FNL-10RBS NASO-PHARYNGO-LARYNGOSCOPE Instructions for Use Dec 2017

Instructions for Use This Instructions for Use (hereinafter referred to as “IFU”) contains essential information, such as operating procedures and handling precautions, on using this fiberscope safely and effectively. Before use, fully understand the contents of, and properly follow, this IFU and the instruction manuals of all equipment that are going to be used in combination. Do not use this endoscope for any purpose other than its intended use. Inappropriate use of the fiberscope may result in damage to the equipment or injuries, including, but not limited to, burns, electric shock, perforation, infection, and bleeding. This IFU does not describe specific endoscopic procedures. The specific procedures should be determined according to the discretion of a medical professional. If you have any questions or concerns about any information in this IFU, contact your local PENTAX Medical service facility. The content of the IFU may be changed without prior notice. Unauthorized reproduction of any part of this IFU is prohibited. Keep this IFU and all related instruction manuals in a safe, accessible location.

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Signal words and symbols Signal words The following signal words are used throughout this IFU. WARNING

Indicates a situation that could result in death or serious injury if not avoided.

CAUTION

Indicates a potentially hazardous situation that could result in minor or moderate injury or damage to equipment if not avoided.

NOTE

Indicates supplementary or useful information regarding use.

Symbols The meaning(s) of the symbol(s) on the fiberscope, accessories, and/or on their packaging are as follows: Symbol

Description Caution

Date of manufacture

Type BF applied part

Follow the Instructions for Use

Manufacturer

Authorized representative in the European Community This product complies with the applicable standards harmonised under the Directive 93/42/EEC and Directive 2011/65EU.

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.

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CONTENTS Instructions for Use ... 3 Signal words and symbols ... 4 Important information: Please read before use ... 6 Product summary ...6 Intended use...6 Application...6 Classification ...6 Specifications ...7 Compatible products ...7 Reprocessing before the initial use and reprocessing...7 General warnings and cautions...8 Maintenance management...9

1. Nomenclature and functions ... 10 1-1. Fiberscope...10 1-2. Package contents ...12 1-3. Light source ...14 1-4. System chart...15

2. Preparation and inspection ... 16 2-1. Inspection of the light source...16 2-2. Inspection of the fiberscope...17 2-3. Connection of light source to the fiberscope ...20 2-4. Preparation just before insertion of fiberscope ...20

3. Directions for use ... 22 3-1. Pretreatment...22 3-2. Insertion and observation ...23 3-3. Withdrawal and stopping of device...24

4. Care after use ... 25 4-1. Pre-cleaning ...26 4-2. Cleaning ...28 4-3. High level disinfection...30 4-4. Sterilization and aeration ...32

5. Maintenance... 33 5-1. Storage after use ...33 5-2. Returning the fiberscope for repair ...34 5-3. Disposal...34 5-4. Care and maintenance advice...35

Electromagnetic compatibility (EMC) Specifications

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Important information: Please read before use Product summary This fiberscope captures observation subjects under light transmitted from a dedicated light source and transmits it to the ocular section by optical fiber bundle. The image can be enlarged using the ocular lens to observe the intended area. Angulation operation of the bending section can be done using the angulation control lever on the control body.

Intended use This endoscope is intended to provide optical visualization of the Upper Airway Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Ear, Nasal Passage, Trachea, and Bronchial Tree. The endoscope is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Application Medical Purpose Patient population

Provide images for observation, diagnosis, and visualization. Patients who are considered suitable for the application of this fiberscope by the physicians (pediatric to adult patients).

Intended anatomical area

Ear, Nasal Passage, Trachea, and Bronchial Tree.

User qualifications

Physicians (Experts who have been approved by the endoscopic medical safety administrator at each medical facility. If the eligibility requirements are defined by an official body, such as a government entity and/or an academic society, follow such requirements). Specific training to use this instrument is not required.

