Only For the Americas

INSTRUCTIONS FOR USE

(REPROCESSING)

PENTAX ULTRASOUND
VIDEO BRONCHOSCOPE

EB-1970UK
Product Overview
This instrument photographs the subject of observation using a solid-state image sensor and ultrasound transducer located at the
endoscope tip under the light transmitted from the processor/light source. The target of the observation will be monitored by the
physician using the endoscopic image and ultrasound image displayed on the video monitors. The endoscopic procedure is
performed by inserting an aspiration needle into the instrument channel inlet on the control body.
The bending section angulates in the intended direction and angle by operating the Angulation Control Lever, and air or fluids can
be suctioned from the distal end of the endoscope by operating the Suction Control Valve.

Indication for Use

The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and
therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystems: Nasal Passage,
Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced
per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Application
Medical purpose: Provide images for optical visualization, ultrasound recording, and/or diagnostic aid.
Patient populations: Adults and pediatrics who have been determined by the physician to be appropriate candidates for the use of
this instrument Intended anatomical area: Airways and tracheobronchial tree
User: Medical doctors (expert approved by the medical safety officer to perform for endoscopic examinations at each medical
facility)
Place of Use: Medical facillity

Functions Used Frequently

The frequently used functions in this model are as follows:
•• Angulation capability using control lever
•• Remote control operation using remote buttons
•• Suctioning function

Removable Components
OF-B179 Suction Control Valve
OF-B190 Inlet Seal
OE-B3 Inlet Cap

Warning
The balloon used with this endoscope contains latex, which may cause allergic reactions. Due to the potential for severe allergic
reactions to medical devices containing latex (natural rubber), healthcare professionals are encouraged to identify latex sensitive
patients, professionals, and other high-risk groups and be prepared to treat allergic reactions promptly.

Notes
Read this Instructions for Use (IFU) before reprocessing the endoscope, 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 or the companion Instructions for Use (operation) may result in damage to, and/ or malfunction
of, the equipment.
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 use and the reprocessing of these medical devices. Known risks and/or potential injuries associated with
flexible endoscopic procedures include, but are not limited to, the following: perforation, infection, hemorrhage, burns, and electric
shock.
This IFU describes the procedures for reprocessing and maintenance of the equipment after its use.
For inspection and preparation prior to its use, please refer to the separate Instructions for Use (Operation).
If you have any questions regarding the information in this IFU or concerns pertaining to the safety and/or use of this equipment,
please contact your local PENTAX representative.
Sterility Statement
This endoscope identified in this IFU is a reusable semi-critical device. Since it is packaged non-sterile, it must be high-level
disinfected or sterilized BEFORE inital use. Prior to each subsequent procedure, it must be subjected to an appropriate cleaning
and either high-level disinfection or sterilization process.

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).

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
Symbols on Marking
Symbolesdistinctifs
Symboles distinctifs
Symbol for “MANUFACTURER” Attention, consult instructions for use
Attention, consulter le manuel d’utilisation
Type BF applied part (Safety degree specified by IEC 60601-1)
Symbol for “DATE OF MANUFACTURE” 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.
 TABLE OF CONTENTS

NOMENCLATURE.............................................................................................................................................1
Ultrasound Video Bronchoscope.............................................................................................................1
Endoscope Components and Accesories...............................................................................................3
General
NOMENCLATURE.............................................................................................................................................4

ENDOSCOPE REPROCESSING PROCEDURE FLOw....................................................................................5 Endoscope

Pre-Cleaning
1 CARE AFTER USE......................................................................................................................................6
1-1. General................................................................................................................................................ 6
Leak
1-1-1. Application...................................................................................................................6
Testing
1-1-2. Important Instructions.................................................................................................7
1-1-3. Internal Channels of PENTAX Ultrasound Video Bronchoscope (EB-1970UK)..... 10
1-1-4. Quick Reference of Injection Volumes for Internal Channels................................. 11 Endoscope
Cleaning
1-1-5. Inspection of Reprocessing Accessories................................................................. 12
1-2. Endoscope Reprocessing................................................................................................................. 14
1-2-1. Pre-Cleaning.................................................................................................................14
Endoscope
1-2-2. Leak Testing.................................................................................................................18 Disinfection
1-2-3. Cleaning........................................................................................................................19
1-2-4. High-Level Disinfection...............................................................................................29
Endoscope
1-3. Endoscope components and accessories......................................................................................37
Sterilization
1-3-1. Cleaning........................................................................................................................38
1-3-2. High-Level Disinfection...............................................................................................42
1-3-3. Optional sterilization...................................................................................................45 Accessory
Cleaning

2 POST REPROCESSING AND STORAGE..................................................................................................47

Accessory
3 SERVICING..................................................................................................................................................48
Disinfection

4 APPENDIX...................................................................................................................................................50
4-1. List of Compatible Reprocessing Systems and Agents................................................................ 50 Accessory
Sterilization
 NOMENCLATURE

Ultrasound Video Bronchoscope

EB-1970UK
PVE CONNECTOR ELECTRICAL
CONTACT

STRAIN RELIEF BOOT

VENTING CONNECTOR

UMBILICAL CORD

SCANNING UNIT CONNECTOR CABLE

VENTILATION CAP (OF-C5）

STRAIN RELIEF

INLET SEAL (OF-B190)

SUCTION CONTROL VALVE

(OF–B179)

STRAIN RELIEF BOOTS

INSTRUMENT STRAIN RELIEF BOOT

SUCTION NIPPLE CHANNEL INLET

CONTROL BODY

MODEL DESIGNATION

BOOTS CAP (OE-B3)

Model Name
Minimum Instrument WATER INJECTION
ANGULATION CONTROL LEVER CONNECTOR
Channel Width

Ultrasound Video Bronchoscope EB-1970UK

Minimum Instrument
2.0
Channel Width(I.D. φ mm)

–1–
 PVE SOAKING CAP (OE-C9)

STRAIN RELIEF BOOT

SCANNING UNIT CONNECTOR SCANNING UNIT CONNECTOR

SOAKING CAP (OE-U1)

SCANNING UNIT CONNECTOR LOCK

BENDING SECTION
INSERTION TUBE

DISTAL END

–2–
 NOMENCLATURE

Endoscope Components and Accesories

Endoscope Components

(OF-B179)

・Suction Valve (OF-B179) ・Inlet Seal (OF-B190)

・Inlet Cap (OE-B3)

Accessories

• Bite Block (OF-Z5) ・Balloon Attachment Tool (OE-A53)

・Injection Tube (OE-B5)

–3–
 Reprocessing Accessories

・PVE Soaking Cap (OE-C9) ・Scanning Unit Connector Soaking Cap (OE-U1)

Bristles

・Ventilation Cap (OF-C5) ・Cleaning Adapter (OF-B155) ・Cleaning Brush (CS-C3S)

・Cleaning Brush (CS6002SN/CS6015ST)

Model Number Appearance of Bristles Length of Shaft Diameter of Bristles

CS6002SN 20cm φ 6mm

CS6015ST 150cm φ 6mm

–4–
ENDOSCOPE REPROCESSING PROCEDURE FLOW

Pre-Cleaning
• Preparation
• Wiping of insertion tube
• Flushing the balloon channel with detergent solution
• Aspiration of detergent solution through suction channel
• Transport to cleaning room

Leak Testing

Cleaning
• Preparation
• Cleaning of all external surfaces
• Brushing the suction channel
• Filling channels with detergent solution
• Soaking in detergent solution
• Rinsing
• Drying

High-Level Disinfection
• Preparation
• Filling channels with disinfecting solution
• Soaking in disinfecting solution
• Rinsing
• Drying

–5–
1 CARE AFTER USE

1-1. General
1

NOTE
This IFU has been written in accordance with to 21CFR Part801, ISO 17664, General
and national guidelines on reprocessing of medical products.

1-1-1. Application

WARNING

Reprocessing may affect device functionality. Prior to use, always inspect the
endoscope, components, and accessories for proper function to determine
that they are appropriate for patient use.

Components and Accessories for the Ultrasound Video Bronchoscope

Video Ultrasound
MODEL
TYPE Bronchoscope
Name Number EB-1970UK
Suction Control Valve OF-B179 Y
Endoscope
Inlet Seal OF-B190 Y
Component
Inlet Cap OE-B3 Y
Bite Block-Adult Size OF-Z5 Y
Accessory Injection tube OE-B5 Y
Balloon Installation Device OE-A53 Y
PVE Soaking Cap OE-C9 Y
Scanning Unit Connector Soaking
OE-U1 Y
Cap
Reprocessing Ventilation Cap OF-C5 Y
Accessory Cleaning Adapter OF-B155 Y
Cleaning Brush CS6002SN Y
Cleaning Brush CS6015ST Y
Cleaning Brush CS-C3S Y

Y : YES
N : NO

–6–
 1-1-2. Important Instructions

WARNING
1
••Reusable Medical Devices that are initially supplied non-sterile require
the end user to disinfect or sterilize them prior to initial use and to
subsequently reprocess them after each subsequent use.
••Proper care of the device after each procedure is extremely important.
General
Immediately (within one hour) after the completion of a procedure, the
endoscope, its removable components, and accessories should be both
precleaned and mechanically cleaned with detergent solution. Generally,
if these endoscopes and accessories are not precleaned within 15
minutes and mechanically cleaned within one hour after the conclusion
of the procedure, dried blood, mucus, or other patient debris may cause
damage to the devices or interfere with the ability of the user to properly
reprocess them.
••The use of detergent immediately after each procedure to dissolve and
remove organic contaminants and proteinaceous debris is essential to
the proper care and maintenance of the endoscope. Prior to disinfection
or sterilization, all instruments and components must be meticulously
cleaned. Failure to do so can result in incomplete or ineffective
disinfection and sterilization.
••Always inspect reprocessed endoscopes and accessories prior to use
according to their respective Instructions for Use (IFU).
••During the reprocessing process, always wear protective equipment
(e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross
contamination.
••Contact the manufacturer and follow local regulations regarding safe use,
appropriate handling and disposal of cleaning and disinfection solutions,
including alcohol and rinse water. Material Safety Data Sheets available
from the cleaning and disinfection solution manufacturer should be
consulted to provide guidance to end users about formulation, hazards,
chemical and physical properties, first aid, handling and storage,
stability, precautions, disposal, etc..

