Pentax EG29-i10c Instructions For Use Manual

Instructions for Use

PENTAX Medical Video Upper GI Scope EG29-i10c

Operation

EG29 - i10c

For cleaning, high-level disinfection, and sterilization of the product after use, refer to the

separate Instructions for Use (Reprocessing) with the model name of the endoscope.

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

Caution

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.

Note Indicates supplementary or useful information regarding use.

Symbols Symboles

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

Symbol Description

Caution Attention

Year of Manufacture Année de fabrication

Type BF applied part Partie appliquee du type BF

Do not re - use Ne pas reutiliser

Follow the Instructions for Use Suivre les instructions d’utilisation

Serial Number Numero de serie

Manufacturer Fabricant

Authorized representative in the European Community Representant autorise dans I’Union europeenne

This product complies with the applicable standards harmonised under the Directive 93/42 / EEC and Directive 2011 / 65EU. Ce produit est conformé aux normes harmonisées au titre de la Directive 93/42 / CEE et la Directive 2011 / 65EU

Contents

Instructions for Use

Signal words and symbols

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Important information: Please read before use

Product summary

Intended use

Application

Classiﬁcation

Speciﬁcations

Compatible products

Reprocessing before initial use/Reprocessing / Storage after use

General warnings and cautions

Maintenance management

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1 Package contents

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1-1. Package contents

2 Nomenclature and functions

2-1. Control body and insertion portion

2-2. Scope connector

3 Preparation and inspection

3 - 1. Preparation of the equipment

3 - 2. Inspection of the endoscope

3 - 3. Inspection of accessories and attachment to the endoscope

3 - 4. Inspection and connection of ancillary equipment to the endoscope

3 - 5. Inspection of the endoscopic system

4 Directions for use

4 - 1. Preparation immediately before insertion of the endoscope

4 - 2. Insertion and observation

4 - 3. Using an endoscopic device

4 - 4. Using a nonﬂammable gas

4 - 5. Laser cauterization

4 - 6. Electrosurgery

4 - 7. Withdrawal of the endoscope

4 - 8. Care after use

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5 Troubleshooting

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5 -1. Troubleshooting guide

5 -2. Withdrawal of an endoscope with an abnormality

5 - 3. Returning the endoscope for repair

Disposal

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Electromagnetic compatibility (EMC)

Electromagnetic disturbances

Endoscope speciﬁcations

System chart

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Important information: Please read before use

Product summary

This endoscope is inserted transorally. It visualizes subjects under illumination of the LED (light emitting

diode) at the distal end of the endoscope 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

The PENTAX Medical Video Upper GI Scope EG29 - i10c 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 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

Intended anatomical area Upper gastrointestinal tract (esophagus, stomach) duodenum

User qualiﬁcations

Location of use A medical facility (including the place where the high frequency generator is used)

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

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 of personnel who have been trained to use other endoscopes of this type.

Classiﬁcation

Degree of protection against electric shock for the applied parts

Degree of protection against water IPX7

Mode of operation Continuous operation

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

Speciﬁcations

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Environment

Ambient temperature 10 to 40 ºC

Operating environment

Storage / transportation environment

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Software version

Refer to the back cover for the software version by model(s).

Relative humidity 30 to 85 %RH

Air pressure 700 to 1,060 hPa

Ambient temperature -20 to 60 ºC

Relative humidity 10 to 85 %RH

Air pressure 700 to 1,060 hPa

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Endoscope speciﬁcations

For details, refer to “Endoscope speciﬁcations” (p. 89).

Compatible products

This section describes the equipment that can be used in combination with this endoscope. For more

details, refer to “System chart” (p. 90).

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.

• 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 these endoscopes are shown below. For instructions

on video processor operation, refer to the IFU of the video processor.

