otv-s7h-va_visera_video_system_instructions_dec_200.pdf
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INSTRUCTIONS
VISERA VIDEO SYSTEM
AUTOCLAVABLE CAMERA HEAD
OTV-S7H-VA
For NTSC Type equipment
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 before the first use/reprocessing and storage after use ....
4
Prohibition of improper repair and modification ........................................
4
Signal words .............................................................................................
4
Dangers and warnings .............................................................................
5
Cardiac applications..................................................................................
7
Precautions against frozen or lost endoscopic images .............................
8
Chapter 1
Checking the Package Contents............................
9
Chapter 2
Nomenclature and Functions .................................
10
Chapter 3
Preparation and Inspection ....................................
13
3.1
Inspection of the camera head........................................................
14
3.2
Preparation of ancillary equipment .................................................
14
3.3
Connecting and disconnecting the camera head to the VISERA video
system center OTV-S7V and light source.......................................
15
3.4
Connecting and disconnecting the endoscope ...............................
18
Operation .................................................................
22
4.1
Focus adjustment............................................................................
24
4.2
Positioning the endoscope image ...................................................
24
4.3
Color adjustment.............................................................................
25
4.4
Setting the remote control switches ................................................
25
Reprocessing: General Policy................................
26
5.1
Instructions......................................................................................
26
5.2
Notes for cleaning, disinfection and sterilization .............................
26
5.3
Precautions .....................................................................................
27
Chapter 4
Chapter 5
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Contents
Chapter 6
Compatible Reprocessing Methods and
Chemical Agents......................................................
29
6.1
Compatibility summary....................................................................
29
6.2
Detergent solution ...........................................................................
29
6.3
Disinfectant solution ........................................................................
30
6.4
Rinsing water ..................................................................................
30
6.5
ETO gas sterilization .......................................................................
31
6.6
Steam sterilization (autoclaving) .....................................................
32
Cleaning, Disinfection and Sterilization
Procedures ...............................................................
34
7.1
Required reprocessing equipment ..................................................
34
7.2
Cleaning, disinfection and sterilization procedures .........................
35
7.3
Precleaning .....................................................................................
36
7.4
Manual cleaning ..............................................................................
39
7.5
High-level disinfection .....................................................................
40
7.6
Sterilization .....................................................................................
42
Care, Storage and Disposal ....................................
44
8.1
Wiping the surface and cover glass ................................................
44
8.2
Storage ...........................................................................................
46
8.3
Disposal ..........................................................................................
46
Troubleshooting ......................................................
47
Appendix........................................................................................
48
System chart ............................................................................................
48
Operating environment .............................................................................
50
Transportation and storage environment .................................................
50
Specifications ............................................................................................
51
EMC compliance information ....................................................................
53
Chapter 7
Chapter 8
Chapter 9
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Labels and Symbols
Labels and Symbols
Safety-related labels and symbols are attached to the instrument at the locations
shown below. If labels or symbols are missing or illegible, contact Olympus.
Caution, refer to instructions.
Type BF applied part
Autoclavable camera head
Warning plate
Caution and model name.
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Labels and Symbols
Warning plate
NTSC
2
PAL
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Important Information — Please Read Before Use
Important Information — Please Read
Before Use
Intended use
The instrument has been designed to be used with an Olympus VISERA video
system center OTV-S7V, video adapter, video coupler, special endoscope, light
source, video monitor and other ancillary equipment for endoscopic observation,
diagnosis and treatment.
Do not use this instrument for any purpose other than its intended 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 of all equipment which will be used during the procedure and use the
equipment 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
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. This manual, therefore, does not explain or
discuss clinical endoscopic procedures.
AUTOCLAVABLE CAMERA HEAD
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Important Information — Please Read Before Use
Instrument compatibility
Refer to the “System chart” in the Appendix to confirm that this instrument is
compatible with the ancillary equipment being used. Using incompatible
equipment can result in patient injury and/or equipment damage.
This instrument complies with medical electrical equipment edition 2 (IEC
60601-1-2: 2001). However, when connecting with an instrument that complies
with the medical electrical equipment edition 1 (IEC 60601-1-2: 1993), the whole
system complies with edition 1. (See “EMC compliance information” in the
Appendix for EMC compliance level.)
