LF-TP, DP and GP series TRACHEAL INTUBATION FIBERSCOPE Operational Manual Feb 2007

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

Examples of inappropriate handling ...

7

Battery...

8

Chapter 1

Checking the Package Contents...

9

Checking the Package Contents...

9

Instrument Nomenclature and Specifications ...

12

2.1

Nomenclature...

12

2.2

Endoscope Functions ...

14

2.3

Specifications...

14

Preparation and Inspection ...

18

3.1

Preparation of the Equipment ...

19

3.2

Preparation and Inspection of the Endoscope ...

20

3.3

Preparation and Inspection of Accessories...

22

3.4

Attaching Accessories to the Endoscope...

26

3.5

Preparation, Inspection and Connection of Ancillary Equipment ...

28

3.6

Inspection of the Endoscopic System ...

28

Operation ...

34

4.1

Insertion ...

35

4.2

Withdrawal of the Endoscope ...

44

4.3

Transportation of the Endoscope...

45

4.4

Disposal ...

45

Troubleshooting ...

46

5.1

Troubleshooting Guide...

46

5.2

Returning the Endoscope for Repair...

48

1.1

Chapter 2

Chapter 3

Chapter 4

Chapter 5

LF-TP/DP/GP OPERATION MANUAL

i

Contents

ii

Appendix...

49

System Chart ...

49

LF-TP/DP/GP 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

Lamp

Caution, Hot Surface

Position of Battery

Power On

Power Off

Manufacturer

Authorized representative in the European Community

Serial number

LF-TP/DP/GP 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 a Suction Pump and other ancillary equipment for airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Do not use these instruments for any purpose other than their intended use.

Instruction Manual This instruction manual contains essential information on using these instruments 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 instrument as instructed. Note that the complete instruction manual set for this endoscope consists of this manual and the “OLYMPUS ENF/LF ENDOSCOPE REPROCESSING MANUAL” which also accompanied the endoscope at shipment. The “OLYMPUS ENF/LF ENDOSCOPE REPROCESSING MANUAL” is only applicable for ENF/LF 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 these instruments 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

LF-TP/DP/GP OPERATION MANUAL

Important Information - Please Read Before Use

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 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 given in the endoscope’s companion manual, the “OLYMPUS ENF/LF ENDOSCOPE REPROCESSING MANUAL”. After using this instrument, reprocess and store it according to the instructions given in the endoscope’s companion manual, the “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. Some problems that appear 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.

LF-TP/DP/GP 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 given below when handling this instrument. This information is to be supplemented by the warnings and cautions given in each chapter.

4

•

Never perform angulation forcibly or suddenly. Never forcefully pull or twist the angulated bending section. Patient injury, bleeding and/or perforation can result. It may also become impossible to straighten the bending section during use and/or to withdraw this instrument from the patient. Particular caution is required in the tracheal bifurcation region.

•

Never perform angulation control, suction control or insertion/withdrawal of the endoscope’s Insertion Tube without viewing the endoscopic image. Patient injury can result.

•

Never insert or withdraw the endoscope while the endoscope’s bending section is locked in position. When withdrawing the endoscope, the bending section should follow the form of the body cavity as much as possible. Otherwise, patient injury, bleeding and/or perforation can result. It may also become impossible to straighten the bending section during use and/or to withdraw this instrument from the patient.

LF-TP/DP/GP OPERATION MANUAL

Important Information - Please Read Before Use

•

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 with all patients. Before proceeding, always be sure to confirm that transnasal insertion is possible with the patient. Otherwise, operator and/or 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.

•

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, operator and/or 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.

LF-TP/DP/GP OPERATION MANUAL

5

Important Information - Please Read Before Use

•

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.  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.

LF-TP/DP/GP OPERATION MANUAL

Important Information - Please Read Before Use

•

This instrument has not been designed to be used with Endo-Therapy Accessories. Using Endo-Therapy Accessories can damage the endoscope.

•

Do not coil the Insertion Tube with a diameter of less than 10 cm. Equipment damage can result.

•

Do not strike 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.

•

Do not twist or bend the Bending Section by hands. Equipment damage may result.

•

Do not squeeze the Bending Section forcefully. The Bending Section’s covering may stretch or break and cause water leaks.

•

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

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. •

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

•

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

•

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.

•

The endoscope has not been designed for use in retroflexed observation. Performing retroflexed observation in a narrow lumen may make it impossible to straighten the bending section and/or withdraw the endoscope from the patient.

LF-TP/DP/GP OPERATION MANUAL

7

Important Information - Please Read Before Use

Battery Follow the warnings and cautions given bellow when handling a battery. Inappropriate handling may result in a fire or burns by caused leakage, heat generation, ignition, or explosion of the batteries.  Do not use any other battery than a CR123A or DL123A Lithium Battery.  Never try to disassemble, recharge, or short circuit batteries. Never expose batteries to excessive heat or open flames.  Do not load the battery with its (+) and (–) terminals reversed.  Do not handle a battery with hands wet.  When the instrument will not be used for an extended period of time, remove the battery.  Dispose of used batteries as general waste according to local regulations.

Body oils, dirt or dust on the battery terminals can cause poor contact. Wipe batteries carefully with a dry cloth before use.

8

LF-TP/DP/GP OPERATION MANUAL

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 ENF/LF ENDOSCOPE REPROCESSING MANUAL”.