Model Name Brand Name

EPK- i5500c PENTAX Medical

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Endoscopic device

Category Model Name Brand Name

Biopsy Forceps

Retrieval Basket

Injection Needle

Electro - Surgical Snare

Electro - Surgical Knife

Electro - Surgical Hemostasis Forceps

Spray Catheter

KW - D1816

KW - D2416T

KH - D2416T

KA - D2416T

KB - D2416T

KA1815S

KA2415S

KH2415S

KH2418CS

KS1022CS

KW1815S

KW1818CS

KW2215S

KW2218CS

KW2415R

KW2415S

GB - D1819L020

GB - D2415L030

GB - D2419L020

GB - D2423L035

NI - D1816 - T2304

NI - D1816 - T2305

NI - D1816 - T2306

NI - D1816 - T2308

NI - D2416 -T2304

NI - D2416 -T2306

NI - D2423 -T2305

NI - D1816 - T2504

NI - D1816 - T2505

NI - D2416 -T2504

NI - D2416 -T2505

NI - D2416 -T2506

DO - D2416 -15

DO - D2416 -20

DO - D2416 -25

DH - D2416 -15

DH - D2423- 20

DH - D2416 - 25

DO - D2618

DN - D2718A

DC - D2618

DP - D2518

DP - D2622

DN - D2718B

H - S2518

HS - D2618

HDB2418W

TJ - D2418PB

TJ1817WS

TJ2417WS

PENTAX Medical

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Other ancillary equipment

For instructions, refer to the respective manual provided with each equipment.

Category Description Model Name Brand Name

Irrigation Pump

CO² Insufﬂator EGA - 501P

High Frequency Generator VIO Series

EGA Series

EGA - 500P

VIO 300D

VIO 200S

PENTAX Medical

ERBE

Reprocessing before initial use/Reprocessing/Storage after use

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Reprocessing before the initial use

Warning

The endoscope identiﬁed in this IFU is a reusable semi- critical device.

Since it endoscope and accessories are packaged non- sterile, they must be cleaned and high

level disinfected, or cleaned and sterilized according to the separate IFU (Reprocessing) of this

product before initial use as well as after each procedure and after repair. 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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Reprocessing

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 can NOT be

used again on another patient. The pathogenic agents that cause this disease, which are called

“prions”, can NOT 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.

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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, and cleaning adapter 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).

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.

– Do NOT store the endoscope and its accessories in such a way that they might be

damaged due to contact with other devices.

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 whether or not to conduct an endoscopic examination

in patients determined to have lowered immunity.

• Do NOT use this endoscope with equipment other than those that have been speciﬁed for

combined use. Doing so may result in damage to the endoscope and patient injury.

• Do NOT drop the endoscope onto a hard surface or subject it to severe impact. This applies

particularly to the distal tip lens. Doing so may negatively impact image quality.

• Ensure to attach/connect an appropriate device to the connectors of the scope connector

such suction nipple, air/ water port, water jet port, or venting connector according to the IFU.

Incorrect connection or inappropriate use may result in unforeseen events.

• 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

peration 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 retroﬂexed observations inside a narrow lumen. Doing so may cause patient

injury or make it impossible to withdraw the endoscope.

• 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 endoscopic 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 can NOT 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.

• This product is intended to be used in the electromagnetic environment speciﬁed by

"Electromagnetic disturbances". Using the product in an unintended environment may result

in incorrect exposure control of the light emitted from distal end of the endoscope due to

electromagnetic interference.

Caution

• 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 forcefully attach an accessory to the endoscope. Doing so may result in damage to

the endoscope.

• 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 scope 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.

Package contents

1-1. 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.

If there are any damaged or missing components, do not use the endoscope. Immediately contact your

local PENTAX Medical service facility.

 Endoscope

EG29 - i10c

Figure 1.1

 Accessories

Inlet Seal (OF - B190)

(Installed)

Cleaning Adapter (OF - G17) Cleaning Adapter for Water Jet

Figure 1.2

Ventilation Cap (OE- C28) Venting Connector Adapter (OE- C29)

Connector (OE - C20)

Cleaning Adapter

(OF - B153)

 Accessories

Silicone Oil (OF - Z11) Irrigation Tube (OF - B113) O Ring Set (OF -B192*)

* For Air/ Water Feeding Valve (OF- B188)

Package contents

Check Valve Sets (OE- C15) O Ring Set (OF - B127**)

** For Suction Control Valve (OF - B120)

Cleaning Brush (CS5522A) Bite Block (OF-Z5) Water Jet Check Valve Adapter

Air/ Water Feeding Valve (OF - B188)

(Installed)

 Others

Suction Control Valve (OF- B120)

(Installed)

Cleaning Brush (CS - C13A)

(OE - C12) (Installed)

Water Jet Connector Cap (OF- B118)

(Installed)

IFU (Operation; this document) IFU (Reprocessing) Standard Accessories List

Figure 1.2

Nomenclature and functions

2-1. Control body and insertion portion

Nomenclature and functions

 Alternative view

Control Body

Insertion Portion

(Endoscope

components that

come into direct contact with the

patient.)

