otv-s7proh-hd-xx_camera_head_instructions_sept_2010.pdf
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INSTRUCTIONS
HD AUTOCLAVABLE CAMERA HEAD
OTV-S7ProH-HD-10E
OTV-S7ProH-HD-10Q
OTV-S7ProH-HD-12E
OTV-S7ProH-HD-12Q
For PAL Type equipment
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Contents
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
Signal words..............................................................................................
5
Dangers and warnings ..............................................................................
6
Cardiac applications..................................................................................
8
Precautions against frozen or lost endoscopic images .............................
9
Chapter 1
Checking the Package Contents............................
10
Chapter 2
Nomenclature and Functions .................................
11
Chapter 3
Preparation and Inspection ....................................
15
3.1
Endoscope selection.......................................................................
16
3.2
Inspection of the camera head........................................................
17
3.3
Preparation of ancillary equipment .................................................
17
3.4
Connecting and disconnecting the camera head to
the video system center ..................................................................
17
Connecting and disconnecting the endoscope ...............................
20
Operation .................................................................
24
4.1
Focus adjustment............................................................................
26
4.2
Positioning the endoscopic image ..................................................
27
4.3
Color adjustment.............................................................................
28
4.4
Observation of the NBI image.........................................................
28
4.5
Setting the remote control switches ................................................
29
Reprocessing: General Policy................................
30
5.1
Instructions......................................................................................
30
5.2
Notes for cleaning, disinfection, and sterilization ............................
30
5.3
Precautions .....................................................................................
31
3.5
Chapter 4
Chapter 5
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Contents
Chapter 6
6.1
Compatibility summary....................................................................
33
6.2
Detergent solution ...........................................................................
35
6.3
Disinfectant solution ........................................................................
35
6.4
Rinsing water ..................................................................................
35
6.5
ETO gas sterilization .......................................................................
36
6.6
Steam sterilization (autoclaving) .....................................................
37
6.7
Automatic cleaning/disinfection.......................................................
38
Cleaning, Disinfection, and Sterilization
Procedures ...............................................................
40
7.1
Required reprocessing equipment ..................................................
40
7.2
Cleaning, disinfection, and sterilization procedures ........................
41
7.3
Precleaning .....................................................................................
42
7.4
Manual cleaning ..............................................................................
44
7.5
High-level disinfection .....................................................................
45
7.6
Rinsing after high-level disinfection.................................................
46
7.7
Automatic cleaning/disinfection.......................................................
47
7.8
Sterilization .....................................................................................
48
Care, Storage, and Disposal ...................................
50
8.1
Wiping the surface and cover glass ................................................
50
8.2
Storage ...........................................................................................
51
8.3
Disposal ..........................................................................................
52
Troubleshooting ......................................................
53
Returning the camera head for repair ......................................................
53
Appendix........................................................................................
55
System chart ............................................................................................
55
Operating environment .............................................................................
58
Transportation and storage environment .................................................
58
Specifications ............................................................................................
59
EMC information........................................................................................
62
Chapter 7
Chapter 8
Chapter 9
ii
Compatible Reprocessing Methods and Chemical
Agents....................................................................... 33
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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 CF applied part
Model name plate
Model name
Caution indication
Caution see below
Model name plate (example from OTV-S7ProH-HD-12E)
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Labels and Symbols
Back cover of this instruction manual
Manufacturer
Authorized representative in the European Community
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Important Information — Please Read Before Use
Important Information — Please Read
Before Use
Intended use
These camera heads have been designed to be used with the CV-180 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 these camera heads 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 these camera
heads 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 the 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 EMC standard for medical equipment; edition 2
(IEC 60601-1-2: 2001). However, when connected with an instrument that
complies with EMC standard for medical equipment; edition 1 (IEC 60601-1-2:
1993), the whole system complies with edition 1.
Reprocessing and storage
The camera heads were 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 Chapters 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
The camera heads do 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
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 video system center 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
•
Be sure to prepare another camera head to avoid interruption
of the examination due to equipment failure or malfunction.
