EG16-K10, EG27-i10, EG29-i10 and EG29i10N Video Upper GI Scope Operation Instructions for Use March 2018

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 endoscope 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. 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

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 endoscope, 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.

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Contents Instructions for Use ... 3 Signal words and symbols ... 3 Important information: Please read before use ... 6 Product summary . . ... 6 Intended use ... 6 Application ... 6 Classification ... 6 Specifications .. ... 7 Compatible products . . ... 8 Reprocessing before the initial use, reprocessing, and storage after use ... 9 General warnings and cautions ... 10 Maintenance management ... 11

1 Package contents ... 12 1-1. Package contents . . ... 12

2 Nomenclature and functions ... 14 2-1. Control body, insertion portion . . ... 14 2-2. Connector ... 16

3 Preparation and inspection ... 18 3-1. Preparation of the equipment ... 19 3-2. Inspection of the endoscope ... 21 3-3. Inspection of accessories and attachment to the endoscope ... 29 3-4. Inspection and connection of ancillary equipment to the endoscope . . ... 39 3-5. Inspection of the endoscopic system . . ... 43

4 Directions for use ... 53 4-1. Preparation immediately before insertion of the endoscope . . ... 55 4-2. Insertion and observation ... 56 4-3. Using an endoscopic device ... 59 4-4. Using a non-flammable gas ... 62 4-5. Laser cauterization ... 64 4-6. Electrosurgery (Only for EG27-i10, EG29-i10, and EG29-i10N) ... 65 4-7. Withdrawal of the endoscope . . ... 67 4-8. Care after use ... 68

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5 Troubleshooting ... 70 5-1. Withdrawal of an endoscope with an abnormality .. ... 70 5-2. Returning the endoscope for repair ... 71

Disposal ... 72 Electromagnetic compatibility (EMC) ... 73 Endoscope specifications . . ... 76 System chart ... 77

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Important information: Please read before use Product summary This endoscope visualizes subjects under illumination transmitted from a dedicated video processor with a solid-state image sensor located at the distal end of the endoscope and provides images for observation of the target anatomy through the images reproduced on the video monitor via the video processor. It can be used with endoscopic devices which are introduced from the instrument channel inlet of the control body. The endoscope also allows for angulation operation of the bending sections via operation of the angulation control knob; air/water feeding from the distal end of the endoscope via operation of the air/ water feeding valve; and suction through the channel at the end of the endoscope via operation of the suction control valve.

Intended use This PENTAX Video Upper G.I. endoscope is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, and duodenum. This endoscope is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

Application Medical purposes

Provide images for observation, diagnosis, visualization, and treatment.

Patient population

Patients who are considered suitable for the application of this endoscope by the physicians (pediatric to adult patients).

Intended anatomical area

Upper gastrointestinal tract (esophagus, stomach) duodenum

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 endoscope is not required.

Location of use

A medical facility

Classification

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Degree of protection against electric shock for the applied parts

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

Degree of protection against water

IPX7 (with the soaking cap attached)

Mode of operation

Continuous operation

Specifications ██ 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

██ Software version

For the software version for each model, refer to the back cover. ██ Endoscope specifications

For details, refer to “Endoscope specifications” (p. 76).

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Compatible products This section describes the equipment that can be used in combination with this endoscope. For more details, refer to “System chart” (p. 77). For the equipment used in combination during cleaning/high-level disinfection/sterilization, refer to the separate IFU (Reprocessing) of this endoscope. 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 When this endoscope 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.

██ Video processor Video processor models that can be connected with these endoscopes are shown below. For instructions on video processor operation, refer to the IFU of the respective video processor.

Endoscopes

EG16-K10

EG27-i10 EG29-i10 EG29-i10N

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Model name EPK-3000 EPK-i7000 series EPK-i5000 series EPK-i EPK-p (C) EPK-100p*(only for PAL model endoscope) (*EPK-100p is not available in China.) EPK-i7000 series EPK-i5000 series EPK-i

Brand Name

PENTAX Medical

Reprocessing before the initial use, reprocessing, and storage after use ██ Reprocessing before the initial use The endoscope 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 the separate IFU (Reprocessing) of this product 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.

██ Reprocessing

After use, the endoscope 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 endoscope may result in its non-optimal function of and/or damage to the endoscope 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 instruments and equipment. The instruments 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, 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 instruments.

██ Storage after use

Warning Observe the following guidelines. Failure to do so may result in contamination of the endoscope with bacteria or pose a risk of infection to patients and/or users. –– Ensure that all removable accessories, such as air/water feeding valve, suction control valve, inlet seal, cleaning adapter, and soaking caps are removed from the endoscope when storing. –– Do NOT store the endoscope in areas of high humidity or high temperature. –– Do NOT store the endoscope, its components, and accessories in the carrying case. –– Ensure that the endoscope, its components, and accessories are completely moisture-free before storage. –– Before the next use, the endoscope, 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 endoscopes, 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 endoscope, its accessories, and devices, so that they do NOT hit against each other.