WARNING

Endoscopes are semi-critical devices that require cleaning and at least high-
level disinfection. Use only legally marketed solutions and/or automated
endoscope reprocessors (AERs) for which validation testing with PENTAX
products has been performed by their manufactures. A list of legally marketed
solutions/systems that have been determined to be compatible with PENTAX
brand products is contained in this manual.

–7–
CAUTION
To avoid damaging the endoscope, do NOT twist, rotate or excessively bend
any of the strain reliefs [(1), (2)] during inspection, clinical use, reprocessing, 1
or any handling activity. Be particularly cautious regarding the insertion tube
strain relief [(1)]. When wiping the insertion tube and the umbilical cable, use
a slow back and forth motion to wipe them along the tube/cable. Never apply
excessive force or torque to these strain reliefs or tubes/cables. General

(2)

(2)

(1)

Figure 1.1

–8–
 NOTE
This IFU contains detailed recommendations on the manual reprocessing of
1 PENTAX endoscopes using PENTAX supplied cleaning/disinfecting adapters.
AERs may also be used to reprocess flexible endoscopes. However, only
those AERs should be used whose manufacturers provide device-specific
instructions and have validation data to support each AER claim with respect
General
to PENTAX instruments. AER manufacturers should be consulted for their
specific claims including, but not necessarily limited to:
a) the ability of the AER to provide a cleaned and high-level disinfected (or
sterilized) endoscope and endoscope components (e.g., valves),
b) the identification of any special feature (internal channel) or endoscope
component that cannot 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
from within endoscope channels,
f) m a i n t e n a n c e p r o c e d u r e s f o r w a t e r f i l t e r r e p l a c e m e n t a n d / o r
decontamination of the filtration system to ensure water of suitable
quality,
g) compliance with local regulations and/or guidelines.

NOTE
PENTAX flexible endoscopes should not be exposed to temperatures in excess
of 140oF (60oC) during either reprocessing or storage. During reprocessing,
depending upon the detergents used, the endoscopes may be damaged even
if the temperature does not exceed 140oF (60oC). A list of detergents that are
compatible with PENTAX endoscopes is contained in this manual.

NOTE
All of the steps in the validated reprocessing protocol described in this
manual are intended to be performed in rapid succession and as a single,
continual procedure. There should be no breaks in between steps of the
protocol that are of sufficient duration to permit the endoscope to dry to
such an extent that dislodged debris and/or microbial contaminants would be
permitted to dry onto any endoscope surface. In the event that drying of the
endoscope occurs due to an excessive break in the reprocessing procedure,
the procedure should be completely repeated, beginning with the first pre-
cleaning step.

–9–
1-1-3. Internal Channels of PENTAX Ultrasound Video Bronchoscope (EB-
1970UK)
The following internal schematic diagram is designed to help users better understand the
intricate construction of PENTAX endoscope. Please note that all solution entrance ports and 1
flow pathways are illustrated below.

(1) Suction Channel

(4) General
(2) Balloon Channel
(6) (3) Instrument
(5)
Channel Inlet
(4) Inlet Seal
(1)
(3) (5) Suction Cylinder
(6) Cleaning Adapter
(OF-B155)
(7) Injection Tube
(2) (OE-B5)
(8) Water Injection
(8)
Port
(9) Scanning Unit
Connector
Soaking Cap
(7)
(OE-U1)
(9) (10) Scanning Unit
Connector
(10)
(11) Ventilation Cap
(OF-C5)
(12) PVE Soaking
Cap (OE-C9)

(11)

(12)

Figure 1.2

– 10 –
 1-1-4. Quick Reference of Injection Volumes for Internal Channels
The following table has been provided as a service to help users better understand the injection
volumes for internal channels of ultrasound video bronchoscope.
1

Cleaning Process
General

Cleaning
Ultrasound Maximum Injection Volumes(mL)
Internal
Video Volume
Channel Rinse
Bronchoscopes Capacity(mL) Detergent Air
Water
Suction ① :25 mL ① :35 mL ① :35 mL
5 mL
Channel ② :25 mL ② :35 mL ② :35 mL
EB-1970UK
Balloon
0.5 mL 10 mL 15 mL 15 mL
Channel
① Injecting from suction nipple
② Injecting from inlet seal (OF-B190)

High Level Disinfection Process

High Level Disinfection Alcohol Rinse

Ultrasound Maximum Injection Volumes (mL) Injection Volumes (mL)
Internal
Video Volume Sterile
Channel
Bronchoscopes Capacity (mL) Disinfectant Rinse Air Alcohol Air
Water
Suction ① :25 mL ① :35 mL ① :35 mL ① :35 mL ① :35 mL
5 mL
Channel ② :25 mL ② :35 mL ② :35 mL ② :35 mL ② :35 mL
EB-1970UK
Balloon
0.5 mL 10 mL 15 mL 15 mL 10 mL 15 mL
Channel
① Injecting from suction nipple
② Injecting from inlet seal (OF-B190)

– 11 –
1-1-5. Inspection of Reprocessing Accessories
Before use, inspect reprocessing accessories according to the following procedure.

WARNING 1

••Replace a reprocessing accessory with a new one when inspection of the

device indicates that it is damaged or unable to function properly.
General

1-1-5-1. Inspection of PVE Soaking Cap (OE-C9)

1) Check that there is no cracking on the outer surfaces of the PVE Soaking Cap.
2) Check that there are no scratches, cracking, or chipping of the sealing surfaces inside
the PVE Soaking Cap.

Sealing Surfaces

Figure 1.3

1-1-5-2. Inspection of Scanning Unit Connector Soaking Cap (OE-U1)

1) Check that there is no cracking on the outer surfaces of the Scanning Unit Connector
Soaking Cap.
2) Check that there are no scratches, cracking, or chipping of O-ring (OS-A69) of the
Scanning Unit Connector Soaking Cap. Replace O-ring (OS-A69) if it is worn or
damaged.

Figure 1.4

– 12 –
 1-1-5-3. Inspection of Ventilation Cap (OF-C5)
1) Make sure that the Locking Groove of the Ventilation Cap is not deformed.
2) Check that there are no scratches, cracking, or chipping of the O-ring inside the
1 Ventilation Cap.

General

Figure 1.5

1-1-5-4. Inspection of Cleaning Adapter (OF-B155)

1) Check that there are no scratches, cracking, or chipping of the sealing surfaces inside
the Cleaning adapter.

Sealing Surface

Figure 1.6

1-1-5-5. Inspection of Cleaning Brushes (CS-C3S/CS6002SN/CS6015ST)

1) Make sure that there are no missing bristles on Cleaning Brushes.
2) Check that there is no kinking or bending of the Cleaning Brush Shaft.

– 13 –
1-2. Endoscope Reprocessing
Ultrasound Video Bronchoscope can be subjected to the following cleaning, disinfection, and
optional sterilization process.
1
Optional
Cleaning
Ultrasound Video High-Level Sterilization
Bronchoscope Disinfection Steam
Manual Ultrasonic
Sterilization
EB-1970UK Y N Y N

Y : YES
N : NO
Endoscope
Pre-Cleaning
1-2-1. Pre-Cleaning

WARNING

••During reprocessing, always wear protective equipment (e.g., gloves,

gowns, face masks, etc.) to minimize the risk of cross contamination.
••Pre-cleaning is intended to remove visible debris from the endoscope
immediately after its withdrawl from the patient, in order to increase the
effectiveness of the subsequent cleaning procedure. Endoscopes that are
withdrawn from the patient are soiled with debris such as blood, tissues,
and mucus. When such debris dries, it cannot be adequately removed
in the subsequent cleaning procedure. It should be noted that pre-
cleaning cannot substitute for the mechanical cleaning process. Always
mechaniclly clean the endoscope after pre-cleaning.
••The latex balloon is for single patient use. Discard it after each
procedure and never reuse it.
••During pre-cleaning, never wipe the insertion tube with alcohol or
disinfecting solution. These solutions may fix organic contaminants and
proteinaceous debris to the instrument and have an adverse effect on
endoscope functionality and proper reprocessing.
••When using detergent, use only legally marketed brands that have been
tested and found to be compatible by PENTAX. A list of detergents that
are compatible with PENTAX endoscopes is contained in this manual.
••When flushing detergent solution through the Balloon Channel, ensure
that detergent solution exits from the endoscope distal end. If not,
the Balloon channel might be blocked. Never use an endoscope with a
blocked channel. Contact your local PENTAX facility to arrange for repair
of the device.

