VNLx-J10-Video Naso-Pharyngo-Laryngoscope Operation Instructions for Use March 2016

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 instrument 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. In addition, review and fully understand the contents of the separate IFU for reprocessing (hereinafter referred to as “IFU (Reprocessing)”). Inappropriate use of the product 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.

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

Warning

Caution

Note

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

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

Indicates supplementary or useful information regarding use.

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

Description Caution, Refer to Instructions for Use

Date of manufacture

Type BF applied part

Do not re-use

Sterilized using irradiation

Use-by date

Batch Code

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.

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Contents Instructions for Use········································································································ 3 Signal words and symbols···························································································· 3 Important information: Please read before use··························································· 7 Product summary···································································································································7 Intended use··········································································································································7 Application··············································································································································7 Classification··········································································································································7 Specifications·········································································································································8 Compatible products······························································································································8 Reprocessing before the first use, reprocessing, and storage after use·············································· 10 General warnings and cautions············································································································ 11 Maintenance management·················································································································· 12

1 Package contents····································································································· 14 1-1.

Package contents······················································································································ 14

2 Nomenclature and functions·················································································· 16 2-1.

Control body, insertion portion·································································································· 16

2-2.

Connector Unit and Light Guide Plug························································································ 18

3 Preparation and inspection···················································································· 20 3-1.

Preparation of the equipment···································································································21

3-2.

Inspection of the endoscope····································································································22

3-3.

Inspection of accessories and attachment to the endoscope···················································28

3-4.

Inspection and connection of ancillary equipment to the endoscope·······································34

3-5.

Inspection of the endoscopic system·······················································································37

4 Directions for use···································································································· 44 4-1.

Preparation immediately before insertion of the endoscope····················································45

4-2.

Insertion and observation··········································································································46

4-3.

Using an endoscopic device (For VNL15-J10)············································································49

4-4.

Laser cauterization (For VNL15-J10)··························································································52

4-5.

Electrosurgery (For VNL15-J10)·································································································53

4-6.

Withdrawal of the endoscope···································································································54

4-7.

Care after use····························································································································54

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5 Troubleshooting······································································································· 56 5-1.

Troubleshooting guide···············································································································56

5-2.

Withdrawal of an endoscope with an abnormality····································································59

5-3.

Returning the endoscope for repair···························································································60

Disposal························································································································· 61 Electromagnetic compatibility (EMC)········································································· 62 Endoscope specifications···························································································· 65 System chart················································································································· 66

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Important information: Please read before use Product summary „„VNL8-J10/VNL11-J10 This instrument is inserted transorally or transnasally. It acquires images of an observation target using solid-state image sensors arranged at the distal end of the endoscope, illuminated by light from a dedicated video processor or a stroboscopic light source. The images of the target site are displayed on a monitor via the video processor. Angulation operation of the bending section can be performed by using the angulation control lever in the control body. „„VNL15-J10 This instrument is inserted transorally or transnasally. It acquires images of an observation target using solid-state image sensors arranged at the distal end of the endoscope, illuminated by light from a dedicated video processor or a stroboscopic light source. The images of the target site are displayed on a monitor via the video processor. It can be used with endoscopic devices, each of which is introduced from the instrument channel inlet of the control body. Operations of the instrument include bending of the bending section by operating the angulation control lever and suctioning from the instrument channel at the distal end of the endoscope by pressing the suction control valve.

Intended use This instrument is intended to provide images for observation, diagnosis, visualization, and treatment of the nasal cavity, oral cavity, pharynx, larynx, and trachea. NEVER use this instrument for any purpose other than that for which it has been designed.

Application Medical purposes Patient population

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

Intended anatomical area

Nasal cavity, pharynx, larynx, trachea

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 for

TYPE BF applied part (when connected to a compatible PENTAX Medical

the applied parts

video processor)

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 „„Environment

Operating environment

Storage/transportation environment

Ambient temperature

10°C–40°C

Relative humidity

30%–85% RH

Air pressure

700–1,060 hPa

Ambient temperature

−20°C to 60°C

Relative humidity

10%–85% RH

Air pressure

700–1,060 hPa

„„Software version Refer to the back cover for the software version by model(s). „„Endoscope specifications For details, refer to “Endoscope specifications” (p.65).

Compatible products This section describes the equipment that can be used in combination with this instrument. For more details, refer to “System chart” (p.66). For the equipment used in combination during cleaning/high-level disinfection/sterilization, refer to the separate IFU (Reprocessing). The combinations of equipment and accessories that can be used with this product are 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 instructions for use with PENTAX Medical products.

