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OLYMPUS

OLYMPUS Scopes Gastrointestinal System

INSTRUCTIONS

EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

OLYMPUS GIF TYPE XP160

OLYMPUS GIF TYPE 160

OLYMPUS GIF TYPE Q160

OLYMPUS GIF TYPE 1TQ160

OLYMPUS GIF TYPE XTQ160

EVIS EXERA COLONOVIDEOSCOPE

OLYMPUS CF TYPE Q160L/I

OLYMPUS CF TYPE Q160AL/I

OLYMPUS PCF TYPE 160AL/I

EVIS EXERA SIGMOIDOVIDEOSCOPE

OLYMPUS CF TYPE Q160S

Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope, for reprocessing information.

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

Contents

Symbols

Symbols

The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this instrument are as follows:

Refer to instructions.

Endoscope

TYPE BF applied part

Manufacturer

Authorised representative in the European Community

Important Information — Please Read Before Use

Important Information — Please Read

Before Use

Intended use

These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment.

Use the GIF-XP160, GIF-160, GIF-Q160, GIF-1TQ160, GIF-XTQ160 for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach and duodenum).

Use the CF-Q160L/I, CF-Q160AL/I, PCF-160AL/I for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).

Use the CF-Q160S for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon).

Do not use these instruments for any purpose other than their intended uses.

Applicability of endoscopy and endoscopic treatment

If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the hospital’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risk (their natures, 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.

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 which 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” whose cover lists the model of your endoscope. 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, please contact Olympus.

User qualifications

The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures. For details on the clinical endoscopic procedures, the physician and operator are requested to form judgments from their viewpoints as specialists.

Instrument compatibility

Refer to the “System chart” in the Appendix 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 EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument that complies with EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

Important Information — Please Read Before Use

Reprocessing before the first use/reprocessing and storage after use

This instrument was not cleaned, disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope.

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

Spare equipment

Be sure to prepare another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction.

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 can result. This instrument is to be repaired by Olympus technicians only.

Signal words

The following signal words are used throughout this manual:

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

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.

Important Information — Please Read Before Use

Indicates additional helpful information.

Warnings and cautions

Follow the warnings and cautions given below when handling this instrument. This information is to be supplemented by the warnings and cautions given in each chapter.

•After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion reprocessing manual. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

•Do not strike, bend, hit, pull, twist, or drop the endoscope’s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope 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 can result. It may also become impossible to straighten the bending section during an examination.

•Never insert or withdraw the endoscope’s insertion tube while the bending section is locked in position. Patient injury can result.

•Do not touch the light guide of the endoscope connector immediately after removing it from the light source because it is extremely hot. Operator or patient burns can result.

•Never perform flexibility adjustment, operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion tube without viewing the endoscopic image. Never use endo-therapy accessories without viewing the endoscopic image. Patient injury can result.

Important Information — Please Read Before Use

•Never perform flexibility adjustment, operate the bending section, feed air or perform suction, insert or withdraw the endoscope’s insertion tube while the image is frozen. Never use endo-therapy accessories while the image is frozen. Patient injury can result.

•Regardless of the flexibility of the endoscope’s insertion tube, never insert or withdraw it with excessive force. Otherwise, patient injury could result.

•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 not be visible.

•Do not coil the insertion tube or universal cord into a diameter of less than 12 cm. Equipment damage can result.

•Do not touch the electrical contacts inside the electrical connector. CCD damage may result.

•Do not apply shock to the distal end of the insertion tube, particularly the objective lens surface at the distal end. Visual abnormalities 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 leaks.

•Turn the video system center OFF before connecting or disconnecting the videoscope cable from the electrical connector on the endoscope. Turn the switch ON or OFF only when the videoscope cable is connected to both the video system center and electrical connector on the endoscope. Failure to do so can result in equipment damage, including destruction of the CCD.

•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 may cause water leaks.

Important Information — Please Read Before Use

•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 faulty contact can result.