Distal End

Bending Section

Figure 2.1

Insertion Tube

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 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 (OF-

B194).

9. Air / Water Feeding Valve (OF-B188)

Attach to the air/water feeding cylinder. Covering the hole on the valve button feeds air to the air/ water

nozzle at the distal end of the endoscope. Depressing the valve button feeds water to the air/ water

nozzle at the distal end of the endoscope.

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)

Nomenclature and functions

EG29-i10c

Figure 2.2

Minimum Instrument Channel Width

3.2

Model Name

2-2. Scope connector

Model Name Country of Origin

Nomenclature and functions

 Alternative view

Scope Connector

Serial Number Date of Manufacture

Water Jet Connector Cap (OF - B118)

Umbilical Cord

Electrical ContactsManufacturer Label

Figure 2.3

14. Suction Nipple

Connect the suction tube on the suction source to the suction nipple.

15. Air/ Water Port

Connect the air/ water feeding hose on the water bottle assembly to the air/ water port.

16. Water Jet Port

Attach a water jet check valve adapter (OE- C12).

1 7. Water Jet Check Valve Adapter (OE- C12)

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).

18. Venting Connector

Attach the ventilation cap (OE- C28) or leakage tester via the venting connector adapter (OE - C29)

here.

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.

Preparation and inspection

Refer to “5 -1. Troubleshooting guide” (p. 76) for assistance in diagnosing an endoscope malfunction. If the

problem persists after troubleshooting or there is an apparent failure, do not use the endoscope. 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 endoscope with a suspected

abnormality. Doing so may result in malfunction, endoscope damage, and / or injury to the patient

and / or user.

• Ensure that another endoscope is also prepared to avoid interruption of the procedure due to

endoscope failure or unforeseen events.

Preparation and inspection

3-1. Preparation of the equipment

Prepare the endoscope, accessories, ancillary equipment, and protective equipment. Refer to the

“Compatible products” to prepare the ancillary equipment as necessary and to the IFU provided with the

video processor for its inspection.

 Endoscope

 Accessories

Preparation and inspection

Air/ Water Feeding Valve (OF - B188) Suction Control Valve (OF- B120) Inlet Seal (OF- B190 or OF - B215*)

* Optional item

Irrigation Tube (OF - B113) Water Jet Check Valve Adapter (OE- C12) Silicone Oil (OF- Z11)

Water Jet Connector Cap (OF- B118) Bite Block (OF-Z5)

 Ancillary Equipment

Video Processor Monitor Water Bottle Assembly

Endoscopic Device Gas / Water Feeding Valve (OF- B194*)

* Optional item

Gas Adapter (OF - G11*)

* Optional item

Suction Source

Irrigation Pump (EGA- 500P)

 Protective Equipment (example)

Gloves Goggles Mask Medical Gown

 Other Equipment

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

Figure 3.1

CO² Insufﬂator (EGA - 501P)

Preparation and inspection

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

• Do NOT excessively twist, bend, or rotate any of the strain relief boots on the instrument (See

Figure 3.2 (A) and (B)) 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 (A)) 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.

Figure 3.2

(A)

Do Not Twist or Rotate

(B)

Do Not Forcefully Bend

Bending Section

Do Not Forcefully Bend

Figure 3.3

Note

In case the endoscope is hot / cold immediately after cleaning, high -level disinfection, and/ or

sterilization, wait until it returns to room temperature before using it. Lens fogging, which will

result in blurry images, might result from abrupt changes in environmental temperature.

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Carrying the endoscope by hand

When carrying the endoscope by hand, loosely loop the umbilical cord and insertion portion, hold the

control body and the scope connector in gloved hand, and hold insertion portion (near the bending

section) in the other gloved hand as shown in Figure 3.4.

Preparation and inspection

Figure 3.4

(1)

(2)

(6)

(5)

Inspection of the entire endoscope

Warning

NEVER use the endoscope with any abnormality in function. Doing so may result in endoscope

damage, detachment of parts into the patient’s body cavity, endoscope malfunction during

use, and / or injury to the patient and / or user.

