PDF - PENTAX Medical

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INSTRUCTIONS FOR USE
(REPROCESSING/MAINTENANCE)
PENTAX VIDEO GI SCOPES
90i SERIES
90K SERIES
This instruction for use describes the recommended procedures for the reprocessing and
maintenance of the equipment after its use.
For the inspection and direction for use, please refer to the separate operation
instruction for use.
Intended Use (Gastroscopes)
These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Upper
Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach,
Duodenum and Small Bowel.
These instruments are introduced via the mouth or the nose as decided by the physician, when indications consistent with the
need for procedure are observed in adult and pediatric patient populations.
Never use these endoscopes for any purpose other than that for which they have been designed.
The EG-2790i, 2990i, and 2990Zi can only be used with PENTAX video processor, model EPK-i series.
The EG-1690K, 2490K, 2790K, 2990K, 3490K, and 3890TK can be used with PENTAX video processor, model EPK-i series or
EPK-1000.
Intended Use (Duodenoscopes)
The model ED-3490TK, the Video Duodenoscopes are intended to provide optical visualization of (via a video monitor), and
therapeutic access to, the Billiary Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems:
Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts.
These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in
adult and pediatric patient populations.
The ED-3490TK can only be used with PENTAX video processors, model EPK-i series or EPK-1000.
Intended Use (Colonoscopes)
These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Lower
Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel.
These instruments are introduced via the rectum when indications consistent with the need for the procedure are observed in
adult and pediatric patient populations. Never use these endoscopes for any purpose other than that for which they have been
designed.
The EC-2990Li/Fi/Mi, 3490Fi/Mi/Li, 3490TLi/TFi/TMi, 3890Fi/Fi2/Mi/Mi2/Li, and 3890LZi/FZi/MZi can only be used with PENTAX
video processor, model EPK-i series.
The EC-3490FK/MK/LK, 3890FK/FK2/MK/MK2/LK, and 3890TLK/TFK/TMK can be used with PENTAX video processor, model
EPK-i series or EPK-1000.
Intended Use (Small Bowel Enteroscopes)
The model VSB-2990i, the Video Small Bowel Enteroscopes are intended to provide optical visualization of (via a video monitor),
and therapeutic access to, the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues;
and subsystems: Esophagus, Stomach, Duodenum and Small Bowel. These instruments are introduced via the mouth or the
rectum as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric
patient populations.
The VSB-2990i can only be used with PENTAX video processor, model EPK-i series.
Sterility Statement
These endoscopes identified in this instruction for use (IFU) are reusable semi-critical medical devices. Since they are packaged
non-sterile, they must be cleaned and either high-level disinfected or sterilized BEFORE initial use. Prior to each subsequent
procedure, they must be subjected to an appropriate cleaning and either high-level disinfection or sterilization process. After
servicing, all endoscopes and their components must be reprocessed prior to clinical use.
Contraindication
Please consult regional and national health authority recommendations and requirements regarding protocols to follow in order to
reprocess and/or destroy endoscopes that will be used or have been determined to have been used (post procedure) on patients
afflicted with Creutzfeldt-Jacob Disease (CJD or vCJD).
Notes
This IFU has been written having regard to ISO 17664 and national guidelines on reprocessing of medical products (e.g., RKI,
DGS/DHOS).
Read this IFU before operating, and save this book for future reference. Failure to read and thoroughly understand the information
presented in this IFU, as well as those developed for ancillary endoscopic equipment and accessories, may result in serious
injury including infection by cross contamination to the patient and/or user. Furthermore, failure to follow the instructions in this
IFU and the companion IFU may result in damage to, and/or malfunction of, this equipment.
This IFU describes the recommended procedures for the reprocessing and maintenance of the equipment after its use.
It is the responsibility of each medical facility to ensure that only well educated and appropriately trained personnel, who are
competent and knowledgeable about the endoscopic equipment, antimicrobial agents/processes and hospital infection control
protocol be involved in the reprocessing of these medical devices.
Current infection control guidelines require that G.I. endoscopes and other semi-critical medical devices, that normally come into
contact with intact mucous membranes, such as in the gastrointestinal tract, must at least be cleaned and high-level disinfected
before patient use. Only the user can determine if an instrument has undergone appropriate infection control procedures prior to
each clinical use. It must be recognized that infection control practices involve many complex and often controversial issues which
are constantly evolving. PENTAX strongly recommends that user remain informed of the latest federal and local regulations, and
encourages users to follow infection control guidelines developed by various organizations for health care professionals.
The text contained in this IFU is common for various types/models of PENTAX endoscopes and users must carefully follow only
those sections and instructions pertaining to the specific instrument models identified on the separate IFU.
If you have any questions regarding any of the information in this IFU or concerns pertaining to the safety and/or use of this
equipment, please contact your local PENTAX representative.
TABLE OF CONTENTS
1. INTERNAL CHANNELS OF PENTAX ENDOSCOPES ...............................................................................1
1-1. Internal Channels ..........................................................................................................3
1-1-1. Video Colonoscopes/Gastroscopes ............................................................................3
1-1-2. Video Gastroscopes with a Single/Common Channel for Air/Water Delivery ...........................4
1-1-3. Video Duodenoscopes ...........................................................................................5
1-1-4. Two-Channel (Biopsy/Instrument) Video Endoscopes ......................................................6
1-2. Reprocessing System .....................................................................................................7
1-2-1. Video Colonoscopes/Gastroscopes ............................................................................7
1-2-2. Video Gastroscopes with a Single/Common Channel for Air/Water Delivery ...........................8
1-2-3. Video Duodenoscopes ......................................................................................... 10
1-2-4. Two-Channel (Biopsy/Instrument) Video Endoscopes .................................................... 11
2. CARE AFTER USE ................................................................................................................. 13
2-1. Endoscopes ............................................................................................................... 15
2-1-1. Pre-Cleaning .................................................................................................... 16
2-1-2. Leakage Testing ................................................................................................ 17
2-1-3. Cleaning ......................................................................................................... 17
2-1-4. High-Level Disinfection ....................................................................................... 36
2-1-5. Sterilization ..................................................................................................... 42
2-2. Endoscopic Accessory Instruments (EAIs) and Endoscope Components ....................................... 45
2-2-1. Cleaning ......................................................................................................... 45
2-2-2. High-Level Disinfection ....................................................................................... 47
2-2-3. Sterilization ..................................................................................................... 49
2-3. Water Bottle Assembly .................................................................................................. 51
3. POST REPROCESSING ............................................................................................................ 53
3-1. Servicing .................................................................................................................. 54
3-2. Care and Maintenance Tips ............................................................................................ 56
4. NOMENCLATURE AND FUNCTION ............................................................................................... 59
4-1. Video Endoscope ........................................................................................................ 59
Conventions
Throughout this IFU, the following conventions will be used to indicate a potentially hazardous situation which, if not avoided;
WARNING
: could result in death or serious injury.
CAUTION
: may result in minor or moderate injury or property-damage.
NOTE
: may result in property-damage. Also, advises owner/operator about important information on the use of this
equipment.
Prescription Statement
Federal (U.S.A) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical
professional.
Symbols on Marking
Symboles distinctifs
Symbol for “MANUFACTURER”
Attention, consult instructions for use
Attention, consulter le manuel d’utilisation
Symbol for “DATE OF MANUFACTURE”
Type BF applied part (Safety degree specified by IEC 60601-1)
Partie appliquée de type BF (niveau de sécurité spécifié par la norme CEI 60601-1)
Symbol for “Authorised Representative in the European Union”
このCEマーキングはEC指令への適合宣言マークです。
The CE marking assures that this product complies with the requirements of the EC directive for safety.
Das CE Zeichen garantiert, daß dieses Produkt die in der EU erforderlichen Sicherheitsbestimmungen erfüllt.
Le logo CE certifie que ce produit est conforme aux normes de sécurité prévues par la Communauté Européenne.
II marchio CE assicura che questo prodotto è conforme alle direttive CE relative alla sicurezza.
La marca CE asegura que este producto cumple todas las directivas de seguridad de la CE.
1. INTERNAL CHANNELS OF PENTAX ENDOSCOPES
The following internal schematics have been provided as a service to help users
better understand the intricate construction of PENTAX endoscopes. Knowledge
of the various internal channels and tubes within an instrument and their relation
to each other allows one to care for and reprocess the endoscope more easily and
with greater confidence.
Much time and effort has been expended into designing endoscopes and their
cleaning/disinfecting components so that reprocessing of the instruments before
each patient use can be effectively and efficiently performed by either manual
methods or automated processes.
Connectors on most PENTAX cleaning/disinfecting adapters and instrument
channel inlet incorporate standard size luer-lock and/or luerslip fittings to easily
accommodate reprocessing devices or systems available from other manufacturers.
As can be seen from these internal schematics, the PENTAX cleaning system
promotes efficient unidirectional flow of solution beginning from connections at
the light guide plug, traveling up tubings in the umbilical cord to the valve
cylinders in the control body, passing through the channels in the insertion tube
and finally exiting nozzles or channel openings at the distal tip of the endoscope.
The elimination of multiple branching of channels, combined with a direct and
straightforward pathway for solutions to travel maximizes flow efficiency and
ensures contact of detergent/disinfectant/sterilant with all internally exposed
channel surfaces.
WARNING:
(in the U.S.A. or other countries adhering to FDA regulations)
It is imperative that flexible endoscopes and other semi-critical
devices be reprocessed using at least high-level disinfection with
a legally marketed disinfectant. Only legally marketed
endoscope automated reprocessing devices/systems whose
device specific claims have been validated by the Automated
Endoscope
Reprocessor(AERs)/Washer-Disinfectors(WD)
manufacturers and/or anti-microbial agents which have been
tested and found to be compatible by PENTAX should be used
with PENTAX products.
It should be noted that only legally marketed AERs and
reprocessing devices/systems, or cleared antimicrobial agents
which have been tested by PENTAX and found to be compatible
with the materials in PENTAX endoscopes should be used with
PENTAX products. All AER reprocessing claims, reprocessing
instructions, validation studies, and compliance with local
regulations and/or professional guidelines are the responsibility
of the AER manufacturer.
–1–
Items required for reprocessing:
• Syringes: various sizes can be
used including 10/20cc, 50/60cc,
etc.
• Tray/Reprocessing basin (at least
40 cm by 40 cm/16 in × 16 in)
• Soft Sponge
• Personal protective equipment
(PPE) including gloves, face mask,
etc.
• Soft sterile gauze
• PVE soaking cap OE-C9
• PENTAX cleaning adapter OF-B153
• PENTAX cleaning adapter OF-G17
• PENTAX water jet check valve
adapter OE-C12
• PENTAX irrigation tube OF-B113
• PENTAX suction channel selector
OF-B161
• PENTAX two-channel cleaning
adapter OF-B162
Model
Instrument
Channel
Single
Two
• PENTAX inlet seal
• PENTAX channel cleaning brush
CS6021T
• PENTAX cylinder cleaning brush
CS-C9S
• PENTAX channel cleaning brush
CS-6030SN
• Detergent
• Disinfectant
• 70-90% medical grade ethyl or
isopropyl alcohol
• Source of compressed/forced air
Common
Direction of View
A/W
channel Forward Oblique
Water
Jet
EG-2790i
X
X
EG-2990i
X
X
EG-1690K
X
EG-2490K
X
X
EG-2790K
X
X
EG-2990K
X
X
X
EG-2990Zi
X
X
X
EG-3490K
X
X
X
X
X
EG-3890TK
X
X
X
X
ED-3490TK
X
X
EC-2990Li/Fi/Mi
X
X
X
X*
EC-3490Fi/Mi/Li
X
X
X
EC-3490FK/MK/LK
X
X
X
EC-3490TLi/TFi/TMi
X
X
X
EC-3890Fi/Fi2/Mi/
Mi2/Li
X
X
X
EC-3890FK/FK2/MK/
MK2/LK
X
X
X
EC-3890LZi/FZi/MZi
X
X
X
X
X
X
EC-3890TLK/TFK/TMK
VSB-2990i
X
X
* See p.5 for drawing of elevator mechanism
–2–
Elevator
mechanism
1-1. Internal Channels
1-1-1. Video Colonoscopes/Gastroscopes
EG-2490K/2790K/2990K/3490K, EG-2790i/2990i, EG-2990Zi,
EC-3490FK/MK/LK, EC-3890FK/FK2/MK/MK2/LK,
EC-2990Li/Fi/Mi, EC-3490Fi/Mi/Li, EC-3490TLi/TFi/TMi,
EC-3890Fi/Fi2/Mi/Mi2/Li, EC-3890LZi/FZi/MZi, VSB-2990i
Inlet Seal
Water Feeding Channel
Instrument
Channel Inlet
Air/Water
Feeding Valve
Suction Control Valve
Air Feeding Channel
Water Nozzle
Air Nozzle
Instrument Channel
*Water Jet Channel
EG-2990i/2990Zi
Air Feeding Channel
Instrument Channel
Air/Water
Nozzle
*Water Jet Channel
*Scopes with Water Jet System
*Water jet check valve
adapter
OE-C12
with
Check-valve
OE-C14
Water Feeding
Tube
Air Feeding Tube
*Water Jet Port
Water Bottle
Assembly
Air
Pump
Suction Tube
Suction Source
Video Processor
The illustration above shows the actual routes taken by air, water, suction and
water jet through “single biopsy/instrument channel” PENTAX Video endoscopes.
During clinical use a check-valve, OE-C14 should be attached to the check valve
unit, OE-C12 within the PENTAX water jet channel system.
–3–
1-1-2. Video Gastroscopes with a Single/Common Channel for Air/Water Delivery
EG-1690K
Air/Water Feeding Valve
Instrument Channel Inlet
Inlet Seal
Air/Water Feeding Channel
Air/Water Nozzle
Instrument Channel
Air Feeding Tube
Water Feeding
Tube
Suction Tube
Air
Pump
Water Bottle
Assembly
Suction Source
Video Processor
The illustration above shows the actual routes taken by air, water and suction
through PENTAX video endoscopes with a single/common channel for air/water
delivery and suction.
–4–
1-1-3. Video Duodenoscopes
ED-3490TK
Inlet Seal
Air Feeding Channel
Air/Water Nozzle
Instrument Channel
* Elevator mechanism in ED-series distal tip
Air Feeding Tube
Water Feeding
Tube
Suction Tube
Air
Pump
Water Bottle
Assembly
Suction Source
Video Processor
The illustration above shows the actual routes taken by air, water and suction
through PENTAX video duodenoscopes.
NOTE:
The elevator control wire/channel is completely sealed and
therefore not exposed to potential contaminants and/or patient
debris.
–5–
1-1-4. Two-Channel (Biopsy/Instrument) Video Endoscopes
EG-3890TK, EC-3890TLK/TFK/TMK
Instrument
Channel Inlet
Air Feeding Channel
Air Nozzle
Inlet Seal
Air/Water
Feeding Valve
Instrument
Channel
Selecter
Water
Nozzle
Instrument Channel
*Water Jet Channel
Suction Tube
* Scopes with
Water Jet System
* Water jet check valve adapter
OE-C12 with
Check-valve
OE-C14
Air Feeding
Tube
* Water
Jet Port
Air
Pump
Water Feeding Tube
Water Bottle
Assembly
Suction Source
Video Processor
The illustration above shows the actual routes taken by air, water, suction and
water jet through PENTAX Two-Channel (biopsy/instrument) video endoscopes.
During clinical use a check-valve, OE-C14 should be attached to the check
valve, OE-C12 within the PENTAX water jet channel system.
–6–
1-2. Reprocessing System
1-2-1. Video Colonoscopes/Gastroscopes
EG-2490K/2790K/2990K/3490K, EG-2790i/2990i, EG-2990Zi,
EC-3490FK/MK/LK, EC-3890FK/FK2/MK/MK2/LK,
EC-2990Li/Fi/Mi, EC-3490Fi/Mi/Li, EC-3490TLi/TFi/TMi,
EC-3890Fi/Fi2/Mi/Mi2/Li, EC-3890LZi/FZi/MZi, VSB-2990i
Cleaning Adapter
Inlet Seal
Air Feeding Channel
Water Nozzle
Instrument Channel
Air Nozzle
EG-2990i/2990Zi
Instrument (OF-B153)
Channel Inlet
*Water Jet Channel
Air Feeding Channel
*Scopes with Water Jet System
Instrument Channel
Air/Water
Nozzle
Water Feeding
Tube
*Water Jet Channel
PVE Soaking Cap
(ATTACH)
Air Feeding Tube
Cleaning Adapter
OF-G17
*Irrigation Tube
OF-B113
*OE-C12 without check-valve
Suction Tube
Suction Nipple
Ventilation Cap
(REMOVE)
Luer-Slip Syringe with
Cleaning/Disinfecting
Solution
CAUTION:
BEFORE IMMERSING:
a) The “Red” ventilation cap must be taken OFF.
b) The PVE Soaking cap should be securely ON the electrical
contacts.
To reprocess a PENTAX video endoscope, first an appropriate cleaning
detergent and then a high-level disinfectant or sterilant must be exposed to all
internal lumens as well as to all external instrument surfaces and endoscope
components (air/water feeding valve, suction control valve, etc.). Exposure
times, concentration, and temperature of detergent and disinfectant/sterilant must
be strictly adhered to.
–7–
Please note that all solution entrance ports and flow pathways are illustrated
above.
*Be aware that during reprocessing check-valves, OE-C14 should be removed
from the check valve, OE-C12 to allow for unrestricted flow of reprocessing
agents through the PENTAX water jet channel system.
WARNING:
Prior to disinfection or sterilization of all instruments and
components must be scrupulously cleaned including manual
brushing of all brushable channels.
1-2-2. Video Gastroscopes with a Single/Common Channel for Air/Water Delivery
EG-1690K
Inlet Seal
Air/Water Nozzle
Cleaning Adapter (OF-B153)
Instrument Channel
Air Feeding Tube
Water Feeding
Tube
Suction Tube
Cleaning Adapter OF-G17
PVE Soaking Cap (ATTACH)
Suction Nipple
Ventilation Cap
(REMOVE)
Solution
–8–
CAUTION:
BEFORE IMMERSING:
contacts.
To reprocess a PENTAX video endoscope with a single/common channel, first
an appropriate cleaning detergent and then a high-level disinfectant or sterilant
must be exposed to all internal lumens as well as to all external instrument
surfaces and endoscope components (air/water feeding valve, suction control
valve, etc.). Exposure times, concentration, and temperature of detergent and
disinfectant/sterilant must be strictly adhered to. Please note that all solution
entrance ports and flow pathways are illustrated above.
WARNING:
–9–
1-2-3. Video Duodenoscopes
ED-3490TK
Inlet Seal
Air/Water Nozzle
Cleaning Adapter OF-B153
Air Feeding Channel
Instrument Channel
Air Feeding Tube
Water Feeding
Tube
Suction Tube
Cleaning
Adapter OF-G17
PVE Soaking Cap (ATTACH)
Suction Nipple
Ventilation Cap
(REMOVE)
Solution
CAUTION:
BEFORE IMMERSING:
contacts.
To reprocess a PENTAX video endoscope, first an appropriate cleaning
components (air/water feeding valve, suction control valve, etc.). Exposure
times, concentration, and temperature of detergent and disinfectant/sterilant must
be strictly adhered to. Please note that all solution entrance ports and flow
pathways are illustrated above.
– 10 –
NOTE:
• Since the elevator control wire/channel is fully enclosed and
not exposed to patient material, it does not require special
reprocessing. However, the actual elevator mechanism (front,
back and base) must be cleaned and thoroughly reprocessed.
• Be aware that all recessed areas around the elevator
mechanism should be thoroughly cleaned with an
appropriately sized cylinder cleaning brush (e.g. CS-C9S) and
in a cleaning detergent solution.
WARNING:
1-2-4. Two-Channel (Biopsy/Instrument) Video Endoscopes
Instrument Channel
Inlet
Air Feeding Channel
Water Nozzle
Suction Channel
Selector OF-B161 or
Two channel cleaning
adapter OF-B162
Inlet Seal
Cleaning Adapter OF-B153
Air Nozzle
Instrument Channel
Water Jet Channel*
*Scopes with
Water Jet System
Suction Tube
Cleaning Adapter
OF-G17
*lrrigation Tube
*OF-B113
PVE Soaking Cap
(ATTACH)
Water Feeding Tube
OE-C12 without check-valve*
Air Feeding Tube
Ventilation Cap
(REMOVE)
Luer-Slip Syringe
with
Solution
– 11 –
CAUTION:
BEFORE IMMERSING:
contacts.
To reprocess a PENTAX Two-Channel Video Endoscope, first a cleaning
components (air/water feeding valve, suction control valve, etc.).
Exposure times, concentration, and temperature of detergent and disinfectant/
sterilant must be strictly adhered to.
Please note that all solution entrance ports and flow pathways are illustrated
above. Be aware that during reprocessing check-valves, OE-C14 should be
removed from the check valve, OE-C12 to allow for unrestricted flow of
reprocessing agents through the PENTAX water jet channel system.
WARNING:
– 12 –
2. CARE AFTER USE
IMPORTANT INSTRUCTIONS
Cleaning-Disinfection-Sterilization: PENTAX Endoscopes
To maintain maximum performance and a long service life of the endoscope,
proper care after each procedure is extremely important. Immediately after (at
least within one hour) the completion of a procedure, the endoscope and its
components should be thoroughly and carefully cleaned. If the endoscope or its
components are left uncleaned for some time after use, dried blood, mucous,
contrast material or other patient debris may cause damage to the instrument
(component) or may interfere with the ability of the user to properly reprocess
the endoscope or component.
NOTE:
This reprocessing/maintenance instruction for use contains
detailed recommendations on the manual reprocessing of
PENTAX endoscopes using PENTAX supplied cleaning/disinfecting
adapters. Automated endoscope reprocessors(AERs)/WasherDisinfectors (WDs) may provide a means of reprocessing flexible
endoscopes, including PENTAX instruments. However, only those
Automated endoscope reprocessors(AERs)/Washer-Disinfectors
(WDs) should be used whose manufacturers provide devicespecific instructions and have validation data that support each
AER/WD claim with respect to PENTAX model instruments. AER/
WD manufacturers should be consulted for their specific claims
including but not necessarily limited to
a) the ability of the AER/WD to provide a cleaned and high-level
disinfected (or sterilized) endoscope and endoscope
components (eg., valves),
b) the identification of any special feature area (internal
channel) or endoscope component that can not be
reprocessed and therefore requires manual reprocessing,
c) the microbial quality of the rinse water,
d) the inclusion of an “automated” alcohol rinse cycle,
e) the inclusion of a terminal drying cycle that removes the
majority of water/fluid within endoscope channels,
f) maintenance procedures for water filter replacement and/or
decontamination of the filtration system to ensure the
microbial claim of water, etc.
g) compliance with local regulations and/or guidelines.
– 13 –
CAUTION:
(Automated Reprocessing) Unless the AER/WD has validated
channel monitoring capability for device-specific endoscope
models,
• prior to "automated reprocessing" check and confirm the
patency of any lumens/channels to ensure that all internal
channels are unblocked and/or unclogged
• prior to use of any AER/WD confirm the integrity of all channel
tubes and recommended channel cleaning adapters
• once tubing sets are connected to the appropriate channels,
check the tubing to confirm that there are no kinks or crimps
that could restrict flow of solution throughout the endoscope
• (if the unit allows) during reprocessing check and confirm that
reprocessing solutions are exiting expected channel ports
Failure to adhere to the above recommendations could result in
inadequate cleaning, disinfection (or sterilization) of and/or
improper removal of residues from all instrument channels/
surfaces.
Summary of PENTAX Reprocessing Instructions
PENTAX reprocessing instructions can be broken down into six basic steps.
1.
2.
3.
4.
Pre-Cleaning (in the Examination Room) Section 2-1-1
Leakage Testing (in a designated Decontamination Area) Section 2-1-2
Cleaning (in a designated Decontamination Area) Section 2-1-3
High-Level Disinfection or Sterilization
(in a designated Decontamination Area) Section 2-1-4, 2-1-5
5. Endoscopic Accessory Instruments (EAIs) and Endoscope Components
Section 2-2
6. Post Reprocessing Chapter 3
NOTE:
The instructions for manual reprocessing of PENTAX endoscope
contained in this instruction for use are consistent with
reprocessing guidelines, developed by medical professional
organizations (eg., SGNA, ASGE, APIC, ESGE) and/or national
consensus groups (including ASTM).
NOTE:
Contact the manufacturer and follow local regulations regarding
safe use, appropriate handling and disposal of cleaning and
disinfection solution including alcohol. Material Safety Data
Sheets (Health and Safety Data Sheets or similar documents
depending upon country) available from the cleaning and
disinfection solution (including alcohol) manufacturer should
provide guidance to end users about composition, hazards,
chemical and physical properties, first aid, handling and storage,
stability, precautions, disposal, etc. associated with cleaning and
disinfection solution including alcohol.
– 14 –
2-1. Endoscopes
WARNING:
The importance of meticulous mechanical cleaning of the
endoscope and its removable components cannot be
overemphasized. Prior to disinfection or sterilization, all
instruments and components must be scrupulously cleaned.
Failure to do so could result in incomplete or ineffective
disinfection and sterilization. During the reprocessing process,
always wear protective garments such as gloves, gowns, face
masks, etc. to minimize the risk of cross contamination.