The included Biopsy Valves are different by country or region as follows: • North and South America

20 pieces of sterile Single-use Biopsy Valve • Europe (except for UK)

20 pieces of non-sterile Single-use Biopsy Valve • UK and other countries and regions

10 pieces of non-sterile Biopsy Valve

LF-TP/DP/GP OPERATION MANUAL

9

Chapter 1 Checking the Package Contents

Endoscope

Channel-opening Cleaning Brush (MH-507)

Channel cleaning Brush (BW-15B for LF-TP)

Suction Connector Cleaning Brush (BW-15SH for LF-DP/GP)

Channel Cleaning Brush (BW-7B for LF-DP/GP)

Light guide adapter (MAJ-1413)

Single-use Biopsy Valve 1 (MAJ-210, 20 pcs)

Biopsy Valve 2 (MD-495, 1 package)

10

ETO Cap (MB-156)

Instruction Manual (Operation)

1

for North and South America, and Europe (except for UK) only

2

for UK and other countries

LF-TP/DP/GP OPERATION MANUAL

Instruction Manual (Reprocessing)

Chapter 1 Checking the Package Contents

LF-TP/DP/GP OPERATION MANUAL

11

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature

Battery Holder Cap

Attachment Ring

CE marking

Crossed-out wheeled bin’ symbol Socket

Lamp Holder

12

LF-TP/DP/GP OPERATION MANUAL

8. Miniature Light Source (MAJ-524, Optional)

Chapter 2 Instrument Nomenclature and Specifications

6. Eyepiece Frame (Viewfinder)

Eyepiece Section

Suction Connector

7. Diopter Adjustment Ring

4. Single-use Biopsy Valve (MAJ-210) or Biopsy Valve (MD-495)

Light Guide

5. Suction Channel 3. Suction Valve (MD-493) 2. UP/DOWN Angulation Control Lever

Suction Valve Housing Suction Lever Serial Number

Control Section

ETO Cap (MB-156) Venting Connector Boot

Insertion Tube/Working Length

Distal End 1. Bending Section

LF-TP/DP/GP OPERATION MANUAL

13

Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope Functions 1. Bending Section Moves the Distal End of the endoscope when the UP/DOWN Angulation Control Lever is operated. 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. Suction Valve (MD-493) Depresses the Suction Lever to activate suction. Note that the Biopsy Valve must be attached. 4. Single-use Biopsy Valve (MAJ-210) or Biopsy Valve (MD-495) A syringe may be inserted into the valve for feeding and aspirating fluids. 5. Suction Channel Functions as: Suction Channel; fluid feed channel (from a syringe connected to the Biopsy Valve). 6. Eyepiece Frame (Viewfinder) The Viewfinder contains an index mark indicating the UP direction of the Bending Section. 7. Diopter Adjustment Ring Adjusts the operator’s focus. This does not affect focusing for photography. 8. Miniature Light Source (MAJ-524, Optional) Includes the lamp and a Lithium Battery. Transmits light to the endoscope.

2.3

Specifications Environment Operating environment

Ambient temperature

10 – 40qC (50 – 104qF)

Relative humidity

30 – 85%

Atmospheric pressure

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

Transportation and storage environment

Ambient temperature

–47 to 70qC (–52.6 to 158qF)

Relative humidity

10 – 95%

Atmospheric pressure

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

14

LF-TP/DP/GP OPERATION MANUAL

Chapter 2 Instrument Nomenclature and Specifications

Specifications  LF-TP Optical System

Insertion Tube

Field of View

90q

Depth of Field

3 – 50 mm

Distal End Outer Diameter

ø 5.1 mm

Insertion Tube Outer Diameter ø 5.2 mm Working Length Suction Channel

Channel Inner Diameter

Bending Section

Angulation Range

Total Length

600 mm ø 2.6 mm UP 180q, DOWN 130q 855 mm

 LF-DP Optical System

Insertion Tube

Field of View

90q

Depth of Field

3 – 50 mm

Distal End Outer Diameter

ø 3.1 mm

Insertion Tube Outer Diameter ø 3.1 mm Working Length Suction Channel

Channel Inner Diameter

Bending Section

Angulation Range

Total Length

LF-TP/DP/GP OPERATION MANUAL

600 mm ø 1.2 mm UP 120q, DOWN 120q 855 mm

15

Chapter 2 Instrument Nomenclature and Specifications

 LF-GP Optical System

Insertion Tube

Field of View

90q

Depth of Field

4 – 50 mm

Distal End Outer Diameter

ø 3.8 mm

Insertion Tube Outer Diameter ø 4.1 mm Working Length Suction Channel

Channel Inner Diameter

Bending Section

Angulation Range

600 mm ø 1.5 mm UP 120q, DOWN 120q

Total Length

855 mm

Medical Devices Directive

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a

Year of manufacture

1912345 The last digit of the year of manufacture is the second digit of the serial number.

Degree of protection against electric shock

16

LF-TP/DP/GP OPERATION MANUAL

TYPE BF applied part

Chapter 2 Instrument Nomenclature and Specifications

 Miniature Light Source (MAJ-524, Optional) Halogen Lamp

Lithium Battery

Output

2.5 V, 1.7 W

Average Life

approx. 20 hours

Product Number

CR123A/DL123A

Average Life

approx. 60 minutes

Medical Devices Directive

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class I

WEEE Directive

In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste, but should be collected separately. Refer to your local Olympus distributor for return and/or collection systems available in your country.

LF-TP/DP/GP OPERATION MANUAL

17