Note Erster Absatz wird auch zu Bullet [B_ind0_bull] • When this instrument 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. • Some products are not available depending on the sales region. For details, contact your local PENTAX Medical service facility.

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„„Video Processor Video processor models that can be connected with this instrument are shown below. For instructions on video processor operation, refer to the respective IFU supplied with each video processor. Model Name

Brand Name

EPK-3000 EPK-i7010 EPK-i7000/EPK-i7000(A) EPK-i5000

PENTAX Medical

EPK-i EPK-1000 EPK-100p

„„Endoscopic Device (For VNL15-J10) Endoscopic devices that can be used in combination with this instrument are shown below. For instructions on endoscopic device operation, refer to the respective IFU supplied with each endoscopic device. Category

Description

Illustration

Model Name

Brand Name

KW1806S

Reusable Biopsy Forceps with Window

KW1811S

Biopsy

PENTAX Medical

Forceps

KA1806S

Reusable Crocodile Biopsy Forceps

KA1811S

„„Other ancillary equipment For instructions, refer to the respective manual supplied with each equipment. Category

Description ICC Series

High Frequency Generator VIO Series Light Source

Laryngeal Strobe

Model Name

Brand Name

ICC 350 ICC 200 VIO 300D

ERBE

VIO 200S Model 9400

PENTAX Medical

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Reprocessing before the first use, reprocessing, and storage after use „„Reprocessing before the first use This instrument is shipped non-sterile. Before the first use and prior to each subsequent use, it must be subjected to appropriate cleaning, highlevel disinfection, and/or sterilization processes according to the instructions in the separate IFU (Reprocessing) of this instrument. „„Reprocessing After use, the instrument must be subjected to appropriate cleaning, high-level disinfection, and/or sterilization processes before storage. Perform cleaning, high-level disinfection, and/or sterilization according to the separate IFU (Reprocessing) of this instrument. Insufficient and/or incomplete cleaning, high-level disinfection, and/or sterilization of this instrument may result in its non-optimal function of and/or damage to the instrument and may pose a risk of infection to the patient and/or users. This instrument can be sterilized using the STERRAD® NX®/100NX® system.

Warning When using the instrument and accessories in patients with Creutzfeldt–Jakob disease (CJD) or variant Creutzfeldt–Jakob disease (vCJD), ensure to use dedicated instruments only for such patients or immediately dispose of the instruments after use in an appropriate manner. The pathogenic agents that cause (v)CJD cannot be destroyed or inactivated by cleaning, high-level disinfection, and sterilization methods specified in the separate IFU (Reprocessing) of this instrument. Follow the respective guidelines in your country/region for handling of (v)CJD patients.

„„Storage after use Warning Adhere to the following guidelines. Failure to do so may result in contamination of the instrument with bacteria or pose a risk of infection to patients and or/users. -- Store the detachable accessories (suction control valve, inlet seal, cleaning adapter, soaking cap, etc.) separate from the instrument. -- Do NOT store the instrument in areas of high humidity or high temperature. -- Do NOT store the instrument, its components, and accessories in the carrying case. -- Ensure that the instrument, its components, and accessories are completely moisture-free before storage. -- Before the next use, the instrument, 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 the separate IFU (Reprocessing).

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Caution Observe the following precautions when storing the instruments, its accessories, or device. Failure to do so may result in damage to property. -- Endoscope insertion portion, umbilical cord, and endoscopic devices should be kept as straight as possible during storage. -- Keep away from chemicals, direct sunlight, or ultraviolet rays. -- Maintain adequate distances between the instrument, its accessories, and devices, so that they do NOT hit against each other.

Note It is recommended to store the instrument hanging down straight in a well-ventilated room or cabinet dedicated for instrument storage. For storage after use, also refer to the separate IFU (Reprocessing) of this instrument.