•Do not attempt to bend the endoscope’s insertion tube with excessive force. Otherwise, the insertion tube may be damaged.

•Do not attempt to bend the endoscope’s insertion tube with excessive force unless flexibility is at the stiffest position. Otherwise, the insertion tube may be damaged.

•The endoscope contains a memory chip that stores information about the endoscope and communicates this information to the CV-160. Although the memory chip is durable, damage will prevent data from being backed up on it. When data are lost or damaged, contact Olympus.

•Electromagnetic interference may occur on this instrument 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 instrument, or shielding the location.

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 given below;

•Over-insufflating the lumen may cause patient pain and/or perforation.

•Applying prolonged suction with the distal end in contact with the mucosal surface may cause bleeding or suction lesions.

•Retroflexing the endoscope within the esophagus or duodenal bulb may cause mucosal trauma or impaction of the endoscope (for GIF models only).

Important Information — Please Read Before Use

•Inserting, withdrawing and using endo-therapy accessories without a clear endoscopic image may cause burns 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.

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package

Contents

Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus. This instrument was not disinfected or sterilized before shipment.

Before using this instrument for the first time, reprocess it according to the instructions given in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope.

Endoscope

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature

and Specifications

2.1Nomenclature

GIF-XP160, GIF-160, GIF-Q160

Universal cord

Air pipe

3. Air supply connector

3. Water supply connector

Light guide

Product name and serial number Electrical contacts

4. Endoscope connector

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications

PCF-160AL/I

Universal cord

1. Suction connector

Air pipe

3. Air supply connector

3. Water supply connector

Light guide

Product name and serial number Electrical contacts

4. Endoscope connector

Biopsy valve (MB-358)

10. Instrument channel port

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications

2.2Endoscope functions

1.Suction connector

This connector connects the endoscope to the suction tube of the suction pump.

2.S-cord connector mount

This mount connects the endoscope with the Olympus electrosurgical unit via the S-cord. The S-cord conducts leakage current from the endoscope to the electrosurgical unit. To connect the S-cord, refer to the instruction manual for the electrosurgical unit.

3.Water supply connector and air supply connector

These connectors connect the endoscope to the water container via the water container tube, to supply water to the distal end of the endoscope.

4.Endoscope connector

This connector connects the endoscope to the output socket of the light source and transmits light from the light source to the endoscope.

5.Electrical connector

This connector connects the endoscope to the video system center via the videoscope cable. The endoscope contains a memory chip that stores information about the endoscope and communicates this information to the video system center CV-160. For more details, refer to the instruction manual of the CV-160.

6.UP/DOWN angulation control knob

When this knob is turned in the “U” direction, the bending section moves UP; when the knob is turned in the “D” direction, the bending section moves DOWN.

7.UP/DOWN angulation lock

Moving this lock in the “F” direction frees angulation. Moving the lock in the opposite direction locks the bending section at any desired position.

8.Suction valve (MH-443)

This valve is depressed to activate suction. The valve is used to remove any fluid, debris, flatus or air from the patient.

9.Air/water valve (MH-438)

The hole in this valve is covered to insufflate air and the valve is depressed to feed water for lens washing. It also can be used to feed air to remove any fluid or debris adhering to the objective lens.

Chapter 2 Instrument Nomenclature and Specifications

18.Flexibility adjustment ring (for CF-Q160AL/I, PCF-160AL/I only)

Turn this ring to adjust the flexibility of the insertion tube.

When the “z” mark on the ring is aligned with the “ ” mark at the bottom of the grip section, the insertion tube has the softest condition. To decrease the

flexibility, turn the ring so that the numbers are aligned with the “ ” mark (“3” corresponds to the stiffest condition). In the section between “z” and “3”, insertion tube flexibility can be changed gradually regardless of the positions of other index markings (“1” and “2”).

2.3Specifications

Operating environment

Chapter 2 Instrument Nomenclature and Specifications

Specifications

Endoscope functions

Chapter 2 Instrument Nomenclature and Specifications