ENF-P3,T3,L3,XP,P4 RHINO-LARYNGOFIBERSCOPE Operation Manual Operation Manual Aug 2006

Contents

Contents Symbols...

1

Important Information - Please Read Before Use...

2

Intended Use ...

2

Instruction Manual ...

2

User Qualifications ...

2

Instrument Compatibility...

3

Reprocessing and Storage ...

3

Repair and Modification ...

3

Signal Words...

4

Warnings and Cautions ...

4

Chapter 1

Checking the Package Contents...

8

Checking the Package Contents...

8

Instrument Nomenclature and Specifications ...

10

2.1

Nomenclature...

10

2.2

Endoscope Functions ...

16

2.3

Specifications...

17

Preparation and Inspection ...

20

3.1

Preparation of the Equipment ...

21

3.2

Preparation and Inspection of the Endoscope ...

22

3.3

Preparation and Inspection of Accessories (ENF-T3 Only) ...

24

3.4

Attaching Accessories to the Endoscope (ENF-T3 Only) ...

26

3.5

Preparation, Inspection and Connection of the Ancillary Equipment

28

3.6

Inspection of the Endoscopic System ...

28

Operation ...

30

4.1

Insertion ...

31

4.2

Using Endo-Therapy Accessories (ENF-T3 Only) ...

35

4.3

Withdrawal of the Endoscope ...

36

4.4

Transportation of the Endoscope...

37

1.1

Chapter 2

Chapter 3

Chapter 4

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

i

Contents

Chapter 5

ii

Troubleshooting ...

38

5.1

Troubleshooting Guide...

38

5.2

Returning the Endoscope for Repair...

40

Appendix...

41

System Chart ...

41

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

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. Caution Do not reuse. Lot number Type BF applied part Endoscope Manufacturer Authorized representative in the European Community Serial number For US Customers only For a Symbols Glossary, visit us: http://www.olympus-global.com/en/common/pdf/symbolsglossary.pdf

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

1

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 Light Source, Documentation Equipment, Display Monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic diagnosis and biopsy (ENF-T3 only) within the nasal and nasopharyngeal lumen. Do not use these instruments for any purposes other than their intended uses.

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 instruments as instructed. Note that the complete instruction manual set for this endoscope consists of this manual and the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL” or “OLYMPUS ENF/LF ENDOSCOPE REPROCESSING MANUAL” which also accompanied the endoscope at shipment. The “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL” is for the endoscopes without channel, and the “OLYMPUS ENF/LF ENDOSCOPE REPROCESSING MANUAL” is for the endoscopes with a channel. 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.

2

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

Important Information - Please Read Before Use

Instrument Compatibility Refer to the “System Chart” in Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment damage.

Reprocessing and Storage This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in the endoscope’s companion manual, the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL” or “OLYMPUS ENF/LF ENDOSCOPE REPROCESSING MANUAL”. After using this instrument, reprocess and store it according to the instructions in the endoscope’s companion manual, the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL” or “OLYMPUS ENF/LF ENDOSCOPE REPROCESSING MANUAL”. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.

Repair and Modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or user injury and/or equipment damage can result. Problems that appear not to be malfunctions may be correctable by referring to Chapter 5, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 5, contact Olympus.

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

3

Important Information - Please Read Before Use

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.

Indicates additional helpful information.

Warnings and Cautions Follow the warnings and cautions described below when handling this instrument. This information is supplemented by the warnings and cautions described in each chapter.

4

•

Never use Electrosurgical Accessories because the Distal End of this instrument is not insulated. Using Electrosurgical Accessories may result in patient injury.

•

Never operate the bending section, perform suction, insert or withdraw the endoscope’s insertion tube without viewing the endoscopic image. Patient injury can result.

•

The shape and size of the nasal cavity and its suitability for transnasal insertion may vary from patient to patient. No endoscope, including this one, can always be inserted transnasally into all patients. Before proceeding, always be sure to confirm that transnasal insertion is possible with the patient. Otherwise, patient injury can result or the endoscope could become lodged and be 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 such as bleeding or perforation may result.

