brightness.
Whenever possible, avoid close, stationary viewing.
When the endoscope is not being used, always turn the
light source off.
20
•
Wear personal protective equipment to guard against
dangerous chemicals and potentially infections material,
such as eye wear, a face mask, moisture-resistant clothing
and chemical-resistant gloves that fit properly and are long
enough so that your skin is not exposed.
•
When performing endoscopic treatment, be prepared to
perform open surgery as an emergency measure in case of a
malfunction of the endoscope or other system component
(light source, video system center, camera head, monitor,
cables, insufflation unit, etc.).
•
Never attempt to lift the entire assembly by the camera cable
while the camera head is attached to the endoscope. Doing
so could damage the cable.
•
Never use a clamp or forceps to attach the camera cable to
another object. Doing so could damage the cable.
•
Be careful not to scratch the camera cable with a
sharp-tipped instrument.
HD CAMERA HEAD OTV-S7ProH-HD-L08E