Caution

Clear images can NOT be obtained if there is any foreign material attached to the objective

lens or light guides. Water vapor from the foreign material may be released in response to

heating by the light passing through these components, obscuring the image.

Preparation and inspection

1. Check the entire surface of the endoscope for any visible adhered material.

2. 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.

3. 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 to the gauze.

Bending Section

Magniﬁed View

(1)

Figure 3.5

4. Check the case of the distal end of the endoscope (especially around the periphery of the instrument

channel) for any abnormalities such as deformation or chipping.

(1)

(1) Adhesive Bands

(1) Objective Lens

(2) Light Guides

(4)

(3)

Figure 3.6

5. Check the objective lens at the distal end of the endoscope and the light guides for any abnormalities

such as attachment of foreign material, scratches, or chipping, and ensure that there is no gap on

the periphery of the lens.

6. Ensure that there are no scratches, clouding, or peeling on the surface of the adhesive glue around

the objective lens at the distal end of the endoscope and that it has a glossy surface.

(2)

(3) Air/ water Nozzle

(4) Case

(5) Instrument Channel

(6) Water Jet Nozzle

7. Gently clean the objective lens and light guides with clean gauze or a cotton- tip applicator moistened

(5)

(1)

with 70% – 90% medical grade ethyl or isopropyl alcohol. Check that there is no attachment of the

adhesive to the gauze.

8. Check the air/ water nozzle at the distal end of the endoscope for any abnormalities such as

clogging, dents, deformations, chipping, etc.

9. Using both hands, form an arch with the insertion tube as shown in Figure 3.7. Slide the insertion

tube in the direction of the arrows in Figure 3.7, and check that the entire insertion tube can be bent

smoothly and easily to form an arch.

Approx. 30 cm

Approx. 20 cm

Figure 3.7

10. Check the entire surface of the umbilical cord for abnormalities such as wrinkles, scars, sharp

edges, clouding of the surface, catching, protrusions, attachment of foreign materials, detachment

of parts, etc.

11. Check the control body, scope connector, and electrical contacts for abnormalities such as

scratches, deformities, loose parts, etc. Pay special attention when checking the parts shown in

the Figure 3.8. Using a clean lint- free cloth, gently hold these parts and move them in various

directions to ensure that there are no abnormalities such as looseness.

(2)

(4)

(3)

(1) Suction Cylinder & Air/ Water

Feeding Cylinder

(2) Instrument Channel Inlet

(3) Water Jet Port

(4) Air/ Water Port

(5) Suction Nipple

Preparation and inspection

Figure 3.8

12. Check the electrical contacts for any attachment of foreign materials such as residual chemical

solution, water deposit, sebum, dust and gauze lint, etc.

Note

In case there are any attachment of foreign material or the endoscope has been left unused

for a prolonged period of time, wipe the electrical contacts with gauze moistened with

70% – 90% medical grade ethyl or isopropyl alcohol. After wiping, dry the electrical contacts

sufﬁciently.

13. Ensure that the electrical contacts are sufﬁciently dry.

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.

Preparation and inspection

█

Inspection of bending function

Warning

Do NOT use an endoscope that can NOT be smoothly angulated, can NOT be fully angulated

in any direction, or has excessive play in the angulation control lever. Use of an endoscope

with any of these conditions may result in damage to the device, malfunction during use,

and / or patient injury.

1. Turn the up / down angulation lock lever and right / left angulation lock knob in the “F ►” direction

until they stop to release the lock of the angulation control knobs.

Figure 3.9

2. Turn the up/down and right/ left angulation control knobs slowly in each direction until they stop,

and return them to their original position. Check that the angulation control knobs operate smoothly

with no roughness or catching.

Figure 3.10

3. Check that the bending section angulates in the direction in which the angulation control knobs are

turned and that the maximum angulation can be achieved.

RIGHT

Figure 3.11

4. Turn the angulation control knobs back to the neutral position. Check that the bending section

returns to a straight orientation.

DOWN

LEFT

DOWN LEFT

Neutral Position

UP RIGHT

Preparation and inspection

Figure 3.12

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Pentax EG29-i10c Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual