EC38-i10Nx Series Video Colonoscope 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 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 to the user and/or patient, 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.

1

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

Follow the Instructions for Use Manufacturer Fabricant Authorized representative in the European Community This product complies with the applicable standards harmonised under the Directive 93/42/EEC and Directive 2011/65EU. General mandatory action sign

General prohibition sign

2

Contents Instructions for Use········································································································ 1 Signal words and symbols···························································································· 1 Important information: Please read before use··························································· 5 Product summary···································································································································5 Intended use··········································································································································5 Application··············································································································································5 Classification··········································································································································5 Specifications·········································································································································5 Compatible products······························································································································6 Reprocessing before the first use, reprocessing, and storage after use················································8 General warnings and cautions··············································································································9 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····································································································20

3-3.

Inspection of accessories and attachment to the endoscope···················································29

3-4.

Inspection and connection of ancillary equipment to the endoscope·······································40

3-5.

Inspection of the endoscopic system·······················································································44

4 Directions for use···································································································· 57 4-1.

Before insertion of the endoscope····························································································59

4-2.

Insertion and observation··········································································································60

4-3.

Using an endotherapy device····································································································64

4-4.

Using a non-flammable gas·······································································································67

4-5.

Laser cauterization····················································································································69

4-6.

Electrosurgery···························································································································70

4-7.

Withdrawal of the endoscope···································································································72

4-8.

Care after use····························································································································73 3

5 Troubleshooting······································································································· 75 5-1.

Troubleshooting guide···············································································································75

5-2.

Withdrawal of an endoscope with an abnormality····································································79

5-3.

Returning the endoscope for repair···························································································80

Disposal························································································································· 81 Electromagnetic compatibility (EMC)········································································· 82 Endoscope specifications···························································································· 85 System chart················································································································· 86

4

Important information: Please read before use Product summary This instrument 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 endotherapy devices, 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 knobs, feeding air and water from the distal end of the endoscope by pressing the air/water feeding valve, and suctioning from the instrument channel at the distal end of the endoscope by pressing the suction control valve. This instrument incorporates multiple sensor coils. The position of the coils can be detected with a dedicated navigation control unit to calculate the shape of the endoscope.

Intended use This instrument is intended to provide images for observation, diagnosis, visualization, and treatment of the colon and terminal ileum and provide endoscope shape images when it is used in combination with the navigation control unit. 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

Colon and terminal ileum

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

Specifications „„Environment

Operating environment

Storage/transportation environment

Ambient temperature

10–40°C

Relative humidity

30–85% RH

Air pressure

700–1,060 hPa

Ambient temperature

-20 to 60°C

Relative humidity

10–85% RH

Air pressure

700–1,060 hPa

5

„„Frequency The drive signal frequency when the navigation control unit is used is 18–20.75 kHz. For details on the frequency characteristics and other specifications, refer to the IFU of the navigation control unit. „„Software version Refer to the back cover for the software version by model(s). „„Endoscope specifications For details, refer to “Endoscope specifications” (p.85).

Compatible products This section describes the equipment that can be used in combination with this instrument. For more details, refer to “System chart” (p.86) 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 • 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.

„„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-i7010 EPK-i7000/EPK-i7000(A) EPK-i5000 EPK-i5010

6

PENTAX Medical

„„Navigation control unit Navigation control unit model that can be connected with this instrument is shown below. For instructions on navigation control unit operation, refer to the IFU of the navigation control unit. Model Name

Brand Name

NCU-7000

PENTAX Medical

„„Endotherapy device Endotherapy devices that can be used in combination with this instrument are shown below. For instructions on endotherapy device operation, refer to the respective IFU supplied with each endotherapy device. Category

Description

Illustration

EC38-i10NL/EC38-i10NF

Brand Name

Reusable Biopsy Forceps with

KW2422R

Window Single Use Biopsy Forceps with

KW-D2423T

Window Single Use Biopsy Forceps with Window and Biopsy Forceps

KH-D2423T

Spike Reusable Crocodile Biopsy

KA2422S

Forceps Single Use Crocodile Biopsy

KA-D2423T

PENTAX Medical

Forceps Single Use Crocodile Biopsy Forceps with

KB-D2423T

Spike Retrieval

Single Use

Basket

Retrieval Basket

Injection

Single Use

Needles

Injection Needle

GB-D2419L020

GB-D2423L035 NI-D2423-T2304 NI-D2423-T2305 NI-D2423-T2306

Sprayer

Single Use Sprayer

TJ-D2423PB

7

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

Description

Model Name

Brand Name

EGA Series

EGA-500P

PENTAX Medical

ICC Series High Frequency Generator VIO Series

ICC 350 ICC 200 VIO 300D

ERBE

VIO 200S

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, high-level 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.

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 the cleaning, highlevel 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, posing a risk of infection to patients and or/users. -- Store the detachable accessories (air/water feeding valve, suction control valve, inlet seal, etc.), cleaning adapters, and soaking caps, 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). 8

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 endotherapy 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 infection, 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 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, air/water feeding, and suctioning, use of endotherapy 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. • When using the navigation control unit and inserting the endoscope for procedures, always check the endoscopic image via the video processor together with the endoscope shape image via the navigation control unit. Inserting the endoscope based on the endoscope shape image only may result in patient injury. • Do NOT forcefully insert and withdraw the instrument. Doing so may result in patient injury.

9

Warning • If the instrument/suction channel becomes blocked or clogged due to the accumulation of debris, an accessory that 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. • When inserting the endoscope into narrow lumina, Do NOT rotate the endoscopic image using the video processor. Doing so may result in patient injury or make the withdrawal of the endoscope impossible. • Do NOT use the endoscope in combination with the navigation control unit for a patient using a pacemaker. An AC magnetic field may cause the pacemaker to malfunction or fail, causing serious damage to the cardiac function of the patient. • Do NOT use the endoscope in combination with the navigation control unit for a pregnant woman. The effect of an AC magnetic field on a fetus is NOT yet clear.

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.

10

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.

11

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, 1.2, and 1.3 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

EC38-i10NL/EC38-i10NF

Figure 1.1

12

„„ Accessories

Irrigation Tube (OF-B113)

Inlet Seal (OF-B190)

O Ring Set (OF-B192*) * For Air/Water Feeding Valve (OF-B188)

O Ring Set (OF-B127**) ** For Suction Control Valve (OF-B120)

Silicone Oil Lubricant (OF-Z11)

Check Valve Set (OE-C15***) *** For Water Jet Check valve Adapter (OE-C12)

Cleaning Brush (CS6021T)

Cleaning Brush (CS-C9S)

Cleaning Adapter (OF-B153)

Cleaning Adapter (OF-G17)

PVE Soaking Cap (OE-C9)

PENTAX Medical Soaking Cap for Navigation Connector (OE-C27)

Ventilation Cap (OE-C21) „„ Endotherapy Device**** **** This is an optional device depending on the sales region.

Biopsy Forceps (KW2422R) „„ Others

IFU (Operation; this document)

IFU (Reprocessing)

Standard Accessories List

Figure 1.2

13

Package contents

1

2 2 2-1.

Nomenclature and functions

Control body, insertion portion

Nomenclature and functions

7 3

1

9

10 12

5 2 4

Distal End Bending Section

11 Control Body

13

1

10

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

6 8

Figure 2.1

14

Insertion Tube

1

Minimum Instrument Channel Width

Model Name

Figure 2.2

15

2 Nomenclature and functions

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. 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 Left/Right 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 Left/Right Angulation Lock Knob By turning counterclockwise, left/right 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 endotherapy 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

Electrical Contacts

16

Manufacturer Label

17

2

PVE Connector (180° rotatable) 10

Nomenclature and functions

14 Water Jet Connector Cap (OF-B118) 19

Date of Manufacture

Umbilical Cord

Serial Number 18

21

15

20

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 of the suction source. 16 Air/Water Port Connect the air/water feeding hose of the water bottle assembly. 17 Water Jet Port Attach the water jet check valve adapter (OE-C12). 18. Water Jet Check Valve Adapter (OE-C12) Attach to the water jet port. Attach the irrigation tube (OF-B113) and feed sterile water through the water jet nozzle at the distal end of the endoscope from the syringe or irrigation pump. When not using the irrigation tube, cover the adapter with the water jet connector cap (OF-B118).

16

2 Nomenclature and functions

19 Navigation Connector Connect the cable of the navigation control unit. 20 Venting Connector Attach the ventilation cap or the endoscope connector of the leakage tester here. 21 Feedback Terminal When using an electrosurgical device, connect the electrosurgical unit’s endoscope feedback cord (S-cord) or the condenser earth cable (OL-Z4).

17

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.75). 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.80).

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.

18

3-1.

Preparation of the equipment

Prepare the endoscope, accessories, ancillary equipment, and protective equipment. Refer to the “Compatible products” (p.6) to prepare the ancillary equipment as necessary and to the IFU supplied with the video processor and the navigation control unit for their inspection. „„ Endoscope

3 Preparation and inspection

„„ Accessories

Air/Water Feeding Valve (OF-B188)

Suction Control Valve (OF-B120)

Irrigation Tube (OF-B113)

Water Jet Check Valve Adapter (OE-C12)

Inlet Seal (OF-B190)

Silicone Oil Lubricant (OF-Z11)

„„ Ancillary equipment

Video Processor

Monitor

Navigation Control Unit

Endotherapy Device

Irrigation Pump (EGA-500P) or Syringe

Goggles

Mask

Gas/Water Feeding Valve (OF-B194*) * Optionally available

Suction Source Gas Adapter (OF-G11*) * Optionally available „„ Protective equipment (example)

Chemical-resistant gloves

Medical gown

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

Figure 3.1

19