Location of use

A Medical facility

Classification Degree of protection against electric shock TYPE BF applied part (when connected to a compatible PENTAX Medical for the applied parts

light source)

Degree of protection against water

IPX7 (with the soaking cap attached)

Mode of operation

Continuous operation

Use in an oxygen-rich environment

Suitable

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Specifications Q Environment

Operating environment

Storage/transportation environment

Ambient temperature

10 to 40°C

Relative humidity

30 to 85% RH

Air pressure

700 to 1,060 hPa

Ambient temperature

-20 to 60°C

Relative humidity

0 to 85% RH

Air pressure

700 to 1,060 hPa

Compatible products This section describes the equipment that can be used in combination with this fiberscope. For more details, refer to “System chart” (p.15) The combination of equipment that can be used with this fiberscope is listed below. Prior to use, the product must be prepared and inspected according to its IFU.

WARNING • PENTAX Medical does NOT warrant compatibility with unlisted products. If products are NOT listed, contact the manufacturer of the equipment or accessory to confirm the compatibility and IFU with PENTAX Medical products. • When this fiberscope is used in combination with other equipment, depending on how it is connected, it may result in malfunction and/or unforeseen events to patients and/or medical professionals. Pre-use operation checks and risk management associated with such changes are recommended, particularly when the equipment used in combination is changed, added, or upgraded.

Q Light source Light source models that can be connected with this fiberscope are shown below. For instructions on light source operation, refer to the IFU of the respective light source. Model Name BS-LL1

Brand Name PENTAX Medical

Reprocessing before the initial use and reprocessing Q Reprocessing before the initial use The fiberscope identified in this IFU is a reusable semi-critical device. Since it is packaged non-sterile, it must be cleaned and high level disinfected, or cleaned and sterilized, or cleaned and disinfected and additionally can be sterilized (if applicable) according to this IFU before initial use. Insufficient reprocessing may increase the risk of cross contamination.

NOTE The wording "high level disinfection" in this IFU defines the disinfection of the endoscope and the accessories with a completely virucidal disinfectant.

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Q Reprocessing After use, the fiberscope must be appropriately cleaned, high level disinfected and/or sterilized and stored. Insufficient and/or incomplete cleaning, high level disinfection, and/or sterilization of this fiberscope may result in its non-optimal function of and/or damage to the fiberscope and may pose a risk of infection to the patient and/or users.

WARNING When using an endoscope and its accessories on patients with Creutzfeldt-Jakob disease (CJD) or variant Creutzfeldt-Jakob disease (vCJD), use only dedicated endoscopes and equipment. The endoscope and equipment used on these patients must be discarded so that they cannot be used again on another patient. The pathogenic agents that cause this disease, which are called "prions", cannot be destroyed or inactivated using the cleaning, high level disinfection, and sterilization methods presented in this IFU. Please consult the guidelines that apply to your country or region for more detailed information regarding the handling of prion-contaminated endoscopes.

NOTE It is recommended to store the endoscope hanging down straight in a well-ventilated room or cabinet dedicated for endoscope storage.

General warnings and cautions WARNING • The medical facility should determine restrictions or non-use of the fiberscope in patients suspected of having lowered immunity. • Users as well as the assisting personnel should always wear protective equipment (e.g., gloves, goggles, masks, medical gowns, etc.) to minimize the risk of cross contamination, as patient's body fluids may be dispersed from fiberscope components. • Do NOT use this fiberscope for any purpose other than its intended use. Doing so may result in patient injury. • Do NOT use this fiberscope with equipment other than those that have been specified for combined use. Doing so may result in damage to the fiberscope or patient injury. • Do NOT drop this fiberscope or apply a strong shock to it. Doing so may result in damage to the fiberscope. In particular, do NOT apply a strong shock to the lens surface at the distal end. Visual abnormalities may occur, which may result in unforeseen events. • Ensure to attach/connect an appropriate device to the venting connector according to the IFU. • Always check the endoscopic image during fiberscope angulation and fiberscope insertion and withdrawal. • Do NOT forcefully insert and withdraw the fiberscope. Doing so may result in patient injuries, including bleeding and perforation. • Do NOT perform reverse observations inside a narrow lumen. Doing so may cause patient injury or make it impossible to withdraw the fiberscope. • Transnasal insertion must be determined appropriately and cautiously according to the discretion of a medical professional. ??No instrument, including this one, can always be inserted transnasally into all patients. Ensure that transnasal insertion is possible for the patient by considering the shape and size of the patient’s nasal cavity as well as his/her receptivity. ??Do NOT forcefully insert the instrument transnasally. Doing so may result in injury to the patient’s nasal cavity. ??Before transnasal insertion, apply the appropriate pretreatment such as enlarging the nasal cavity, etc. to the patient. Failure to do so may result in patient injury.

