Pentax EB-1970TK User manual

PENTAX VIDEO BRONCHOSCOPES
INSTRUCTIONS FOR USE
（REPROCESSING)
EB-1970TK
EB-1170K, EB-1570K
EB-1970K, EB-1575K
EB-1975K, EB-1990i
Only For the Americas

Product Overview
These instruments photograph the subject of observation using a solid-state image sensor located at the endoscope tip under the
light transmitted from the processor/light source. The target of the observation is monitored by the physician using the endoscopic
image displayed on the video monitor. The endoscopic procedure is performed by inserting biopsy forceps and other endoscopic
accessories 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 PENTAX Video Bronchoscopes (EB Family) have been designed to be used with a PENTAX Video Processor (including Light
Source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary
equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Application
Medical purpose: Provide images for optical visualization, recording, and/or diagnostic aid.
Patient populations: Adults and lowercase 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 endoscopic examinations at each medical facility)
Place of Use: Medical facillity
Functions Used Frequently
The frequently used functions in these endoscope models 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
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 hyphen 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).
The text contained in this IFU is common to various types/models of PENTAX endoscopes, and users must carefully follow only
those sections and instructions pertaining to the specific instrument model in question.
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.

Sterility Statement
The endoscopes identified in this IFU are reusable semicritical devices. Since they are packaged non-sterile, they must be high-
level disinfected or sterilized BEFORE inital use. Prior to each subsequent procedure, they must be subjected to appropriate
cleaning and either high-level disinfection or sterilization processes.
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
Symboles distinctifs
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 certie 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.
Attention, consult instructions for use
Attention, consulter le manuel d’utilisation
Symbol for “Authorised Representative in the European Union”
Symbol for “DATE OF MANUFACTURE”
Symbol for “MANUFACTURER”
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)
Symbols on Marking
Symboles distinctifs

TABLE OF CONTENTS
NOMENCLATURE............................................................................................................................................1
Video Bronchoscopes ..............................................................................................................................1
NOMENCLATURE............................................................................................................................................3
Endoscope Components and Accessories ............................................................................................ 3
ENDOSCOPE REPROCESSING PROCEDURE FLOW..................................................................................5
1 CARE AFTER USE.....................................................................................................................................6
1-1. General...............................................................................................................................................6
1-1-1. Application ..................................................................................................................6
1-1-2. Important Instructions................................................................................................7
1-1-3. Internal Channels of Video Bronchoscopes ............................................................10
1-1-4. Quick Reference of Injection Volumes for Internal Channel ..................................11
1-1-5. Inspection of Reprocessing Accessories ................................................................ 12
1-2. Endoscope Reprocessing ................................................................................................................ 14
1-2-1. Pre-Cleaning................................................................................................................14
1-2-2. Leak Testing................................................................................................................17
1-2-3. Cleaning.......................................................................................................................18
1-2-4. High-Level Disinfection.............................................................................................. 28
1-2-5. Optional Sterilization.................................................................................................. 35
1-3. Endoscope components and accessories .....................................................................................39
1-3-1. Cleaning.......................................................................................................................40
1-3-2. High-Level Disinfection.............................................................................................. 44
1-3-3. Optional sterilization ..................................................................................................47
2 POST REPROCESSING AND STORAGE .................................................................................................50
3 SERVICING.................................................................................................................................................51
4 APPENDIX ..................................................................................................................................................53
4-1. PENTAX Medical Compatible Reprocessing Systems/Agents .....................................................53
Endoscope
Pre-Cleaning
Endoscope
Cleaning
Endoscope
Disinfection
Endoscope
Sterilization
Accessory
Cleaning
Accessory
Disinfection
Accessory
Sterilization
Leak
Testing
General