CAUTION:
To avoid damaging the endoscopes, do NOT twist, rotate or bend
excessively any of the strain relief boots (1), (2) during pre-use
inspection, clinical use, reprocessing, or any handling activity.
Be particularly cautious for the insertion tube strain relief
boot(1). When wiping the insertion tube and the cable, use a
slow back and forth motion to wipe them along the tube/cord.
Never apply excessive force or torque on these strain relief
boots or slim tubes/cords.
L U
L U
F
F
F
F
D
D
R
R
Do NOT Bend
D R
F
F
L U
Do NOT Twist or Rotate
(1)
(2)
Figure 2.1
– 15 –
2-1-1. Pre-Cleaning
Immediately after removing the endoscope from the patient, gently wipe all
debris from the insertion tube with gauze or the like moistened with a
cleaning detergent solution.
F
L U
1)
D
R
Figure 2.2
2)
Place the distal end of the endoscope into detergent solution and aspirate
through the biopsy/suction channel for 5 ~ 10 seconds. Alternate aspiration
of solution and air several times to create agitation for better pre-cleaning.
When finished, pull the distal tip out of the solution.
Figure 2.3
3)
4)
Set A/W Drain lever on the water bottle assembly to the drain position.
With the air pump of the video processor ON and set to the HIGHEST
pressure setting, depress the air/water feeding valve of the endoscope fully
until all water has been discharged from the endoscope. Alternate covering
of the hole in the valve and depressing the valve to forcefully expel mucous,
debris, etc. which may have entered the air and water nozzles.
(Only for models with a water jet channel system)
Attach the irrigation tube, OF-B113 to the water jet check valve adapter,
OE-C12. Connect a syringe filled with detergent solution to the OF-B113,
and flush the channel with the detergent. Fill the syringe with air and flush
through the channel several times to force any residual solution out of the
channel.
– 16 –
(1)
(1) Irrigation Tube
(OF-B113)
(2) Water Jet Check Valve
Adapter
(OE-C12)
(2)
Figure 2.4
5)
(For ED-3490TK) Using a 10/20 mL syringe filled with detergent solution,
inject the solution onto and surrounding the elevator mechanism so that all
recessed areas within the distal endoscope tip are exposed to the detergent.
2-1-2. Leakage Testing
Before reprocessing and/or immersion in any fluids, PENTAX endoscopes
should be tested for the loss of integrity in their watertight construction by using
PENTAX brand leakage testers. For specific details on PENTAX recommended
leak detection procedures, please refer to the instructions supplied with
PENTAX leakage testers.
CAUTION:
Various types of endoscope leakage testers exist including
manual, electro-mechanical and “automated” versions, some of
which are stand alone units and others which may be integrated
into AERs/WDs. It must be recognized that PENTAX does not
evaluate non-PENTAX leakage tester systems to satisfy their
specific product claims, for their effectiveness to accurately
detect leaks and/or for their compatibility with PENTAX
endoscopes. Insufficient pressures may reduce the likelihood for
accurate leak detection, especially if the endoscope’s distal
bending section is not flexed during testing. Excessive pressures
may adversely affect the endoscope, especially if pressurization
occurs during automated reprocessing at elevated temperatures.
PENTAX accepts no responsibility for use of non-PENTAX leakage
testers.
Users should check with the leakage tester manufacturer and
confirm their specific product claims, including compatibility with
PENTAX endoscopes at various temperatures and their ability to
detect leaks with/without fluid immersion and with/without
flexing of the endoscope’s distal bending section.
2-1-3. Cleaning
1)
Prepare a basin with water and an appropriate cleaning detergent per
detergent manufacturer’s instructions. The solutions should either be
cleaning detergents or other cleaning agents specially formulated to clean
flexible endoscopes. For specific brands of compatible solutions, please
contact your local PENTAX service facility or sales representative.
– 17 –
CAUTION:
BEFORE IMMERSING:
a) The PVE Soaking cap should be securely ON the electrical
contacts.
b) The “Red” ventilation cap must be taken OFF.
(1) PVE Soaking Cap
(OE-C9)
(2) Ventilation Cap
(OF-C5)
(1)
(2)
Figure 2.5
CAUTION:
The use of a cleaning detergent immediately after each
procedure to dissolve and remove organic contaminants and
proteinaceous debris is essential to the care and maintenance of
the endoscope from the standpoints of infection control and
functionality.
2)
Immerse the endoscope and its components in fresh detergent solution.
After removing the removable components, thoroughly (but gently) wash
the entire surface of the endoscope and its components.
(1)
(1) Suction Control Valve
(OF-B120)
(2) Air/Water Feeding
Valve (OF-B188)
(3) Inlet Seal(s)
(OF-B190)
(the second one is for
two-channel
video endoscopes only)
(4) Suction Channel
Selector (OF-B161)
(two-channel
endoscopes only)
Adapter (OE-C12)
(endoscopes with jet
system only)
(6) Water Jet Connector
Cap (OF-B118)
(endoscopes with
jet system only)
(2)
(4)
(3)
(5)
(6)
Figure 2.6
Make sure that the recessed areas such as the channel openings, valve cylinders,
elevator mechanism (if present), distal endoscope tip, etc. are brushed clean
using the provided brushes.
– 18 –
NOTE:
Cleaning detergent refers to cleaning solution specially
formulated for use and compatible with flexible endoscopes.
3) Manual Cleaning of Channels and/or Ports/Cylinders by Brush
A variety of special brushes have been provided to mechanically brush clean the
entire suction/instrument channels, all cylinders, ports and valves. The entire
endoscope should be immersed in detergent solution during the remainder of the
cleaning procedure.
CAUTION:
1) It is highly recommended that ONLY PENTAX cleaning
brushes specified in our instructions for use should be used
to clean PENTAX endoscopes.
2) PENTAX cleaning brushes have been specially designed to
clean various PENTAX internal channel systems and valves/
ports/cylinders. Validation studies have been performed
supporting the use of PENTAX supplied brushes and cleaning
adapters for cleaning PENTAX endoscopes following PENTAX
manual reprocessing instructions.
3) Over the years some other manufacturers’ cleaning brushes/
devices have been found to damage PENTAX endoscopes
and/or create the need for servicing as some cleaning
devices can become lodged (“stuck”) inside various lumens
of PENTAX endoscopes. The likelihood for endoscope damage
or servicing increases if a cleaning device does not have a
protective tip (or contains any sharp-edged surface), if its
flexible shaft uses a flimsy plastic material that is not firm
enough to allow for easy accessory advancement and/or if
the proper sequence and/or direction of channel cleaning is
not followed as described in PENTAX instructions for use.
4) The cleaning brushes should always be inserted as described
in PENTAX reprocessing/maintenance instructions for use.
5) It is recommended that cleaning brushes should be grasped
about 5 cm (2 inches) from any channel ports/openings while
advancing/withdrawing a brush. To avoid endoscope and
brush damage, do not use force.
6) To prevent excess friction between brush and channel, do
NOT tightly coil the endoscope while brushing. Keep the
insertion tube and umbilical cord as straight as possible and
never attempt to pass the cleaning brush through a fully
angulated endoscope. Failure to follow these instructions
could result in endoscope or brush damage.
7) The channel cleaning brushes CS6021T (disposable) should
NOT be inserted from the suction cylinder into suction tube
within the umbilical cord.
Bristles from the CS6021T could become stuck within the
suction cylinder when pulling it out from the suction nipple at
the PVE Connector.
– 19 –
a)
Models with a Water Jet channel
EG-2990Zi, 2990K, 3490K, 3890TK,
EC-3490FK/MK/LK, 3890FK/FK2/MK/MK2/LK, EC-2990Li/Fi/Mi, 3490Li/Fi/Mi,
3490TLi/TFi/TMi, 3890Fi/Fi2/Mi/Mi2/Li, 3890LZi/FZi/MZi
EG-2990i/2990Zi
(7) Air/Water Feeding Valve
Air Feeding Channel
(8) Air/Water Cylinder
Instrument Channel
Air/Water
Nozzle
Water Jet Channel*
Inlet Seal
(3) Instrument
Channel Inlet
(4) Suction Cylinder
(2) Instrument Channel
Air Feeding Tube
Water Feeding Tube
OE-C12 without
check-valve
(9) Water Jet Check Valve Adapter
Water Jet
Connector Cap
Air/Water Port
(10) Water Jet Cylinder
(1) Suction Tube
Suction Nipple
Fig
Place
Brush
Entrance
(1)
Suction Tube
CS6021T
Suction Nipple
(2)
Instrument Channel
CS6021T
Suction Cylinder
Distal Tip
[p.25]4)-c)
(3)
CS-C9S
—
[p.25]4)-a)
(4)
Suction Cylinder
CS-C9S
Suction Cylinder
—
[p.27]4)-e)
(5)
CS-C9S
—
[p.27]4)-f)
(6)
Elevator Mechanism
CS-C9S
—
—
—
(7)
CS-C9S
Air/water feeding valve
—
[p.28]5)-a)
(8)
Air/Water Cylinder
CS-C9S
Air/Water Cylinder
—
[p.29]5)-b)
CS-C9S
Water Jet Adapter
—
[p.29]6)-a)
CS-C9S
Water Jet Cylinder
—
[p.30]6)-b)
(9)
(10)
Water Jet Check Valve
Adapter
Water Jet Cylinder
Exit
– 20 –
Section
Suction
Cylinder
[p.25]4)-b)
b)
Models without a Water Jet channel system
EG-1690K
Inlet Seal
(3) Instrument
Channel Inlet
Air/Water Nozzle
Water Feeding Tube
Air Feeding Tube
(1) Suction Tube
Air/Water Port
Suction Nipple
Fig
Place
Brush
Entrance
(1)
Suction Tube
CS6021T
Suction Nipple
(2)
Instrument Channel
CS6021T
Suction Cylinder
Distal Tip
[p.25]4)-c)
(3)
CS-C9S
—
[p.25]4)-a)
(4)
Suction Cylinder
CS-C9S
Suction Cylinder
—
[p.27]4)-e)
(5)
CS-C9S
—
[p.27]4)-f)
(6)
Elevator Mechanism
CS-C9S
—
—
—
(7)
CS-C9S
—
[p.28]5)-a)
(8)
Air/Water Cylinder
CS-C9S
Air/Water Cylinder
—
[p.29]5)-b)
– 21 –
Exit
Suction
Cylinder
Section
[p.25]4)-b)
ED-3490TK
Inlet Seal
(6) Elevator
Mechanism
(3) Instrument
Channel Inlet
Air Feeding Channel
Water Feeding Tube
Air Feeding Tube
Air/Water Port
(1) Suction Tube
Suction Nipple
Fig
Place
Brush
Entrance
(1)
Suction Tube
CS6021T
Suction Nipple
(2)
Instrument Channel
CS6021T
Suction Cylinder
Distal Tip
[p.25]4)-c)
(3)
CS-C9S
—
[p.25]4)-a)
(4)
Suction Cylinder
CS-C9S
Suction Cylinder
—
[p.27]4)-e)
(5)
CS-C9S
—
[p.27]4)-f)
(6)
Elevator Mechanism
CS-C9S
—
[p.27]4)-g)
(7)
CS-C9S
—
[p.28]5)-a)
(8)
Air/Water Cylinder
CS-C9S
Air/Water Cylinder
—
[p.29]5)-b)
The areas in back of/
surrounding elevator
– 22 –
Exit
Suction
Cylinder
Section
[p.25]4)-b)
EG-2490K, EG-2790K, EG-2790i, VSB-2990i
Inlet Seal
(3) Instrument Channel Inlet
Air Feeding Tube
Water Feeding Tube
(1) Suction Tube
Fig
Place
(1)
Suction Tube
(2)
Instrument Channel
(3)
(4)
Brush
CS6021T/
CS6030SN*
CS6021T/
Entrance
Suction Nipple
Exit
Suction
Cylinder
Section
[p.25]4)-b)
Suction Cylinder
Distal Tip
[p.25]4)-c)/
[p.26]4)-d)*
CS-C9S
—
[p.25]4)-a)
Suction Cylinder
CS-C9S
Suction Cylinder
—
[p.27]4)-e)
(5)
CS-C9S
—
[p.27]4)-f)
(6)
Elevator Mechanism
N/A
—
—
[p.27]4)-g)
(7)
CS-C9S
—
[p.28]5)-a)
(8)
Air/Water Cylinder
CS-C9S
Air/Water Cylinder
—
[p.29]5)-b)
CS6030SN*
*(For VSB-2990i)
– 23 –
c) Models with Two Blopsy/Instrument Channels
(8) Instrument Channel Inlet
Inlet Seal
(5) Selector
(10) Air/Water
Cylinder
(4) Selector Cylinder*
Water Jet Channel
(2) Suction Channel
(11) Water Jet Check
Valve Adapter
Air Tube
(1) Suction Tube
(12) Water Jet Cylinder
Water Tube
Suction Nipple
Fig
Place
Brush
Entrance
(1)
Suction Tube
CS6021T
Suction Nipple
(2)
Suction Channel
CS6021T
Suction Cylinder
(3)
Instrument Channel
CS6021T
Distal Tip
[p.26]4)-c)
(4)
Selector Cylinder
CS-C9S
Selector Cylinder
—
[p.28]4)-h)
(5)
Selector
CS-C9S
Selector
—
[p.28]4)-i)
(6)
Suction Cylinder
CS-C9S
Suction Cylinder
—
[p.27]4)-e)
(7)
CS-C9S
—
[p.27]4)-f)
(8)
CS-C9S
—
[p.25]4)-a)
(9)
CS-C9S
—
[p.28]5)-a)
(10)
Air/Water Cylinder
CS-C9S
Air/Water Cylinder
—
[p.29]5)-b)
(11)
Water Jet Check Valve Adapter CS-C9S
Water Jet Adapter
—
[p.29]6)-a)
(12)
Water Jet Cylinder
Water Jet Cylinder
—
[p.30]6)-b)
CS-C9S
– 24 –
Exit
Suction
Cylinder
Selector
Cylinder
Section
[p.25]4)-b)
[p.26]4)-c)
4)
Brush clean the entire instrument/suction channel system:
(a)
Insert the large bristle of the cylinder cleaning brush (CS-C9S)
into the instrument channel inlet until the grip is stopped at the
inlet and scrub clean the surface inside the instrument channel
inlet and then gently withdraw the brush.
Repeat several times ensuring that only a clean brush is
introduced into the cylinder each time.
(1)
(3)
(1) Cylinder Cleaning
Brush (CS-C9S)
(2) Channel Cleaning
Brush (CS6021T/
CS6030SN)
Brush (CS6021T/
CS6030SN)
(2)
Figure 2.7
(1)
Brush (CS-C9S)
Inlet
(2)
Figure 2.8
(b)
(c)
Using the long channel cleaning brush CS6021T, insert back
end (blue) of the shaft of brush into the opening of the suction
nipple and gently pass the brush until it appears in the suction
control valve receptacle (suction cylinder). Grasp the back end
of the brush shaft and gently pull the brush from the receptacle.
This will clean the suction tube within the umbilical cord. Brush
this channel at least 2 times OR until it is visibly clean.
(For VSB-2990i) Using the long channel cleaning brush
CS6030SN, insert the brush into the opening of the suction
nipple and gently pass the brush until it appears in the suction
control valve receptable (suction cylinder).
(ALL ENDOSCOPES EXCEPT VSB-2990i and TWOCHANNEL VIDEO ENDOSCOPES) Insert the CS6021T (blue
coded end) into the opening at the bottom of the suction control
valve receptacle (suction cylinder) on the control head and
gently advance until it exits the endoscope distal tip. Grasp the
back end of the brush shaft and then gently pull the brush from
the endoscope distal tip. DO NOT USE EXCESS FORCE.
Brush this channel at least 2 times OR until it is visibly clean.
– 25 –
(TWO-CHANNEL VIDEO ENDOSCOPES ONLY) Insert the
CS6021T (blue coded end) into the opening at the bottom of the
suction control valve receptacle (suction cylinder) on the
control head and gently advance until it exits the selector
cylinder. Then, brush clean the selector cylinder and the selector
itself. Grasp the back end of the brush shaft and then gently pull
the brush from the cylinder of the suction channel selector. DO
NOT USE EXCESS FORCE. Brush this channel at least 2 times
OR until it is visibly clean.
(TWO-CHANNEL VIDEO ENDOSCOPES ONLY)
Insert the CS6021T (blue coded end) into the instrument
channel inlet and gently advance until it exits the endoscope
distal tip. Be sure to clean both channels very carefully. Then,
grasp the back end of the brush shaft and then gently pull the
brush from the endoscope distal tip. DO NOT USE EXCESS
FORCE. Repeat at least 2 times until it is visibly clean.
TWO-CHANNEL VIDEO ENDOSCOPES ONLY
(1)
(2)
(2)
(3)
Brush
(CS-C9S)
Brush (CS6021T)
Brush (CS6021T)
Brush (CS6021T)
(4)
Figure 2.9
(d)
(For VSB-2990i) Insert the brush (CS6030SN) into the opening at the
bottom of the suction control valve receptacle (suction cylinder) on
the control head and gently advance until it exits the endoscope distal
tip. DO NOT USE EXCESS FORCE. Then gently withdrawal the
brush. Repeat at least 3 times until it is visibly clean.
NOTE:
• The CS6021T is provided non-sterile for one time use. Never
reuse the brush on more than one instrument.
• When using the tri-bristled brush CS6021T, slowly remove it
from the endoscope being careful not to fling patient debris/
contaminants into the air as the bristles exit the endoscope.
– 26 –
(e)
Using the large bristle of the cylinder cleaning brush (CS-C9S),
scrub clean the surfaces inside the suction control valve
receptacle (suction cylinder) on the control head. Do NOT
insert the brush excessively.
(1)
Brush (CS-C9S)
Figure 2.10
NOTE:
Be sure to inspect the bottom of the suction control valve
receptacle (suction cylinder) on the control head for any debris.
(f)
Scrub all internal and external surfaces of the suction control
valve OF-B120 using the smaller end of the cylinder cleaning
brush (CS-C9S).
(OF-B120)
Brush (CS-C9S)
(1)
(2)
Figure 2.11
(g)
(For ED-3490TK) Using the CS-C9S brush clean the distal tip
of the endoscope including the elevator mechanism and all area
around the elevator itself.
Brush (CS-C9S)
(1)
Figure 2.12
– 27 –
NOTE:
• Do NOT squeeze or severely bend the insertion tube.
• Do NOT use any abrasive materials.
• Be careful to avoid damage to the distal lenses.
WARNING:
Worn or damaged valves and/or O-rings should be replaced
with new ones. The entire valve mechanism should be subjected
to a high-level disinfection or sterilization procedure prior to
use (O-ring set, model OF-B127, is optionally available). Failure
to do so could result in continuous aspiration which in certain
clinical situations can suction tissue into the distal channel
opening at the scope tip and/or create a loss of insufflated air via
the suction system. A compromised valve could also result in the
potential for reflux or spit-back of patient fluids that may
present infection control risks.
(h)
Insert the large bristle of the cylinder cleaning brush (CS-C9S) into
the opening of the suction channel selector cylinder and scrub clean
the surface inside the cylinder of the suction channel selector and then
gently withdraw the brush. Repeat several times ensuring that only a
clean brush is introduced into the cylinder each time.
Brush (CS-C9S)
(1)
Figure 2.13
(i)
Scrub all internal and external surfaces of the selector using the
smaller side of the cylinder cleaning brush (CS-C9S).
(1)
(1) Suction Channel
Selector
(OF-B161)
Brush (CS-C9S)
(2)
Figure 2.14
5)
Manual Cleaning of A/W Valve and Cylinder by Brush
a) Remove the air/water feeding valve (OF-B188). Scrub all internal and
external surfaces of the valve using the smaller end of the cylinder
cleaning brush (CS-C9S). Repeat several times OR until the bristle of
the brush becomes visibly clean.
– 28 –
(1)
Valve (OF-B188)
Brush (CS-C9S)
(2)
Figure 2.15
WARNING:
Worn or damaged valves (OF-B188 and O-rings in particular)
should be replaced with new ones which has already been
subjected to a high-level disinfection or sterilization procedure
(O-ring set, model OF-B192, is optionally available). Failure to
do so could create a risk of cross contamination to the end users
due to the potential for reflux or spit-back of patient fluids out of
the air/water feeding valve. It could also create continuous air
flow or excessive air insufflation and result in the potential
patient injury such as pneumatic perforation.
b) Using the larger end of the CS-C9S cleaning brush, scrub clean the
surfaces inside the air/water cylinder. Repeat brushing at least 3 times
OR until it becomes visibly clean.
Brush (CS-C9S)
(1)
Figure 2.16
6)
Manual Cleaning of Water Jet Check Valve Adapter by brush
(Endoscopes with Water Jet System)
a) The water jet check valve adapter (OE-C12) should already have been
removed from the endoscope. Remove the detachable check-valve,
model OE-C14 from the adapter unit, OE-C12. Clean all surfaces of
the OE-C14 and the OE-C12 using the special cylinder cleaning brush
CS-C9S and detergent solution.
(1)
(2)
(3)
Figure 2.17
– 29 –
Adapter (OE-C12)
(2) Check-Valve (OE-C14)
Brush
(CS-C9S)
NOTE:
The check-valve OE-C14 is a reusable component and it as well
as the OE-C12 water jet check valve adapter, irrigation tube and
water jet channel should be reprocessed after each use.
WARNING:
A worn or damaged check valve should be replaced with a new
one which has already been subjected to cleaning, a high level
disinfection or sterilization procedure. For repeated use, always
ensure that the check valve has already been reprocessed. A
damaged, worn or missing check valve could create a risk of
cross-contamination to the end user due to the potential for
reflux (spit-back) of patient fluids through an unsealed path. If
the check valve is not attached properly, it could fall off during
the endoscopic procedure and results in potential for end user
cross-contamination.
CAUTION:
If there is any doubt as to the suitability for use of the check
valve, replace with a fully reprocessed one prior to each
procedure. A set of 10 pieces of the OE-C14 check-valve are
optionally available in a package as model OE-C15.
NOTE:
The PENTAX endoscope components, OE-C12 water jet check
valve adapter, OE-C14 check-valve and OF-B113 irrigation
tube may all be subjected to ultrasonic cleaning and prevacuum steam sterilization.
b) Using the larger bristled end of CS-C9S, brush clean inside the
surfaces of the water jet cylinder.
Brush
(CS-C9S)
(1)
Figure 2.18
NOTE:
Brushing of internal channels and/or ports/cylinders is not a
substitute for exposure to an appropriate cleaning solution.
Manual cleaning by brush complements and augments the
cleaning effectiveness of chemical cleaning.
– 30 –
7)
Chemical Cleaning by Detergent Solution
CAUTION:
Current PENTAX manual cleaning instructions have been
validated using cleaning detergent solutions. For non-enzymatic
solutions always adhere to the specific manual cleaning
instructions developed by the manufacturer of the detergent
product. When using a non-enzymatic detergent during
automated reprocessing refer to the validated cleaning
instructions developed by the manufacturer of the Automated
Endoscope Reprocessor(AER) or Washer-Disinfector (WD) units/
systems.
Channel
Adapters/Components
to be attached
Air and
OF-B153
Water
OF-G17
Syringe
Instument
Rinse water
10/20 mL 25 mL or more 80 mL or more
OF-B153
Biopsy/
Detergent
50 mL or more
Inlet Seal(s)
OF-B161/OF-B162
(Two-Channel
Endoscopes)
50/60 mL
200 mL or
more
100 mL or
400 mL or
more
more
OE-C12 with OE-C14
Water Jet
removed
10/20 mL 10 mL or more 30 mL or more
OF-B113
a) For Air/Water Cleaning
(I)
The cleaning adapter OF-B153 should be attached to the air/
water cylinder and suction cylinder. This adapter caps (seals)
off the air/water and suction cylinders to allow unidirectional
flow of solution through these delivery/aspiration systems.
i) Raise the locking cap and slide the side covers (marked with
) downward.
ii) Align the cylinder guide over the air/water and suction
cylinder ports.
iii) Slide the OF-B153 forward.
iv) Holding the side covers (marked with ), push down and
slide the locking cap under the locking tab to secure.
v) Lock the locking cap with the locking tab of the base.
i)
(2)
(1)
(1) Locking Cap
(2) Rubber Seal
(3) Base
(3)
ii)
(2)
(1)
(3)
– 31 –
(1) Cylinder Guide
(2) Cylinder Ports
(3) Cylinder Inlets
iii)
iv)
(1) End of Locking Cap
(2) Locking Tab
(1)
(2)
(1) Locking Tab
v)
(1)
(1)
Figure 2.19
NOTE:
It is imperative that the cleaning adapter OF-B153 be securely
attached to their respective valve cylinders. Failure to properly
match and secure the cleaning adapter could result in ineffective
and incomplete reprocessing.
(II)
The cleaning adapter OF-G17 has a standard ANSI luer lock
connector to which a 10/20 mL syringe or other device should
be attached. Connect OF-G17 to the air/water port on the PVE
connector/plug. At least 25 mL of fresh detergent should be
flushed through this connector and will simultaneously flow
through both the air and water feeding channels within the
endoscope. Check and confirm that the flushed detergent
solution exits the distal Air/Water nozzle(s). If the endoscope
has two separate nozzles, solution should flow out of BOTH
nozzles. Once proper flow has been confirmed, the OF-G17
should be removed. Please refer to the internal schematics.
(2)
(1) Cleaning Adapter
(OF-G17)
(OF-B153)
(1)
Figure 2.20
Provided the cleaning detergent is allowed to remain in contact with the internal
channel surfaces for the recommended exposure time, the cleaning solution
should dissolve and clean any remaining debris within these channels.
– 32 –
NOTE:
If blockage of the line is encountered, avoid use of excessive
pressure to prevent endoscope damage.
b) For Biopsy/Suction Cleaning
(I)
Install a inlet seal to the instrument channel inlet prior to
injecting cleaning solution into the suction system.
(TWO-CHANNEL VIDEO ENDOSCOPES) Install inlet seals
to each instrument channel inlets. Reattach the suction channel
selector (OF-B161).
If the two channel cleaning adapter, OF-B162, was used, attach
the OF-B162 instead of the OF-B161.
(1)
(2)
(OF-B153)
(2) Inlet Seal (OF-B190)
or Suction Channel
Selecter (OF-B161/
Two Channel Cleaning
Adapter (OF-B162) for
TWO-CHANNEL
VIDEO
ENDOSCOPES
Figure 2.21
WARNING:
When the suction channel selector, OF-B161, is used, each
channel should be flushed separately with detergent to ensure
contact with all instrument channel surfaces. Use the suction
channel selector to direct flow to each, separate channel.
Provided the entire endoscope remains immersed under
detergent solution during this cleaning process, the suction
channel selector mechanism should be removed and soaked
separately in detergent.
(II)
A 50/60 mL syringe or other device may be attached to the
suction nipple. At least 50 mL of fresh detergent solution should
be flushed through the entire instrument/suction channel
system. Check and confirm that the flushed detergent solution
exits the distal instrument channel opening(s). Once proper
flow has been confirmed, the OF-B153 should be removed.
As an alternative, solution can be drawn into the instrument
channel by attaching tubing from an aspirator to the suction
nipple, as long as the aspirator is turned on, detergent solution
can be suctioned through the endoscope.
Then, remove OF-B153, inlet seal(s) and OF-B161/162 (TWOCHANNEL VIDEO ENDOSCOPES).
– 33 –
c) For Water Jet System
(1)
(1) Irrigation Tube
(OF-B113)
Adapter
(OE-C12)
(2)
Figure 2.22
WARNING:
Although the water jet system may not be clinically used during
each procedure, it still MUST be properly cleaned and subjected
to the same disinfection/sterilization processes as other internal
channels of the endoscope.
(I)
(II)
(III)
The water jet check valve adapter (OE-C12) should first be
attached to the water jet port. Do NOT attach a check-valve
(OE-C14) during the cleaning process.
Next, snap the irrigation tube (OF-B113) into the water jet
check valve adapter.
Using a 10/20 mL syringe, fresh detergent solution at least 10
mL or more should be injected into the irrigation tube through
the entire length of the water jet channel until it exits the
endoscope distal tip. Check and confirm that the flushed
detergent solution flows out from the distal Water Jet channel
opening. Once proper flow has been confirmed, the OE-C12
should be removed.
d) (For ED-3490TK)
(I)
(II)
Using a 10/20 mL syringe, inject the cleaning detergent solution
to clean the elevator mechanism and recessed areas surrounding
it within the endoscope distal tip.
While the ENTIRE endoscope remains immersed, inject
cleaning detergent via syringe all around the elevator
mechanism, including behind it to ensure that entrapped air
bubbles do not prevent contact of detergent solution with
potentially contaminated surfaces.
WARNING:
Avoid introduction of air during the
that no air bubbles exit from the
endoscope distal tip. The presence
prevent contact of the detergent with
– 34 –
flushing process. Confirm
channel openings at the
of the air bubbles could
channel surfaces.
WARNING:
The cleaning detergent solution should remain in contact with
ALL internal channels and external endoscope surfaces for the
time period recommended by the manufacturer of the detergent.
8)
Prior to rinsing, attach the previously removed adapters and components
and purge all internal channels with air (using a syringe) to expel residual
detergent solution out from each channel.
9) Using clean water, immerse the entire endoscope as well as all removed
components and thoroughly rinse all items. While fully immersed,
manipulate valve mechanisms and inject clean water via syringe into/
through removable endoscope components.
10) With all cleaning adapters, including irrigation tube, attached to the
endoscope, flush all previously air purged channels with clean water (80 mL
for the air water feeding channel, 200 mL for the suction channel, 30 mL for
the water jet channel). All internal channels must be thoroughly rinsed to
remove residual detergent and debris.
WARNING:
It is important that ALL internal channels (air, water,
instrument, water jet, etc.), external endoscope surfaces and
components be thoroughly rinsed with clean water to remove
residual detergent solution.
11) Remove the endoscope and its components from the solution.
12) Rinse water remaining within the channels should be purged using air to
prevent dilution and/or adulteration of antimicrobial agents to be used in the
subsequent disinfection or sterilization process.
NOTE:
Following a water rinse and air purge 70-90% medical grade
ethyl or isopropyl alcohol, (30 mL for the air and water feeding
channels, 70 mL for the suction/ instrument channels and 10 mL
for the water jet channel) followed by compressed air, not
greater than 165kPa (24psi), may be used to facilitate drying.
13) Gently dry all external surfaces of the endoscope with a soft gauze or the
like. Do NOT put tension on the insertion tube on the endoscope while
drying since the outer cover of the bending section may be excessively
stretched.
WARNING:
Prior to disinfection or sterilization, it is imperative that any
solutions previously used in the cleaning process be thoroughly
rinsed and dried. Failure to do so could result in ineffective or
incomplete disinfection and sterilization.
– 35 –
CAUTION:
NEVER subject the endoscope to ultrasonic cleaning methods
employing high-frequency ultrasound.
2-1-4. High-Level Disinfection
Before any attempt is made to disinfect the endoscope, the complete cleaning
procedure described elsewhere in this instructions for use must have been
completed. Prior to high-level disinfection, the end user should confirm the
minimum effective concentration (MEC) of reused disinfectant as per the
manufacturer’s instructions. Before complete immersion in any disinfecting
solution the endoscope should have been “Leak Tested” as described elsewhere
in this instruction for use.
WARNING:
It is imperative that flexible endoscopes and other semi-critical
devices be reprocessed using at least high-level disinfection with
a legally marketed disinfectant. Only legally marketed
endoscope automated reprocessing devices/systems whose
device specific claims have been validated by the AER/WD
manufacturer and/or anti-microbial agents which have been
tested and found to be compatible by PENTAX should be used
with PENTAX products.
Endoscopes are semi-critical devices that require at least highlevel disinfection.
Only use legally marketed solutions and/or automatic endoscope
reprocessing machines or washing disinfection machines whose
manufacturers have made validation testing with PENTAX
products (specific to Pentax endoscope model number).
A listing of legally marketed solutions/systems which have been
determined to be compatible with PENTAX brand products is
available from your local PENTAX dealer/authorized service
provider.
Be aware of the important note regarding infection control on
the inside cover of this instruction for use.
CAUTION:
BEFORE IMMERSING, confirm that
a) The “Red” ventilation cap is taken OFF.
b) The PVE Soaking cap is securely ON the electrical contacts.
(1) PVE Soaking Cap
(2) Ventilation Cap
(1)
(2)
Figure 2.23
– 36 –
Adapters/
Channel
Components to be
Syringe Disinfectant
attached
Air and
Water
OF-B153
10/20
OF-G17
mL
Inlet Seal(s)
Instument
OF-B161/OF-B162
(Two-Channel Video
OE-C12 with OE-C14
removed
OF-B113
1)
flush
80 mL or
30 mL or
more
more
more
200 mL or
70 mL or
more
more
more
100 mL or
400 mL or
140 mL or
more
more
more
10/20
10 mL or
30 mL or
10 mL or
mL
more
more
more
50/60
mL
Endoscopes)
Water Jet
Alcohol
50 mL or
OF-B153
Biopsy/
25 mL or
Rinse
water
The air/water/instrument channel disinfecting adapters consisting of two
separate components OF-B153 and OF-G17 should be installed on the
endoscope from the previous cleaning procedure.
(I)
Air/Water feeding channel cleaning adapter OF-G17
incorporates a standard ANSI luer lock connector to which a 10/
20 mL syringe or other device should be attached. At least 25
ml of fresh (or reused actively effective) disinfecting solution
should be flushed through this connector and will
simultaneously flow through both the air and water feeding
(Please refer to the internal schematics)
(2)
(OF-G17)
(OF-B153)
(1)
Figure 2.24
(II)
After the entire endoscope is completely immersed, and the air
and water feeding channels have been filled with disinfecting
solution, cleaning adapter OF-G17 and syringe should be
removed.
(III) Adhere to proper exposure times for the disinfectant.
(IV) Confirm that an inlet seal is already attached to the instrument
channel inlet during the next step.
– 37 –
WARNING:
The suction channel selector OF-B161 or the two channel
cleaning adapter OF-B162 should already be installed on the
endoscope from the previous cleaning procedure. When the
suction channel selector OF-B161 is used, each channel should
be flushed separately with disinfectant to ensure contact with all
instrument channel surfaces. Use the suction channel selector
mechanism to direct flow to each separate channel. Providing
the entire endoscope remains immersed under disinfectant
solution during reprocessing, the suction channel selector
mechanism or the two channel cleaning adapter OF-B162 should
be removed and soaked separately in disinfectant.
2)
A 50/60 mL syringe (or other device) can be attached to the suction nipple.
At least 50 mL of fresh (or reused actively effective) disinfecting solution
should be flushed through or drawn into the entire suction system.
(1)
(2)
(OF-B153)
(2) Inlet Seal(s)
(OF-B190)
Figure 2.25
3)
(For ED-3490TK)
While the endoscope tip remains immersed, inject disinfectant via syringe
all around the elevator mechanism, including behind it to ensure that
entrapped air bubbles do not prevent contact of disinfecting solution with
potentially contaminated surfaces.
4)
Only for models with a water jet channel system
(1)
(2)
Figure 2.26
– 38 –
(1) Irrigation Tube
(OF-B113)
Adapter
(OE-C12)
NOTE:
Ensure that the removable check-valve OE-C14
been detached from the adapter unit prior
disinfectant into the water jet channel system. This
unrestricted flow of reprocessing agents into and
entire water jet channel system.
(I)
(II)
(III)
has already
to injecting
will allow for
through the
The irrigation tube (OF-B113) with standard luer lock fitting
should already be attached to the water jet cylinder. Fresh (or
actively effective used) disinfecting solution more than 10 mL
should be flushed through this connection into the water jet
channel and exit from the endoscope distal tip.
Please refer to the internal schematics. Avoid introduction of air
bubbles during this flushing process.
Confirm that no air bubbles are present and the entire water jet
channel is filled with disinfectant.
Remove the irrigation tube OF-B113, the water jet check valve
adapter OE-C12 and syringe.
WARNING:
Although the water jet system may not be clinically used during
each procedure, it still MUST be properly cleaned and subjected
to the same disinfection/sterilization processes as other internal
WARNING:
Avoid introduction of air during the flushing process. Confirm
that no air bubbles exit from the channel openings at the
endoscope distal tip. The presence of the air bubbles could
prevent contact of the disinfectant with channel surfaces.
5)
As long as the entire instrument is immersed in disinfecting solution, the
cleaning adapters, the syringes used in previous steps, the inlet seal should
be removed while the instrument remains fully under the disinfecting
solution. The removal of component parts and cleaning adapters from the
endoscope will eliminate the risk of mated surfaces not being exposed to the
liquid chemical germicide.
(1) Never remove the PVE
soaking cap.
D
R
F
L U
DC
(1)
Figure 2.27
– 39 –
WARNING:
The disinfecting solution should remain in contact with ALL
internal surfaces of the channels and external endoscope
surfaces for the time period recommended by the manufacturer
of the disinfectant.
6)
7)
8)
9)
While fully immersed, manipulate valve mechanisms and inject disinfectant
via syringe into/through removable endoscope components. This will
remove entrapped air bubbles that could inhibit contact of solution with
component surfaces and provide for better exposure of surfaces to
germicide. Make sure disinfectant is injected into/through the inlet seal. The
endoscope’s component parts, including all valves, should remain in contact
with the disinfecting solution for the time period recommended by the
manufacturer of the solution.
After the endoscope and its component parts have been in contact with the
disinfecting solution for an appropriate time, flush all channels with air to
purge remaining disinfectant, then remove the endoscope and its
components from the solution. Thoroughly rinse the entire endoscope and
all its components with sterile water. Typical rinsing recommendations
following exposure to an appropriate disinfectant solution containing no
surfactants call for three separate complete immersions in fresh sterile
water.
A syringe filled with sterile water should be attached to adapter OF-G17 to
flush at least 80 mL of water from the air and water feeding channels of the
endoscope. Then fill a syringe with air and flush through the air and water
feeding channels several times to force any residual water out of the tubing
and nozzles. Dry thoroughly.
With a syringe filled with sterile water, the cleaning adapter OF-B153 and
inlet seal attached, rinse the entire suction system, including the instrument
channel by flushing a total of at least 200 mL of water. Then flush air
through the instrument channel several times to remove residual water. Dry
thoroughly.
(I)
(II)
Attach the water jet connector cap, OF-B118, and the water jet
check valve adapter OE-C12 to the endoscope. Prior to
attaching the adapter to the water jet port, ensure the detachable
check-valve has already been removed from the adapter unit.
Connect a syringe filled with sterile water to the irrigation tube,
Part OF-B113 and flush at least 30 mL of water out of the
channel. Then fill the syringe with air and flush through the
channel several times to force any residual water out of the
channel. Dry thoroughly.
The quantity of rinse water described above equates to at least
three times the volume per internal channel system.
– 40 –
CAUTION:
Adequately rinse all internal channels and endoscope surfaces
with sterile water to remove residual disinfectant solution.
Insufficient rinsing may result in mucosal inflammation due to
exposure to residual disinfectant solution.
NOTE:
Ideally, all final rinses should be made with sterile water or
bacteria-free water whose microbial quality has been confirmed
via monitoring. After water rinsing, 70-90% medical grade ethyl
or isopropyl alcohol should be flushed through all channels, (30
mL for the air and water feeding channels, 70 mL for the suction
channel and 10 mL for the water jet channel) followed by
compressed air, not greater than 165kPa (24 psi) to facilitate
drying. Channel cleaning adapters should be used for alcohol
flushing/rinsing and forced air drying. The outer surfaces of the
endoscopes can be dried by gently wiping with a sterile gauze or
lint-free cloth saturated with alcohol.
Regardless of the quality of the rinse water used, a dry
instrument accomplished by a final alcohol rinse followed by
forced air is essential to prevent bacteria colonization and/or
infections associated with waterborne microorganisms. Such
infections are more likely to occur when wet/contaminated
instruments are used on patients whose immune systems are
compromised or suppressed or when these devices are used in
anatomical areas considered sterile and/or susceptible to these
organisms.
10) Following an alcohol rinse, the following steps may be performed to aid in
the drying process, if filtered compressed or forced air is not available.
(I)
Remove the channel adapters OF-B153, channel adapter OFG17, and irrigation tube OF-B113, reinstall the previously
reprocessed suction control valve, air/water feeding valve,
water jet check valve adapter OE-C12 with the check-valve OEC14, and the inlet seal.
(II) Attach the endoscope to an external suction source, and aspirate
air through the channel of the endoscope to remove any residual
alcohol and to air dry channel surfaces.
– 41 –
(III)
Remove the PVE soaking cap and attach the endoscope to the
processor with the air pump turned ON to its HIGHEST pressure
setting and the A/W drain lever of the water bottle assembly set
in the DRAIN position, depress the air/water feeding valve of the
endoscope fully until all alcohol has been discharged from the
endoscope. Thoroughly drain all alcohol from the air channel as
well by covering the hole in the air/water feeding valve. Repeat
until no moisture or alcohol is seen exiting the endoscope or
distal tip.
(1) A/W
(2) DRAIN
(1)
(2)
Figure 2.28
11) Gently dry all external surfaces of the endoscope with a soft gauze or the
like. Do NOT put tension on the insertion tube while drying since the outer
cover of the bending section may be excessively stretched. Dry the
objective lens with a cottontip applicator.
WARNING:
If the endoscope is to be stored after reprocessing, detach
removable valves, components, etc. All channels should be
completely dry before storage.
CAUTION:
PENTAX recommended rinsing parameters described in this
section on high-level disinfection apply to the use of a 2.4%
alkaline Glutaraldehyde solution containing no surfactants.
Always check with the manufacturer of the liquid chemical
germicide (or AER/WD for “automated reprocessing”) to confirm
that their specific rinsing instructions are based upon validated
test data demonstrating that no harmful levels of residues
remain on any device or lumen surfaces that may pose a risk to
patient and/or user.
2-1-5. Sterilization
Before any attempt is made to sterilize the endoscope, the complete cleaning
procedure as described elsewhere in this instruction for use must have been
completed.
NOTE:
NEVER place the endoscope in a steam autoclave!!
– 42 –
A) Ethylene Oxide Gas Sterilization (Recommended)
Ethylene Oxide (ETO) Gas Sterilization can be performed on these
endoscopes, provided the following special instructions, which may differ
from other endoscopes, are followed to ensure the proper performance of the
instrument. Adhere to the sterilization manufacturer’s instructions and
always use a biological indicator.
1)
The endoscope must first have been properly cleaned and thoroughly dried
according to the instructions in this instruction for use and each of the
component parts should be removed.
(1)
OF-B120
Valve OF-B188
(3) Inlet Seal(s) (the
second one is for twochannel endoscopes
only)
(4) Suction Channel
Selector OF-B161
(two-channel video
endoscopes only)
Adapter OE-C12
system only)
(6) Water Jet Connector
Cap OF-B118
system only)
(2)
(4)
(3)
(5)
(6)
Figure 2.29
WARNING:
Failure to thoroughly dry all surface areas could result in
incomplete or ineffective sterilization.
Moisture could prevent contact of the ETO gas with the actual
contaminated surfaces.
CAUTION:
Prior to placing these Endoscopes in a Gas Sterilizer or Aeration
Chamber:
a) The “Red” ventilation cap MUST be “ON” securely.
b) The PVE soaking cap should be “OFF” the electrical contacts.
This is opposite of the immersion instructions.
(1) PVE Soaking Cap
(OE-C9)
(2) Ventilation Cap (OFC5)
(1)
(2)
Figure 2.30
– 43 –
2)
The following parameters for Ethylene Oxide Gas Sterilization are
proposed.
Temperature:
55°C (131°F)
Relative Humidity: 50%RH
EO Concentration : 600-650 mg/L
Gas Exposure Time: 5 Hours
Aeration:
12 Hours at 55°C (131°F)
CAUTION:
Adequately aerate the endoscope to remove any remaining
ethylene oxide. Insufficient aeration may adversely affect the
human body.
B) Other Methods of Sterilization
Other types of cleaning and/or disinfection/sterilization systems/processes
are available for the reprocessing of medical devices. However, due to the
heat sensitive nature and/or the specific biocompatible materials used in the
construction of flexible endoscopes, some of these marketed systems/
processes/solutions could have detrimental effects on flexible endoscopes.
To avoid the potential for instrument damage and/or endoscope failure, check
the compatibility of such reprocessing systems/solutions first with the OEM
of the reprocessing agent/sterilization process.
Prior to using other methods, confirm the specific compatibility and
sterilization claims of ANY sterilizing methods/processes with the sterilizer
manufacturer and ensure manufacturer that they have performed
microbiological validation studies that support their claims of achieving
sterilization of device specific flexible endoscopes and endoscope
components.
CAUTION:
Use appropriate chemical indicators and/or biological monitors
as recommended by the manufacturer of the sterilizer.
WARNING:
In addition to efficacy and compatibility claims always check
with the manufacturer of the sterilizer/disinfector to confirm
their specific product claims including compatibility and confirm
that they have test data supporting their claims and
demonstrating that no harmful levels of any residues (active/
inert ingredients, their byproducts or derivatives of the
processed devices) remain on any instrument or lumened
surfaces that may pose a risk to patients and users.
– 44 –
2-2. Endoscopic Accessory Instruments (EAIs) and Endoscope Components
WARNING:
Current infection control guidelines require that biopsy forceps
and similar endoscopic accessory instruments which enter sterile
tissue or the vascular system or break the mucosal barrier must
be sterilized before each patient use. For patient contact
endoscopic accessories, follow the specific and detailed
reprocessing instructions supplied with each product.
2-2-1. Cleaning
CAUTION:
Not
all
manufacturers
of
Automated
Endoscope
Reprocessors(AERs)/Washer-Disinfectors (WDs) make specific
claims nor provide special instructions for reprocessing all of the
removable endoscope components that are integral to the safe
and effective operation of flexible endoscopes. Therefore, should
the AER/WD manufacturer’s instructions not specifically address
reprocessing of any particular endoscope component (air/water
feeding valve, suction control valve, inlet seal, irrigation tube,
check valve, selector mechanism, etc.) in the AER/WD, then
those components must be reprocessed manually as described
in PENTAX instructions/labeling. Prior to use, check with each
AER/WD manufacturer as to their specific claims with respect to
reprocessing individual endoscope components.
CAUTION:
NEVER use ultrasonic cleaning methods with ultrasound on the
endoscope itself.
1)
2)
3)
4)
Reusable endoscopic accessory instruments such as biopsy forceps and
removable endoscope components such as suction valve should be cleaned
immediately (at least within one hour) after each use since dried blood,
mucous, or other debris may cause damage to the instrument and render the
mechanism inoperable, or may interfere with the ability of the user to
reprocess the device or component.
Place the EAIs and/or components in a basin with fresh cleaning detergent
solution for the time period, concentration, and temperature recommended
by the manufacturer of the detergent being careful not to tightly coil or kink
the flexible shaft.
Clean the handle and flexible shaft by gently wiping with a soft gauze or the
like. The biopsy cups and pivot pin area should be carefully and gently
cleaned with a soft brush. Removal components such as air/water, suction
control valve should be manipulated and detergent injected directly into/
onto components surfaces and then brushed clean.
Rinse all residual detergent from the forceps by immersing the entire
forceps under clean water and manipulating the handle and cup mechanism.
– 45 –
5)
Ultrasonic cleaning of forceps and similar accessories is then
recommended, provided the manufacturer’s instructions and the parameters
below are followed: Heavily soiled and/or difficult-to-manually clean
components such as valve mechanisms, inlet seals, etc. should be
ultrasonically cleaned prior to subsequent high-level disinfection or
sterilization.
Frequency Range 44 kHz ± 6%
Time
5 minutes
CAUTION:
DO NOT use caustic or abrasive solutions in the ultrasonic
cleaner.
NOTE:
All detergent must be removed from the inner mechanism of the
forceps and individual endoscope components.
Any detergent that remains after the water evaporates may
cause increased friction that may render the mechanism
inoperable. Residual detergent may also interfere in the
subsequent biocidal process.
6)
After cleaning and thorough rinsing, the endoscopic accessory instruments
and components should be gently dried using a soft gauze or the like. Avoid
tight coiling or kinking and do NOT put tension on the flexible shaft of the
forceps and similar endoscopic accessory instruments.
NOTE:
Other PENTAX reusable accessories (channel cleaning adapters,
cleaning brushes, bite block, etc.) and endoscope components
(inlet seals, air/water and suction control valves, etc.) not
specifically identified previously should be cleaned in a similar
manner
as
above.
Ultrasonic
cleaning
methods
are
recommended for accessories and endoscope components
whose entire surfaces are not easily accessible by manual
cleaning.
Heavily soiled components such as valve mechanisms, inlet
seals, etc. should be ultrasonically cleaned prior to subsequent
high-level disinfection or sterilization. For these specific items,
please refer to their separate operation instructions for uses or
instruction sheets.
– 46 –
NOTE:
It is imperative that ultrasonic cleaning of the Endoscopic
Accessory Instruments(EAIs) and other components be
performed PRIOR to steam sterilization. Only those PENTAX
accessories identified by their pink colored handle, labeled as
being autoclavable or identified below may be subjected to
steam sterilization.
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
PENTAX biopsy forceps
PENTAX bite block OF-Z5
PENTAX water bottle OS-H4/OS-H5
PENTAX suction control valve OF-B120
PENTAX A/W feeding valve OF-B188
PENTAX inlet seal OF-B190
PENTAX cleaning Adapter OF-G17
PENTAX cylinder cleaning Brush CS-C9S
PENTAX channel cleaning brushes CS6030SN
PENTAX cleaning adapter OF-B153
PENTAX Gas/Water Feeding Valve OF-B194
*PENTAX suction channel selector OF-B161
*PENTAX instrument channel cleaning adapter OF-B162
**PENTAX irrigation tube OF-B113
**PENTAX water jet check valve adapeter OE-C12
**PENTAX check-valve OE-C14
**PENTAX water jet connector cap OF-B118
***PENTAX distal rubber hood OE-A58/OE-A59
*two-channel endoscopes only
**endoscopes with a water jet system only
***for Zoom endoscopes only
Also, please refer to the instruction for use supplied with each
accessory.