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

General warnings and cautions Warning • The medical facility should determine restrictions or non-use of the endoscope 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 instrument components such as the instrument channel inlet and the suction control valve. • Do NOT use this endoscope for any purpose other than its intended use. Doing so may result in patient injury. • Do NOT use this endoscope with equipment other than those that have been specified for combined use. Endoscope operation in the freeze or magnification mode may result in damage to the endoscope and patient injury. • Do NOT drop this endoscope or apply a strong shock to it. Doing so may result in damage to the endoscope. 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 connectors of the PVE connector such suction nipple, air/water port, venting connector, or feedback terminal according to the IFU. • Always check the endoscopic image during endoscope angulation, air/water feeding, 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 endoscope and/ or patient injury. • Do NOT forcefully insert and withdraw the endoscope. 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 endoscope.

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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 instrument/suction 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. • Transnasal insertion must be determined appropriately and cautiously according to the discretion of a medical professional. –– No endoscope, 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 endoscope 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.

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

Maintenance management The service life of this endoscope 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

Package contents

1-1.

Package contents

Package contents

Check the package contents according to the separate Standard Accessories List provided 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 endoscope; immediately contact your local PENTAX Medical service facility (Optional depending on the model.). „„ Endoscope

EG-K10/i10 series

Figure 1.1 „„ Accessories

PVE Soaking Cap (OE-C9)

Inlet Seal (OF-B190) (Installed)

Cleaning Brush (CS-C9S)

Cleaning Brush (CS6021T)

Cleaning Adapter (OF-G17)

Silicone Oil Lubricant (OF-Z11)

Figure 1.2 12

„„ Accessories

Cleaning Adapter (OF-B153)

Irrigation Tube (OF-B113) (Only for EG29-i10, EG29-i10N)

Ventilation Cap (OF-C5)

O Ring Set (OF-B192*) * For Air/Water Feeding Valve

O Ring Set (OF-B127**) ** For Suction Control Valve

Check Valve Set (OE-C15) (Only for EG29-i10, EG29-i10N)

Bite Block (OF-Z5)

Air/Water Feeding Valve (OF-B188) (Installed)

Suction Control Valve (OF-B120) (Installed)

Water Jet Check Valve Adapter (OE-C12) (Only for EG29-i10, EG29-i10N) (Installed)

Water Jet Connector Cap (OF-B118) (Only for EG29-i10, EG29-i10N) (Installed)

Package contents

1

„„ Endoscopic device*** *** This is an optional device depending on the sales region.

Biopsy Forceps (EG16-K10: KW1818CS), (EG27-i10: KW2415R), (EG29-i10/i10N: KW2415R) „„ Others

IFU (Operation; this document)

IFU (Reprocessing)

Standard Accessories List

Figure 1.2

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2 2 2-1.

Nomenclature and functions

Control body, insertion portion

„„ Endoscope

Nomenclature and functions

7

3

1

9

10 12

5 2 4

Distal End 11

Bending Section

Control Body

13

„„ Alternative view 1

10

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

6 8

Figure 2.1

14

Insertion Tube

＊.＊

Minimum Instrument Channel Width

＊＊＊＊-＊＊＊ Model Name

Figure 2.2 2.8 EG27- i10

3.2 EG29 - i10N

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2 Nomenclature and functions

1. Remote Buttons 1-4 Functions assigned to each button can be remotely controlled by pressing each of the remote buttons. Functions of the remote buttons 1-4 are assigned from the video processor. Refer to the IFU of the respective video processor for assignment of functions to each remote button. 2. Up/Down Angulation Control Knob By turning in the “▲U” direction, the bending section moves upwards. By turning in the “▲D” direction, the bending section moves downwards. 3. Up/Down Angulation Lock Lever By turning counterclockwise, upward/downward bending of the bending section is locked. By turning in the “F ►” direction, the bending lock is released. 4. Right/Left Angulation Control Knob By turning in the “▲R” direction, the bending section moves to the right. By turning in the “▲L” direction, the bending section moves to the left. 5. Right/Left Angulation Lock Knob By turning counterclockwise, right/left bending of the bending section is locked. By turning in the “F ►” direction, the bending lock is released. 6. Suction Cylinder Attach the suction control valve (OF-B120). 7. Suction Control Valve (OF-B120) Attach to the suction cylinder. Depress it to suction fluids or air through the instrument channel of the endoscope. 8. Air/Water Feeding Cylinder Attach the air/water feeding valve (OF-B188) or the optionally available gas/water feeding valve (OFB194). 9. Air/Water Feeding Valve (OF-B188) Attach to the air/water feeding cylinder. Covering the hole on the top of the valve feeds air from the air nozzle at the distal end of the endoscope. Depressing the valve feeds water from the water nozzle. 10. Strain Relief Boot The strain relief boot protects the connecting parts. 11. Instrument Channel Inlet The instrument channel inlet is an inlet for endoscopic devices. Attach the inlet seal (OF-B190). 12. Inlet Seal (OF-B190) The inlet seal is attached to the instrument channel inlet to avoid fluid/air leakage. 13. Model Name Label The model name label shows the model name, minimum instrument channel width, and other related information. (Figure 2.2)

2-2.