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CAUTION • Do NOT excessively twist, rotate, or bend any of the insertion portions, strain relief boot. Doing so may damage the fiberscope. • Electromagnetic interference may occur with equipment labeled with the following symbol or near mobile RF communication equipment such as mobile phones. If electromagnetic interference occurs, reorient or relocate the fiberscope or shield the location of use.

Maintenance management The service life of this fiberscope is 6 years after date of shipment with the following conditions. • Perform inspection before use, care after use, storage, and replacement of consumables according to this IFU. • Have a specialist specified by PENTAX Medical perform repairs and at least annual periodic inspections.

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1. Nomenclature and functions 1-1. Fiberscope

0 Dptr positioning marks (white dots) Rotate the diopter adjusting ring to align the two positioning marks (white dots) when taking an image or when using the observer scope or a TV camera.

Waterproof mark The blue line here indicates the fiberscope is fully immersible.

Diopter adjusting ring Rotate the ring to adjust the focus and enable visibility by the technician.

Model name

Strain relief boot

D D U U

Venting connector Attach the ventilation cap (OF-C5) or the endoscope connector of the leakage tester here.

Angulation control lever By turning in the “▼ U” direction, the bending section moves upwards. By turning in the “▲ D” direction, the bending section moves downwards. Ventilation cap red (OF-C5) Be sure to attach this cap to prevent damage to the insertion portion when performing ETO gas sterilization. This cap must be removed before immersion. NOTE See important separate section, 4. Care after use, regarding the use of this cap.

Eyepiece

Ocular lens Look into the lens to see the index in the field of view mask. The index indicates the upper side of the bend.

Figure 1.1

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Distal end

FNL-10RBS

Light guide

Objective lens

Bending section

portion t) Insertion the patien ntact with co to in e that com (the parts

Light source joint section Connect the BS-LL1 or the light guide cable BS-LC1.

CAUTION The control body side of the insertion portion is reinforced with strain relief boot to protect the connecting parts. Do NOT excessively twist, rotate, or bend any of the insertion portions, strain relief boots. Doing so may damage the fiberscope.

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1-2. Package contents NOTE • Some accessories are optional. Refer to the separate standard accessories list.

Check the package contents according to the separate standard accessories list provided with this fiberscope. If there are any damaged or missing components, do not use the fiberscope; immediately contact your local PENTAX Medical service facility. (Optional depending on the model.) Q Accessories

LED Light Source (BS-LL1)

Ventilation Cap

Eyepiece Cap (OF-D6)

Silicone Oil

(Installed)

(OF-Z11)

(OF-C5)

Soaking Cap (BS-B1) Red dot

Fiber optic cable

Light Guide Plug In addition to PENTAX light sources, light sources from other manufacturers can be connected by using an adapter.

Connecting collar Securely mounts the light source to the fiberscope.

Light Guide Cable (BS-LC1) Using the removable Light guide cable (BS-LC1), other conventional light sources can be used. For details on the preparation and inspection of the light guide cable, refer to the IFU provided with the light guide cable.

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WARNING • The light guide cable (BS-LC1) is waterproof and is immersible in solutions with or without being attached to the fiberscope. The ETO gas sterilization can be performed. However, NEVER place the light guide cable in a steam sterilization nor subject it to ultrasonic cleaning methods. • Immediately after use, the metal light guide plug of the light guide cable (BS-LC1) may be HOT. To avoid burns, do NOT touch the area immediately after use. Grasp the plastic light guide plug to avoid contact with this potentially hot surface.

Q Other

Instructions for Use (This document)

Standard Accessories List

Figure 1.2

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1-3. Light source WARNING • Do NOT touch the lamp and the lamp cover during and / or immediately after use to avoid burns. • Mount the lamp cover securely to maintain its watertight integrity and to prevent creation of short-circuit. Failure to do so may result in damage to the equipment or unforeseen events. • NEVER place the light sources in a steam sterilization nor subject them to ultrasonic cleaning methods. This is extremely dangerous, as it may cause the battery to burst. • Always turn off and unplug the light sources when not in use. • Do NOT drop this device or subject it to any other impact. This may cause the lamp to go out or other malfunctions. Do NOT use this device if it has been dropped. • (BS-LL1) The lamp will not turn on unless the BS-LL1 is connected to a fiberscope.

