ENF-VT RHINO-LARYNGO VIDEOSCOPE Instructions Feb 2007

Contents

Chapter 6 6.1

Compatibility summary...

43

6.2

Detergent solution ...

44

6.3

Disinfectant solution ...

44

6.4

Rinsing water ...

45

6.5

ETO gas sterilization ...

45

6.6

Steam sterilization (autoclaving) of accessories ...

47

Chapter 7

Cleaning, Disinfection and Sterilization Procedures ... 48

7.1

Required reprocessing equipment ...

48

7.2

Cleaning, disinfection and sterilization procedures ...

53

7.3

Precleaning ...

55

7.4

Leakage testing...

59

7.5

Manual cleaning ...

61

7.6

High-level disinfection ...

68

7.7

Rinsing after high-level disinfection...

70

7.8

Sterilization ...

73

7.9

Cleaning, disinfection and sterilization procedures for reusable parts and reprocessing equipment... 73

Chapter 8

Cleaning and Disinfection Equipment ...

80

Placing the endoscope in the tub (EW-30, OER)...

81

Storage and Disposal ...

82

9.1

Storage ...

82

9.2

Disposal ...

82

Chapter 10 Troubleshooting ...

83

10.1 Troubleshooting guide ...

83

10.2 Withdrawal of the endoscope with any abnormality ...

86

10.3 Returning the endoscope for repair...

87

Appendix...

88

System chart ...

88

EMC information...

91

8.1

Chapter 9

ii

Compatible Reprocessing Methods and Chemical Agents... 43

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

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

TYPE BF applied part

Endoscope

Manufacturer

Authorized representative in the European Community

Lot number

Serial number

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

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Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumens. Do not use the instrument for any purpose other than its intended 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 instruments as instructed. 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, physician and operator are requested to form judgments from their viewpoints as specialists.

2

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

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 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.

Reprocessing before the first use/reprocessing and storage after use 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 Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”. After using this instrument, reprocess and store it according to the instructions given in Chapters 5 through 9. 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 operator injury and/or equipment damage can result. This instrument is to be repaired by Olympus technicians only.

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

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

•

After using this instrument, reprocess and store it according to the instructions give in Chapter 5, “Reprocessing: General Policy” through Chapter 9, “Storage and Disposal”. Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.

•

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

•

Never operate the bending section, perform suction, insert or withdraw the endoscope’s insertion tube while the image is frozen. Patient injury can result.

•

Never use endo-therapy accessories while the image is frozen. Patient injury can result.

•

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

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

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 and perforation of the mucous membranes by inappropriate using. Observe the following cautions on the illumination.  Always set the minimum required brightness. The brightness of the image on a video monitor may differ from actual brightness. 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, be sure to use the automatic brightness control of the light source. The automatic brightness control can keep the illumination light properly. Refer to the instruction manual of the light source and video system for details.  Do not continue observation in proximity or keep the endoscope’s distal end 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.

•

If the endoscopic image dims during use, this may be a sign that blood or mucus is adhered to the light guide on the endoscope’s distal end. 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 injury to the patient and/or operator.

•

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.

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

5

Important Information - Please Read Before Use

6

•

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.

•

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 light guide connector will be pulled out from the output socket of the light source.

•

Do not pull the video cable. The endoscopic image may not be visible.

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

Important Information - Please Read Before Use

•

Do not coil the insertion tube, the universal cord or the video cable into a diameter of less than 10 cm. Equipment damage can 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.

•

Do not insert the video connector while the electrical contacts are wet. The endoscopic image may not be visible.

•

The endoscope’s remote switches cannot be removed from the control section. Pressing or pulling them with excessive force can break the switches and/or may cause water leaks.

•

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.

Precaution for disappeared or frozen endoscopic image •

If the endoscopic image unexpectedly disappears or the frozen image cannot be restored during an examination, immediately stop using the instrument and withdraw the endoscope from the patient. Continued use of the endoscope in such condition may cause 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.

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

7

Important Information - Please Read Before Use

 Connect the video connector and video system center completely. Otherwise, faulty contact can result.  Do not bend, hit or twist the insertion section, control section, universal cord and video connector. The endoscope may be damaged and water leaks and/or breakage of internal parts like CCD cable can result.  If bubbles emerge from the endoscope continuously during leakage test, do not use the endoscope. Water may enter from the hole and short the internal circuit. This may result in breakage of the switch and CCD.

