chf-v_choledocho_videoscope_instructions_may_2008.pdf
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INSTRUCTIONS
CHOLEDOCHO VIDEOSCOPE
OLYMPUS CHF TYPE V
(For PAL type only)
Page 3
Contents
Contents
Symbols.........................................................................................
1
Important Information — Please Read Before Use....................
2
Intended use ............................................................................................
2
Applicability of endoscopy and endoscopic treatment .............................
2
Instruction manual.....................................................................................
3
User qualifications ....................................................................................
3
Instrument compatibility ...........................................................................
3
Reprocessing before the first use/reprocessing and storage after use.....
4
Spare equipment ......................................................................................
4
Maintenance management .......................................................................
4
Prohibition of improper repair and modification ........................................
4
Signal words..............................................................................................
5
Warnings and cautions .............................................................................
5
Precaution for disappeared or frozen endoscopic image..........................
10
Examples of inappropriate handling..........................................................
11
Chapter 1
Checking the Package Contents............................
12
Chapter 2
Instrument Nomenclature and Specifications ......
14
2.1
Nomenclature..................................................................................
14
2.2
Endoscope functions.......................................................................
16
2.3
Specifications..................................................................................
18
Preparation and Inspection ....................................
21
3.1
Preparation of the equipment..........................................................
22
3.2
Inspection of the endoscope ...........................................................
23
3.3
Preparation and inspection of the accessories ...............................
26
3.4
Attaching accessories to the endoscope ........................................
27
3.5
Inspection and connection of ancillary equipment ..........................
29
3.6
Inspection of the endoscopic system ..............................................
31
Operation .................................................................
35
4.1
Insertion ..........................................................................................
38
4.2
Using EndoTherapy accessories ....................................................
42
4.3
Using a laser system.......................................................................
45
4.4
Withdrawal of the endoscope..........................................................
46
Chapter 3
Chapter 4
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Contents
Chapter 5
Reprocessing: General Policy................................
47
5.1
Notes for cleaning, disinfection, and sterilization ............................
47
5.2
Precautions .....................................................................................
48
Chapter 6
Compatible Reprocessing Methods and Chemical
Agents....................................................................... 52
6.1
Compatibility summary....................................................................
52
6.2
Detergent solution ...........................................................................
57
6.3
Ultrasonic cleaning..........................................................................
57
6.4
Disinfectant solution ........................................................................
58
6.5
Rinsing water ..................................................................................
59
6.6
Automatic cleaning/disinfection.......................................................
60
6.7
Ethylene oxide gas sterilization.......................................................
60
6.8
Steam sterilization (autoclaving) of accessories .............................
63
Cleaning, Disinfection, and Sterilization
Procedures ...............................................................
66
7.1
Required reprocessing equipment ..................................................
67
7.2
Cleaning, disinfection, and sterilization procedures ........................
75
7.3
Precleaning .....................................................................................
77
7.4
Transportation of the endoscope ....................................................
81
7.5
Leakage testing...............................................................................
82
7.6
Manual cleaning ..............................................................................
87
7.7
Disinfection .....................................................................................
96
7.8
Rinsing and drying after disinfection ...............................................
99
7.9
Automatic cleaning/disinfection.......................................................
101
7.10 Sterilization .....................................................................................
102
Chapter 7
Chapter 8
Maintenance Procedures of Equipment for
Reprocessing ........................................................... 104
Chapter 9
Storage, Transporting the Endoscope Outside
the Hospital and Disposal....................................... 105
9.1
Storage ...........................................................................................
105
9.2
Storage of reprocessing equipment and the leakage tester
(WA23070A) ...................................................................................
106
9.3
Transporting the endoscope outside the hospital ...........................
106
9.4
Disposal ..........................................................................................
106
Chapter 10 Troubleshooting ...................................................... 107
ii
10.1 Troubleshooting guide ....................................................................
108
10.2 Withdrawal of the endoscope with an irregularity............................
111
10.3 Returning the endoscope for repair.................................................
112
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Contents
Appendix ....................................................................................... 113
System chart ............................................................................................
113
EMC information .......................................................................................
117
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Contents
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CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Symbols
Symbols
The meaning(s) of the symbol(s) shown on the component packaging, the back
cover of the instruction manual, and/or the instrument are as follows:
Refer to instructions.
Caution
TYPE BF applied part
Endoscope
Lot number
Do not reuse.
Manufacturer
Authorized representative in the European Community
Serial number
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Important Information — Please Read Before Use
Important Information — Please Read
Before Use
Intended use
This instrument has been designed to be used with an Olympus video system
center, light source, documentation equipment, monitor, EndoTherapy
accessories, and other ancillary equipment for endoscopic diagnosis and
treatment within the bile duct. Do not use the instrument for any purpose other
than its intended use.
Applicability of endoscopy and endoscopic treatment
If there is an official standard on the applicability of endoscopy and endoscopic
treatment that is defined by the hospital’s administration or other official
institutions such as academic societies on endoscopy, follow that standard.
Before starting endoscopy and endoscopic treatment, thoroughly evaluate its
properties, purposes, effects, and possible risks (their natures, 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/endoscopic treatment and take proper measures if the risks to the
patient become greater than the potential benefits.
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CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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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 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.
Terms used in this manual
NBI (Narrow Band Imaging) observation
This is a special observation using the narrow band observation light.
Normal light observation (WLI (White Light Imaging) observation)
This is an observation using the standard RGB illumination.
User qualifications
If there is an official standard on the qualification of endoscopy and endoscopic
treatment that is defined by the medical administration or other official
institutions such as the academic society on endoscopy, follow the standard. If
there is no official qualification standard, 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 medical safety manager of the hospital or person
in charge of the department should select a physician who is performing the
planned endoscopic treatment safely by following the official guidelines set by
the academic society of endoscopy, etc.
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 the EMC standard for medical electrical
equipment; edition 2 (IEC 60601-1-2: 2001). However, when connecting with an
instrument that complies with the EMC standard for medical electrical
equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with
edition 1 (see “EMC information” on page 117 for EMC compliance level).
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Important Information — Please Read Before Use
Reprocessing before the first use/reprocessing and
storage after use
This instrument was not cleaned, 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, “Reprocessing: General Policy” through Chapter 9, “Storage,
Transporting the Endoscope Outside the Hospital and Disposal”. Improper
and/or incomplete reprocessing or storage can present an infection-control risk,
cause equipment damage or reduce performance.
Spare equipment
Be sure to prepare another endoscope to avoid that the examination will be
interrupted due to equipment failure or malfunction.
Maintenance management
The probability of failure of the endoscope 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. An endoscope with an observed irregularity
should not be used, but should be inspected by following Section 10.1,
“Troubleshooting guide” on page 108. If the irregularity is still observed after
inspection, contact Olympus.
Prohibition of improper repair and modification
This instrument 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. Some problems that appear to be malfunctions
may be correctable by referring to Chapter 10, “Troubleshooting”. If the problem
cannot be resolved using the information in Chapter 10, contact Olympus.
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.
4
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Important Information — Please Read Before Use
Signal words
The following signal words are used throughout this manual:
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.
Warnings and cautions
Follow the warnings and cautions given below when handling this instrument.
This information is to be supplemented by the warnings and cautions given in
each chapter.
•
Push the video connector until it clicks into the video system
center, then confirm that the video connector is securely
attached by pulling it gently. An improper connection will
damage the CCD. A damaged CCD will display no image
and make the distal end hot, which could cause operator
and/or patient burns.
•
After using this instrument, reprocess and store it according
to the instructions given in Chapter 5, “Reprocessing:
General Policy” through Chapter 9, “Storage, Transporting
the Endoscope Outside the Hospital and Disposal”. Using
improperly or incompletely reprocessed or stored instruments
may cause patient cross-contamination and/or infection.
•
Do not strike, bend, hit, pull, twist, or drop the endoscope’s
distal end, insertion tube, bending section, and control
section with excessive force. The endoscope may be
damaged and could cause patient injury, such as burns,
bleeding, and/or perforation. It could also cause parts of the
endoscope to fall off inside the patient.
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Important Information — Please Read Before Use
•
Never perform angulation control forcibly or abruptly. Never
forcefully pull, twist or rotate the angulated bending section.
Patient injury, bleeding and/or perforation can result. It may
also become impossible to straighten the bending section
during an examination.
•
Never perform angulation control or insertion/withdrawal of
the endoscope’s insertion tube without viewing the
endoscopic image. Patient injury, bleeding and/or perforation
can result.
•
Never insert or withdraw the endoscope’s insertion tube while
the UP/DOWN angulation is locked. Patient injury and/or
equipment damage can result.
•
Although the illumination light emitted from the endoscope’s
distal end is required for endoscopic observation and
treatment, it may also alter living tissues by, for example,
causing protein denaturation of living tissue, or perforation of
the intestines.
Observe the following warnings with regard to illumination.
Always set the minimum required brightness. The
brightness of the image on a monitor may differ from the
actual brightness at the distal end of the endoscope.
Pay attention to the brightness level setting of the light
source, particularly when operating the electrical shutter
function of a video system center. When using a light
source and video system center that are compatible with
the light source’s automatic brightness control function,
make sure to use the function. The automatic brightness
control function can better maintain the illumination level.
Refer to the instruction manual for the light source and the
video system center for further details.
Do not continue observation in close proximity to tissue or
keep the distal end of the endoscope in contact with living
tissue for a long time.
When the endoscope will not be used for a long period, be
sure to turn OFF the light source or activate the light
shield function (standby mode, etc.) so that the
endoscope is not illuminated unnecessarily.
6
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Important Information — Please Read Before Use
•
Do not touch the metal part of the light guide and the light
guide connector immediately after removing the light guide
from the endoscope and light source because they are
extremely hot. Operator and/or patient injury can result.
•
Never insert or withdraw the insertion tube abruptly or with
excessive force. Patient injury, bleeding and/or perforation
can result.
•
Never use high-frequency EndoTherapy accessories
because the endoscope’s distal end is not insulated. Using
high-frequency accessories presents a risk of electric shock
to the patient and/or may damage of the endoscope.
•
When the endoscopic image does not appear on the monitor,
the CCD may have been damaged. Turn the video system
center OFF immediately. Continued power supply in such a
case will cause the distal end to become hot and could cause
operator and/or patient burns.
•
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 or patient injury can result.
•
If the endoscopic image becomes dimmer during the
procedure, it may indicate that blood or mucus is adhering to
the light guide lens on the distal end of the endoscope.
Carefully withdraw the endoscope from the patient and
remove blood or mucus to restore optimum illumination and
to ensure the safety of the examination. If you continue to
use the endoscope with its light guide lens obstructed, the
temperature at the distal end may rise and cause mucosal
burns to the patient. It may also cause patient and/or
operator injury.
•
Generally, reprocessing agents1 are aggressive and might
affect the distal end of the endoscope. When the effect
progresses, fogging of the inner lenses might appear, which
results in a foggy video image. Any further use of the
endoscope under this condition might lead the lens to come
off. Before inserting the endoscope into a patient, make sure
that no foggy video image appears, and wipe the outer
surface of the lens at the distal end of the endoscope with a
soft cloth. In case a foggy image appears, stop using the
endoscope immediately.
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Important Information — Please Read Before Use
•
For reasons described below, do not rely on the NBI2
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 differentiation or
establishing the presence or absence of dysplasia or
neoplastic changes within mucosa or mucosal lesions.
•
Be sure to prepare another endoscope to avoid that the
examination will be interrupted due to equipment failure or
malfunction.
1
Contact Olympus for the names of specific brands that have
been tested for compatibility with the endoscope.
2
NBI stands for Narrow Band Imaging. For more details, refer
to the instruction manual for the video system center CV-180
or OTV-S7Pro.
8
•
Do not pull the universal cord during an examination. The
light guide connector will be pulled out from the output socket
of the light source and the endoscopic image will not be
visible.
•
Do not pull the video cable during an examination. The
endoscopic image may not be visible anymore.
•
Do not coil the insertion tube, universal cord or video cable
into a diameter of less than 10 cm. Equipment damage can
result.
•
Do not apply shock to the distal end of the insertion tube,
particularly the objective lens surface at the distal end.
Visual abnormalities may result.
•
Do not twist or bend the bending section with your hands.
Equipment damage may result.
•
Do not squeeze the bending section forcefully. The covering
of the bending section may stretch or break, and it may
cause water leaks.
•
Do not insert the video connector while the electrical contacts
are wet and/or dirty. Doing so may result in electric shock,
causing severe damage to the endoscope and compromising
patient and/or operator safety.
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Important Information — Please Read Before Use
•
The endoscope’s remote switches cannot be removed from
the control section. Pressing or pulling them with excessive
force can break the switches and/or may cause water leaks.
•
Turn the video system center ON or OFF only when the video
connector is connected to it. In particular, confirm that the
video system center is OFF before connecting or
disconnecting the video connector to/from the video system
center. Failure to do so can result in equipment damage,
including destruction of the CCD.
•
When the endoscope is dropped or the distal end of the
endoscope receives hard impact, the endoscope may be
damaged even if no visible damage of the lens on the distal
end can be found. In this case, stop using the endoscope,
and contact Olympus.
•
Do not attempt to bend the endoscope’s insertion tube with
excessive force. Otherwise, the insertion tube may be
damaged.
•
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 endoscope contains a memory chip that stores
information about the endoscope and communicates this
information to the video system center OTV-S7Pro or
CV-180.
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Important Information — Please Read Before Use
Precaution for disappeared or frozen endoscopic
image
•
If the endoscopic image unexpectedly disappears or the
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
in such condition may cause patient injury, such as bleeding
and/or perforation.
•
Follow the precautions given below. Otherwise, the
endoscopic image may disappear unexpectedly or the frozen
image may not be restored during the examination.
Connect the video connector and video system center
properly by pushing the video connector until it clicks.
Otherwise, faulty contact can result.
Make sure that the video connector and its electrical
contacts are completely dry before connecting the video
connector to the video system center. Wet contacts could
cause the equipment to malfunction.
Do not bend, hit or twist the insertion tube, control section,
universal cord and video connector. The endoscope may
be damaged and water leaks and/or breakage of internal
parts like the CCD cable can result.
If air bubbles emerge from the endoscope continuously
during the leakage test, do not use the endoscope. Water
may enter the instrument and cause a short circuit. This
may result in breakage of the switches and CCD.
10
•
Turn the video system center ON or OFF only when the video
connector is connected to it. In particular, confirm that the
video system center is OFF before connecting or
disconnecting the video connector to/from the video system
center. Failure to do so can result in equipment damage,
including destruction of the CCD.
•
Do not hit or bend the electrical contacts on the video
connector. The connection to the video system center may
be impaired and faulty contact can result.
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Important Information — Please Read Before Use
Examples of inappropriate handling
Details on clinical endoscopic technique are the responsibility of trained
specialists. Patient safety in endoscopic examinations and endoscopic treatment
can be ensured through appropriate handling by the physician and the medical
facility. Examples of inappropriate handling are given below:
•
Applying prolonged suction with the distal end in contact with the
mucosal surface, with higher suction pressure than required or with
prolonged suction time may cause bleeding and/or lesions.
•
Inserting, withdrawing and using EndoTherapy accessories without a
clear endoscopic image may cause patient injury, bleeding, burns and/or
perforation.
•
Inserting or withdrawing the endoscope or operating the bending section
without a clear endoscopic image may cause patient injury, bleeding
and/or perforation.
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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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 cleaned, disinfected, or sterilized before shipment.
Before using this instrument for the first time, reprocess it according to the
instructions given in Chapters 5, “Reprocessing: General Policy” through 7,
“Cleaning, Disinfection, and Sterilization Procedures”.
Never use high-frequency EndoTherapy accessories
because the endoscope’s distal end is not insulated. Using
high-frequency accessories poses a risk of electrical shock to
the patient and/or damage of the endoscope may result. This
could also happen when using the forceps/irrigation plug of
the isolated type.
12
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Chapter 1 Checking the Package Contents
Endoscope
Channel-opening
cleaning brush
(MH-507)
Biopsy valve
(MAJ-579, 10 pcs)
Suction valve
(MAJ-207, 10 pcs)1
Single-use suction valve
(MAJ-209, 20 pcs)1
Suction cleaning
adapter
(MAJ-1077)
Forceps/irrigation plug
(Isolated type)
(MAJ-891)
Channel cleaning brush
(BW-15B)
Instruction manual
ETO cap (MB-156)
Instruction manual
(Forceps/irrigation plug
(Isolated type))
1 These products may not be available in some areas.
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature
and Specifications
2.1
Nomenclature
14. ETO Cap
10. Light guide connector
Universal cord
13. Venting connector
Video cable
Light guide
Serial number
12. UP mark
Electrical contacts
14
NTSC/PAL label
11. Video connector
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Chapter 2 Instrument Nomenclature and Specifications
4. Suction valve
(MAJ-207)
3. UP/DOWN angulation lock
5. Single-use suction
valve (MAJ-209)
2. UP/DOWN angulation
control lever
Control section
15. Identification mark for
STERRAD® 200/NX material
compatibility
6. Forceps/irrigation
plug (Isolated type)
(MAJ-891)
7. Instrument channel port
8. Color code
Light guide lens
9. Remote switches
Object lens
Boot
Suction cylinder
Instrument channel
Insertion tube/working length
Distal end
9. Remote switches
1. Bending section
Top view
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope functions
1. Bending section
The bending section moves the distal end of the endoscope when the UP/
DOWN angulation control lever is operated.
2. UP/DOWN angulation control lever
When turned in the “U” direction, the bending section moves UP; when
turned in the “D” direction, the bending section moves DOWN.
3. UP/DOWN angulation lock
Pushing this lever in the “F ” direction frees the angulation. Pushing the
lever in the opposite direction locks the bending section at any desired
position.
4. Suction valve (MAJ-207)
The suction valve is depressed to activate suction. The valve is also used to
remove any fluid or debris adhering to the objective lens.
Do not use the suction valve (MAJ-207) for more than 6
procedures.
5. Single-use suction valve (MAJ-209)
The suction valve is depressed to activate suction. The valve is also used to
remove any fluid or debris adhering to the objective lens.
The single-use suction valve (MAJ-209) is designed for a
single use only. Do not attempt to reuse or resterilize.
6. Forceps/irrigation plug (Isolated type) (MAJ-891)
Accessories are inserted through the forceps port. Fluid can be fed through
the irrigation port.
7. Instrument channel port
This channel is used for the insertion of EndoTherapy accessories and for
feeding fluid.
8. Color code
The color code is used to quickly determine the compatibility of
EndoTherapy accessories. The endoscope can be used with EndoTherapy
accessories that have the same color code.
• Blue:
CHF-V
9. Remote switches “1” to “4”
The functions of remote switches 1 to 4 can be selected on the video system
center. When selecting the functions, refer to the instruction manual for the
video system center.
16
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Chapter 2 Instrument Nomenclature and Specifications
10. Light guide connector
The light guide connector connects the endoscope to the output socket of
the light source and transmits light from the light source to the endoscope.
11. Video connector
The video connector connects the endoscope to the output socket of the
video system center so that the endoscopic image becomes visible.
The endoscope contains a memory chip that stores information about the
endoscope and communicates this information to the video system center
OTV-S7Pro or CV-180. For more details, refer to the instruction manual for
the OTV-S7Pro or CV-180.
12. UP mark
When the video connector is connected to the video system center, this
mark is facing upward.
13. Venting connector
Attach the ETO cap or leakage tester here.
14. ETO Cap
The ETO cap must be installed prior to ethylene oxide gas sterilization and
aeration and removed prior to immersion or clinical examination. The cap
must also be attached when the endoscope is transported outside the
hospital (shipment, return for repairs, etc.).
15. Identification mark for STERRAD® 200/NX material compatibility
This mark indicates that this endoscope has material compatibility with the
STERRAD® 200/NX Sterilization System. The endoscope without this
mark is not applicable to STERRAD® 200/NX.
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Chapter 2 Instrument Nomenclature and Specifications
2.3
Specifications
Environment
Operating
environment
Ambient temperature
10 – 40C (50 – 104F)
Relative humidity
30 – 85%
Atmospheric pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
Transportation and
storage
environment
Ambient temperature
–47 to 70C (–52.6 to 158F)
Relative humidity
10 – 95%
Atmospheric pressure
700 – 1060 hPa
(0.7 – 1.1 kgf/cm2)
(10.2 – 15.4 psia)
18
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Chapter 2 Instrument Nomenclature and Specifications
Specifications
Endoscope
Model
Optical system
CHF-V
Field of view
120
Direction of view
Insertion tube
0 (Forward viewing)
Depth of field
3 – 50 mm
Distal end outer
diameter
ø 4.9 mm
Distal end enlarged
1. Objective lens
2. Light guide lens
3. Instrument channel outlet
3.
UP
2.
1.
2.
DOWN
Insertion tube outer
diameter
Working length
Instrument
channel
Channel inner diameter
Minimum visible
distance
ø 5.2 mm
380 mm
ø 2.0 mm
3 mm
Direction from which
EndoTherapy
accessories enter and
exit the endoscopic
image
Bending section
Angulation range
UP 160, DOWN 130
Total length
660 mm
NBI1
Available
1 NBI stands for Narrow Band Imaging. For more details, refer to the
instruction manual for the video system center CV-180 or OTV-S7Pro.
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V
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Chapter 2 Instrument Nomenclature and Specifications
Medical Devices
Directive
EMC
This device complies with the
requirements of Directive 93/42/EEC
concerning medical devices.
Classification: Class II a
Applied standard;
IEC 60601-1-2: 2001
This instrument complies with the
standards listed in the left column.
CISPR 11 of emission:
Group 1, Class B
This instrument complies with the
EMC standard for medical electrical
equipment; edition 2 (IEC 60601-1-2:
2001). However, when connecting to
an instrument that complies with the
EMC standard for medical electrical
equipment; edition 1 (IEC 60601-1-2:
1993), the whole system complies
with edition 1.
Year of manufacture
2001234
The last digit of the year of
manufacture is the second digit of the
serial number.
Degree of protection
against electric
shock
20
TYPE BF applied part
CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V