CAUTION Prepare a spare battery before examinations. See the instructions for use of the PENTAX light source for information on the specified battery name and how to change the battery.

1) LED Light Source (BS-LL1) (Battery Type) Endoscope recognition pin

Lens

Power switch Indication at power ON (Green)

Connecting collar Battery replacement indicator (Yellow) LED test adapter (Black)

Model designation

Red dot

Battery housing cap

Press toward the main unit

Inspection prior to use and battery life can be checked by pushing the LED test adapter continuously.

Figure 1.3 NOTE The BS-LL1 and LED test adapter are immersible in solution. ETO sterilization can be performed on the entire light source.

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1-4. System chart This section shows the system chart (configuration) for this fiberscope and the ancillary equipment.

WARNING Use this fiberscope in combination only with compatible products shown in "Compatible products" (p. 7) and the "System chart". Failure to do so may result in lowered function and patient/user injury or damage to the equipment.

Patient environment 3DWLHQWHQYLURQPHQW

Fiberscope

LED Light Source (BS-LL1) (Battery Type)

Light Guide Cable (BS-LC1)

AX NT PE

Light source (LH-150PC)

1. OF-Z5 (optional)

Figure 1.4 1. Bite Block (OF-Z5) (optional)

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2. Preparation and inspection Before use, the fiberscope, accessories, light source, and other components must be prepared and carefully inspected according to the IFU. Any equipment used in combination with the fiberscope must also be prepared and inspected according to the respective instruction manuals. Always perform pre-use inspection before each use.

WARNING Always perform pre-use inspection before each use. NEVER use a fiberscope with a suspected abnormality. Doing so may result in malfunction, fiberscope damage, and/or injury to the patient and/or user.

CAUTION Ensure that another fiberscope is also prepared to avoid interruption of the procedure due to fiberscope failure or unforeseen events.

2-1. Inspection of the light source For details on the preparation and inspection of the light source, refer to the IFU of the respective light source.

WARNING • Do NOT use the light source where explosive or flammable gases are present or in an oxygen rich environment. Failure to observe this precaution may cause the light source to catch fire. • Do NOT look directly at the light emitted from the distal end of the fiberscope or the light source. The intense light may cause eye injuries. Turn off the lamp when looking directly at the distal end of the fiberscope.

NOTE This fiberscope can be used with the LED light source (BS-LL1). For details, refer to the IFU of the respective light source.

By attaching the light guide cable (BS-LC1), other conventional light

%6/&

sources can be used. Connecting collar Indication (Red Dot)

NOTE For details, refer to the IFU of the respective PENTAX light source.

Light source socket Indication (Red Dot)

Figure 2.1

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2-2. Inspection of the fiberscope Prepare a fiberscope that has been reprocessed according to the procedure specified in this IFU.

WARNING • NEVER disassemble or modify the fiberscope. Doing so may impair its original functionality and possibly result in serious injury to the patient and/or user. • NEVER use the fiberscope with any abnormality in function. Doing so may result in fiberscope damage, detachment of parts into the patient’s body cavity, fiberscope malfunction, and/or injury to the patient and/or user. • Use only sterile water for inspection. Failure to do so may result in contamination of the fiberscope with waterborne bacteria and other microorganisms. Do NOT use water that has been left uncovered for a prolonged period of time. • Before the next use, the fiberscope, its components, and accessories that have been stored inappropriately or for a prolonged period of time must be subjected to appropriate cleaning, high level disinfection, and/or sterilization processes according to this IFU.

CAUTION The fibers used in this product may yellow due to repeated exposure to stroboscopic light emissions or X-ray emissions. This may cause the observation image to look excessively yellow.

NOTE In case the fiberscope is hot/cold immediately after cleaning, high level disinfection, and/or sterilization, wait until it returns to room temperature before using it. Observation may be hindered by fogging of lens and other effects because of the difference in the temperature of the fiberscope and the room.