•
This product 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 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
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 of 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.
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Important Information — Please Read Before Use
Cardiac applications
8
•
Use only the devices listed in the “System chart” for
endoscopic observation or treatment of the heart or areas
near the heart. Other combinations of equipment may cause
ventricular fibrillation or seriously affect the cardiac function
of the patient.
•
For cardiac applications, never support the endoscope with a
metal surgical arm that is not electrically isolated from the
ground. If not isolated, the endoscope will be connected to
the ground through the surgical arm and bed, and will
conduct unexpected leakage current that may seriously
affect the cardiac function of the patient.
•
The use of medical devices not specifically designed for
cardiac applications may cause ventricular fibrillation or
seriously affect the cardiac function of the patient. As
specified by international standard IEC 60601-1, any
“Applied part” used for observation or treatment of the heart
or areas near the heart must meet “TYPE CF applied part”
requirements for low electrical leakage current. When using
metal endoscopes for endoscopic cardiac applications, the
“Applied part” requirements include all devices directly
connected to the endoscope, such as the light-guide cable,
camera head, and telescope holder. Each of these devices
must individually meet the “TYPE CF applied part”
requirements for leakage current limits if they are to be used
for cardiac applications.
•
The Olympus light-guide cables and camera heads listed in
the “System chart (TYPE CF applied part)” that are suitable
for cardiac applications bear a
symbol.
•
The Olympus SH-1 surgical telescope holder has an
electrically isolated arm structure that isolates the endoscope
from the ground. This design makes the SH-1 suitable for
cardiac applications.
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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, 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.
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.
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; 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”.
Depending upon the camera head purchased, it may appear different from that
shown in the figure below.
Camera head
(OTV-S7ProH-HD-10E/12E)
Camera head
(OTV-S7ProH-HD-10Q/12Q)
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Instruction manual
Instruction manual
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Chapter 2 Nomenclature and Functions
Chapter 2 Nomenclature and Functions
3. Endoscope mount lock
2. Endoscope mount
4. Focus ring
1. Remote control switch SW3
1. Remote control switch SW1
1. Remote control switch SW2
9. Magnification ratio indicator
5. Endoscope lock ring
OTV-S7ProH-HD-10E
8. UP mark
7. Video plug
6. Camera cable
1. Remote control switch SW3
Electrical contacts
1. Remote control switch SW2
1. Remote control switch SW1
2. Endoscope mount
5. Endoscope lock ring
4. Focus ring
9. Magnification ratio indicator
OTV-S7ProH-HD-10Q
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Chapter 2 Nomenclature and Functions
3. Endoscope mount lock
2. Endoscope mount
4. Focus ring
1. Remote control switch SW3
1. Remote control switch SW1
5. Endoscope lock ring
1. Remote control switch SW2
9. Magnification ratio indicator
OTV-S7ProH-HD-12E
1. Remote control switch SW3
1. Remote control switch SW2
1. Remote control switch SW1
2. Endoscope mount
5. Endoscope lock ring
4. Focus ring
9. Magnification ratio indicator
OTV-S7ProH-HD-12Q
1. 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.
2. Endoscope mount
The endoscope is connected to this mount.
3. Endoscope mount lock
This lever is moved to lock and unlock the endoscope mount.
4. Focus ring
This ring is rotated for initial focus adjustment of the endoscopic image.
5. Endoscope lock ring
Operating this ring locks the endoscope to the mount.
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Chapter 2 Nomenclature and Functions
6. Camera cable
This cable connects the camera head to the video system center.
7. Video plug
This plug is connected to the video connector socket on the front panel of
the video system center.
8. UP mark
This mark is facing upward when the video plug is connected to the video
system center.
9. Magnification ratio indicator
This mark indicates the magnification ratio.
Camera head type
Magnification ratio
OTV-S7ProH-HD-10E/10Q
1.0X
OTV-S7ProH-HD-12E/12Q
1.2X
Table 2.1
Please note that some products may not have this magnification ratio
indicator.