WARNING

••Please note that the Balloon channel must undergo all steps of the
endoscope reprocessing procedure, regardless of whether it was used
during a clinical procedure.

– 14 –
 CAUTION
••Immediately after use, the metal light guide plug and electrical contacts/
1 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.
••Prior to pre-cleaning the endoscope, leave the PVE connector attached
to the video processor and the scanning unit connector attached to the
ultrasound scanning unit.
••In order to prevent damage to the endoscope, do not place any objects
other than inlet seal (OF-B190), Suction Control Valve (OF-B179), and
Endoscope Injection Tube (OE-B5) into the closed container used to transport the
Pre-Cleaning endoscope to the reprocessing area.
••When attaching or removing the latex balloon, be careful not to demage
the endoscope, especially the sensitive transducer, optical lenses or
bending section at the distal portion.

CAUTION
In order to avoid damaging the endoscope, never subject it to suction in
excess of 66kPa.

NOTE
If the use of detergent solution is not permitted in the procedure room,
remove the endoscope from the procedure room and perform pre-cleaning in
another location.

1-2-1-1. Items required

•• Protective equipment such as gloves, gowns, face masks, etc.

•• Detergent solution, Endozime (Ruhof Corporation)

•• External suction source

•• 500 mL basin

•• Lint-free gauze

•• 30 mL luer slip syringe

•• Inlet seal (OF-B190)

•• Suction control valve (OF-B179)

•• Injection tube (OE-B5)

1-2-1-2. Preparation
1) Wear personal protective equipment.
2) Prepare a 500 mL basin with detergent solution per manufacturer's instructions
(temperature, concentration). In the case of ENDOZIME, add 30 mL of ENDOZIME
concentrate to 3.8 L (1 gallon) of clean potable water at 20°C~30°C (68°F~86°F).

– 15 –
1-2-1-3. Wiping of the insertion tube
1) Turn off the lamp switch of the video processor.
2) Immediately after removing the endoscope from the patient, gently wipe the
entire length of the insertion tube three times using lint-free gauze soaked with the 1
detergent solution.

Endoscope
Pre-Cleaning

Figure 1.7

3) Carefully remove the balloon attached to the distal end of the endoscope and discard
it. By removing the portion of the balloon attached to the back end of the distal tip
with fingers first, the balloon can then be easily removed. The latex balloon is for
single patient use. Discard it after each procedure, and never reuse it.

Figure 1.8

1-2-1-4. Flushing of balloon channel with detergent solution

1) Attach injection tube (OE-B5) to the water injection port of endoscope, and attach a
30 mL syringe filled with detergent solution to OE-B5.
(1) OE-B5
(2) Water Injection Port

(2)

(1)

Figure 1.9

2) Place the distal end of endoscope into a basin.

3) Flush the balloon channel with 10 mL of detergent solution, and ensure that it exits
from the endoscope distal end.

– 16 –
 4) While the endoscope distal end is still in the basin, using a 30 mL syringe filled with
air, flush the balloon channel with 15 mL of air to purge as much residual detergent
solution as possible.
1
1-2-1-5. Aspiration of detergent solution through the suction channel
1) Connect inlet seal (OF-B190) and suction control valve (OF-B179) to the endoscope.
2) Connect a suction tube from an external suction source to the endoscope suction
nipple.
3) Turn on the external suction source.
Endoscope
4) Place the distal end of the endoscope into a basin, and aspirate detergent solution
Pre-Cleaning through the suction channel by pressing suction control valve (OF- B179) for 10
seconds.
(1) OF-B190
(2) (1)
(2) OF-B179
(3) External Suction Source

(3)

Figure 1.10

5) Remove the distal end from the detergent solution, and aspirate air through the
suction channel by pressing suction control valve (OF-B179) for 10 seconds.
6) Turn off the external suction source.
7) Disconnect tubing from the endoscope suction nipple.

1-2-1-6. Transport to cleaning room

1) Turn off the power to the video processor, and detach the PVE connector from the
video processor.
2) Turn off the power to the ultrasound scanning unit, and detach the scanning
connector from the ultrasound scanning unit.
3) Transport the precleaned endoscope to the cleaning room in a closed container.

– 17 –
1-2-2. Leak 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 a leakage tester.
1
CAUTION
Various types of manual and automated endoscope leakage testers exist.
Some are stand-alone units, and others may be integrated into an AER.
PENTAX does not evaluate non-PENTAX leakage testers to verify their specific
product claims with repect to their effectiveness to accurately detect leaks
and/or 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. Also, 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 Leak
Testing
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.

– 18 –
 1-2-3. Cleaning

WARNING
1
••During reprocessing, always wear protective equipment (e.g., gloves,
gowns, face masks, etc.) to minimize the risk of cross contamination.
••In order to ensure thorough cleaning, be sure to perform all cleaning
steps. The effectiveness of each cleaning step will influence the
effectiveness of subsequent steps. Failure to properly follow the cleaning
steps described may result in incomplete or ineffective cleaning,
disinfection and sterilization of endoscope, and may cause a cross-
infection risk.
••Immediately (within one hour) after the completion of a procedure,
the endoscope and its components should be thoroughly and carefully
cleaned with detergent solution. If the endoscope and its components
are left uncleaned for an excessive time after use, dried blood, mucus,
or other patient debris may cause damage or interfere with the ability of
the user to properly reprocess the device.
••For cleaning, use only legally marketed detergents that have been
tested according to the instructions of the manufacturer and found to
Endoscope be compatible by PENTAX. A list of detergents that are compatible with
Cleaning
PENTAX endoscopes is contained in this manual
••Fresh detergent solution must be used for each endoscope that is
reprocessed.

WARNING

••Please note that the Balloon channel must undergo all steps of the
endoscope reprocessing procedure, regardless of whether the it was
used during a clinical procedure.

CAUTION
••PVE soaking cap (OE-C9) and scanning unit connector soaking cap (OE-
U1) must be properly secured over the electrical contacts. Failure to
do so can result in water invasion and damage to the endoscope. If an
endoscope is cleaned without these soaking caps attached, do not use
it, and contact your local PENTAX service facility or sales representative.
••Ventilation cap (OF-C5) must be taken OFF during reprocessing. Failure
to do so can result in damage to the endoscope. If an endoscope is
cleaned with the ventilation cap attached, do not use it, and contact
your local PENTAX service facility or sales representative.
••During cleaning, never twist, rotate, or bend the insertion portion,
umbilical cable, and scanning unit connector cable excessively.
••Never subject the endoscope to ultrasonic cleaning methods.
••In order to prevent damage to the endoscope, do not place any objects
other than the reprocessing accessories listed in section 1-2-3-1 when
immersing it in a cleaning basin.

– 19 –
1-2-3-1. Items required
•• Protective equipment such as gloves, gowns, face masks, etc., to minimize the
risk of cross contamination.

•• Detergent solution, Endozime (Ruhof Corporation) 1

•• Clean potable water

•• Basin sufficient is size to immerse the entire endoscope (at least 50 cm in width
x 40 cm in depth x 15 cm in height)

•• Lint-free gauze

•• 30 mL luer slip syringe

Reprocessing accessories

•• PVE soaking cap (OE-C9)

•• Scanning unit connector soaking cap (OE-U1)

•• Cleaning brush (CS6002SN)

Endoscope
•• Cleaning brush (CS6015ST) Cleaning

•• Cleaning brush (CS-C3S)

•• Cleaning adapter (OF-B155)

•• Inlet seal (OF-B190)

•• Injection tube (OE-B5)

1-2-3-2. Preparation
1) Wear personal protective equipment.
2) Attach PVE soaking cap (OE-C9) and scanning unit connector soaking cap
(OE-U1) to the endoscope
3) Detach ventilation cap (OF-C5) from the endoscope.
(1) OE-C9
(1) (2) OE-U1
(3) OF-C5

(3)

(2)

Figure 1.11

4) Fill a basin with a sufficient volume of detergent solution to completely immerse

the endoscope. Prepare the detergent solution in accordance with the manufacturer’s
instructions (temperature, concentration). In the case of ENDOZIME, add 30 mL of
ENDOZIME concentrate to 3.8 L (1 gallon) of clean potable water at 20°C~30°C
(68°F~86°F).

– 20 –
 1-2-3-3. Cleaning of all external surfaces

CAUTION
1 ••Do not squeeze or severely bend the insertion tube.
••Do not use any abrasive materials.
••Be careful to avoid damage to the distal lenses.

1) Fully immerse the endoscope with the components attached in the detergent solution.
2) Detach the inlet seal (OF-B190), suction control valve (OF-B179), injection tube
(OE-B5) and water injection port cap (OE-B3) from the endoscope.
(1) OF-B190
(2)
(1) (2) OF-B179
(3) OE-B5
(4) OE-B3

(4)

Endoscope
Cleaning (3)

Figure 1.12

3) Open the cap of the inlet seal (OF-B190) and place it in the detergent solution.
(1) OF-B190
(1)

Figure 1.13

4) OF-B190 and OE-B5 should be reprocessed with the endoscope, because they
will be used for cleaning/disinfection of the endoscope. OF-B179 and OE-B3 will
be reprocessed separately from the endoscope, because they will not be used for
cleaning/disinfection of the endoscope. (see Section 1-3 “Endoscope components
and accessories”)
5) While still immersed in the detergent solution, wash the entire surface of endoscope
three times with a lint-free gauze.
6) Brush the balloon attachment groove with the CS-C3S cleaning brush for 30 seconds.
7) Visually inspect the entire surface of the endoscope to insure that no soil is present,
paying special attention to areas such as the balloon attachment groove, distal end,
and control body, which are the most likely regions to retain visible soil.