General warnings and cautions Warning • The medical facility should determine restrictions or non-use of the instrument in patients suspected of having lowered immunity. • Users as well as the assisting personnel should always wear protective equipment (e.g., chemical-resistant gloves, goggles, masks, medical gowns, etc.) to minimize the risk of crosscontamination, as patient’s body fluids and/or chemical liquid may be dispersed from instrument components such as the instrument channel inlet and the suction control valve. • Do NOT use this instrument for any purpose other than its intended use. Doing so may result in patient injury. • Do NOT use this instrument with equipment other than those that have been specified for combined use. Doing so may result in damage to the instrument or patient injury. • Do NOT drop this instrument or apply a strong shock to it. Doing so may result in damage to the instrument. 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. • Always check the endoscopic image during endoscope angulation and suctioning, use of endoscopic devices, and endoscope insertion and withdrawal. Ensure that these operations are performed in the normal (non-frozen, non-magnified) mode. Endoscope operation in the freeze or magnification mode may result in damage to the instrument and/or patient injury. • Do NOT forcefully insert and withdraw the instrument. Doing so may result in patient injury. • 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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Warning • After using operational/cleaning accessories (e.g., forceps, needles, snares, brushes etc.) with the endoscope, carefully check that all accessories are intact and that no parts have fallen off and become lodged within the endoscope’s instrument/suction channel. Furthermore, ensure that any therapeutic devices (e.g., clips, stents, etc.) passed through the channel are accounted for after use. If the channel becomes blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. In such a case, contact your local PENTAX Medical service facility to have the endoscope repaired. The use of an endoscope with a blocked internal channel may result in ineffective reprocessing and/or the introduction of debris and/or device components into a patient during a subsequent procedure, posing a risk of cross-contamination.

Caution • Do NOT excessively twist, rotate, or bend any of the insertion portions, strain relief boots, or umbilical cord. Doing so may damage the instrument. • Do NOT hit the remote buttons with hard objects or pull or twist them. Doing so may cause internal damage to the instrument that may lead to water leaks. • Do NOT attach or detach the PVE connector of the instrument while the power of the video processor is turned on. Doing so may damage the instrument. • 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 instrument or shield the location of use.

Maintenance management The service life of this instrument is 6 years depending on 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 annual periodic inspections.

Caution • After every 100 cycles of STERRAD® NX®/100NX® exposure, the instrument should be returned to an authorized PENTAX Medical service facility for repair. Replacement of the insertion tube and bending section will be necessary, and other components may also require repair or replacement. • The repair/replacement of parts may be necessary prior to reaching 100 cycles, depending upon the condition of the instrument.

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1

1 Package contents

1-1.

Package contents

Package contents

Check the package contents according to the separate Standard Accessories List supplied with this product. For detail picture of the contents/accessories, refer to Figure 1.1 and 1.2 in the IFU. If there are any damaged or missing components, do not use the instrument; immediately contact your local PENTAX Medical service facility. „„ Endoscope

VNL8-J10/VNL11-J10

VNL15-J10

Figure 1.1

14

„„ Accessories [For VNL8 - J10, VNL11- J10, VNL15 - J10]

Ventilation Cap (OF - C5)

PVE Soaking Cap (OE - C9)

PENTAX Medical Single Use Suction Control Valve (OF - B205*) *Sterile (electron beam sterilization)

Inlet Seal (OF - B190)

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits (CS4010A)

PENTAX Medical PROfILE Single Use Endoscope Cleaning Brush Kits (CS - C11A)

Package contents

1

[For VNL15 - J10]

PENTAX Medical Cleaning Adapter (OF - B212)

PENTAX Medical O Ring Set (OF - B214**) **For PENTAX Medical Cleaning Adapter (OF - B212)

PENTAX Medical Cleaning Cap for Instrument Channel Inlet (OF - B218)

„„ Endoscopic device (For VNL15 - J10)*** ***This is an optional device depending on the sales region.

Biopsy Forceps (KW1806S) „„ Others

IFU (Operation; this document)

IFU (Reprocessing)

Standard Accessories List

Figure 1.2

15

2 2 2-1.

Nomenclature and functions

Control body, insertion portion

Nomenclature and functions

4 VNL8-J10/VNL11-J10

VNL15-J10 1

1 5

D U

D U

7 5 2 Distal End Bending Section

6

Control Body

8

Insertion Portion (The parts which come into contacts with the patient)