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

Important Information - Please Read Before Use

•

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 be difficult to withdraw. 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 insertion immediately. Otherwise, operator and/or patient injury can result or the endoscope could become lodged and be difficult to withdraw.

•

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.

•

Never insert or withdraw the endoscope Insertion Tube while the UP/DOWN Angulation Lock is fixed. Patient injury can result.

•

Do not touch the Light Guide immediately after removing it from the Light Source because it is extremely hot.

•

Although the illumination light emitted from the endoscope’s distal end is required for endoscopic observation and treatment, it may also cause alteration of living tissues such as protein denaturation of liver tissue and perforation of the intestines by inappropriate using. Observe the following warnings on the illumination.

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

5

Important Information - Please Read Before Use

 Always set the minimum required brightness. The brightness of the image on a video monitor may differ from actual brightness at the distal end of endoscope. Especially, operating the electrical shutter function of a video system, pay attention to the brightness level setting of the light source. When a light source and a video system are compatible with the automatic brightness control function, be sure to use the function of the light source. The automatic brightness control function can keep the illumination light properly. Refer to the instruction manual of the light source and the video system for details.  Do not continue observation in proximity to tissue or keep the distal end of the endoscope in contact with a living tissue for a long time.  When discontinuing the use of the endoscope, be sure to turn the light source OFF or activate the light shield function (standby mode etc.) so that the endoscope does not irradiate unnecessary light.

6

•

If the endoscopic image dims during use, this may be a sign that blood or mucus is adhered to the light guide on the distal end of endoscope. Carefully withdraw the endoscope from patient and remove the blood or mucus in order to obtain optimum illumination and to ensure the safety of examination. If you continue to use the endoscope in such a condition, the distal end temperature may rise and cause mucosa burns. It may also cause patient and/or operator injury.

•

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

•

Do not pull the Universal Cord. 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 and Universal Cord with a diameter of less than 10 cm. Equipment damage can result.

•

Do not hit to the Distal End of the Insertion Tube or allow it to strike other objects. The objective lens surface of the Distal End is particularly fragile, and vision abnormalities may result.

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

Important Information - Please Read Before Use

•

Do not twist or bend the Bending Section by 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.

•

The eyepiece section cannot be removed. Do not attempt to rotate it by force.

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. •

Using improperly reprocessed or stored instruments may cause patient cross-contamination and infection.

•

Applying prolonged suction with the Distal End in contact with the mucosal surface may cause bleeding or suction lesions.

•

Inserting and using Endo-Therapy Accessories without a clear endoscopic view may cause perforation.

•

Patient injury may be caused by; inserting or withdrawing the endoscope, applying suction without a clear endoscopic view; forcefully pulling, twisting or rotating the angulated Bending Section.

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

7

Chapter 1 Checking the Package Contents

Chapter 1 Checking the Package Contents 1.1

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 in the endoscope’s companion manual, the “OLYMPUS BF/ENF/LF ENDOSCOPE REPROCESSING MANUAL” or “OLYMPUS ENF/LF ENDOSCOPE REPROCESSING MANUAL”.

In North and South America, the Syringe Valve (MB-884 for ENF-T3) is optional item and not included in the package. In other countries, the package includes the Syringe Valve.

8

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

Chapter 1 Checking the Package Contents

Endoscope

Protection Tube (For ENF-XP only)

Channel Cleaning Brush (BW-15B for ENF-T3)

Channel-opening Cleaning Brush (MH-507 for ENF-T3)

1

Suction Valve Holder (MD-51 for ENF-T3)

ETO Cap (MB-156)

Single-use Biopsy Valve1 (MAJ-210, 20 pcs for ENF-T3)

Instruction Manual (Operation)

Instruction Manual (Reprocessing)

Single-use Biopsy Valve1 (MAJ-1218, 20 pcs for ENF-T3)

Syringe Valve (MB-884 for ENF-T3)

This accessory is not available in some country.