– 21 –
8) If any soil is still present on the balloon attachment grooves on the distal end of the
endoscope, use cleaning brush (CS-C3S) to gently brush the groove until the soil has
been completely removed.
(1) Balloon Attachment 1
Grove

(1)

Figure 1.14

9) In the case of visible soil that might still be found on any part of the distal tip other
than the balloon attachment groove or any other external endoscope surfaces, wipe
the areas in question with lint-free gauze until the soil has been completely removed.
10) Similarly, wash the entire surface of OF-B190 and OE-B5 three times with a lint-
free gauze.

1-2-3-4. Brushing of the suction channel Endoscope

Cleaning

WARNING

••Do not use cleaning brushes other than those that are specified in this
instructions for use. Failure to do so can result in endoscope damage or
incomplete or ineffective cleaning.
••Prior to use, ensure that cleaning brushes are not damaged (e.g., kinked
shaft or bent or missing bristles).
••In order to prevent the disposal of patient debris left in the endoscope
channel into the environment always withdraw brushes slowly.

CAUTION
••In order to avoid damage to the endoscope distal end, never attempt to
insert a cleaning brush into the endoscope distal tip.
••Never apply excessive pressure to introduce or withdraw the brush. This
can result in damage to the endoscope and/or the brush.

Always fully immerse the endoscope during brushing.

1) Insert cleaning brush (CS6002SN) into the opening of the suction nipple, and gently
push it until it appears in the suction cylinder.
(1) CS6002SN
(1) (2) Suction Nipple
(3) Suction Cylinder
(2)

(3)

Figure 1.15

– 22 –
 2) Gently withdraw the brush, and remove debris from the brush head by rubbing it
with gloved fingers.
3) Repeat steps 1 and 2 three additional times.
1 4) Insert cleaning brush (CS6002SN) into the opening at bottom of the suction cylinder,
and advance it for approximately 15 cm until resistance is felt. DO NOT USE
EXCESSIVE FORCE.
(1) CS6002SN
(1)
(2) Suction Cylinder
(2)

Figure 1.16

5) Gently withdraw the brush, and remove debris from the brush head by rubbing it
with gloved fingers.
6) Repeat steps 4 and 5 three additional times.
Endoscope 7) Insert cleaning brush (CS6015ST) into the instrument channel inlet, and gently
Cleaning
advance it until it exits the distal end of the endoscope.
(1) CS6015T
(1) (2) Instrument Channel
Inlet
(2)

Figure 1.17

8) Remove debris from the brush head by rubbing it with gloved fingers. Gently
withdraw the brush.
9) Repeat steps 7 and 8 three additional times.
10) Insert cleaning brush (CS-C3S) into the suction cylinder, and rotate it for one minute.
Do not insert the brush excessively.
(1) CS-C3S
(1) (2) Suction Cylinder

(2)

Figure 1.18

11) Withdraw the brush. Remove debris from the brush head by rubbing it with gloved
fingers.
12) Repeat steps 10 and 11 three additional times.

– 23 –
1-2-3-5. Filling channels with detergent solution

WARNING

••While injecting detergent solution through the channels, avoid the 1

introduction of air. The presence of air bubbles can prevent contact of
the detergent solution with channel surfaces.
••Always fully immerse the endoscope while flushing detergent solution
into the endoscope channel.
••It is imperative that the cleaning adapter (OF-B155) and inlet seal (OF-
B190) be securely attached to the endoscope. Failure to properly connect
and secure the cleaning adapter and inlet seal can result in ineffective
and incomplete reprocessing.

CAUTION
In order to avoid damage to the endoscope, never apply excessive force if
resistance is encountered while flushing detergent solution into channels. Do
not use the endoscope, and contact your local PENTAX service facility or sales
representative.
Endoscope
Cleaning

Always immerse the endoscope, components, and accessories in detergent solution during
cleaning.

Attaching components and accessories to the endoscope

1) Attach inlet seal (OF-B190), cleaning adapter (OF-B155), and injection tube (OE-B5)
to the endoscope.
(1) OF-B190
(2)
(1) (2) OF-B155
(3) OE-B5

(3)

Figure 1.19

Filling the channels with detergent solution

2) Attach a syringe filled with detergent solution to the suction nipple, and inject 25 mL
of detergent solution into the suction channel.
(1) Suction Nipple
(1)

Figure 1.20

– 24 –
 3) Check to confirm that detergent solution flows out from the suction channel opening
on the distal end of the endoscope.
4) Insert a syringe filled with detergent solution to inlet seal (OF-B190), and inject 25
1 mL of detergent solution into the suction channel.
(1) OF-B190

(1)

Figure 1.21

5) Attach a syringe filled with detergent solution to injection tube (OE-B5), and inject
Endoscope 10 mL of detergent solution into the balloon channel.
Cleaning
(1) OE-B5

(1)

Figure 1.22

6) Check to confirm that detergent solution flows out from the balloon channel opening
on distal end.
7) After injecting detergent solution into all channels, detach inlet seal (OF-B190),
cleaning adapter (OF-B155), and injection tube (OE-B5) from the endoscope, and
leave them to soak along with the endoscope in the detergent solution. Open the cap
of inlet seal (OF-B190).
(1) OF-B190
(2)
(1) (2) OF-B155
(2)
(1)
(3) OE-B5

(3)

Figure 1.23

– 25 –
1-2-3-6. Soaking in detergent solution

WARNING

••The detergent solution must remain in contact with ALL internal channels 1
and external endoscope surfaces for the time period recommended by
the manufacturer of the detergent.
••Adhere to the conditions (temperature, concentration, time) specified
by the detergent manufacturer to accomplish effective and complete
cleaning. Use of the detergent solution under conditions that fall outside
the manufacturers directions might damage the endoscope. Use of
a timer or audible alarm is recommended in order not to exceed the
recommended soaking time.
••During immersion, detach all components and accessories (except the
soaking cap) from the endoscope to ensure contact of all endoscope
surfaces with the detergent solution.

CAUTION
Never subject the endoscope to ultrasonic cleaning methods.
Endoscope
Cleaning
1) While fully immersing the endoscope, inlet seal (OF-B190), injection tube
(OE-B5) , and cleaning adapter (OF-B155), ensure that there are no air bubbles on
the endoscope surfaces, distal end, and accessories. If any air bubbles are detected,
flush them away with detergent solution using a syringe.
2) Soak the endoscope, OF-B190, OE-B5, and OF-B155 under conditions (temperature,
concentration, time) specified by the detergent manufacturer. In the case of
Endozime, the immersion time is 3 minutes.

Figure 1.24

3) After soaking, ultrasonically clean inlet seal (OF-B190), injection tube (OE-B5), and
cleaning adapter (OF-B155) according to Section 1-3 “Endoscope components and
accessories”.
Purging detergent solution from the channels
4) After ultrasonic cleaning, attach inlet seal (OF-B190), injection tube (OE-B5), and
cleaning adapter (OF-B155) to the endoscope. (see Figure 1.19, p24)
5) Attach a syringe filled with air to the suction nipple, and flush the suction channel
with 35 mL of air to purge as much residual detergent solution as possible. (see
Figure 1.20, p24)

– 26 –
 6) Insert a syringe filled with air to inlet seal (OF-B190), and flush the suction channel
with 35 mL of air to purge as much residual detergent solution as possible. (see
Figure 1.21, p25)
1 7) Attach a syringe filled with air to injection tube (OE-B5), and flush the balloon
channel with 15 mL of air to purge as much residual detergent solution as possible.
(see Figure 1.22, p25)
8) Remove the endoscope with the components and accessories attached from the
detergent solution.

1-2-3-7. Rinsing

WARNING

It is important that all internal channels, external endoscope surfaces,

and components be thoroughly rinsed with clean water to remove residual
detergent solution. Failure to do so can result in ineffective or incomplete
disinfection and sterilization.

Endoscope
Cleaning
First rinse
1) Place the endoscope with components and accessories attached in a basin of clean
water that is of sufficient volume to completely immerse the endoscope.
2) Detach the inlet seal (OF-B190), injection tube (OE-B5), and cleaning adapter (OF-B155)
from the endoscope. Open the cap of inlet seal (OF-B190). (Figure 1.23, p25)
3) Wipe all exterior surfaces of the endoscope, inlet seal (OF-B190), injection tube (OE-
B5), and cleaning adapter (OF-B155) one time with a lint-free gauze in order to remove
residual detergent solution.
4) While still completely immersed in water, grasp the distal end and control body of the
scope and PVE connector with two hands, and agitate them under the water by moving
them from side to side repeatedly for one minute.

Figure 1.25

– 27 –
5) Grasp the scanning unit connector with two hands, and agitate it under the water by
moving it from side to side repeatedly for one minute.