5

Insertion Tube

1

3

Figure 2.1

16

2

3 4

5 6 7 8

Remote Buttons 1-4 Functions assigned to each button can be remotely controlled by pressing each of the remote buttons. Functions are assigned from the video processor. Refer to the IFU supplied with the video processor for assignment of functions to each remote button. Angulation Control Lever By moving the angulation control lever toward the “▼U” direction, the bending section moves upwards. By moving the angulation control lever toward the “▲D” direction, the bending section moves downwards. Suction Cylinder (For VNL15-J10) Attach the PENTAX Medical Single Use Suction Control Valve (OF-B205). PENTAX Medical Single Use Suction Control Valve (OF-B205)*1 (For VNL15-J10) The suction control valve is attached to the suction cylinder. Fluids and air can be suctioned through the instrument channel by depressing the suction control valve. Strain Relief Boot The strain relief boot protects the connecting parts. Instrument Channel Inlet (For VNL15-J10) The instrument channel inlet is an inlet for endoscopic devices. Attach the inlet seal (OF-B190). Inlet Seal (OF-B190) (For VNL15-J10) The inlet seal is attached to the instrument channel inlet to avoid fluid/air leakage. Model Name Label The model name label shows the model name, minimum instrument channel width, and other related information. (Figure 2.2)

Minimum Instrument Channel Width

STERRAD® NX™/100NX™ system compatibility identification symbol

Model Name

Figure 2.2 *1: The following products will hereafter be referred to as follows. PENTAX Medical Single Use Suction Control Valve = suction control valve

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2 Nomenclature and functions

1

2-2.

Connector Unit and Light Guide Plug PVE Connector (180° rotatable)

Serial Number

Date of Manufacture

2

Electrical Contacts

Nomenclature and functions

Manufacturer Label

5 10

Light Guide Cable

9

Figure 2.3 9

Light Guide Plug The light guide plug transmits the light received from the light source to the distal end of the endoscope. 10 Venting Connector Attach the ventilation cap or the endoscope connector of the leakage tester here.

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Nomenclature and functions

2

19

3 3

Preparation and inspection

Before use, the instrument, accessories, video processor, and other components must be prepared and carefully inspected according to the IFU. Any equipment used in combination with the instrument must also be prepared and inspected according to the respective instruction manuals. Always perform pre-use inspection before each use. Ensure that another instrument is also prepared to avoid interruption of the procedure due to instrument failure or unforeseen events.

Preparation and inspection

An instrument with suspected abnormality should be assessed with reference to the “5-1. Troubleshooting guide” (p.56). If the problem persists after troubleshooting or there is an apparent failure, do not use the instrument; send it for repair according to “5-3. Returning the endoscope for repair” (p.60).

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

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3-1.

Preparation of the equipment

Prepare the endoscope, accessories, ancillary equipment, and protective equipment. Refer to the “Compatible products” (p.8) to prepare the ancillary equipment as necessary and to the IFU supplied with the video processor for its inspection. „„ Endoscope

Preparation and inspection

3 „„ Accessory

Suction Control Valve (OF-B205) [For VNL15-J10]

Inlet Seal (OF-B190) [For VNL15-J10]

„„ Ancillary Equipment

Video Processor

Monitor

Bite Block (OF-Z5) [sold separately]

Suction Source [For VNL15-J10]

Stroboscopic Light Source Device (Model 9400)

Endoscopic Device [For VNL15-J10] „„ Protective Equipment (example)

Chemical-resistant Gloves

Goggles

Mask

Medical Gown

„„ Others Gauze, sterile water, container for sterile water, etc.

Figure 3.1

21

3-2.

Inspection of the endoscope

Prepare the instrument that has been reprocessed according to the procedure specified in the separate IFU (Reprocessing) of this instrument.

Warning • NEVER disassemble or modify the instrument. Doing so may impair its original functionality and possibly result in serious injury to the patient and/or user. • NEVER use an instrument with any abnormality. Doing so may result in instrument damage, detachment of parts into the patient’s body cavity, malfunction during use, 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 instrument with waterborne bacteria and other microorganisms. Do NOT use water that has been left uncovered for a prolonged period of time

3 Preparation and inspection

Caution • Do NOT excessively twist, rotate, or bend any of the strain relief boots [as indicated by (A) and (B) in Figure 3.2]. Doing so may result in instrument damage. In particular, handle the strain relief boot of the insertion portion [as indicated by (A) in Figure 3.2] with care because it has a small diameter. Do NOT squeeze the strain relief boots of both umbilical cord branches at the same time as this may damage the equipment. • When carrying the instrument, do NOT grasp or carry it only by its umbilical cord or insertion portion. Moreover, do NOT squeeze or forcefully bend the bending section (Figure 3.3). Doing so may damage the instrument.

Do Not Twist or Rotate

Do Not Forcefully Bend

(B) (B) (B) (A)

Figure 3.2

22