– 1 –
BENDING SECTION
INSERTION TUBE
ANGULATION CONTROL LEVER
ANGULATION LOCK LEVER
EB-1170K, EB-1570K, EB-1970TK only
CONTROL BODY
INSTRUMENT
CHANNEL INLET
SUCTION NIPPLE
STRAIN RELIEF BOOT
STRAIN RELIEF BOOT
MODEL DESIGNATION
STERRAD®NX™ system material compatibility identification symbol
This symbol denotes an endoscope model's material compatibility with
the STERRAD®NX™ system. (EB-1575K, EB-1975K, EB-1990i)
Endoscopes that do not have this symbol are incompatible with
the STERRAD®NX™ system. (EB-1170K, EB-1570K, EB-1970K,
EB-1970TK)
SUCTION CONTROL VALVE (OF–B179)
UMBILICAL CABLE
INLET SEAL (OF–B190)
ELECTRICAL
CONTACTS
PVE CONNECTOR
VENTILATION CAP OF-C5
VENTING CONNECTOR
PVE SOAKING CAP OE-C9
STRAIN RELIEF BOOT
Minimum Instrument Channel Width
Model Name


NOMENCLATURE
Video Bronchoscopes
EB-1970TK, EB-1170K, EB-1570K, EB-1970K, EB-1575K,
EB-1975K, EB-1990i

– 2 –
BENDING SECTION
INSERTION TUBE
ANGULATION CONTROL LEVER
ANGULATION LOCK LEVER
EB-1170K, EB-1570K, EB-1970TK only
CONTROL BODY
INSTRUMENT
CHANNEL INLET
SUCTION NIPPLE
STRAIN RELIEF BOOT
STRAIN RELIEF BOOT
MODEL DESIGNATION
STERRAD®NX™ system material compatibility identification symbol
This symbol denotes an endoscope model's material compatibility with
the STERRAD®NX™ system. (EB-1575K, EB-1975K, EB-1990i)
Endoscopes that do not have this symbol are incompatible with
the STERRAD®NX™ system. (EB-1170K, EB-1570K, EB-1970K,
EB-1970TK)
SUCTION CONTROL VALVE (OF–B179)
UMBILICAL CABLE
INLET SEAL (OF–B190)
ELECTRICAL
CONTACTS
PVE CONNECTOR
VENTILATION CAP OF-C5
VENTING CONNECTOR
PVE SOAKING CAP OE-C9
STRAIN RELIEF BOOT
Minimum Instrument Channel Width
Model Name


Video Bronchoscopes EB-1170K EB-1570K EB-1970K EB-1970TK EB-1575K EB-1975K EB-1990i
Minimum Instrument
Channel Width (I.D. φmm) 1.2 2.0 2.8 3.2 2.0 2.8 1.2
Table of Minimum Instrument Channel Width

– 3 –
NOMENCLATURE
Endoscope Components and Accessories
Endoscope Components
・Suction Valve (OF-B179)
・Inlet Seal (OF-B190)
Accessories
・Bite Bock (OF-Z5)

– 4 –
Accessories for Reprocessing
・PVE Soaking Cap (OE-C9)
・Ventilation Cap (OF-C5)
・Cleaning Brush (CS-C3S)
・Cleaning Brush (CS6002SN/CS6015ST/CS3010S)
・Cleaning Adapter (OF-B155)
Model Number Appearance of Bristles Length of Shaft Diameter of Bristles
CS6002SN 20cm φ6mm
CS6015ST 150cm φ6mm
CS3010S 100cm φ3mm

– 5 –
Pre-Cleaning
• Preparation
• Wiping of insertion tube
• Aspiration of detergent solution through suction channel
• Transport to cleaning room
Leak Testing
Cleaning
• Preparation
• Cleaning of all external surfaces
• Brushing of suction channel
• Filling of detergent solution into suction channel
• Soaking in detergent solution
• Rinsing
• Drying
High-Level Disinfection
• Preparation
• Filling of disinfecting solution into suction channel
• Soaking in disinfecting solution
• Rinsing
• Drying
Optional Sterilization
Sterilization using STERRAD® NX™ system (EB-1575K,
EB-1975K, EB-1990i only)
• Preparation
• Wrapping
• Sterilization Parameter Selection
CAUTION
STERRAD®NX™ Validation data has not been generated for endoscope
models in this manual other than EB-1575K, EB-1975K, and EB-1990i.
ENDOSCOPE REPROCESSING PROCEDURE FLOW

– 6 –
1-1. General
NOTE
This Instructions for Use (IFU)has been written in accordance with 21CFR
Part801, ISO 17664, 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 Video Bronchoscopes
TYPE
MODEL Video Bronchoscopes
Name Number
EB-1570K
EB-1970K
EB-1970TK
EB-1575K
EB-1975K
EB-1170K
EB-1990i
Endoscope
Component
Suction Control Valve OF-B179 Y Y
Inlet Seal OF-B190 Y Y
Accessory Bite Block - Adult Size OF-Z5 Y Y
Reprocessing
Accessory
PVE Soaking Cap OE-C9 Y Y
Ventilation Cap OF-C5 Y Y
Cleaning Adapter OF-B155 Y Y
Cleaning Brush CS6002SN Y Y
Cleaning Brush CS6015ST YN
Cleaning Brush CS3010S N Y
Cleaning Brush CS-C3S Y Y
Y: YES
N : NO
1
1 CARE AFTER USE
General

– 7 –
General
1
1-1-2. Important Instructions
WARNING
•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.
Immediately (within one hour) after the completion of a procedure,
the endoscope and its removable components, and accessories should
be both pre-cleaned 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 or 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 semicritical 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 manufacturers. A list of legally
marketed solutions/systems that have been determined to be compatible with
PENTAX brand products is contained in this manual.

– 8 –
General
1
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,
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.
Do NOT Twist or Rotate Do NOT Bend
(1)
(2)
Figure 1.1
CAUTION
•EB-1575K, EB-1975K, EB-1990i can be sterilized using the STERRAD®
NX™ system. For more detail, refer to sections 1-2-5-1 and 1-3-3-2 of
this instruction for use.
•Video bronchoscopes other than EB-1575K, EB-1975K, EB-1990i are
incompatible with sterilization using STERRAD®NX™ system.
•After every 100 cycles of STERRAD®NX™ exposure, the endoscope
should be returned to an authorized PENTAX service facility for repair.
Replacement of the insertion tube and bending section will be necessary
and other components may also require service.
•Although STERRAD®NX™ compatible endoscopes are generally capable
of withstanding up to 100 cycles of exposure to STERRAD®NX™, repair/
replacement of components might be necessary prior to 100 cycles,
depending upon the condition of the endoscope.
•Be sure to attach the ventilation cap (OF-C5) to the venting connector
before performing STERRAD®NX™ sterilization.

– 9 –
General
1
NOTE
This IFU contains detailed recommendations on the manual reprocessing of
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
to PENTAX instruments. AER manufacturers should be consulted for their
specic 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) maintenance procedures for water filter replacement and/or
decontamination of the filtration system to ensure water of suitable
quality,
g) compliance with local regulations and/or guidelines.
NOTE
PENTAX exible endoscopes should not be exposed to temperatures in excess
of 140oF (60oC) during either reprocessing or storage. During reprocessing
depending upon the detergent used, the endoscope 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 rst pre-
cleaning step.

– 10 –
General
1
1-1-3. Internal Channels of Video Bronchoscopes
The following internal schematic is designed to help users better understand the intricate
construction of PENTAX endoscopes. Please note that all solution entrance ports and flow
pathways are illustrated below.
(1)
(7)
(3)
(4)
(5)
(6)
(2)
(1) Suction Channel
(2) Instrument
Channel Inlet
(3) Inlet Seal
(OF-B190)
(4) Suction Cylinder
(5) Cleaning Adapter
(OF-B155)
(6) Ventilation Cap
(OE-C5)
(7) PVE Soaking Cap
(OE-C9)
Figure 1.2

– 11 –
General
1
1-1-4. Quick Reference of Injection Volumes for Internal Channel
The following table is designed to to help users better understand the injection volumes for
internal channel of video bronchoscopes.
Video
Bronchoscopes
Internal
Channel
Maximum
Volume
Capacity (mL)
Cleaning
Injection Volumes (mL)
Detergent Rinse
Water Air
EB-1170K
Suction
Channel
4 mL
①:25 mL
②:25 mL
①:35 mL
②:35 mL
①:35 mL
②:35 mL
EB-1570K 6 mL
EB-1970K 8 mL
EB-1970TK 9 mL
EB-1575K 6 mL
EB-1975K 8 mL
EB-1990i 4 mL
①Injecting from suction nipple
②Injecting from inlet seal (OF-B190)
Cleaning Process
Video
Bronchoscopes
Internal
Channel
Maximum
Volume
Capacity (mL)
High Level Disinfection
Injection Volumes (mL)
Alcohol Rinse
Injection Volumes (mL)
Disinfectant
Sterile
Rinse
Water
Air Alcohol Air
EB-1170K
Suction
Channel
4 mL
①:25 mL
②:25 mL
①:35 mL
②:35 mL
①:35 mL
②:35 mL
①:15 mL
②:15 mL
①:35 mL
②:35 mL
EB-1570K 6 mL
EB-1970K 8 mL
EB-1970TK 9 mL
EB 1575K 6 mL
EB-1975K 8 mL
EB-1990i 4 mL
①Injecting from suction nipple
②Injecting from inlet seal (OF-B190)
High Level Disinfection Process

– 12 –
1-1-5. Inspection of Reprocessing Accessories
Before use, inspect reprocessing accessories according to the following procedure.
WARNING
•Replace reprocessing accessory with a new one when inspection of the
device indicates that it is damaged or unable to function properly.
1-1-5-1. Inspection of PVE Soaking Cap (OE-C9)
1) Check that there is no cracking on the outer surface of the PVE Soaking Cap.
2) Check that there are no scratches, cracking, or chipping of the sealing surfaces inside
the PVE Soaking Cap.
Figure 1.3
1-1-5-2. Inspection of Ventilation Cap (OF-C5)
1) Make sure that of the Locking Groove Potion of the Ventilation Cap is not deformed.
2) Check that there are no scratches, cracking, or chipping of the O-ring inside the
Ventilation Cap.
Figure 1.4
General
1

– 13 –
1-1-5-3. Inspection of Cleaning Adapter (OF-B155)
1) Check that there are no scratches, cracking, or chipping of the sealing surfaces inside
the Cleaning adapter.
Figure 1.5
1-1-5-4. Inspection Cleaning Brushes (CS-C3S/CS6002SN/CS6015ST/CS3010S)
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.
General
1

– 14 –
1-2. Endoscope Reprocessing
Video bronchoscopes can be subjected to the following cleaning, disinfection, and optional
sterilization process.
Video
Bronchoscopes
Cleaning High-Level
Disinfection
Optional Sterilization
Manual Ultrasonic Steam
Sterilization
STERRAD®
NX™ system
EB-1170K YNYN N
EB-1570K YNYN N
EB-1970K YNYN N
EB-1970TK YNYN N
EB-1575K YNYNY
EB-1975K YNYNY
EB-1990i YNYNY
Y: YES
N : NO
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 withdrawal from the patient, in order to withdrawal
subsequent cleaning procedure. Endoscopes that are 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 mechanically clean the endoscope
after pre-cleaning.
•During pre-cleaning, never wipe the insertion tube with alcohol or
disinfecting solution. These solutions may x 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.
CAUTION
•Immediately after use, the metal light guide plug and 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.
•Prior to pre-cleaning the endoscope, leave the PVE connector attached to
the video processor.
•In order to prevent damage to the endoscope, do not place any objects
other than Inlet Seal (OF-B190) and Suction Control Valve (OF-B179)
with the endoscope in the closed container used for transport to the
reprocessing area.
Endoscope
Pre-Cleaning
1

– 15 –
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
solution in another location.
1-2-1-1. Items required
•Protective equipment such as gloves, gowns, face masks, etc., to minimize the
risk of cross contamination.
•Detergent solution, Endozime (Ruhof Corporation)
•External suction source
•500 mL basin
•Lint-free gauze
•30 mL luer lock syringe
•Inlet seal (OF-B190)
•Suction control valve (OF-B179)
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).
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 detergent
solution.
Figure 1.6
Endoscope
Pre-Cleaning
1