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

9

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature  ENF-P3/XP/P4 Universal Cord

9. Eyepiece Frame (Viewfinder) 10. Diopter Adjustment Ring

Boot

Eyepiece Section

2. UP/DOWN Angulation Control Lever

Control Section

10

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

Venting Connector

Serial Number

Light Guide

8. Endoscope Connector

1. Bending Section Distal End

Insertion Tube/Working Length

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

11

Chapter 2 Instrument Nomenclature and Specifications

 ENF-L3

Universal Cord

9. Eyepiece Frame (Viewfinder) 10. Diopter Adjustment Ring

Boot

3. UP/DOWN Angulation Lock Eyepiece Section

2. UP/DOWN Angulation Control Lever

Control Section

12

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

Venting Connector

Serial Number

Light Guide

8. Endoscope Connector

1. Bending Section Distal End

Insertion Tube/Working Length

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

13

Chapter 2 Instrument Nomenclature and Specifications

 ENF-T3

Universal Cord

5. Single-use Biopsy Valve

Suction Lever 11. Syringe Valve (MB-884) 9. Eyepiece Frame (Viewfinder)

4. Suction Valve

10. Diopter Adjustment Ring

Suction Valve Housing

Suction Connector

7. Instrument Channel 6. Color Code Boot

3. UP/DOWN Angulation Lock Eyepiece Section

2. UP/DOWN Angulation Control Lever

Control Section

14

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

Venting Connector

Serial Number

Light Guide

8. Endoscope Connector

1. Bending Section Distal End

Insertion Tube/Working Length

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

15

Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope Functions 1. Bending Section Moves the Distal End of the endoscope by operating the UP/DOWN Angulation Control Lever. 2. UP/DOWN Angulation Control Lever When turned in the “U” direction, the Bending Section moves UP; when turned in the “D” direction, the Bending Section moves DOWN. 3. UP/DOWN Angulation Lock (ENF-T3/L3 only) Turning this lever in the “F ” direction frees angulation. Turning the lever in the opposite direction locks the Bending Section at any desired position. 4. Suction Valve (MD-493 for ENF-T3) Depresses the Suction Lever to activate suction. Note that the Biopsy Valve must be attached. 5. Single-use Biopsy Valve (ENF-T3 only) Accessories may be inserted through the slit in this valve. A syringe may be inserted for the introduction of fluids. 6. Color Code (ENF-T3 only) Used to quickly determine the compatibility of Endo-Therapy Accessories. (The endoscope can be used with Endo-Therapy Accessories that have the same color code.) •

ENF-T3 (Blue)

7. Instrument Channel (ENF-T3 only) Functions as: Channel for the insertion of Endo-Therapy Accessories: Suction channel; fluid feed channel (from a syringe via the Biopsy Valve). 8. Endoscope Connector Connects to the Light Source. Transmits light from the Light Source to the endoscope. 9. Eyepiece Frame (Viewfinder) The Viewfinder contains an index mark indicating the UP direction of the Bending Section. 10. Diopter Adjustment Ring Adjusts the operator’s focus. This does not affect focusing for photography. 11. Syringe Valve (MB-884 for ENF-T3) Allows direct connection between the Suction Channel and a syringe for instillation and retrieval of fluids (e.g. anesthetics, etc.).

16

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

2.3

Specifications Environment Operating environment

Ambient temperature

10 – 40C (50 – 104F)

Relative humidity

30 – 85%

Atmospheric pressure

700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Standard storage Ambient temperature environment (e.g. Relative humidity within the hospital) Atmospheric pressure

5 – 40C (41 – 104F) 10 – 95% 700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Transportation Ambient temperature environment Relative humidity (conditions during Atmospheric pressure transportation and short-term storage)

–47 to 70C (–52.6 to 158F) 10 – 95% 700 – 1060 hPa (0.7 – 1.1 kgf/cm2) (10.2 – 15.4 psia)

Specifications  ENF-P3 Optical System

Field of View

85

Depth of Field

5 to 50 mm

Insertion Tube

Distal End Outer Diameter

ø 3.4 mm

Flexible Tube Outer Diameter

ø 3.6 mm

Working Length

255 mm

Bending Section

Angulation Range

Total Length

ENF-P3/T3/L3/XP/P4 OPERATION MANUAL

UP 130, DOWN 130 485 mm

17