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1) Check that the fiberscope is cleaned, high level disinfected and/or sterilized before using on each patient. Prepare the fiberscope that has been reprocessed according to the procedure specified in this IFU.

NOTE Flexible endoscopes and other sophisticated medical instruments are constructed of special materials, unique parts and intricate components with strict dimensional tolerances. Specialized assembly techniques and application of specific sealants and/or adhesives are required to ensure the watertight integrity and maintain the functionality of these devices. It is therefore imperative that endoscopes be routinely checked to ensure that parts used in their construction are not loose, missing or compromised that could otherwise negatively affect the functionality of these devices. Compromised or loose components could result in device failure, endoscope damage (via fluid invasion) and/or in incomplete decontamination of used instruments. PENTAX recommends that prior to use endoscopes should be carefully inspected for their integrity and checked for any “looseness” in the mating or joining of components including the following parts/areas:

(1) Light source socket (2) Venting connector

(2)

(1)

One method to check for looseness is to lightly grip the exposed part, and while grasping the component carefully attempt to move it in various directions. Use of a lint-free gauze while grasping metal parts is recommended as a protection for one’s fingers. If any part/ component remains loose (after attempting to tighten) and/or if there is any indication or suspicion of an abnormality or outward signs of damage, do NOT use the endoscope. Contact your local PENTAX Medical service facility.

CAUTION • Do NOT excessively twist, bend, or rotate any of the strain relief boot on the instrument (See (1) in the figure to identify the strain relief boot). Doing so may result in fiberscope damage. Pay special attention to the careful handling of the strain relief boot of the insertion portion of the endoscope, because it has a small diameter and is more likely to suffer damage due to mishandling. • When carrying the fiberscope, do NOT grasp or carry it only by its insertion portion. Moreover, do NOT squeeze or forcefully bend the bending section. Doing so may damage the fiberscope. 

Do Not twist or rotate

Do Not forcefully bend

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2) Inspection of the entire fiberscope a) Check the entire surface of the fiberscope for any visible adhered material. Bending section b) Check the entire surface of the insertion portion for abnormalities such as wrinkles, scars, sharp edges, clouding of the surface, dents, catching, protrusions, attachment of foreign materials, detachment of parts, etc. Adhesive band Adhesive band Magnified view c) Check the surface of the adhesive bands on both ends of the bending section for abnormalities such as scratches, clouding, and peeling. With clean gauze, lightly wipe the surface of the adhesive bands to ensure that there is no catching and/or attachment of the adhesive on the gauze. d) Check the case of the distal end of the fiberscope (especially Figure 2.2 around the periphery of the instrument channel) for any abnormalities such as deformation or chipping. Light guide e) Similarly, when using the light guide cable (BS-LC1), check the condition of the light guide cable for abnormalities such as wrinkles, scars, dents, etc. f) Check the objective lens at the distal end of the fiberscope and the light guides for any abnormalities such as attachment of foreign Case material, scratches, or chipping, and ensure that there is no gap on the periphery of the lens. Objective lens g) Ensure that there are no scratches, clouding, or peeling on the surface of the adhesive glue around the objective lens at the distal Figure 2.3 end of the fiberscope and it looks glossy. h) Gently clean the objective lens and light guides with clean gauze or a cotton-tip applicator moistened with 70%–90% medical grade ethyl or isopropyl alcohol. Check that there is no attachment of the adhesive on the gauze.

NOTE Clear images cannot be obtained when there are any attachment of foreign material or residuals on the objective lens or light guides. When a fiberscope with any attachment of foreign material or residuals on the objective lens or light guides is used, vapor may be generated from the water contents of the attachment of foreign material or residuals being heated by the light.

Figure 2.4

i) Form an arch with the insertion tube as shown in Figure 2.4 using both hands. By sliding the insertion tube in the direction of the arrow in the left Figure, check that the entire insertion portion can be bent smoothly and easily to form an arch. j) Check that the fiberscope is cleaned, high level disinfected and/or sterilized before using it. 3) Inspection of the angulation mechanism Ensure that there is nothing near the bending section that would hinder its operation, and inspect the angulation mechanism while the insertion portion is kept straight. a) Slowly rotate the angulation control lever and check that the lever moves smoothly and that the bending section bends normally within the maximum angle range.