Figure 1.26

6) Grasp inlet seal (OF-B190), injection tube (OE-B5), and cleaning adapter (OF-B155)
with a hand, and agitate them under the water by moving them from side to side
repeatedly for one minute.
Endoscope
7) Attach inlet seal (OF-B190), injection tube (OE-B5), and cleaning adapter (OF-B155) Cleaning
to the endoscope. (Figure 1.19, p24)
8) Attach a syringe filled with water to the suction nipple, and flush the suction channel
with 35 mL of water. (Figure 1.20, p24)
9) Insert a syringe filled with water to inlet seal (OF-B190), and flush the suction
channel with 35 mL of water. (Figure 1.21, p25)
10) Attach a syringe filled with water to injection tube (OE-B5), and flush the balloon
channel with 15 mL of water. (Figure 1.22, p25)
11) Remove the endoscope with the components and accessories attached from the water.
12) Attach a syringe filled with air to the suction nipple, and flush the suction channel
with 35 mL of air to purge as much residual water as possible.(Figure 1.20, p24)
13) Insert a syringe filled with air to inlet seal (OF-B190), and flush the suction channel
with 35 mL of air. (Figure 1.21, p25)
14) Attach a syringe filled with air to injection tube (OE-B5), and flush the balloon channel
with 15 mL of air to purge as much residual water as possible. (Figure 1.22, p25)
Second rinse
15) Fill a basin with clean water and repeat steps 1 to 14 in order to perform a second rinse.
Third rinse
16) Fill a basin with clean water and repeat steps 1 to 14 in order to perform a third rinse.
Fourth rinse
17) Fill a basin with clean water and repeat steps 1-14 in order to perform a fourth rinse.
18) Detach inlet seal (OF-B190), injection tube (OE-B5), and cleaning adapter (OF-B155)
from the endoscope. (Figure 1.23, p25)

1-2-3-8. Drying

1) Gently wipe and dry all external surfaces of endoscope, components, and accessories
with a clean, lint-free gauze.

– 28 –
 1-2-4. High-Level Disinfection
Prior to high-level disinfection, the end user should confirm the minimum effective
concentration (MEC) of reused disinfectant as per the manufacturer’s instructions.
1
WARNING

••During the reprocessing process, always wear protective equipment

(e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross
contamination.
••Prior to disinfection, it is imperative that any solutions previously used in
the cleaning process be thoroughly rinsed and dried. Failure to do so can
result in ineffective or incomplete disinfection.
••For high-level disinfection, use an appropriate disinfecting solution
according to the instructions of the disinfectant manufacturer
(temperature, concentration, time). Adhere to the instructions to
accomplish effective and complete disinfection. The endoscope may be
damaged if exposed to a disinfectant under conditions other than those
specified by the disinfectant manufacturer.
••Use only a legally marketed disinfectant that has been tested according
to the instructions provided by the manufacturer and found to be
compatible by PENTAX. A list of disinfectants that are compatible with
PENTAX endoscopes is contained in this manual.
••It is imperative that ALL internal channel surfaces be in contact with
Endoscope the disinfecting solution for the time period recommended by the
Disinfection manufacturer of the solution.
••Ideally, all final rinses should be performed with sterile water, clean
potable water, or water that meets the requirements of the health care
facility.
••Regardless of the quality of the rinse water used, it is essential to
perform a final alcohol rinse followed by forced air in order to completely
dry the endoscope channels and prevent bacterial colonization and/or
infections associated with waterborne microorganisms.
••The basin that is used to perform disinfectant immersion must be
thoroughly cleaned prior to filling it with disinfectant solution.

WARNING

••Please note that the Balloon channel must undergo all steps of the
endoscope reprocessing procedure, regardless of whether it was used
during a clinical procedure.

– 29 –
 CAUTION
••Prior to disinfection, attach PVE soaking cap (OE-C9) and scanning unit
connector soaking cap (OE-U1). Failure to do so can result in water 1
invasion and damage to the endoscope. If the endoscope is disinfected
without these soaking caps attached, do not use the endoscope, and
contact your local PENTAX service facility or sales representative.
••Prior to disinfection, detach the ventilation cap (OF-C5). Failure to do so
can result in damage to the endoscope. If the endoscope is disinfected
with the ventilation cap attached, do not use it, and contact your local
PENTAX service facility or sales representative.
••During disinfection, never twist, rotate or bend the insertion tube and
umbilical cable excessively.
••In order to prevent damage to the endoscope, do not place any objects
other than the reprocessing accessories described in section 1-2-4-
1 of this instruction for use with the endoscope when immersing the
endoscope in a disinfection basin.

1-2-4-1. Items required

•• Protective equipment such as gloves, gowns, face masks, etc., to minimize the
risk of cross contamination.

•• Disinfecting solution, Cidex Activated Dialdehyde Solution (Johnson & Endoscope

Disinfection
Johnson).

•• Sterile water (preferred) or clean potable water

•• 70-90% medical grade ethyl or isopropyl alcohol

•• Basin to immerse the entire endoscope (at least 50 cm in width x 40 cm in depth

x 15 cm in height)

•• Sterile gauze

•• 30 mL luer slip syringe

Reprocessing accessories

•• PVE soaking cap (OE-C9)

•• Scanning unit connector soaking cap (OE-U1)

•• Cleaning adapter (OF-B155)

•• Inlet seal (OF-B190)

•• Injection tube (OE-B5)

1-2-4-2. Preparation
1) Wear personal protective equipment.
2) Attach PVE soaking cap (OE-C9) and scanning unit connector soaking cap (OE-U1)
to the endoscope.

– 30 –
 3) Ensure that ventilation cap (OF-C5) is detached from the endoscope.

(1) (1) OE-C9

(2) OE-U1
(3) OF-C5
1

(3)

(2)

Figure 1.27

4) Prepare a basin with a sufficient volume of disinfecting solution that is of sufficient

volume to completely immerse.

1-2-4-3. Filling the channels with disinfecting solution

WARNING

••When filling endoscope channels with disinfectant, avoid the introduction

of air. The presence of air bubbles can prevent contact of the disinfectant
with channel surfaces.
Endoscope
••Always immerse the endoscope while filling endoscope channels with
Disinfection
disinfectant.
••It is imperative that cleaning adapter (OF-B155) and inlet seal (OF-B190)
be securely attached to the endoscope. Failure to properly mount and
secure the cleaning adapter and inlet seal can result in ineffective and
incomplete reprocessing.

Always fully immerse the endoscope, components, and accessories in the disinfecting
solution during disinfection.

Attaching components and accessories to the endoscope

1) Fully immerse the endoscope in the disinfecting solution, and attach inlet seal (OF-
B190), cleaning adapter (OF-B155), and injection tube (OE-B5) to the endoscope.
(1) OF-B190
(2) (2) OF-B155
(1)
(3) OE-B5

(3)

Figure 1.28

– 31 –
Filling the channels with disinfecting solution
2) Attach a syringe filled with disinfecting solution to the suction nipple, and inject 25
mL of the disinfecting solution into the suction channel.
(1) Suction Nipple 1
(1)

Figure 1.29

3) Confirm that the disinfecting solution flows out from the suction channel opening on
the distal end.
4) Insert a syringe filled with disinfecting solution to inlet seal (OF-B190), and inject
25 mL of the disinfecting solution into the suction channel.
(1) OF-B190

(1)

Endoscope
Disinfection

Figure 1.30

5) Attach a syringe filled with disinfecting solution to injection tube (OE-B5), and
inject 10 mL of the disinfecting solution into the balloon channel.
(1) OE-B5

(1)

Figure 1.31

6) Check and confirm that disinfecting solution flows out from the balloon channel
opening on the distal end of the endoscope.

– 32 –
 7) After injecting disinfecting solution into all channels, detach inlet seal (OF-B190),
cleaning adapter (OF-B155), and injection tube (OE-B5) from the endoscope, and
leave them with the endoscope in the disinfecting solution. Open the cap of inlet seal
1 (OF-B190).
(1) OF-B190
(1)
(2) (2) OF-B155
(2)
(1)
(3) OE-B5

(3)

Figure 1.32

1-2-4-4. Soaking in disinfecting solution

WARNING

••The disinfecting solution must remain in contact with all internal channels
and external endoscope surfaces for the time period recommended by
Endoscope
Disinfection the disinfectant manufacturer.
••Adhere to the conditions (temperature, concentration, time) specified
by the disinfectant manufacturer to accomplish effective and complete
disinfection. Disinfectant solution use under conditions that fall outside
the manufacturer directions might damage the endoscope. Use of a timer
or audible alarm is recommended in order not to exceed recommended
soaking time.
••During immersion, detach the components and accessories (except the
soaking caps) from the endoscope to ensure contact of all endoscope
surfaces with the disinfecting solution.

1) Fully immerse the endoscope, inlet seal (OF-B190), injection tube (OE-B5), and
cleaning adapter (OF-B155) to ensure that there are no air bubbles on the endoscope
surfaces, distal end, and accessories. If any air bubbles are detected, flush them away
with disinfecting solution using a syringe.
2) Soak the endoscope, inlet seal (OF-B190), injection tube (OE-B5), and cleaning
adapter (OF-B155) under the conditions (temperature, concentration, time) specified
by the disinfectant manufacturer. In the case of CIDEX Activated Dialdehyde
Solution, the immersion time is 45 minutes at 25°C.Activated Dialdehyde Solution,
the immersion time is 45 minutes at 25°C.