Connector

„„ EG29-i10, EG29-i10N Electrical Contacts

Manufacturer Label

16 16

2

17 17

PVE Connector (180° rotatable) 10 10

Nomenclature and functions

14 14 Date of Manufacture

19 19

Serial Number

Water Jet Connector Cap (OF-B118) Umbilical Cord

18 „„ Alternative view

18

20 20

15 15

Figure 2.3 14. Light Guide Plug The light guide plug transmits the light received from the light source to the distal end of the endoscope.. 15. Suction Nipple Connect the suction tube on the suction source to the suction nipple. 16. Air/Water Port Connect the air/water feeding hose on the water bottle assembly to the air/water port. 17. Water Jet Port (Only for EG29-i10, EG29-i10N) Attach a water jet check valve adapter (OE-C12). 18. Water Jet Check Valve Adapter (OE-C12) (Only for EG29-i10, EG29-i10N) Use it by attaching to the water jet port. Connect the irrigation tube (OF-B113) to send sterile water from a syringe or irrigation pump to the water jet nozzle at the distal end of the endoscope. When an irrigation tube is not connected, close it with the water jet connector cap (OF-B118). 19. Venting Connector Attach the ventilation cap (OF-C5) or the endoscope connector of the leakage tester here. 20. Feedback Terminal (Only for EG27-i10, EG29-i10, EG29-i10N) When using an electrosurgical device, connect the electrosurgical unit’s endoscope feedback cord (S-cord) or the condenser earth cable (OL-Z4/OL-Z3: check the package contents according to the separate standard accessories list provided with this product.).

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„„ EG27-i10

Electrical Contacts

Manufacturer Label

16

16

PVE Connector (180° rotatable)

10

10

2

14

Nomenclature and functions

14 Date of Manufacture

Umbilical Cord

Serial Number „„ Alternative view

20 20

15

15

Figure 2.4 „„ EG16-K10

Electrical Contacts

Manufacturer Label 16

16 PVE Connector (180° rotatable) 10

14

10

14

Date of Manufacture Serial Number

Umbilical Cord

„„ Alternative view

15

15

Figure 2.5 17

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Preparation and inspection

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

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If any abnormality is suspected during inspection, do not use the endoscope; send it for repair according to “5-2. Returning the endoscope for repair” (p. 71).

Warning Preparation and inspection

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

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

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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 provided with the video processor for its inspection. „„ Endoscope

3 Preparation and inspection

Feedback terminal only for EG27-i10 EG29-i10, and EG29-i10N

„„ Accessories

Air/Water Feeding Valve (OF-B188)

Suction Control Valve (OF-B120)

Inlet Seal (OF-B190)

Silicone Oil Lubricant (OF-Z11)

Water Jet Check Valve Adapter (OE-C12) (Only for EG29-i10, EG29-i10N)

Irrigation Tube (OF-B113) (Only for EG29-i10, EG29-i10N)

Water Jet Connector Cap (OF-B118) (Only for EG29-i10, EG29-i10N)

Bite Block (OF-Z5)

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„„ Ancillary Equipment

Video Processor

Monitor

Water Bottle Assembly

Endoscopic Device

Gas/Water Feeding Valve (OF-B194*) * Optional item

Gas Adapter (OF-G11*) * Optional item

3 Preparation and inspection

Suction Source

Condenser Earth Cable (OL-Z4/OL-Z3) „„ Protective Equipment (example)

Gloves

Goggles

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

Figure 3.1

20

Mask

Medical Gown

3-2.

Inspection of the endoscope

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

Warning • NEVER disassemble or modify the endoscope. Doing so may impair its original functionality and possibly result in serious injury to the patient and/or user. • NEVER use an endoscope with any abnormality. Doing so may result in endoscope 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 endoscope with waterborne bacteria and other microorganisms. Do NOT use water that has been left uncovered for a prolonged period of time.

Preparation and inspection

3

Caution • Do NOT excessively twist, bend, or rotate any of the strain relief boots on the instrument (See Figure 3.2 (1) and 3.2 (2) to identify the strain relief boots). Doing so may result in instrument damage. Pay special attention to the careful handling of the strain relief boot of the insertion portion (See Figure 3.2 (1)) of the endoscope, because it has a small diameter and is more likely to suffer damage due to mishandling. • When carrying the endoscope, 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 result in equipment damage.

(1)

Do Not Twist or Rotate

(2)

Do Not Forcefully Bend

Figure 3.2

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