2-2-2. High-Level Disinfection
Before any attempt is made to disinfect endoscopic accessory instruments and/or
scope components such as bite block, air/water and suction control valve,
brushes, etc. the complete cleaning procedure as described elsewhere in this
instruction for use, must have been completed. Heavily soiled components such
as valve mechanisms, inlet seals, etc. should be ultrasonically cleaned prior to
subsequent high-level disinfection.
1)
2)
3)
The entire accessory or component should be immersed in disinfecting
solution.
Accessory and component surfaces should remain in contact with the
disinfecting solution for the time period recommended by the manufacturer
of the solution. To ensure better contact, manipulate components such as
valves while injecting disinfectant into/onto components surfaces, including
all lumens.
After the item has been in contact with the disinfecting solution for the
appropriate amount of time, remove it from the disinfecting solution.
– 47 –
4)
5)
Rinse all residual disinfecting solution from the accessory/component by
immersing it under sterile water.
After thoroughly rinsing, the items should be gently dried using a soft gauze
or the like. Compressed air may also be used to facilitate drying.
NOTE:
Ideally, all final rinses should be made with sterile water or
bacteria-free water whose microbial quality has been confirmed
via monitoring. After water rinsing, 70-90% medical grade ethyl
or isopropyl alcohol should be flushed through lumens of the
endoscopic instruments, as well as any removable scope
components including valve mechanisms, followed by
compressed air, not greater than 165kPa (24psi) to facilitate
drying. External instrument and component surfaces can be
dried by gently wiping with a sterile gauze or lint-free cloth
saturated with alcohol.
Regardless of the quality of the rinse water used, a dry
instrument accomplished by a final alcohol rinse followed by
forced air is essential to prevent bacteria colonization and/or
infections associated with waterborne microorganisms. Such
infections are more likely to occur when wet/contaminated
instruments are used on patients whose immune systems are
compromised or suppressed or when these devices are used in
anatomical areas considered sterile and/or susceptible to these
organisms.
WARNING:
The addition of defoaming agents to the water supply and/or
automated reprocessing system is NOT recommended. Due to
their nature, these silicone based agents cling tenaciously to
surfaces. Unless they are rinsed very thoroughly, a “barrier”
which could reduce the effectiveness of the disinfection/
sterilization process could be created. Additionally, repeated use
of such defoamers could eventually lead to residual silicone build
up resulting in equipment malfunction such as clogged air and
water feeding channels. Similarly, silicone residues can deposit a
“film” onto the distal objective lens causing “blurry” endoscopic
images.
– 48 –
2-2-3. Sterilization
WARNING:
Current infection control guidelines require that biopsy forceps
and similar accessories which enter sterile tissue or vascular
system or break the mucosal barrier must be sterilized before
each patient use.
For patient contact endoscopic accessories, follow the specific
and detailed reprocessing instructions supplied with each
product.
Before any attempt is made to sterilize the accessories and/or individual
endoscope components, the complete cleaning procedures as described
elsewhere in this instruction for use must have been completed. Heavily soiled
components such as valve mechanisms, inlet seals, etc. should be ultrasonically
cleaned prior to subsequent sterilization.
CAUTION:
Use only the type of packaging material and package
configuration as recommended by the manufacturer of the
sterilizer. Use appropriate chemical indicators and/or biological
monitors as recommended by the manufacturer of the sterilizer.
NOTE:
The following sterilization parameters are only valid with
sterilization equipment that is properly maintained and
calibrated.
• Steam Sterilization (Autoclaving) Recommended
NOTE:
The PENTAX accessories and scope components listed on page
47 may be subjected to Steam Autoclaving.
1)
2)
Prior to steam sterilization, all autoclavable endoscopic accessory
instruments and endoscopic components previously identified should be
thoroughly cleaned using manual and ultrasonic cleaning methods as
described elsewhere in this instruction for use.
Autoclaving can then be performed under the following conditions:
For USA
Sterilizer Type
Prevacuum
Temperature
Exposure Time
Drying Time
132°C
4 minutes
30 minutes
135°C
3 minutes
16 minutes
NOTE: (For USA)
Validation testing of these parameters was performed using
Kimbely Clark Wrap KC-600.
– 49 –
For countries except USA
Item
Condition
Sterilizer Type
Prevacuum
Exposure Condition
134°C - 137 °C x 3-18 minutes
CAUTION:
NEVER place the endoscope in a steam autoclave nor subject it
to high-frequency ultrasonic cleaning methods!
• ETO GAS sterilization
1)
ETO gas sterilization can be performed on these accessories and/or
components, provided they have first been properly cleaned and thoroughly
dried.
CAUTION:
PENTAX Distal Rubber Hood OE-A58/A59 can’t be ETO sterilized.
2)
Following ETO gas sterilization, aeration is required (12 Hours at 55).
NOTE:
For ethylene oxide sterilization of PENTAX accessories and
endoscope components, follow the same ETO parameters as for
PENTAX endoscopes (see page 47).
– 50 –
2-3. Water Bottle Assembly
Each water bottle assembly should be cleaned and sterilized at least on a daily
basis or more frequently depending upon the patient and/or type of endoscopic
procedure. As with all endoscopic accessories, prior to sterilization, water bottle
assemblies must be scrupulously cleaned. Failure to do so could result in
incomplete or ineffective sterilization.
NOTE:
Be careful when handling the water bottle assembly. DO NOT
carry the bottle by the A/W Connector or the hose. When the
bottle cap has been removed from the bottle, be careful in
handling the water feeding stem.
I.
Cleaning of Water Bottle Assembly
Reprocessing At-A-Glance
Autoclave
Manual
Pre-Cleaning
1.
2.
3.
Ultrasonic
Cleaning
Rinse
and Dry
Steam
Sterilize
Cooling
After use, the entire bottle assembly (bottle, cap and tubing) should be
washed with fresh detergent solution and a dampened gauze or scrub
brush. Complete immersion in a cleaning detergent solution should be
performed for soiled items to make contact with all surfaces of the
water bottle assembly including the inner surface of the tubing system.
Ultrasonic cleaning of the entire water bottle assembly is then
recommended to access difficult to reach areas, provided the operating
frequency is 44 kHz ± 6% for a period of at least 5 minutes.
After washing with a cleaning solution, all surfaces of the water bottle
assembly should be thoroughly rinsed with clean water and dried.
Gauze or lint-free cloth can be used to wipe dry most surfaces.
Compressed air and 70-90% medical grade ethyl or isopropyl alcohol
should be used to facilitate drying of hard to reach areas.
CAUTION:
To avoid disconnection and/or bursting of the internal tubing,
always set A/W Drain lever to the Air/Water position (upright)
and use less than 165 kPa (24psi) air pressure during forced air
drying.
II.
Sterilization of Water Bottle Assembly
Before any attempt is made to sterilize the water bottle assembly, the
complete cleaning procedure described above must have been completed
and all items are thoroughly dry. Failure to scrupulously clean the water
bottle assembly prior to the sterilizing process could result in incomplete or
ineffective sterilization.
– 51 –
CAUTION:
Use only the type of packaging material and package
configuration as recommended by the manufacturer of the
sterilizer. Use appropriate chemical indicators and/or biological
monitors as recommended by the manufacturer of the sterilizer.
NOTE:
The following sterilization parameters are only valid with
sterilization equipment that is properly maintained and
calibrated.
Steam Sterilization (Autoclaving)
PENTAX water bottle assembly, Model OS-H4/OS-H5 has been designed
to withstand high-pressure steam sterilization procedures providing the
following parameters are adhered to:
For USA
Sterilizer Type
Prevacuum
Temperature
Exposure Time
Drying Time
132°C
4 minutes
30 minutes
135°C
3 minutes
16 minutes
NOTE:
Validation testing of these parameters was performed using
Kimberly Clark Wrap KC-600.
For countries except USA
Item
Condition
Sterilizer Type
Prevacuum
Exposure Condition
134°C - 137°C x 3-18 minutes
During steam sterilization, ensure that the cap and tubing section have been
removed from the water bottle container.
Make sure that the drain lever on the water bottle cap has been set on the
A/W position (upright).
– 52 –
3. POST REPROCESSING
1)
Following reprocessing, the endoscope may either be reused or placed in
storage.
WARNING:
If the endoscope is to be stored after reprocessing, detach
removable valves, components, etc. All channels should be
completely dry before storage.
NOTE:
When utilizing chemo-thermal processes for reprocessing
PENTAX endoscopes, the instruments should be allowed to
return to room temperature prior to use and/or further handling.
2)
Prior to reuse, ensure that instrument has been properly inspected and fully
prepared for the next clinical procedure.
NOTE:
Refer to the companion PENTAX Instructions for Use(Operation)
describing in detail the recommended instructions on the
inspection, use and operation of these endoscopes.
3)
4)
5)
Prior to storage, ensure that all internal channels, endoscope components,
instrument surfaces and accessories are thoroughly dry.
A cotton tipped applicator moistened with 70-90% medical grade ethyl or
isopropyl alcohol may be used to carefully remove any films or residues left
upon the lens surfaces, such as the distal objective lens.
The endoscope should be hung in a clean, dry, well-ventilated storage
cabinet at room temperature. The insertion tube and light guide cable should
be hung and kept as straight as possible during storage.
CAUTION:
• Make sure that all removable components such as the air/water
feeding valve, suction control valve, water jet components, inlet seal are detached from the endoscope. This will allow for
better air circulation throughout the internal channels to ensure
thorough drying.
• NEVER store the endoscope, its components and accessories in
the carrying case, as this type of dark, humid and unventilated
environment is conducive to bacteria colonization, which
increases the risk of cross contamination. These cases are
intended for transportation of the instrument, not storage.
• NEVER store the endoscope in areas of high humidity, high
temperatures or in direct exposure to sunlight or X-rays.
• Avoid storage of the endoscope in cabinets, which have any
sharp edges, exposed nails/screws, etc. Contact with sharp
objects can puncture, scratch or otherwise damage the
endoscope.
– 53 –
3-1. Servicing
Prior to returning any instrument for repair to PENTAX, the instrument should
first undergo appropriate reprocessing/decontamination procedures for the
purpose of infection control. Check with your local PENTAX service facility for
more details.
1)
2)
3)
4)
5)
6)
All instruments requiring repair should be shipped in the original carrying
case with appropriate packing along with comments describing the
instrument damage and complaint.
A repair purchase order number, contact name and phone number of the
individual responsible for authorizing repairs, as well as shipping address
should be included.
The “Red” ventilation cap should be attached to the instrument if it will be
shipped by air freight.
Any accessories and/or endoscope components potentially related to the
endoscope damage or complaint should also be returned with the
endoscope.
PVE soaking caps should also be returned with the endoscope to check/
confirm the integrity of their watertight seal.
After servicing, all endoscopes must be reprocessed prior to patient use.
– 54 –
WARNING:
Instrument repairs should only be performed by an authorized
PENTAX service facility. PENTAX assumes no liability for any
patient/user injury, instrument damage or malfunction, or
REPROCESSING FAILURE due to repairs made by unauthorized
personnel.
Your local PENTAX distributor can provide a list of “compatible”
reprocessing agents with PENTAX endoscopes based upon
material compatibility and functionality studies performed by
PENTAX, Japan. These tests of course apply only to genuine
PENTAX parts, components and materials including proprietary
adhesives, sealants, lubricants, etc. specifically selected for use
in PENTAX endoscopes to satisfy their original design criteria.
PENTAX manual reprocessing instructions supplied with each
product have been validated for PENTAX endoscopes utilizing
exclusive PENTAX parts/materials and assembled based upon
proprietary PENTAX manufacturing technologies and/or servicing
techniques.
It must be recognized that PENTAX does not evaluate nonPENTAX parts, components, materials and/or servicing methods
and therefore questions regarding material compatibility and/or
functionality of PENTAX instruments built with these
unauthorized, untested and unapproved items, materials,
repair/assembly methods must be referred to the third party
service organization and/or device remanufacturer. It is
unknown to PENTAX if serviced or remanufactured instruments
(performed by unauthorized PENTAX entities) which still bear a
PENTAX label are within PENTAX device specifications and/or if
unauthorized activities have significantly changed the
instrument’s performance, intended use, safety and/or
effectiveness.
These companies should confirm the ability for these serviced/
remanufactured devices to be reprocessed safely and effectively
with reprocessing agents/systems recognized as compatible by
PENTAX for standard PENTAX products. These third party
companies and/or remanufacturers should be consulted to
confirm if they have performed reprocessing validation studies
on instrument models which they have serviced (or
remanufactured) that support the cleaning, high-level
disinfection and/or sterilization of these endoscopes via the
normal endoscope OEM reprocessing recommendations,
standard AER device-specific instructions and/or their own
unique reprocessing recommendations.
Ultimately, owners of these medical devices are responsible for
selecting an appropriate service facility or vendor whose
activities render an instrument to the same expectations and
quality of a finished device supplied by the endoscope OEM.
7)
For disposal of instruments, follow local or country regulations.
– 55 –
3-2. Care and Maintenance Tips
Flexible endoscopes have been an invaluable tool in the medical community’s
armamentarium to successfully diagnose and treat a wide variety of illnesses in
patients for several decades. Perhaps due to their longevity and progressive
design changes over the years which have simplified their use, flexible
endoscopes have been somewhat taken for granted and have erroneously not
been considered highly technological medical devices.
In fact, current generation flexible endoscopes although easier to clinically use,
are much more sophisticated than ever. Special reprocessing instructions must be
followed to ensure the instruments are patient ready and patient safe. Special
care and handling must be exercised and practiced to prevent instrument
malfunction and prolong the reliability of the endoscope.
The burden of responsibility to ensure safe and reliably functioning instruments
is left in the hands of the healthcare professionals who actually care for and
reprocess flexible endoscopes.
Naturally, equipment manufacturers share in this responsibility and tremendous
efforts have been made in designing instruments which could be reprocessed and
maintained as easy as possible. However, due to the nature of their use and
application, flexible endoscopes must be subjected to special cleaning
procedures, followed by a disinfection or sterilization process after each and
every patient use.
To highlight and simplify, what may appear to some as being complicated
maintenance and reprocessing instructions, PENTAX strongly recommends the
users review the following suggestions and advice on the care and maintenance
of your PENTAX flexible endoscopes.
These tips, particularly those involving endoscope reprocessing should not be
construed as “shortcuts” and are not intended as substitute directions for
complete instructions found elsewhere in the instruction for use.
 Avoid soaking of the endoscope with accessories (forceps, injection or
aspiration needles, etc.) or any sharp edged objects which could
inadvertently scratch or cut the distal bending section sheath. (Subsequent
flexing back and forth of the rubber sheath could eventually stretch the
scratched rubber until a pinhole and leak develops.)
 Exposure to a compatible cleaning detergent is essential to thorough
cleaning of all surfaces of the endoscope. Rinsing and drying after cleaning
is imperative to prevent dilution and/or adulteration of the disinfectant/
sterilant.
– 56 –
 Not all manufacturers of automated endoscope reprocessors (AERs) make
specific claims nor provide special instructions for reprocessing all of the
removable scope components that are integral to the safe and effective
operation of flexible endoscopes. Therefore, should the AER manufacturer’s
instructions not specifcally address reprocessing of any particular scope
component (air/water feeding valve, suction valve, inlet seal, irrigation tube,
check valve, etc.) in the AER, then those components must be reprocessed
manually as described in PENTAX instructions/labeling. Prior to use, check
with each AER manufacturer as to their specific claims with respect to
reprocessing individual endoscope components.
 Do NOT reuse disposable endoscope accessory instruments (EAIs) or
endoscope component intended for single patient or one time use.
 Do NOT expose the endoscope or Endoscope Accessory Instruments (EAIs)
or endoscope component to harsh chemical solutions. Strictly adhere to
exposure times recommended by the manufacturers of compatible solutions.
 Avoid contact of any flexible portion of the endoscope with any sharp edge
objects (bed frames, table top corners, sink drains, accessories hanging in
storage cabinets, etc.) at any time during the handling, reprocessing or
storage of the endoscope.
 Avoid stretching of the bending section rubber sheath at the distal portion of
the endoscope. During mechanical cleaning with a dampened gauze, do
NOT use excessive force. A gentle back and forth wiping motion should be
sufficient to remove gross debris. Subsequent soaking in a cleaning
detergent will clean the remainder of debris.+
 Disinfectants and sterilants are toxic substances by nature. All residual
solution must be thoroughly rinsed and dried prior to each patient use.
 The key to preventing clogged air, water or water jet channels/nozzles is to
immediately flush the channels with either air pressure or fluid/detergent
right after removal from the patient. This should be followed by brushing of
each accessible channel and then soaking with a cleaning detergent.
 Avoid attempting to remove or unscrew endoscope components which should
not be removed. Parts such as the distal portion of the light guide plug, any
inlet ports and any strain relief boots on either the insertion tube or umbilical
cable are essential to the watertight integrity of the instrument. Removal or
loosening of these components and subsequent immersion could lead to fluid
invasion into the endoscope and/or compromise effective reprocessing.
 Check for any sharp edges on all surfaces of an automated cleaning/
disinfecting unit which may come in contact with an endoscope. Some units
may have sharp edged wire mesh filters and baskets or inlet/outlet ports
which could damage your endoscope.

When utilizing chemo-thermal processes for reprocessing PENTAX
endoscopes, the instruments should be allowed to return to room
temperature prior to use and/or further handling.
– 57 –
 Do NOT overtighten the cap to the water bottle assembly. The metal pipe at
the top of the PENTAX water bottle assembly functions as an inlet port for
air from the light source. This inlet pipe should not be used as a leverage
tool to tighten the cap to the water container. Overtightening could cause
the plastic cap to crack.
 Make sure that the air/water/instrument channel cleaning adapter is
securely attached to the top of the air/water and suction cylinders.
 Do NOT introduce air bubbles into the endoscope’s internal channels
during flushing of cleaning and/or disinfecting/sterilizing solutions as these
bubbles could interfere in the effectiveness of the disinfection/sterilization
process.
 Do NOT store the endoscope, its components or accessories in the carrying
case as this type of dark, humid and unventilated environment is conducive
to bacteria colonization which increases the risk of cross-contamination.
 Prior to each use, check the condition of all endoscope accessory
instruments.
Do NOT use any accessories with kinked or bent flexible shafts.
Do NOT use forceps with misaligned cups and/or bent needles/spikes.
Do NOT use aspiration or injection needles which are not retractable or
whose sharp tips can not be protected.
Do NOT use cleaning brushes without smooth or rounded distal tips.
Do NOT use instruments with exceptionally long distal rigid sections or
whose outer diameter restricts passage through the instrument channel/
channel inlet.
Use of any of the above accessories could result in channel damage and
costly repairs.
 Verification of the Minimum Effective Concentration (MEC) of active
ingredients (via test strips or similar methods) is recommended to ensure
potency of the liquid chemical germicide to achieve high-level disinfection/
sterilization.
WARNING:
Instrument repairs should only be performed by an authorized
PENTAX service facility. PENTAX assumes no liability for any
patient/user injury, instrument damage or malfunctions, or
REPROCESSING FAILURE due to repairs made by
unauthorized personnel.
WARNING:
NEVER drop this equipment or subject it to severe impact as it
could compromise the functionality and/or safety of the unit.
Should this equipment be mishandled or dropped, do not use it.
Return it to an authorized PENTAX service facility for inspection
or repair.
– 58 –
4. NOMENCLATURE AND FUNCTION
4-1. Video Endoscope
AIR/WATER FEEDING VALVE (OF-B188)
Covering of hole in the top of the valve delivers
pressurized air. Covering of the hole and fully
depressing the valve delivers pressurized water.
INLET SEAL
Allows passage of accessories while
preventing escape of fluids and air.
SUCTION CONTROL VALVE (OF-B120)
Depress to remove fluids or air through
the instrument channel.
INSTRUMENT
CHANNEL INLET
For introduction of
biopsy forceps
and other accessories.
BUTTON 1
Push to freeze an image.
BUTTON 2
Push to activate the hardcopy system that
was selected between “FILE” and “HARD COPY”.
CONTROL BODY
BUTTON 1
BUTTON 2
BUTTON 4
MODEL DESIGNATION
BUTTON 3
RIGHT/LEFT ANGULATION
CONTROL KNOB
UP/DOWN ANGULATION LOCK LEVER
When this lever is in the “F” position, turned clockwise,
the bending section moves freely. When turned fully counterclockwise,
the bending section becomes progressively more stabilized.
UP/DOWN ANGULATION
CONTROL KNOB
RIGHT/LEFT ANGULATION LOCK
KNOB
Functions similar to Up/Down lock
ELEVATOR MECHANISM
CONTROL KNOB
(DUODENOSCOPES ONLY)
BUTTON 4
Turn clockwise to activate magnification
(EG-2990i/2990Zi, EC-3490i/3490Ti/3890i/3890Zi Series).
To guide and direct cannula or
forceps.
BUTTON 3
Push to activate the VCR for recording live procedures or to
enhance the endoscopic image (EPK-1000).
STRAIN RELIEF BOOT
UMBILICAL CORD
NOTE:
The function of each button can be changed. For more details, refer
to the manual supplied with the EPK-i series or the EPK-1000.
EG-1690K/2490K/2790K/2990K/3490K,
EG-3890TK, ED-3490TK,
EC-2990i/3490Ti/3490K/3890K /3890TK
series
Scope
EG-2790i
VSB-2990i
EG-2990i/2990Zi
EC-3490i/3890i/
3890Zi series
Processor
EPK-i series
EPK-i series
EPK-1000
Button 1
Freeze
Freeze
Freeze
Freeze
Button 2
Hard Copy
Hard Copy
Hard Copy
Hard Copy
Button 3
VCR
VCR
VCR (for NTSC)
Enhance (for PAL)
VCR
Button 4
Enhance
—
Enhance (for NTSC)
AVE/PEAK (for PAL)
Enhance
Magnification
Control Lever
—
Magnification
—
—
– 59 –
EPK-i series
NOTE:
To avoid damaging the endoscope, do NOT twist, rotate or bend
excessively any of the strain reliefs.
DISTAL END
(Refer to the inside rear cover of this instruction for use)
STRAIN RELIEF BOOT
BENDING SECTION
INSERTION TUBE
WATER JET PORT
Allows connection of special irrigation tube
(OF-B113) for pressurized source of a spray
directed at the endoscopically visualized surface.
AIR/WATER PORT
To connect feeding tube from water
bottle assembly.
VENTING CONNECTOR
Accepts “RED” Ventilation cap.
Also accepts Leakage Tester.
VENTILATION CAP OF-C5 RED
Provides venting of endoscope interior to equalize
internal and external pressures. This cap must be
removed before immersion.
NOTE: See important separate section regarding the use
of this cap!
PVE CONNECTOR
Can be rotated
within a 180
range.
ELECTRICAL CONTACTS
PVE SOAKING CAP
OE-C9
This cap must be securely attached before
immersion. Align the black arrow on the
soaking cap with the green dot at the base
of the silver collar surrounding the
electrical contacts on the PENTAX PVE
connector. Press the cap down onto the
metal collar and turn clockwise to secure.
FEED BACK TERMINAL
(Not available in EG-1690K) To
connect the OL-Z3 cable
from the PENTAX video
processor, model EPK-i series,
EPK-1000.
SUCTION NIPPLE
For attachment to
external suction source.
LIGHT GUIDE PLUG
Transmits light from light source
to distal end of endoscope.
NOTE:
Ensure that the PVE soaking cap has been securely attached
(by properly rotating it) to prevent the cap from coming off
during reprocessing. Failure to securely attach the PVE soaking
cap can result in scope damage.
WARNING
Immediately after use, the metal light guide plug and the electrical
contacts/pins of the endoscope may be HOT. To avoid burns, do
not touch these areas immediately after use. For safer handling
after a procedure, grasp the PVE connector housing.
– 60 –
HOYA Corporation
2-7-5 Naka-Ochiai, Shinjuku-ku, Tokyo 161-8525 Japan
PENTAX Medical (Shanghai) Co., Ltd.
Room 701, 291 Fumin Road, Shanghai, China 200031
Tel: +86-21-61701555
Fax: +86-21-61701655
PENTAX Medical Singapore Pte. Ltd.
438A Alexandra Road, #08-06 Alexandra Technopark Singapore 119967
Tel: +65-6271-1669
Fax: +65-6271-1691
PENTAX Medical Company
A Division of PENTAX of America, inc.
3 Paragon Drive Montvale, New Jersey 07645-1782 USA
Tel: +1-201-571-2300 Toll Free: +1-800 431-5880
Fax: +1-201-391-4189
PENTAX Canada Inc.
1770 Argentia Road Mississauga, Ontario L5N 3S7 Canada
Tel: +1-905-286-5585
Fax: +1-905-286-5571
PENTAX Europe GmbH
Julius Vosseler Strasse 104, 22527 Hamburg, Germany
Tel: +49-40-561-920
Fax: +49-40-560-4213
EC
REP
PENTAX U.K. Ltd.
PENTAX House, Heron Drive, Langley SLOUGH SL3 8PN, Great Britain
Tel: +44-1753-792792
Fax: +44-1753-792794
Manufacturing Site
HOYA Corporation, PENTAX Miyagi Factory
30-2 Okada, Aza-Shimomiyano, Tsukidate, Kurihara-shi, Miyagi 987-2203 Japan
 Specifications are subject to change without notice and without any obligation
on the part of the manufacturer.
88151
2014. 03.
6217001
Z863
R16
printed in JAPAN

PDF - PENTAX Medical

Transcription

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