– 33 –
 1

Figure 1.33

Purging of disinfecting solution from channels

3) After soaking, attach inlet seal (OF-B190) with the cap closed, injection tube (OE-
B5), and cleaning adapter (OF-B155) to the endoscope. (Figure 1.28, p31)
4) Attach a syringe filled with air to the suction channel, and flush the suction channel
with 35 mL of air to purge as much residual disinfecting solution as possible. (Figure
1.29, p32)
5) Insert a syringe filled with air to OF-B190, and flush the suction channel with 35 mL
of air to purge as much residual disinfecting solution as possible. (Figure 1.30, p32)
6) Attach a syringe filled with air to OE-B5, and flush the balloon channel with 15 mL of
air to purge as much residual disinfecting solution as possible. (see Figure 1.31, p32) Endoscope
Disinfection
7) Remove the endoscope with the components and accessories attached from the
disinfecting solution.

1-2-4-5. Rinsing

WARNING

••Ideally, all final rinses should be performed with sterile water. However,
if sterile water is not used, use potable water or the water that meets
the requirements of the health care facility.
••The basin that is used to perform rinsing of the endoscope and
accessories must be thoroughly cleaned prior to filling it with rinse water.
••The rinse volumes recommended for removing residual disinfectant from
channels are sufficient for 14-day glutaraldehydes (CIDEX Activated
Dialdehyde Solution). If extended shelf-life glutaraldehydes, or other
FDA-cleared, commercially available high level disinfectants are
used, consult with the disinfectant manufacturer for details regarding
recommended rinse water volumes.

First rinse
1) Place the endoscope with components and accessories attached into a basin of sterile
water that is of sufficient volume to completely immerse the endoscope.
2) Detach the inlet seal (OF-B190), injection tube (OE-B5), and cleaning adapter
(OF-B155) from the endoscope. Open the cap of OF-B190. (Figure 1.32, p33)
3) Wipe all exterior surfaces of the endoscope, OF-B190, OE-B5, and OF-B155 two
times with a sterile gauze in order to remove residual disinfecting solution.

– 34 –
 4) While still completely immersed in water, grasp the distal end and control body of
the endoscope and PVE connector with two hands, and agitate them under the water
by moving them from side to side for one minute.
1

Figure 1.34

5) Grasp the scanning unit connector with two hands, and agitate it under the water by
moving it from side to side for one minute.

Endoscope
Disinfection

Figure 1.35

6) Grasp inlet seal (OF-B190), injection tube (OE-B5), and cleaning adapter (OF-B155)
with a hand, and agitate them under water by moving them from side to side for one
minute.
7) Attach inlet seal (OF-B190), injection tube (OE-B5), and cleaning adapter (OF-B155)
to the endoscope. (Figure 1.28, p31)
8) Attach a syringe filled with water to the suction nipple, and flush the suction channel
with 35 mL of water. (Figure 1.29, p32)
9) Insert a syringe filled with water to inlet seal (OF-B190), and flush the suction
channel with 35 mL of water. (Figure 1.30, p32)
10) Attach a syringe filled with water to injection tube (OE-B5), and flush the balloon
channel with 15 mL of water. (see Figure 1.27, p28).
11) Remove the endoscope with the components and accessories attached from the water.
12) Attach a syringe filled with air to the suction nipple, and flush the suction channel
with 35 mL of air to purge as much residual water as possible. (see 1.25, p27)
13) Insert a syringe filled with air to inlet seal (OF-B190), and flush the suction channel
with 35 mL of air to purge as much residual water as possible. (see Figure 1.26, p27)

– 35 –
14) Attach a syringe filled with air to injection tube (OE-B5), and flush the balloon channel
with 15 mL of air to purge as much residual water as possible. (see Figure 1.27, p28)
Second rinse
15) Fill a basin with sterile water and repeat steps 1 to 14 in order to perform a second rinse. 1
Third rinse
16) Fill a basin with sterile water and repeat steps 1 to 14 in order to perform a third rinse.
Fourth rinse
17) Fill a basin with sterile water and repeat steps 1-14 in order to perform a fourth rinse.
18) Remove the endoscope and its components from the basin of water and place them
on a clean, dry, lint-free cloth.

1-2-4-6. Drying

WARNING

Regardless of the quality of the rinse water used, it is essential to perform

a final alcohol rinse followed by forced air in order to completely dry the
endoscope channels and prevent bacterial colonization and/or infections
associated with waterborne microorganisms.

Flushing the channels with alcohol

Endoscope
1) Attach a syringe filled with 70-90% medical grade ethyl or isopropyl alcohol to the Disinfection
suction nipple, and flush the suction channel with 15 mL of alcohol. (Figure 1.29, p32)
2) Insert a syringe filled with 70-90% medical grade ethyl or isopropyl alcohol to the
inlet seal (OF-B190), and flush the suction channel with 15 mL of alcohol. (Figure
1.30, p32)
3) Attach a syringe filled with 70-90% medical grade ethyl or isopropyl alcohol to the
injection tube (OE-B5), and flush the balloon channel with 10 mL of alcohol. (see
Figure 1.31, p32)
Purging of alcohol from channel
4) Attach a syringe filled with air to the suction nipple, and flush the suction channel
with 35 mL of air to expel residual alcohol. (Figure 1.29, p32)
5) Insert a syringe filled with air to inlet seal (OF-B190), and flush the suction channel
with 35 mL of air to expel residual alcohol. (Figure 1.30, p32)
6) Attach a syringe filled with air to injection tube (OE-B5), and flush the balloon channel
with 15 mL of air to expel residual alcohol. (see Figure 1.31, p32)
7) Ensure that no alcohol drips from the distal end of the endoscope. If any, repeat steps 4-6.
8) Detach inlet seal (OF-B190), injection tube (OE-B5), and cleaning adapter (OF-B155)
from the endoscope. (Figure 1.32, p33)
Drying all external surfaces
9) Gently dry all external surfaces of the endoscope, components, and accessories with
a sterile gauze.

– 36 –
 1-3. Endoscope components and accessories
Endoscope components and accessories can be subjected to the following cleaning, disinfection,
and sterilization.
1
Model Cleaning High-Level Steam
Name Number Manual Ultrasonic Disinfection Sterilization
Suction Control
OF-B179 Y Y Y Y
Endoscope Valve
Component Inlet Seal OF-B190 Y Y Y Y
Inlet Cap OE-B3 Y Y Y Y
Bite Block OF-Z5 Y Y Y Y
Injection Tube OE-B5 Y Y Y Y
Accessory Balloon
Installation OE-A53 Y Y Y Y
Device
PVE Soaking
OE-C9 Y* N Y* N
Cap
Scanning Unit
Connector OE-U1 Y* N Y* N
Soaking Cap
Reprocessing
Ventilation Cap OF-C5 N N N N
Accessory
Cleaning
OF-B155 Y Y Y Y
Adapter
Cleaning Brush CS6002SN Y Y Y Y
Cleaning Brush CS6015ST Y Y Y Y
Cleaning Brush CS-C3S Y Y Y Y

Y : YES
N : NO
* : The PVE Soaking Cap (OE-C9) and scanning unit connector soaking cap (OE-U1) should
be attached to the endoscope during cleaning and disinfection procedures.

Accessory NOTE
Cleaning
Automated Endoscope Reprocessor (AER) manufacturers may not make
specific claims or provide special instructions for reprocessing all of the
removable endoscope components and accessories that are integral to the
safe and effective operation of flexible endoscopes. Therefore, should the
AER manufacturer's instructions not specifically address reprocessing of any
particular endoscope component (suction valve, inlet seal, etc.), reprocess
those components manually as described in this manual. Prior to use, check
with the AER manufacturer regarding their specific claims with respect to
reprocessing individual endoscope components.

– 37 –
1-3-1. Cleaning

WARNING
1
••During the reprocessing process, always wear protective equipment
(e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross
contamination.
••Endoscope components and accessories should be thoroughly cleaned
with detergent solution within one hour after the conclusion of an
endoscopic procedure. If they are left uncleaned for greater than one
hour after use, dried blood, mucus or other patient debris may cause
damage to them or interfere with the ability of the user to properly
reprocess them.
••For cleaning, use only legally marketed detergents which have been
tested and found to be compatible by PENTAX. A list of detergents that
are compatible PENTAX components and accessories is contained in this
manual.
••Fresh detergent solution must be used for each set of endoscope
components and accessories.

1-3-1-1. Items required

•• Protective equipment such as gloves, gowns, face masks, etc., to minimize the
risk of cross contamination.

•• Detergent solution, Endozime (Ruhof Corporation)

•• Clean potable water

•• Basin (at least 25 cm in width x 20 cm in depth x 15 cm in height )

•• Lint-free gauze
Accessory
•• 10 mL luer slip syringe Cleaning
•• Ultrasonic cleaner (frequency range: 44 kHz +/-6%)

1-3-1-2. Cleaning procedure

Preparation
1) Wear personal protective equipment.
2) Prepare a basin with detergent solution per manufacturer’s instructions (temperature,
concentration). In the case of ENDOZIME, add 30 mL of ENDOZIME concentrate
to 3.8 L (1 gallon) of clean potable water at 20°C~30°C (68°F~86°F).
3) Fully immerse the components and accessories, and keep them immersed in the
detergent solution during the following cleaning procedure.

– 38 –
 4) Open the cap of inlet seal (OF-B190) during cleaning.

Figure 1.36

Cleaning of all external surfaces

5) Wash all surfaces of components and accessories three times with a lint-free gauze.
Cleaning of brushes
6) Wash the brush heads of cleaning brushes (CS6002SN, CS6015ST, CS-C3S) by
rubbing them with gloved fingers for 30 seconds.
Manipulating of valve mechanisms
7) While fully immersed, manipulate the suction control valve (OF-B179) mechanism
four times.

Figure 1.37

Accessory
Cleaning Filling lumens with detergent solution
8) Using a syringe filled with detergent solution, inject 4 mL of detergent solution
directly into the lumen of suction control valve (OF-B179).

Figure 1.38

9) Using a syringe filled with the detergent solution, Inject 4 mL of detergent solution
into the lumen of injection tube (OE-B5).

Figure 1.39

– 39 –
Soaking in detergent solution
10) While fully immersed, ensure that there are no air bubbles on the surfaces of the
components and accessories. If any bubbles are detected, flush them away with
detergent solution using a syringe. 1
11) Soak the components and accessories in detergent solution according to the
instructions (temperature, concentration, time) specified by the detergent
manufacturer. In the case of Endozime, the immersion time is at 3 minutes
12) Remove the components and accessories from the detergent solution.

1-3-1-3. Ultrasonic Cleaning

WARNING

All components and accessories must be ultrasonically cleaned prior to high-

level disinfection or sterilization.

CAUTION
DO NOT use caustic or abrasive solutions in the ultrasonic cleaner.

1) Prepare detergent solution per the manufacturer’s instructions (temperature,

concentration). In the case of ENDOZIME, add 30 mL of ENDOZIME concentrate
to 3.8 L (1 gallon) of clean potable water at 20°C~30°C (68°F~86°F).
2) Immerse the components and accessories in the detergent solution.
3) Using a syringe filled with detergent solution, inject detergent solution directly into
each lumen of the suction control valve (OF-B179) and injection tube (OE-B5).
4) Perform ultrasonic cleaning under the following conditions:
Frequency Range: 44 kHz +/- 6 % Time: 5 minutes
Accessory
5) After completion of the ultrasonic cleaning process, remove the components and Cleaning
accessories from the ultrasonic cleaner.

1-3-1-4. Rinsing

WARNING

All residual detergent solution must be removed from the components and
accessories. Residual detergent solution may interfere with subsequent
disinfection or sterilization processes.

First rinse
1) Prepare a basin with clean water, and fully immerse the components and accessories.
2) Wipe all exterior surfaces of the components and accessories two times with a lint-
free gauze in order to remove residual detergent solution.
3) While still completely immersed in water, agitate them under the water by moving
them from side to side for one minute.

– 40 –
 4) Manipulate the suction control valve (OF-B179) mechanism four times in the water,
and using a syringe filled with water, flush the lumen of the valve with 5 mL of
water. (see Figure 1.37, p39 and Figure 1.38, p39)
1 5) Using syringe filled with water filled, flush the lumen of the injection tube (OE-B5)
with 5 mL of water. (see see Figure 1.39, p39)
6) Discard the water.
Second rinse
7) Fill a basin with clean water and repeat steps 2-6 in order to perform a second rinse.
Third rinse
8) Fill a basin with clean water and repeat steps 2-6 in order to perform a third rinse.
Fourth rinse
9) Fill a basin with clean water and repeat steps 2-6 in order to perform a fourth rinse.
10) Remove all components and accessories from the water.
Purging of water from lumens
11) Using a syringe filled with air, flush the lumen of the suction valve (OF-B179) to
purge residual water. (see Figure 1.38, p39)
12) Using a syringe filled with air, flush the lumen of injection tube (OE-B5) to purge
residual water. (see see Figure 1.39, p39)

1-3-1-5. Drying
1) Wipe all surfaces of components and accessories gently with a clean, dry lint-free
gauze.

Accessory
Cleaning

– 41 –
1-3-2. High-Level Disinfection

WARNING
1
••During the reprocessing process, always wear protective equipment
(e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross
contamination.
••Prior to disinfection all components and accessories must be meticulously
cleaned. Failure to do so can result in incomplete or ineffective
disinfection.
••For high-level disinfection, use disinfecting solution according
to instructions of the disinfectant manufacturer (temperature,
concentration, time). Use only legally marketed disinfecting solutions
that have been tested and found to be compatible by PENTAX. A list of
disinfectant solutions that are compatible with PENTAX components and
accessories is contained in this manual.
••Adhere to the instructions specified by the disinfectant manufacturer
to accomplish effective and complete disinfection. Failure to do so may
result in damage to the endoscope components and accessories.
••Ideally, all final rinses should be performed with sterile water. However,
if sterile water is not used, use clean potable water that meets the
requirements of the health care facility.
••Regardless of the quality of the rinse water used, it is essential
to perform a final alcohol rinse followed by forced air in order to
completely dry the lumens of components and accessories, and prevent
bacteria colonization and/or infections associated with waterborne
microorganisms.
••The basin that is used to perform disinfectant immersion must be
thoroughly cleaned prior to filling it with disinfectant solution.
••Verification that the potency of the liquid chemical germicide is at or
above its Minimum Effective Concentration (MEC) (using recommended
test strips or similar methods) is required to ensure that high-level
disinfection/sterilization can be achieved.

1-3-2-1. Items required

Accessory
•• Protective equipment such as gloves, gowns, face masks, etc., to minimize the Disinfection
risk of cross contamination.

•• Disinfecting solution, Cidex Activated Dialdehyde Solution (Johnson &

Johnson)

•• Sterile water (preferred) or clean potable water

•• 70-90% medical grade ethyl or isopropyl alcohol

•• Basin (at least 25 cm in width x 20 cm in depth x 15 cm in height )

•• Sterile gauze

•• 10 mL luer slip syringe

– 42 –
 1-3-2-2. Disinfection procedure
Preparation
1) Wear personal protective equipment.
1 2) Prepare a basin of disinfecting solution per manufacturer’s instructions (temperature,
concentration).
3) Fully immerse the components and accessories, and keep them immersed in the
disinfecting solution during the following disinfection procedure.
4) Open the cap of inlet seal (OF-B190) and full immerse it in disinfecting solution. (see
Figure 1.36, p39)
Manipulating the valve mechanism
5) While fully immersed, manipulate the suction control valve (OF-B179) mechanism
four times. (see Figure 1.37, p39)
Filling of disinfecting solution into the lumens
6) Using a syringe filled with the disinfecting solution, inject 4 mL of disinfecting
solution directly into the lumen of the suction control valve (OF-B179). (see Figure
1.38, p39)
7) Using a syringe filled with the disinfecting solution, inject 4 mL or more of disinfecting
solution into the injection tube (OE-B5). (see Figure 1.39, p39)
8) Spray the outer surfaces of each connector portion of injection tube (OE-B5) with
10 mL of disinfecting solution. Rotate the injection tube (OE-B5) while spraying in
order to ensure that all connector surfaces are contacted.

Figure 1.40

Soaking in disinfecting solution

Accessory
Disinfection 9) While fully immersed, ensure there are no air bubbles on the surfaces of components
and accessories. If any air bubbles are detected, flush them away with disinfecting
solution using a syringe.
10) Soak them in disinfecting solution according to the instructions (temperature,
concentration, time) specified by the disinfectant manufacturer. In the case of
CIDEX Activated Dialdehyde Solution, the immersion time is 45 minutes at 25°C.
11) Remove the components and accessories from the disinfecting solution.

1-3-2-3. Rinsing
First rinse
1) Prepare a basin with sterile water and immerse the components and accessories.
2) Wipe all exterior surfaces of the components and accessories two times with a sterile
gauze in order to remove residual disinfecting solution.
3) While still completely immersed in water, agitate them under the water by moving
them from side to side for one minute.

– 43 –
4) Manipulate the suction control valve (OF-B179) mechanism four times in the water,
and using a syringe filled with water, flush the lumen of the valve with 5 mL of
water. (see Figure 1.37, p39 and Figure 1.38, p39)
5) Using a syringe filled with water, flush the lumen of the injection tube (OE-B5) with 1
5 mL of water. (see see Figure 1.39, p39)
6) Discard the water.
Second rinse
7) Fill a basin with clean water and repeat steps 2-6 in order to perform a second rinse.
Third rinse
8) Fill a basin with clean water and repeat steps 2-6 in order to perform a second rinse.
Fourth rinse
9) Fill a basin with clean water and repeat steps 2-6 in order to perform a fourth rinse.
10) Remove all components and accessories from the water.
Purging of water from lumens
11) Using a syringe filled with air, flush the lumen of suction valve (OF-B179) to purge
residual water. (see Figure 1.38, p39)
12) Using a syringe filled with air, flush the lumen of injection tube (OE-B5) to purge
residual water. (see see Figure 1.39, p39)

1-3-2-4. Drying

WARNING

Regardless of the quality of the rinse water used, it is essential to perform a

final alcohol rinse followed by forced air in order to completely dry the lumens
of components and accessories, and prevent bacterial colonization and/or
infections associated with waterborne microorganisms.

Flushing of lumens with alcohol

1) Using a syringe filled with 70-90% medical grade ethyl or isopropyl alcohol, flush
the lumen of suction valve (OF-B179) with 2 mL of alcohol. (see Figure 1.38, p39) Accessory
2) Using a syringe filled with 70-90% medical grade ethyl or isopropyl alcohol, flush Disinfection
the lumen of suction valve (O��������������������������������������������������
E�������������������������������������������������
-B5) with 2 mL of alcohol. (see Figure 1.38, p39)
Purging of alcohol from lumens
3) Using a syringe filled with air, flush the lumen of suction valve (OF-B179) with air
to purge residual alcohol. (see Figure 1.38, p39)
4) Using a syringe filled with air, flush the lumen of suction valve (OE-B5) with air to
purge residual alcohol. (see Figure 1.38, p39)
Drying of all external surfaces
5) Gently dry all external surfaces of components and accessories with a sterile gauze
moistened with 70-90% medical grade ethyl or isopropyl alcohol.

