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OLYMPUS

OLYMPUS CF and PCF TYPE x190 series EVIS EXERA III COLONOVIDEOSCOPE Operation Manual

Revision Not Listed

OLYMPUS Videoscope Systems

145 Pages

OPERATION MANUAL  INSTRUCTIONS  Symbols  1  Important Information — Please Read Before Use  2  Chapter 1  Checking the Package Contents  13  EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE  Chapter 2  Instrument Nomenclature and Specifications  19  OLYMPUS GIF-XP190N OLYMPUS GIF-H190 OLYMPUS GIF-HQ190 OLYMPUS GIF-1TH190  Chapter 3  Preparation and Inspection  33  Chapter 4  Operation  71  Chapter 5  Troubleshooting  99  EVIS EXERA lll COLONOVIDEOSCOPE  OLYMPUS CF-H190L/I OLYMPUS CF-HQ190L/I OLYMPUS PCF-PH190L/I OLYMPUS PCF-H190L/I  Appendix  Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” with your endoscope model listed on the cover, for reprocessing information... SA: CAUTION: Federal law restricts this device to sale by or on the order of a physician... 111   Contents  Contents Symbols ...  1 Important Information — Please Read Before Use ...  2 Intended use ... 2 Applicability of endoscopy and endoscopic treatment ... 2 Instruction manual ... 3 User qualifications ... 4 Instrument compatibility ...  4 Reprocessing before the first use/reprocessing and storage after use ...  4 Spare equipment ...  Maintenance management ...  Prohibition of improper repair and modification ...  5 Signal words ... 5 Warnings and cautions ...  Precautions for transnasal insertion for GIF-XP190N ...  10 Precautions for disappeared or frozen endoscopic image ...  11 Examples of inappropriate handling ...  12  Chapter 1 Checking the Package Contents ...  13 1...  Checking the package contents list ...  13 Packaged items for the Americas, Europe, Australasia, Middle East, and Africa ...  14 Packaged items for countries other than the Americas, Europe, Australasia, Middle East, and Africa ... 6  Chapter 2 Instrument Nomenclature and Specifications ...  19 2...  Nomenclature and functions ...  19 Control section, insertion section ... 20 Endoscope connector ... 4  2...  Specifications ...  26 Environment ...  26 Function list ... 7 Specifications ... 28  Chapter 3 Preparation and Inspection ...  33 3...  The workflow of preparation and inspection ... 3  3...  Preparation of the equipment ... 35  3...  Inspection of the endoscope ...  36 Inspection of the endoscope ...  Inspection of the passive bending section ...  Inspection of the flexibility adjustment mechanism ... Inspection of the bending mechanisms ... GIF/CF/PCF-190 Series OPERATION MANUAL  36 39 39 40  i
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Page 1

OPERATION MANUAL

INSTRUCTIONS

Symbols

1

Important Information — Please Read Before

Use

2

Chapter 1

Checking the Package Contents

13

EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE

Chapter 2

Instrument Nomenclature and

Specifications

19

OLYMPUS GIF-XP190N

OLYMPUS GIF-H190

OLYMPUS GIF-HQ190

OLYMPUS GIF-1TH190

Chapter 3

Preparation and Inspection

33

Chapter 4

Operation

71

Chapter 5

Troubleshooting

99

EVIS EXERA lll COLONOVIDEOSCOPE

OLYMPUS CF-H190L/I

OLYMPUS CF-HQ190L/I

OLYMPUS PCF-PH190L/I

OLYMPUS PCF-H190L/I

Appendix

Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” with your

endoscope model listed on the cover, for reprocessing information.

USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.

111

Page 3

Contents

Contents

Symbols .............................................................................................................................. 1

Important Information — Please Read Before Use ......................................................... 2

Intended use .......................................................................................................................... 2

Applicability of endoscopy and endoscopic treatment ........................................................... 2

Instruction manual ................................................................................................................. 3

User qualifications ................................................................................................................. 4

Instrument compatibility ......................................................................................................... 4

Reprocessing before the first use/reprocessing and storage after use ................................. 4

Spare equipment ................................................................................................................... 4

Maintenance management .................................................................................................... 5

Prohibition of improper repair and modification ..................................................................... 5

Signal words .......................................................................................................................... 5

Warnings and cautions .......................................................................................................... 6

Precautions for transnasal insertion for GIF-XP190N ......................................................... 10

Precautions for disappeared or frozen endoscopic image ................................................... 11

Examples of inappropriate handling .................................................................................... 12

Chapter 1 Checking the Package Contents ....................................... 13

1.1

Checking the package contents list ..................................................................... 13

Packaged items for the Americas, Europe, Australasia, Middle East, and Africa ............... 14

Packaged items for countries other than the Americas, Europe, Australasia, Middle East,

and Africa ............................................................................................................................ 16

Chapter 2 Instrument Nomenclature and Specifications .................. 19

2.1

Nomenclature and functions ................................................................................. 19

Control section, insertion section ......................................................................................... 20

Endoscope connector .......................................................................................................... 24

2.2

Specifications ......................................................................................................... 26

Environment ........................................................................................................................ 26

Function list ......................................................................................................................... 27

Specifications ....................................................................................................................... 28

Chapter 3 Preparation and Inspection ................................................ 33

3.1

The workflow of preparation and inspection ....................................................... 33

3.2

Preparation of the equipment ................................................................................ 35

3.3

Inspection of the endoscope ................................................................................. 36

Inspection of the endoscope ................................................................................................

Inspection of the passive bending section ...........................................................................

Inspection of the flexibility adjustment mechanism ..............................................................

Inspection of the bending mechanisms ...............................................................................

GIF/CF/PCF-190 Series OPERATION MANUAL

36

39

39

40

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Page 4

Contents

3.4

Inspection of accessories ...................................................................................... 44

Inspection of the air/water and suction valves .....................................................................

Inspection of the biopsy valve (MB-358) .............................................................................

Inspection of the single use biopsy valve (MAJ-1555) ........................................................

Inspection of the auxiliary water inlet cap (MAJ-215) ..........................................................

Inspection of the auxiliary water tube (MAJ-855) ................................................................

Inspection of the mouthpiece (MA-474 or MB-142) (for transoral insertion only) ................

3.5

44

45

46

46

47

47

Attaching accessories to the endoscope ............................................................. 48

Attaching the suction valve ..................................................................................................

Attaching the air/water valve ...............................................................................................

Attaching the biopsy valve ...................................................................................................

Attaching the auxiliary water inlet cap .................................................................................

48

49

50

51

3.6

Inspection of ancillary equipment ........................................................................ 51

3.7

Connection of the endoscope and ancillary equipment ..................................... 52

Connection to the light source .............................................................................................

Connection of the water container .......................................................................................

Connection of the suction tube ............................................................................................

Connection of the auxiliary water tube ................................................................................

3.8

52

53

54

55

Inspection of the endoscopic system .................................................................. 56

Inspection summary ............................................................................................................

Inspection of the endoscopic image ....................................................................................

Inspection of the focus switching function ...........................................................................

Inspection of the remote switches .......................................................................................

Inspection of the air-feeding function ...................................................................................

Inspection of the objective lens cleaning function ...............................................................

Inspection of the suction function ........................................................................................

Inspection of the instrument channel ...................................................................................

Inspection of the auxiliary water feeding function ................................................................

Inspection of the endoscope position detecting function .....................................................

56

57

59

61

62

63

65

67

68

69

Chapter 4 Operation ............................................................................. 71

4.1

Precautions ............................................................................................................. 71

4.2

Insertion .................................................................................................................. 76

Holding and manipulating the endoscope ...........................................................................

Insertion of the endoscope ..................................................................................................

Observation of the endoscopic image .................................................................................

Focus switching ...................................................................................................................

Angulation of the distal end .................................................................................................

Flexibility adjustment ...........................................................................................................

Insertion of the endoscope using the endoscope position detecting unit ............................

Air/water feeding and suction ..............................................................................................

4.3

Using EndoTherapy accessories .......................................................................... 89

Insertion of EndoTherapy accessories into the endoscope .................................................

Operation of EndoTherapy accessories ..............................................................................

Withdrawal of EndoTherapy accessories ............................................................................

Use of nonflammable gases ................................................................................................

High-frequency cauterization treatment ...............................................................................

ii

76

77

81

81

82

83

84

84

GIF/CF/PCF-190 Series OPERATION MANUAL

91

92

93

93

94

Page 5

Contents

4.4

Withdrawal of the endoscope ................................................................................ 95

4.5

Transportation of the endoscope .......................................................................... 97

Transporting within the hospital ........................................................................................... 97

Transporting outside the hospital ......................................................................................... 98

Chapter 5 Troubleshooting .................................................................. 99

5.1

Troubleshooting ..................................................................................................... 99

5.2

Troubleshooting guide ......................................................................................... 100

Angulation ..........................................................................................................................

Air/water feeding ................................................................................................................

Suction ...............................................................................................................................

Image quality or brightness ...............................................................................................

Flexibility adjustment .........................................................................................................

Auxiliary water feeding ......................................................................................................

EndoTherapy accessories .................................................................................................

Endoscope position detecting ............................................................................................

Other ..................................................................................................................................

5.3

Withdrawal of the endoscope with an irregularity ............................................ 105

Withdrawal when the WLI and NBI endoscopic images appear on the monitor ................

Withdrawal when either the WLI or the NBI endoscopic image does not appear

on the monitor ....................................................................................................................

Withdrawal when no endoscopic image appears on the monitor or a frozen image

cannot be restored .............................................................................................................

Withdrawal when the focus setting cannot be switched ....................................................

5.4

100

100

101

102

103

103

103

104

104

105

107

107

108

Returning the endoscope for repair ................................................................... 110

Appendix ............................................................................................... 111

Combination equipment ................................................................................................ 111

System chart ....................................................................................................................... 111

Reprocessing equipment .................................................................................................... 114

Compatible video system center ......................................................................................... 115

Compatible light source ...................................................................................................... 115

Compatible accessories ...................................................................................................... 116

Compatible EndoTherapy accessories ............................................................................... 117

Compatible electrosurgical accessories ............................................................................ 128

EMC information ............................................................................................................ 134

GIF/CF/PCF-190 Series OPERATION MANUAL

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Contents

iv

GIF/CF/PCF-190 Series OPERATION MANUAL

Page 7

Symbols

Symbols

The meaning(s) of the symbol(s) shown on the component packaging, the back cover of the instruction

manual, and/or the instrument are as follows:

Symbol

Description

Refer to instructions.

Endoscope

TYPE BF applied part

Single use only

Lot number

Manufacturer

Authorized representative in the European Community

Serial number

GIF/CF/PCF-190 Series OPERATION MANUAL

1

Page 8

Important Information — Please Read Before Use

Important Information — Please Read Before Use



Intended use

This instrument is intended to be used with an Olympus video system center, endoscope position

detecting unit (for CF-HQ190L/I), light source, documentation equipment, monitor, EndoTherapy

accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic

surgery.

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-XP190N is indicated for use

transorally or transnasally within the upper digestive tract (including the esophagus, stomach, and

duodenum).

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190, GIF-1TH190 are

indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190L/I,

PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid

colon, colon, and ileocecal valve).

Do not use this instrument for any purpose other than its intended use. Select the endoscope to be

used according to the objective of the intended procedure based on the full understanding of the

endoscope’s specifications and functionality as described in this instruction manual.



Applicability of endoscopy and endoscopic treatment

If there are official standards on the applicability of endoscopy and endoscopic treatment that are

defined by the hospital’s administrators or other official institutions, such as academic societies on

endoscopy, follow those standards. Before starting endoscopy and endoscopic treatment, thoroughly

evaluate its properties, purposes, effects, and possible risks (their nature, extent, and probability).

Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its

risks.

Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment

as well as any examination/treatment methods that can be performed in its place, and perform the

endoscopy and endoscopic treatment only after obtaining the consent of the patient.

Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential

benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the

risks to the patient become greater than the potential benefits.

2

GIF/CF/PCF-190 Series OPERATION MANUAL

Page 9

Important Information — Please Read Before Use



Instruction manual

This instruction manual contains essential information on using this instrument safely and effectively.

Before use, thoroughly review this manual and the manuals of all equipment that will be used during

the procedure and use the equipment as instructed.

Note that the complete instruction manual set for this endoscope consists of this manual and the

“REPROCESSING MANUAL” with your endoscope model listed on the cover. It also accompanied the

endoscope at shipment.

Keep this and all related instruction manuals in a safe, accessible location.

If you have any questions or comments about any information in this manual, contact Olympus.

 Terms used in this manual

NBI (Narrow Band Imaging) observation:

This is optical-digital observation using narrowband light.

Normal light observation (or WLI (White Light Imaging) observation):

This is observation using white light.

Normal focus mode (for GIF-HQ190, CF-HQ190L/I):

In this observation mode, the focusing position of the endoscope is optically shifted to a

normal position. At this position, a wider focusing depth can be obtained.

Near focus mode (for GIF-HQ190, CF-HQ190L/I):

In this observation mode, the focusing position of the endoscope is optically shifted to a

near position. At this position, a close-up image can be obtained.

Focus switching (for GIF-HQ190, CF-HQ190L/I):

This is an action to switch the focusing position between the normal focus mode and the

near focus mode.

Image sensor:

The image sensor is a device that converts light into electrical signals.

GIF/CF/PCF-190 Series OPERATION MANUAL

3

Page 10

Important Information — Please Read Before Use



User qualifications

If there are official standards for user qualifications to perform endoscopy and endoscopic treatment

that are defined by the hospital’s medical administrators or other official institutions, such as academic

societies on endoscopy, follow those standards. If there are no official qualification standards, the

operator of this instrument must be a physician approved by the medical safety manager of the

hospital or person in charge of the department (department of internal medicine, etc.).

The physician should be capable of safely performing the planned endoscopy and endoscopic

treatment following guidelines set by the academic societies on endoscopy, etc., and considering the

difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic

procedures.



Instrument compatibility

Refer to “Combination equipment” on page 111 to confirm that this instrument is compatible with the

ancillary equipment being used. Using incompatible equipment can result in patient or operator injury

and/or equipment damage.

This instrument complies with the EMC standard for medical electrical equipment, edition 2

(IEC 60601-1-2: 2001) and edition 3 (IEC 60601-1-2: 2007). However, when connected with an

instrument that complies with the EMC standard for medical electrical equipment, edition 1

(IEC 60601-1-2: 1993), the whole system complies with edition 1.



Reprocessing before the first use/reprocessing and

storage after use

This instrument was not reprocessed before shipment. Before using this instrument for the first time,

reprocess it according to the instructions given in the endoscope’s companion “REPROCESSING

MANUAL” with your endoscope model listed on the cover.

After using this instrument, reprocess and store it according to the instructions given in the

endoscope’s companion reprocessing manual. Improper and/or incomplete reprocessing or storage

can pose an infection control risk, cause equipment damage, or reduce performance.



Spare equipment

Be sure to prepare another endoscope to avoid interruption of the examination due to equipment

failure or malfunction.

4

GIF/CF/PCF-190 Series OPERATION MANUAL

Page 11

Important Information — Please Read Before Use



Maintenance management

The probability of failure of the endoscope and ancillary equipment increases as the number of

procedures performed and/or the total operating hours increase. In addition to the inspection before

each procedure, the person in charge of medical equipment maintenance in each hospital should

inspect the items specified in this manual periodically. An endoscope with an observed irregularity

should not be used, but should be inspected by following Section 5.2, “Troubleshooting guide”. If the

irregularity is still observed after inspection, contact Olympus.



Prohibition of improper repair and modification

This instrument does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to

repair it; patient or operator injury and/or equipment damage may result.

Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than

Olympus’ own authorized service personnel is excluded from Olympus’ limited warranty and is not

warranted by Olympus in any manner.



Signal words

The following signal words are used throughout this manual:

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in

death or serious injury.

CAUTION

Indicates a potentially hazardous situation which, if not avoided, may result in minor

or moderate injury. It may also be used to alert against unsafe practices or potential

equipment damage.

NOTE

Indicates additional helpful information.

GIF/CF/PCF-190 Series OPERATION MANUAL

5

Page 12

Important Information — Please Read Before Use



Warnings and cautions

Follow the warnings and cautions given below when handling this endoscope. This information is to be

supplemented by the warnings and cautions given in each chapter.

WARNING

• After using this endoscope, reprocess and store it according to the instructions

given in the endoscope’s companion “REPROCESSING MANUAL” with your

endoscope model listed on the cover. Using improperly or incompletely

reprocessed or stored instruments may cause patient cross-contamination and/or

infection.

• Before endoscopy, remove any metallic objects (watch, glasses, necklace, etc.)

from the patient. Performing high-frequency cauterization treatment while the

patient is wearing metallic objects may cause burns on the patient in areas around

the metallic objects.

• Do not strike, hit, or drop the endoscope’s distal end, insertion tube, bending

section, control section, universal cord, or endoscope connector. Also, do not bend,

pull, or twist the endoscope’s distal end, insertion tube, bending section, control

section, universal cord, or endoscope connector with excessive force. The

endoscope may be damaged and could cause patient injury, burns, bleeding,

and/or perforations. It could also cause parts of the endoscope to fall off inside the

patient.

• Never perform angulation control forcibly or abruptly. Never forcefully pull, twist, or

rotate the angulated bending section. Patient injury, bleeding, and/or perforation

may result due to unintended retroflexion of the bending section. It may also

become impossible to straighten the bending section during an examination.

• Never insert or withdraw the endoscope’s insertion section while the bending

section is locked in position. Patient injury, bleeding, and/or perforation may result.

• Never perform flexibility adjustment, operate the bending section, feed air or

perform suction, insert or withdraw the endoscope’s insertion section, or use

EndoTherapy accessories without viewing the endoscopic image or while the

endoscopic image is frozen. Patient injury, bleeding, and/or perforation may result.

• Regardless of the flexibility of the endoscope’s insertion tube, never insert or

withdraw the insertion section abruptly or with excessive force. Patient injury,

bleeding, and/or perforation may result.

• If it is difficult to insert the endoscope, do not forcibly insert the endoscope; stop the

endoscopy. Forcible insertion can result in patient injury, bleeding, and/or

perforation.

• When using the electronic zoom function of the video system center, never insert or

withdraw the endoscope’s insertion section or use EndoTherapy accessories while

the image is magnified. Patient injury, bleeding, and/or perforation can result.

6

GIF/CF/PCF-190 Series OPERATION MANUAL

Page 13

Important Information — Please Read Before Use

WARNING

• For GIF-HQ190, CF-HQ190L/I

Never insert or withdraw the endoscope’s insertion section while the focus setting

is set to the near focus mode. Patient injury, bleeding, and/or perforation can result.

• Do not touch the light guide on the endoscope connector immediately after

removing it from the light source because it is extremely hot. Operator or patient

burns can result.

• If the endoscopic image becomes dimmer during the procedure, it may indicate that

blood or mucus is adhering to the light guide lens on the distal end of the

endoscope or that the light guide lens has been discolored. Immediately withdraw

the endoscope from the patient, remove blood or mucus, and confirm that the light

guide lens has no irregularities to use it again. If you continue to use the endoscope

with its obstructed or discolored light guide lens, the temperature at the distal end

may rise, which may cause patient injury or operator and/or patient burns.

• When the endoscopic image does not appear on the monitor, the image sensor

may have been damaged. Turn the video system center OFF immediately.

Continued power supply in such a case will cause the distal end to become hot and

could cause operator and/or patient burns.

• Do not rely on the NBI observation mode alone for primary detection of lesions or to

make a decision regarding any potential diagnostic or therapeutic intervention.

• For CF-HQ190L/II

The endoscope position detecting unit (UPD-3) is designed only to assist the

insertion of an endoscope. Never insert the endoscope into the patient’s body by

observing only the endoscope position display on the endoscope position detecting

unit. Be sure to observe the endoscopic image and insert the endoscope while

confirming the safety. If the endoscope is inserted without observing the

endoscopic image, patient injury, bleeding, and/or perforation can result.

• For CF-HQ190L/I

The endoscope position detecting unit (UPD-3) generates AC magnetic fields. To

prevent critical effects on patients, be sure to adhere to the following:

 Never use the endoscope position detecting unit on a patient with a pacemaker.

The AC magnetic fields generated by the endoscope position detecting unit may

cause malfunction or damage to the pacemaker, exerting critical effects to the

cardiac function of the patient.

 Never use the endoscope position detecting unit on pregnant women or women

observed of being pregnant. Never use the endoscope position detecting unit

close to pregnant women or women observed of being pregnant. The effects of

the AC magnetic field generated by the endoscope position detecting unit on the

unborn baby have not yet been determined.

GIF/CF/PCF-190 Series OPERATION MANUAL

7

Page 14

Important Information — Please Read Before Use

WARNING

• For endoscopes with passive bending function

Be sure to check that the passive bending section bends smoothly by touching it

with your hands before inserting the endoscope into the patient. If any irregularity is

observed on the distal end motion of the endoscope, immediately stop using the

endoscope and withdraw it from the patient. Patient injury, bleeding, and/or

perforation may result.

• For CF/PCF models except PCF-PH190L/I

When combining the endoscope with a splinting tube, there is a risk of perforation

or bleeding due to entanglement of the mucous membrane, or of the tube

separating from the endoscope and remaining in the body. Before use, be sure to

read the instruction manual for the splinting tube to fully understand its

characteristics.

• During endoscopic treatment, keep the insertion section and the bending section

as straight as possible. If there is a loop or a bend on the insertion section or the

bending section, the operation cannot be performed as intended, and patient injury,

bleeding, and/or perforation can result.

CAUTION

• Do not pull the universal cord during an examination. The endoscope connector will

be pulled out from the output socket of the light source and the endoscopic image

will disappear.

• Do not coil the insertion tube or universal cord with a diameter of less than 12 cm.

Equipment damage may result.

• Do not attempt to bend or twist the endoscope’s insertion section with excessive

force regardless of its flexibility. The insertion section may be damaged.

• Do not apply shock to the distal end of the insertion section, in particular the

objective lens surface at the distal end. An abnormal endoscopic image may result.

• Do not twist or bend the bending section with your hands. Equipment damage may

result.

• Do not squeeze the bending section forcefully. The covering of the bending section

may stretch or break and cause water leakage.

• Turn the video system center ON only when the endoscope connector is connected

to the light source. In particular, confirm that the video system center is OFF before

connecting or disconnecting the endoscope connector. Failure to do so can result

in equipment damage, including destruction of the image sensor.

• The endoscope’s remote switches cannot be removed from the control section.

Pressing, pulling, or twisting them with excessive force can break the switches

and/or cause water leakage.

8

GIF/CF/PCF-190 Series OPERATION MANUAL

Page 15

Important Information — Please Read Before Use

CAUTION

• If remote switch 1 does not return to the OFF position after being pressed strongly

from the side, gently pull the switch upwards to return it to the OFF position.

• Do not hit or bend the electrical contacts on the endoscope connector. The

connection to the light source may be impaired and a faulty contact can result.

• If endoscope’s suction is insufficient, select another suction system without using

the endoscope and use it according to the directions given in its instruction manual.

Otherwise, a proper endoscopic image may not appear on the monitor.

• Electromagnetic interference may occur on this endoscope near equipment

marked with the following symbol or other portable and mobile RF (Radio

Frequency) communications equipment, such as cellular phones. If

electromagnetic interference occurs, mitigation measures may be necessary, such

as reorienting or relocating this endoscope, or shielding the location.

• To check the electromagnetic interference from other equipment (any equipment

other than this endoscope or the components that constitute this system), the

system should be observed to verify its normal operation in the configuration in

which it will be used.

NOTE

• All endoscopes listed on the front cover contain a memory chip that stores

information about the endoscope and communicates this information to the video

system center CV-190.

GIF/CF/PCF-190 Series OPERATION MANUAL

9

Page 16

Important Information — Please Read Before Use



Precautions for transnasal insertion for GIF-XP190N

When performing transnasal insertion with the GIF-XP190N, follow the cautions below.

WARNING

• The shape and size of the nasal cavity and its suitability for transnasal insertion

may vary from patient to patient. No endoscope, including the GIF-XP190N, can

always be inserted transnasally into all patients. Before proceeding, always be sure

to confirm that transnasal insertion is possible with the patient by considering both

the size of the patient’s nasal cavity as well as the size of the endoscope’s insertion

section. Patient injury can result or the endoscope could become lodged and

difficult to withdraw.

• Transnasal insertion is accompanied by the risk of inflammation of the nasal cavity.

If this happens, the nasal passage will be constricted, making it more difficult to

withdraw the endoscope. In this case, do not use force to withdraw the endoscope

because patient injury, bleeding, and/or perforation may result.

• Transnasal insertion is accompanied by the risk of bleeding in the nasal cavity. Be

sure to be prepared to deal with any bleeding. When withdrawing the endoscope,

observe the inside of the nasal cavity to ensure that there is no bleeding. Even

when the endoscope has been withdrawn without bleeding, do not allow the patient

to blow his or her nose strongly because this could cause it to start bleeding.

• Before transnasal insertion, apply the appropriate pretreatment and lubrication to

the patient to enlarge the nasal cavity. Otherwise, patient injury can result or the

endoscope could become lodged and difficult to withdraw. When applying a

pretreatment agent through a tube, insert the tube into the same path as the path

planned for the endoscope’s insertion. Otherwise, the treatment will have no effect.

The effects of the pretreatment agent and lubricant will decrease the longer the

procedure lasts. Apply the pretreatment agent or lubricant as required during the

procedure — for example, when withdrawal seems to be difficult.

• Transnasal insertion of the endoscope should be performed carefully. If resistance

to insertion is felt, or the patient reports pain, stop the insertion immediately. Patient

injury can result or the endoscope could become lodged and difficult to withdraw.

• A patient’s sneezing may bend the endoscope forcefully, and it may damage the

endoscope. This could cause patient bleeding and perforation, and the endoscope

could become lodged and difficult to withdraw. If any irregularity is observed, stop

using the endoscope and withdraw it from the patient safely.

• If it becomes impossible to withdraw the transnasally inserted endoscope, pull its

distal end out of the mouth, cut the flexible tube using wire cutters, and after

ensuring that the cut section will not injure the body cavity or nasal cavity of the

patient, withdraw the endoscope carefully. Therefore, always prepare wire cutters

in advance.

10

GIF/CF/PCF-190 Series OPERATION MANUAL

Page 17

Important Information — Please Read Before Use



Precautions for disappeared or frozen endoscopic image

WARNING

• If the endoscopic image disappears unexpectedly or the frozen image cannot be

restored during an examination, immediately stop using the endoscope and

withdraw it from the patient as described in Section 5.3, “Withdrawal of the

endoscope with an irregularity”. Inserting or withdrawing the endoscope, using

EndoTherapy accessories, performing flexibility adjustment, performing suction,

feeding air, or performing angulation control under these conditions could result in

patient injury, bleeding, and/or perforation.

• Follow the precautions given below. Otherwise, the endoscopic image may

disappear unexpectedly or the frozen image may not be restored during the

examination.

 Connect the endoscope connector to the light source completely by pushing the

video connector until it clicks. Otherwise, a faulty contact can result.

 Do not bend, hit, pull, or twist the insertion section, bending section, control

section, universal cord, and endoscope connector. The endoscope may be

damaged, and water leakage and/or breakage of internal parts like the cable

can result.

 Before connecting the endoscope connector to the light source, confirm that the

endoscope connector, including the electrical contacts, is completely dry and

clean. If the endoscope is used with the electrical contacts wet and/or dirty, the

endoscope and light source may malfunction.

 If air bubbles emerge from the endoscope continuously during the leakage test,

do not use the endoscope. Water may enter the endoscope and cause a short

circuit. This may result in image sensor damage.

CAUTION

• Turn the video system center ON only when the endoscope connector is connected

to the light source. In particular, confirm that the video system center is OFF before

connecting or disconnecting the endoscope connector. Failure to do so can result

in equipment damage, including destruction of the image sensor.

• Do not hit or bend the electrical contacts on the endoscope connector. The

connection to the light source may be impaired and a faulty contact can result.

GIF/CF/PCF-190 Series OPERATION MANUAL

11

Page 18

Important Information — Please Read Before Use



Examples of inappropriate handling

Details on clinical endoscopic technique are the responsibility of trained specialists. Patient safety in

endoscopic examinations and endoscopic treatment can be ensured through appropriate handling by

the physician and the medical facility. Examples of inappropriate handling are described below.

WARNING

• Over-insufflating the lumen may cause patient pain, injury, bleeding, and/or

perforation.

• Applying suction with the distal end in prolonged contact with the mucosal surface,

with higher suction pressure than required, or with prolonged suction time may

cause bleeding and/or lesions.

• The endoscope has not been designed for use in retroflexed observation in parts of

the body other than the stomach. Performing retroflexed observation in a narrow

lumen may make it impossible to straighten the angle of the bending section and/or

withdraw the endoscope from the patient. Retroflexed observation in parts of the

body other than the stomach should be performed only when its usefulness is

determined to be greater than the risk that is posed to the patient. Also, do not

operate the endoscope forcibly in retroflexed observation.

• Inserting, withdrawing, and using EndoTherapy accessories without a clear

endoscopic image may cause patient injury, burns, bleeding, and/or perforation.

• Inserting or withdrawing the endoscope, feeding air, applying suction, or operating

the bending section without a clear endoscopic image may cause patient injury,

bleeding, and/or perforation.

• For reasons described below, do not rely on the NBI*1 observation mode alone for

primary detection of lesions or to make a decision regarding any potential

diagnostic or therapeutic intervention.

 NBI has not been demonstrated to increase the yield or sensitivity of finding any

specific mucosal lesion, including colonic polyps or Barrett’s esophagus.

*1

12

Narrow Band Imaging. For more details, refer to the instruction manual for

the video system center CV-190.

GIF/CF/PCF-190 Series OPERATION MANUAL

Page 19

1.1 Checking the package contents list

Chapter 1

1.1

Checking the Package

Contents

Ch.1

Checking the package contents list

Match all items in the package with the components shown below. Inspect each item for damage. If the

endoscope is damaged, a component is missing, or you have any questions, do not use the items;

immediately contact Olympus.

 Endoscope

GIF-XP190N, PCF-PH190L/I

GIF-H190, GIF-HQ190, GIF-1TH190

CF-H190L/I, CF-HQ190L/I, PCF-H190L/I

GIF/CF/PCF-190 Series OPERATION MANUAL

13

Page 20

1.1 Checking the package contents list



Packaged items for the Americas, Europe, Australasia,

Middle East, and Africa

 Items for all endoscope models

Ch.1

Single use combination cleaning

brush (BW-412T, 3 pcs)

Injection tube (MH-946)

Channel plug (MH-944)

AW channel cleaning adapter

(MH-948)

Suction cleaning adapter (MH-856)

ETO cap (MB-156)

Single use biopsy valve

(MAJ-1555, 10 pcs)

Instruction manual for MAJ-1555

Operation manual

Reprocessing manual

14

GIF/CF/PCF-190 Series OPERATION MANUAL

Page 21

1.1 Checking the package contents list

 Items for specific endoscope models

GIF-XP190N

GIF-H190, GIF-HQ190, GIF-1TH190

Endoscopes with auxiliary water

feeding

Ch.1

Mouthpiece

(MA-474, MB-142, 1 pc each)

Mouthpiece (MB-142, 2 pcs)

Auxiliary water tube (MAJ-855)

Endoscopes with flexibility

adjustment

Instructions (leaflet type)

GIF/CF/PCF-190 Series OPERATION MANUAL

15

Page 22

1.1 Checking the package contents list



Packaged items for countries other than the Americas,

Europe, Australasia, Middle East, and Africa

 Items for all endoscope models

Ch.1

Channel cleaning brush (BW-20T)

Injection tube (MH-946)

Channel plug (MH-944)

Channel-opening cleaning brush

(MH-507)

AW channel cleaning adapter

(MH-948)

Suction cleaning adapter (MH-856)

ETO cap (MB-156)

Biopsy valve (MB-358, 10 pcs)

Operation manual

Reprocessing manual

16

GIF/CF/PCF-190 Series OPERATION MANUAL

Page 23

1.1 Checking the package contents list

 Items for specific endoscope models

GIF-XP190N

GIF-H190, GIF-HQ190, GIF-1TH190

Endoscopes with auxiliary water

feeding

Ch.1

Mouthpiece

(MA-474, MB-142, 1 pc each)

Mouthpiece (MB-142, 2 pcs)

Auxiliary water tube (MAJ-855)

Endoscopes with flexibility

adjustment

Instructions (leaflet type)

GIF/CF/PCF-190 Series OPERATION MANUAL

17

Page 24

1.1 Checking the package contents list

Ch.1

18

GIF/CF/PCF-190 Series OPERATION MANUAL

Page 25

2.1 Nomenclature and functions

Chapter 2

Instrument Nomenclature

and Specifications

The instrument nomenclature, functions, and specifications are described in this chapter.

2.1

Nomenclature and functions

GIF/CF/PCF-190 Series OPERATION MANUAL

Ch.2

19

Page 26

2.1 Nomenclature and functions



Control section, insertion section

6

Endoscope model: all models

4

3

5

Ch.2

2

1

8

9

Endoscope model: except

GIF-HQ190, CF-HQ190L/I

10

11

Endoscope model:

GIF-HQ190, CF-HQ190L/I

12

20

11

GIF/CF/PCF-190 Series OPERATION MANUAL

7

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