Reprocessing before the first use/reprocessing and
storage after use
This instrument 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 Chapters 5 through 8. Improper
and/or incomplete reprocessing or storage can present an infection control risk,
cause equipment damage or reduce performance.
Prohibition of improper repair and modification
Never repair by persons other than Olympus-qualified technicians or modify the
instrument, as this may result in injury of the patient or operator as well as
damage to the equipment. If you observe a malfunction or problem during the
inspection or operation of the instrument, contact Olympus.
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.
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Important Information — Please Read Before Use
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.
Dangers and warnings
Follow the dangers and warnings given below when handling this instrument.
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
instrument 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 OTV-S7V in the following
locations. 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.
•
Be sure to prepare another camera head to avoid that the
examination must be interrupted 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 instrument with all equipment
to be used with it.
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Important Information — Please Read Before Use
6
•
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.
•
Do not touch the metal plug of the light guide connector
immediately after removing it from the light source because it
is extremely hot.
•
Never put the endoscope on gauze, surgical drapes or other
flammable material when the light source is turned ON. The
heat generated by the light emitted from the distal end of the
endoscope could burn flammable material.
•
Turn OFF the light source when the endoscope is not in use.
•
Insufficient cleaning, disinfection and/or sterilization may
result in infection of the patient and/or operator. Reprocess
the equipment by observing the instructions given in Chapter
5, “Reprocessing: General Policy” to 7, “Cleaning,
Disinfection and Sterilization Procedures”.
•
Never excessively bend into a diameter of 20 cm or less, pull,
twist, coil, squeeze or apply a crushing force to the camera
cable. The camera cable could become damaged. Moreover,
the illumination light may darken by damaging the light guide.
•
Do not pull the camera cable, as this may disconnect the light
guide connector from the output connector of the light source
and render the endoscopic image invisible.
•
Do not apply shock to the camera head, particularly on the
light guide cover glass surface. Otherwise, it may be
damaged.
•
Be sure not to bring and/or pile up this instrument too close to
other instruments to avoid an electromagnetic interference
from them.
•
Electromagnetic interference may occur on this instrument
near a portable device and a mobile RF communications
equipment such as a cellphone marked with the following
symbol:
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Important Information — Please Read Before Use
Cardiac applications
•
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 otherwise 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 OTV-S7H-VA.
•
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
instrument is electrically connected to metal parts of other
system components and such contact may cause
unintended current flow to the patient.
Keep fluids away from all electrical equipment. If fluid
enters the unit, stop the operation of the equipment at
once and contact Olympus.
Do not prepare, inspect or use this equipment with wet
hands.
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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 instrument 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 instrument
together with sharp-tipped instruments (tweezers,
forceps, knives, etc.). These could scratch or tear holes in
the camera cable, which could allow water to penetrate
and damage electrical circuits inside the instrument.
Do not drop the camera head or allow it to strike other
objects. Strong impacts could damage the electrical
circuits inside the instrument.
Make sure that the video plug and its electrical contacts
are completely dry before connecting the plug to the
OTV-S7V. Wet contacts could cause the equipment to
malfunction.
Never excessively bend into a diameter of 20 cm or less,
pull, twist, coil, squeeze or apply a crushing force to the
camera cable. The camera cable could become
damaged.
Do not use excessive force when wiping the external
surfaces of the camera cable. Otherwise, the camera
cable could become damaged.
While the camera head is attached to the endoscope,
never attempt to lift the entire assembly by the camera
cable. 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 instrument is damaged, a component is missing or you
have any questions, do not use the instrument; immediately contact Olympus.
This instrument 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”.
Instruction manual
Autoclavable camera head
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Chapter 2 Nomenclature and Functions
Chapter 2 Nomenclature and Functions
2. Endoscope lock and rotation ring
3. Focus ring
1. Main body
7. UP mark
4. Camera cable
6. Video plug
Electrical contacts
Metal plug
5. Light guide connector
9. Remote control switch SW1
8.Indication mark
10
9. Remote control switch SW2
9. Remote control switch SW3
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Chapter 2 Nomenclature and Functions
Cover glass
10. Endoscope mount
Light guide output glass
Light guide input glass
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Chapter 2 Nomenclature and Functions
1. Main body
The image sensor (CCD), which converts the endoscopic image into
electrical signals, is located here.
2. Endoscope lock and rotation ring
Operating this ring locks the endoscope to the mount.
3. Focus ring
This ring is rotated for initial focus adjustment of the endoscopic image.
4. Camera cable
Connects the camera head to the OTV-S7V VISERA video system center.
5. Light guide connector
Connects the camera head to the output connector of the light source and
transmits light from the light source to the endoscope.
6. Video plug
This plug is connected to the video connector socket on the front panel of
the OTV-S7V VISERA video system center.
7. UP mark
This mark must face upward when the video plug is connected to the
OTV-S7V.
8. Indication mark
This mark is aligned to the locking cone of the endoscope when the
endoscope is connected to the camera head.
9. Remote control switch SW1, SW2 and SW3
The function of each switch is selected on the OTV-S7V VISERA video
system center. For more information on selecting the functions, refer to the
instruction manual of the OTV-S7V.
10. Endoscope mount
The endoscope is connected to this mount.
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Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection
•
Before each case, prepare and inspect this instrument as
instructed below. Inspect other equipment to be used with
this instrument as instructed in their respective instruction
manuals. Should the slightest irregularity be suspected, do
not use the instrument; contact Olympus. Damage or
irregularity may compromise patient or user safety and may
result in more severe equipment damage.
•
This instrument was not disinfected or sterilized before
shipment. Before using this instrument for the first time,
reprocess it according to the instructions given in Chapters 5
through 7.
•
Using an endoscope that is not functioning properly may
compromise patient or operator safety and may result in
more severe equipment damage.
Refer to Section 3.4, “Connecting and disconnecting the
endoscope” on page 18 to check that the endoscope is firmly
connected to the camera head, and refer to Section 4.1,
“Focus adjustment” on page 24 to check the endoscopic
image is properly displayed on the video monitor.
Prepare this instrument, other compatible equipment to be used with this
instrument (listed in the “System chart” in the Appendix), and paper towels,
basins, lint-free cloths and personal protective equipment, such as eye wear, a
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
Inspection of the camera head
1.
Inspect the camera head for cracks or other damage. Confirm that the
camera cable is not damaged.
2.
Inspect the main body, light guide connector, and video plug for excessive
scratching, which may contain debris.
3.
Refer to Chapter 4, “Operation” in the OTV-S7V’s instruction manual and
inspect the camera head.
4.
Inspect the light guide input glass and light guide output glass to ensure
they are free of dirt.
3.2
Preparation of ancillary equipment
•
To ensure safety, securely connect the power cord of the
OTV-S7V and the light source to a hospital grade receptacle
(wall mains outlet).
•
When using a non-medical video monitor or ancillary
electronic equipment, always connect their power cords to an
isolation transformer, rather than directly to a wall-mains
outlet.
Setup the OTV-S7V, video monitor and other ancillary equipment as described in
the OTV-S7V VISERA video system center’s instruction manual and the
respective instruction manuals for each piece of equipment.
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Chapter 3 Preparation and Inspection
3.3
Connecting and disconnecting the camera head
to the VISERA video system center OTV-S7V and
light source
•
Never excessively bend into a diameter of 20 cm or less, pull,
twist, coil, squeeze or apply a crushing force to the camera
cable. The camera cable and the light guide could become
damaged.
•
Make sure that the video plug and its electrical contacts are
completely dry before connecting the plug to the OTV-S7V.
Wet contacts could cause the equipment to malfunction.
•
Do not connect or disconnect the video plug while the
OTV-S7V 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. Sudden
changes in temperature may damage the componets. Never
rinse the instruments with water in order to cool them.
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Chapter 3 Preparation and Inspection
Connecting
1.
Turn the light source OFF.
2.
Insert the light guide connector completely into the output socket of the light
source, while holding the video plug.
3.
Confirm that the video plug and its electrical contacts are dry (see Figure
3.1). If the video plug is wet, wipe it dry with a clean, lint-free cloth.
Electrical contacts
UP mark
Video plug
Figure 3.1
4.
Turn the OTV-S7V OFF.
5.
Hold the video plug so that the “UP” mark is facing upward (see Figures 3.1
and 3.2).
6.
Hold the OTV-S7V stationary with one hand. With the other hand, push the
video plug into the video connector socket until it clicks (see Figure 3.2).
Locking lever
Video connector socket
Video plug
UP mark
Figure 3.2
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Chapter 3 Preparation and Inspection
Disconnecting
Do not touch the metal plug of the light guide connector
immediately after removing it from the light source because it
is extremely hot. Operator and/or patient injury may result.
Do not pull out the video plug and/or light guide connector by
pulling the camera cable. Otherwise, equipment damage
may occur.
1.
Turn the OTV-S7V OFF.
2.
Turn the light source OFF.
3.
Hold the OTV-S7V 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 3.3).
Locking lever
Video plug
Figure 3.3
4.
Pull out the light guide connector from the light source with one hand,
holding the video plug with the other hand.
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Chapter 3 Preparation and Inspection
3.4
18
•
By attaching the appropriate adapter to the light guide
connector, it can be connected to non-Olympus light sources.
•
For the best light distribution, resolution, and color
reproduction, Olympus light sources are recommended.
Non-Olympus equipment may not produce satisfactory
results.
Connecting and disconnecting the endoscope
•
Do not touch the distal end of the endoscope and the inner
side of the endoscope mount of the camera head
immediately after removing the endoscope from the camera
head, because these parts are very hot and may burn your
hand.
•
If the endoscope is removed from the camera head while the
light source is ON, the illumination light is output from the
endoscope mount. Be sure to turn OFF the light source or
take care not to look at the endoscope mount directly when
removing the endoscope from the camera head. Otherwise,
your eyes may be injured.
•
If the endoscope is not held when the endoscope lock and
rotation ring is moved toward the camera head, the
endoscope could fall and become damaged. Always hold the
endoscope securely.
•
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.
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Chapter 3 Preparation and Inspection
Connecting
1.
Align the locking cone of the endoscope with indication mark of the lock and
rotation ring.
2.
Insert the endoscope mount into the endoscope lock and rotation ring until it
clicks (see Figure 3.4).
Indication mark
Endoscope lock and rotation ring
Locking cone
Endoscope
Figure 3.4
Inspection of the endoscopic image
1.
Turn ON the power switch for the video monitor, the OTV-S7V 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.
Joggle the camera cable and confirm that the endoscopic image is free from
irregularities such as momentary disappearing or flickering.
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Chapter 3 Preparation and Inspection
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 examination, which could lead to patient injury,
bleeding and/or perforation.
Press each remote control switch and confirm that the
programmed functions work properly.
Disconnecting
While holding the endoscope securely, slide the endoscope lock and rotation
ring toward the camera head and then gently pull the endoscope away (see
Figure 3.5).
Endoscope
Endoscope lock and rotation ring
Figure 3.5
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Chapter 4 Operation
Chapter 4 Operation
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. This manual, therefore, does not explain or
discuss clinical endoscopic procedures. It only describes basic operation and
precautions related to the operation of this instrument.
22
•
If an abnormal endoscopic image/function occurs and returns
to its normal condition by itself, the equipment has
malfunctioned. Continued use in such condition may cause
abnormality again and it may not be able to recover to normal
condition. In this case, immediately stop use and withdraw
the endoscope from the patient slowly. Continued use of
such equipment may cause patient injury, bleeding and/or
perforation.
•
If the endoscopic image on the video monitor should
unexpectedly disappear or freeze during an examination and
cannot be restored, turn the OTV-S7V OFF and then ON
again. If the image still does not appear, immediately turn the
OTV-S7V OFF. Disconnect the camera head from the
endoscope and carefully withdraw the endoscope from the
patient, while viewing through the endoscope’s eyepiece. In
addition, be sure to prepare another camera head to avoid
that the examination must be interrupted due to equipment
failure or malfunction.
•
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.
AUTOCLAVABLE CAMERA HEAD