– 44 –
 1-3-3. Optional sterilization

WARNING
1
••Please note that PENTAX Medical has not validated any sterilization
methods for flexible endoscopes.
••During the reprocessing process, always wear protective equipment
(e.g., gloves, gowns, face masks, etc.) to minimize the risk of cross
contamination.
••Prior to sterilization, all instruments and components must be
meticulously cleaned and dried. Failure to do so can result in incomplete
or ineffective sterilization.
••Sterilization efficacy and material compatibility depend on the following
factors:
- thorough cleaning of the device
- load of the devices to be sterilized
- wrapping of the devices to be sterilized
- sterilization cycle parameters
••Use a chemical indicator (CI) and/or biological indicator (BI)
recommended by the manufacturer of the sterilizer to control the
sterilization process and ensure sterilization efficacy.
••After sterilization, ensure that the package is intact. If there are any
signs of abnormalities such as stains, wetness tears, or any other
indications that the packaging has been damaged or opened, repeat the
sterilization process with new packaging.

1-3-3-1. Steam Sterilization

CAUTION
After sterilization, the components and accessories may be hot. To avoid
burns, wait until they return to room temperature before handling.

1-3-3-1-1. Preparation
1) Make sure that the cap of the inlet seal (OF-B190) is close when packaged for
sterilization.
Accessory
Sterilization

(1)

Figure 1.41

– 45 –
1-3-3-1-2. Wrapping

1) Prior to steam sterilization, wrap the components and accessories individually with
two layers of one-ply Kimguard KC200 sterilization wrap (Kimberly-Clark) using
sequential wrapping technique. 1

1-3-3-1-3. Parameters
Steam sterilization can be performed under the following conditions:

Sterilizer Type Temperature Exposure Drying Time

132°C 4 minutes 30 minutes
Pre-vacuum
135°C 3 minutes 16 minutes

NOTE
••Validation testing of these parameters was performed using two layers of
one ply Kimberly Clark Wrap KC-200 Sterilization Wrap (Kimberly-Clark).
Sequential wrapping technique was employed.
••Biological and/or chemical indicators used must be appropriate for the
stated sterilization cycle parameters and cleared by FDA.

Accessory
Sterilization

– 46 –
 2 POST REPROCESSING AND STORAGE
WARNING

••Make sure that all removable components such as the suction control
valve, rubber inlet seal, etc., are detached from the endoscope. This will
allow for better air circulation through the internal channels and permit
thorough drying. All channels should be completely dry before storage.
••Never store the endoscope, its components, and accessories in the
carrying case, as this type of dark, humid, and unventilated environment
is conducive to bacterial colonization and which increases the risk of
cross contamination. These cases are intended for transportation of the
instrument, not storage.

CAUTION
••Never store the endoscope in areas of high humidity, high temperature,
or in direct exposure to sunlight or X-rays.
••Avoid storage of the endoscope in cabinets that have sharp edges,
exposed nails/screws, etc. Contact with sharp objects can puncture,
scratch, or otherwise damage the endoscope.
••When utilizing heated disinfectants for reprocessing PENTAX endoscopes,
the instruments should be allowed to return to room temperature prior
to use and/or further handling.

1) Following reprocessing, the endoscope may either be reused or placed into storage.
2) Prior to storage, ensure that all internal channels, endoscope components, instrument
surfaces and accessories are thoroughly dry.
3) The endoscope should be hung vertically 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.
4) Prior to reuse, ensure that instrument has been properly inspected and fully prepared
for the next clinical procedure.

– 47 –
3 SERVICING
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.
••A list of "compatible" reprocessing agents with PENTAX endoscopes
based upon material compatibility and functionality studies performed
by PENTAX, Japan is contained in this manual. These tests 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.
••Please note that PENTAX does not evaluate non-PENTAX parts,
components, materials and/or servicing methods. Therefore, questions
regarding material compatibility and/or functionality of PENTAX
instruments repaired 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.
••Independent Service Organizations should confirm the ability of these
serviced/remanufactured devices to be reprocessed safely and effectively
with reprocessing agents/systems recognized as compatible by PENTAX
for standard PENTAX products. These companies and/or remanufacturers
should be consulted to confirm whether they have performed
reprocessing validation studies on instrument models which they have
serviced (or remanufactured) that support their cleaning, high-level
disinfection and/or sterilization via the 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 will render an
instrument equivalent to the expectations and quality of a finished device
supplied by the endoscope OEM.

CAUTION
Never drop this equipment or subject it to severe impact, as it can
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. 3

– 48 –
 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) All instruments requiring repair should be shipped in the original carrying case with
appropriate packing along with comments describing the instrument damage and
complaint.
2) 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.
3) The ventilation cap (OF-C5) should be attached to the instrument if it will be shipped
by air freight.
4) Any accessories and/or endoscope components potentially related to the endoscope
damage or complaint should also be returned with the endoscope.
5) Soaking caps should also be returned with the endoscope to check/confirm the
integrity of their watertight seals.
6) After servicing, all endoscopes must be reprocessed prior to patient use.

– 49 –
4 APPENDIX

4-1. PENTAX Medical Compatible Reprocessing Systems/Agents

The information below is based upon material compatibility and functionality studies performed
by HOYA Corporation- PENTAX Medical Division, Japan. Reference to specific brand
name products is not an endorsement of their efficacy. Tests have shown these solutions to be
compatible with materials used in the construction of PENTAX Medical endoscopes, provided
that the manufacturers’ instructions for use are followed. This document has been prepared by
PENTAX Medical Company for PENTAX Medical customers in the United States, Canada and
Latin America.

Important

PENTAX Medical instructions for use contain detailed recommendations for the manual
reprocessing of PENTAX Medical endoscopes using PENTAX Medical supplied cleaning
accessories. Automated Endoscope Reprocessor (AER) product claims are the responsibility of
the AER manufacturer, including but not limited to cleaning, disinfection, sterilization, rinsing,
drying, biocompatibility, reprocessing instructions, required channel adapters, efficacy validation
studies, and compliance with regulatory requirements and/or professional guidelines. Prior to
reprocessing PENTAX Medical brand endoscopes in a specific model AER machine, contact the
AER manufacturer to confirm the following:

•• The AER efficacy claims have been validated for the specific PENTAX Medical model
endoscopes in question.

•• Instructions are available for the specific PENTAX Medical model endoscopes and
endoscope components in question.

Enzymatic Detergents

Product Brand Name Manufacturer

Cidezyme® XTRA (used exclusively in EvoTech ECR)

Advanced Sterilization Products (ASP)
Enzol®

Endozime®
Ruhof Corporation
Endozime® AW Plus

Enzy-Clean Care Fusion

MetriZyme® Metrex Research Corporation

Tergal 800 Custom Ultrasonics

ZymeX™ Enzymatic Cleaner Concentrate Sultan Healthcare

– 50 –
 High Level Disinfectants

The following liquid chemical germicides have received FDA 510(k) clearance for claims of
high level disinfection (HLD). Some HLD products may have multiple label claims and/or may
be FDA-cleared only for use in a legally marketed AER machine that can attain specific use
parameters (e.g., temperature).

Product Brand Name Manufacturer

Cidex® OPA
Cidex® OPA-C (used exclusively in EvoTech ECR)
Advanced Sterilization Products
Cidex® Activated Dialdehyde Solution(14-Day
Glutaraldehyde)

MetriCide® (Glutaraldehyde - may also be marketed

Metrex Research Corporation
as Omnicide NS or MaxiCide® NS)

Sporicidin® (Glutaraldehyde) Contec Incorporated

Rapicide® (Glutaraldehyde) Medivators Inc.

Wavicide®-01 (Glutaraldehyde) Medical Chemical Corporation

Sterilization Agents/Processes

The following agents/processes have received FDA 510(k) clearance for claims of sterilization:

Ethylene Oxide / Carbon Dioxide (80:20 gas mixture)

Ethylene Oxide / Carbon Dioxide (90:10 gas mixture)

– 51 –
MEMO

– 52 –
MEMO

– 53 –
 NOTICE
These instruments are used with Class B Medical Equipment (specified CISPR11) and are
intended for Hospitals, Ambulatory Surgery Centers, or Medical Clinics.
Together, these endoscopes and the compatible processor comply with EN 60601-1-2 for EU,
IEC 60601-1-2 for other countries.
When used in clinical or residential areas near radio and TV receiver units, these instruments
may cause radio interference.
To avoid and resolve adverse electromagnetic effects, do NOT operate these instruments near
the radio frequency energy equipment.

HOYA Corporation
2-7-5 Naka-Ochiai, Shinjuku-ku, Tokyo, 161-8525 Japan
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
Manufacturing Site
HOYA Corporation, PENTAX Miyagi Factory
30-2 Okada, Aza-Shimomiyano, Tsukidate, Kurihara-shi, Miyagi 987-2203 Japan

88900
• Specifications are subject to change without notice and without any obligation
on the part of the manufacturer.
2014. 06 6217001 S021 R04 printed in JAPAN