Pentax EB-1970TK, EB-1570K, EB-1170K, EB-1970K, EB-1975K Instructions For Use Manual

...

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INSTRUCTIONS FOR USE

（REPROCESSING)

PENTAX VIDEO BRONCHOSCOPES

EB-1970TK EB-1170K, EB-1570K EB-1970K, EB-1575K EB-1975K, EB-1990i

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

OF-B190

Suction Control Valve

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

NOTE

Symbols on Marking Symboles distinctifs

The endoscopes identified in this IFU are reusable semicritical devices. Since they are packaged non-sterile, they must be highlevel 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

CAUTION

: could result in death or serious injury.

: may result in minor or moderate injury or property-damage.

: may result in property-damage. Also advises owner/operator about important information on the use of

this equipment.

Prescription Statement

Federal (U.S.A) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical professional.

Symbols on Marking Symboles distinctifs

Symbol for “MANUFACTURER”

Symbol for “DATE OF MANUFACTURE”

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 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

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)

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

General

Endoscope Pre-Cleaning

Leak Testing

Endoscope Cleaning

Endoscope Disinfection

Endoscope Sterilization

Accessory Cleaning

2 POST REPROCESSING AND STORAGE ................................................................................................. 50

3 SERVICING ................................................................................................................................................. 51

4 APPENDIX .................................................................................................................................................. 53

4-1. PENTAX Medical Compatible Reprocessing Systems/Agents ..................................................... 53

Accessory Disinfection

Accessory Sterilization

NOMENCLATURE

Video Bronchoscopes

EB-1970TK, EB-1170K, EB-1570K, EB-1970K, EB-1575K,

EB-1975K, EB-1990i

UMBILICAL CABLE

STRAIN RELIEF BOOT

SUCTION NIPPLE

ANGULATION LOCK LEVER

EB-1170K, EB-1570K, EB-1970TK only

ANGULATION CONTROL LEVER

SUCTION CONTROL VALVE (OF–B179)

INLET SEAL (OF–B190)

INSTRUMENT CHANNEL INLET

CONTROL BODY

STRAIN RELIEF BOOT

MODEL DESIGNATION



STERRAD

This symbol denotes an endoscope model's material compatibility with the STERRAD Endoscopes that do not have this symbol are incompatible with the STERRAD EB-1970TK)

NX™ system material compatibility identification symbol

– 1 –



Model Name

NX™ system. (EB-1575K, EB-1975K, EB-1990i)

NX™ system. (EB-1170K, EB-1570K, EB-1970K,

Minimum Instrument Channel Width

PVE CONNECTOR

STRAIN RELIEF BOOT

VENTING CONNECTOR

PVE SOAKING CAP OE-C9

ELECTRICAL CONTACTS

VENTILATION CAP OF-C5

INSERTION TUBE

BENDING SECTION

Table of Minimum Instrument Channel Width

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

– 2 –

NOMENCLATURE

Endoscope Components

・Suction Valve (OF-B179)

・Inlet Seal (OF-B190)

Accessories

・Bite Bock (OF-Z5)

Endoscope Components and Accessories

– 3 –

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

CS6015ST 150cm

CS3010S 100cm

– 4 –

6mm

3mm

ENDOSCOPE REPROCESSING PROCEDURE FLOW

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.

– 5 –

NOTE

1 CARE AFTER USE

1-1. General

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

MODEL Video Bronchoscopes

TYPE

Endoscope

Component

Accessory Bite Block - Adult Size OF-Z5 Y Y

Reprocessing

Accessory

Suction Control Valve OF-B179 Y Y

Inlet Seal OF-B190 Y Y

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 Y N

Cleaning Brush CS3010S N Y

Cleaning Brush CS-C3S Y Y

Name Number

EB-1570K

EB-1970K

EB-1970TK

EB-1575K

EB-1975K

General

EB-1170K

EB-1990i

Y : YES

N : NO

– 6 –

1-1-2. Important Instructions

WARNING

General

• 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 highlevel 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.

– 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, 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

General

(2)

(1)

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.

– 8 –

NOTE

General

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.

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.

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.

– 9 –

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) Suction Channel (2) Instrument

(7)

(1)

(6)

(2)

(4)

(5)

(3)

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)

General

Figure 1.2

– 10 –

General

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.

Cleaning Process

Video

Bronchoscopes

EB-1170K

EB-1570K 6 mL

EB-1970K 8 mL

EB-1970TK 9 mL

EB-1575K 6 mL

EB-1975K 8 mL

EB-1990i 4 mL

①

Injecting from suction nipple

②

Injecting from inlet seal (OF-B190)

Internal Channel

Suction

Channel

Capacity (mL)

Maximum

Volume

4 mL

Injection Volumes (mL)

Detergent

①

:25 mL

②

:25 mL

Cleaning

Rinse

Water

①

:35 mL

②

:35 mL

①

:35 mL

②

:35 mL

Air

High Level Disinfection Process

Video

Bronchoscopes

EB-1170K

EB-1570K 6 mL

EB-1970K 8 mL

EB-1970TK 9 mL

EB 1575K 6 mL

EB-1975K 8 mL

EB-1990i 4 mL

①

Injecting from suction nipple

②

Injecting from inlet seal (OF-B190)

Internal Channel

Suction

Channel

Capacity (mL)

Maximum

Volume

4 mL

High Level Disinfection

Injection Volumes (mL)

Disinfectant

①

:25 mL

②

:25 mL

Sterile

Rinse

Water

①

:35 mL

②

:35 mL

Alcohol Rinse

Injection Volumes (mL)

Air Alcohol Air

①

:35 mL

②

:35 mL

①

:15 mL

②

:15 mL

①

:35 mL

②

:35 mL

– 11 –

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

General

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

– 12 –

General

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.

– 13 –

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Pentax EB-1970TK, EB-1570K, EB-1170K, EB-1970K, EB-1975K Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

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