WARNING D U

• To avoid damage, be especially careful NOT to hit the distal end of the fiberscobe. NEVER squeeze or severely bend the insertion portion. • Do NOT use a fiberscope with angulation abnormalities such as non-smooth operation, excessive play in the angulation control lever, or excessive angulation attenuation, as the inside of the fiberscope may be damaged. Using the fiberscope in this state may result in worsening of fiberscope damage, malfunction during use, and patient injury.

Up - Down 130°-130°

Figure 2.5

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2-3. Connection of light source to the fiberscope Refer to the IFU of the PENTAX light source involved for complete instructions. 1) Align the red guide mark on the light source with the red guide mark on the light-source connector of the fiberscope. Connecting collar Indication (Red Dot)

Light source socket

2) Insert the light source into the fiberscope. 3) Turn the connecting collar clockwise to tighten. 4) Turn the power switch on and check that light is being emitted

Indication (Red Dot)

from the distal end of the fiberscope.

Figure 2.6 NOTE The light source LED lamp will not light unless attached to an endoscope.

2-4. Preparation just before insertion of fiberscope WARNING • Every fiberscope should be properly cleaned, and disinfected or sterilized before being used for the initial use. The fiberscope should have been properly cleaned, and disinfected or sterilized after any previous use and after being returned for any repairs/service. • Current infection control guidelines require that endoscopes and their patient contact accessories either be sterilized or at least be subjected to high level disinfection. Only the user can determine if an instrument has undergone appropriate infection control procedures prior to each clinical use.

CAUTION If using the BS-LL1 light sources or BS-LC1 with the fiberscope, do NOT carry the fiberscope by the light source or apply excessive force to the fiberscope that may jolt the light source. This may loosen the light source connector or cause missing parts or breakage, resulting in malfunction. If even a small sign of an abnormality is found, stop using this device and contact your local PENTAX Medical facility.

NOTE Contact the manufacturer and follow local regulations regarding safe use, appropriate handling and disposal of cleaning and disinfection solution including alcohol. Material Safety Data Sheets (Health and Safety Data Sheets or similar documents depending upon country) available from the cleaning and disinfection solution (including alcohol) manufacturer should provide guidance to end users about composition, hazards, chemical and physical properties, first aid, handling and storage, stability, precautions, disposal, etc. associated with cleaning and disinfection solution including alcohol.

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1) If the endoscope has just recently been reprocessed, has been prepared or stored properly and passed all pre-procedure inspections, the instrument should be ready to use. If necessary, the fiberscope’s insertion tube may be wiped down with a gauze dampened with 70-90% medical grade ethyl or isopropyl alcohol. 2) Check the optical image of the endoscope. D

U

S RB

AX NT 10 PEFNL-

3) If necessary, gently clean the objective lens with a cotton-tip applicator moistened with 70-90% medical grade ethyl or isopropyl alcohol. 4) The individual user should adjust the diopter adjustment ring to make sure that a clear view can be obtained. No further adjustment should be necessary during a procedure.

Figure 2.7

5) (Fiberscopes to be introduced transorally) Prior to trans-oral insertion of the fiberscope, place a bite-block (mouthpiece) into the patient’s mouth to protect the endoscope from damage during the procedure. Failure to do so can result in scratches, tears and/or crushing of the insertion portion of the endoscope. 6) Apply a medical grade water soluble lubricant to the insertion tube. Do not use petroleum based lubricants

WARNING Do NOT drop this fiberscope or apply a strong shock to it. Doing so may result in damage to the fiberscope. In particular, do NOT apply a strong shock to the lens surface at the distal end. Visual abnormalities may occur, which may result in unforeseen events.

CAUTION Do NOT spray or wipe the surface of the fiberscope insertion portion with an anesthetic (particularly anesthetic spray containing alcohol) or non-medical lubricant (such as petroleum jelly). Doing so could cause cracking or peeling of the external surface of the insertion portion and may result in fiberscope damage.

NOTE The objective lens must be kept free of the lubricant and excess lens cleaner.

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