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Chapter 2 Nomenclature and Functions
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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 any 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 Chapters 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.
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Chapter 3 Preparation and Inspection
3.1
Endoscope selection
Refer to Section 3.5, “Connecting and disconnecting the
endoscope” on page 20 to check that the endoscope is firmly
connected to the camera head, and refer to Section 4.1,
“Focus adjustment” on page 26 to check the endoscopic
image is properly displayed on the monitor.
Select an endoscope according to the type of the camera head to be used.
Camera head type
Endoscope mount type
Compatible endoscopes
OTV-S7ProH-HD-10E/12E
Eyepiece type
Rigid Endoscopes
OTV-S7ProH-HD-10Q/12Q
Quick-lock type
Rigid Endoscopes
Table 3.1
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).
OTV-S7ProH-HD-10E/12E
Eyepiece
OTV-S7ProH-HD-10Q/12Q
Figure 3.1
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Chapter 3 Preparation and Inspection
3.2
Inspection of the camera head
Inspect the camera head for cracks or other damage. Confirm that the camera
cable is not damaged.
3.3
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 nonmedical monitor or other ancillary
equipment, always connect Olympus equipment via an
isolation transformer.
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.
•
After autoclaving, do not use the camera head until it has
cooled down to room temperature. Otherwise, the video
image may be impaired (“noise” etc.).
•
After autoclaving, let all components cool down to room
temperature without additional/accelerated cooling. Never
use cold water to accelerate cooling. Sudden changes in
temperature may damage the components.
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Chapter 3 Preparation and Inspection
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).
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
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Chapter 3 Preparation and Inspection
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 connector socket
Video plug
Figure 3.4
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Chapter 3 Preparation and Inspection
3.5
Connecting and disconnecting the endoscope
When using the OTV-S7ProH-HD-10E/12E
•
If the endoscope is not held firmly when the endoscope lock
ring is moved towards the camera head, the endoscope
could fall off and become damaged. Hold the endoscope
firmly when moving the endoscope lock ring.
•
After the connection, ensure that the endoscope is firmly
connected to the camera head, and not loose. A loose
connection of endoscope and camera head may cause
interference on the endoscopic image.
•
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.
•
Olympus recommends connecting only rigid endoscopes to
this endoscope mount. Although fiberscopes with a rigid
endoscope-type eyepiece can be connected to the
endoscope mount of this camera head, image failure such as
moire may occur.
Connecting
Holding the camera head, gently connect the endoscope’s eyepiece to the
endoscope mount while sliding the endoscope lock ring in the direction of the
arrow. Then release the endoscope lock ring to secure the eyepiece in the
specified position (see Figure 3.5).
Move
Endoscope lock ring
Eyepiece
Endoscope mount
Figure 3.5
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Chapter 3 Preparation and Inspection
Inspection of the endoscopic image
1.
Turn ON the power switch for 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 special light observation function
According to Section 4.4, “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 both the endoscope and camera head firmly. Gently pull out the endoscope
while moving the endoscope lock ring in the direction of the arrow (see Figure
3.5).
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Chapter 3 Preparation and Inspection
When using the OTV-S7ProH-HD-10Q/12Q
•
If the endoscope is not held firmly when the endoscope lock
ring is moved toward the camera head, the endoscope could
fall off and become damaged. Hold the endoscope firmly
when moving the endoscope lock ring.
•
After the connection, ensure that the endoscope is firmly
connected to the camera head and not loose. A loose
connection of endoscope and camera head may cause
interference on the endoscopic image.
Connecting
1.
Disconnect the eyepiece from the endoscope by rotating the eyepiece
counterclockwise.
2.
Insert the exposed eyepiece section into the endoscope lock ring until it
clicks (see Figure 3.6).
Eyepiece
Endoscope mount
Insert
Endoscope lock ring
Figure 3.6
Inspection of the endoscopic image
22
1.
Turn ON the power switch ON for the video 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.
HD AUTOCLAVABLE CAMERA HEAD