•

Turn the VISERA video system center OFF before connecting or disconnecting the video connector to/from the video system center. Turn it ON or OFF only when the video connector is connected to the video system center. Failure to do so can result in equipment damage, including destruction of the CCD.

•

Do not hit or bend the electrical contacts on the video connector. The connection to the video system center may be impaired and faulty contact can result.

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:

8

•

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

•

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

•

Inserting or withdrawing the endoscope, applying suction or operating the bending section without a clear endoscopic image may cause patient injury.

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

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 Chapters 5, “Reprocessing: General Policy” through 7, “Cleaning, Disinfection and Sterilization Procedures”.

Endoscope Single-use biopsy valve1 (MAJ-210, 20 pcs)

Suction cleaning adapter (MAJ-222)

Channel-opening cleaning brush (MH-507)

Suction valve (MAJ-207, 10 pcs)

Biopsy valve2 (MD-495,10 pcs)

Channel cleaning brush (BW-15B)

ETO cap (MB-156)

Instruction manual

1 for Europe (except for UK) and other countries 2 for UK only

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

9

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature

ETO cap 1. Light guide connector

Universal cord

Venting connector

Light guide

Serial number, NTSC/PAL label

Video cable

3. UP mark

Electrical contacts

10

2. Video connector

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

Chapter 2 Instrument Nomenclature and Specifications

5. UP/DOWN angulation lock

6. Suction valve (MAJ-207)

4. UP/DOWN angulation control lever Suction cylinder Slit Control section 7. Single-use Biopsy Valve (MAJ-210) or Biopsy Valve (MD-495)

Instrument channel port

8. Color code 10. Remote switches Boot Insertion tube/working length

Distal end Suction cylinder 9. Bending section 10. Remote switches

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

11

Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Light guide connector This connector connects the endoscope to the output socket of the light source and transmits light from the light source to the endoscope. 2. Video connector This connector connects the endoscope to the socket of the VISERA video system center and makes the endoscopic image visible. 3. UP mark When the video plug is connected to the OTV-S7V, this mark is facing upward. 4. UP/DOWN angulation control lever When this lever is turned in the “U” direction, the bending section moves UP; when the lever is turned in the “D” direction, the bending section moves DOWN. 5. UP/DOWN angulation lock Moving this lever in the “F ” direction frees angulation. Moving the lever in the opposite direction locks the bending section at any desired position. 6. Suction valve (MAJ-207) This valve is depressed to activate suction. The valve is used to remove any fluid and debris that obstruct the visual field.

Use of the suction valve (MAJ-207) is not recommended for more than 6 procedures. 7. Single-use Biopsy Valve (MAJ-210) or Biopsy Valve (MD-495) Accessories may be inserted through the slit in this valve. A syringe may be inserted for the introduction of fluids.

Use of the biopsy valve (MD-495) is not recommended for more than 6 procedures. 8. Color code The color code is 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. 9. Bending section This bending section moves the distal end of the endoscope when the UP/DOWN angulation control lever is operated.

12

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

Chapter 2 Instrument Nomenclature and Specifications

10. Remote switches “1” to “4” The functions of remote switches “1” to “4” can be selected on the VISERA video system center. When selecting functions, refer to the instruction manual for the VISERA video system center.

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)

Transportation and storage environment

Ambient temperature

–47 to 70C (–52.6 to 158F)

Relative humidity

10 – 95%

Atmospheric pressure

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

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

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Chapter 2 Instrument Nomenclature and Specifications

Specifications  ENF-VT Optical system

Direction of view

Insertion tube

90

Field of view

0 (Forward viewing)

Depth of field

5 – 50 mm

Distal end outer diameter

ø 4.8 mm

Distal end enlarged

1. Objective lens 2. Light guide lens 3. Instrument channel outlet 3.

2.

Instrument channel

UP

2.

DOWN

Flexible tube outer diameter

ø 4.9 mm

Working length

365 mm

Channel inner diameter

ø 2 mm

Minimum visible distance

3 mm

1.

Direction from which endo-therapy accessories enter and exit the endoscopic image Bending section Total length

14

Angulation range

UP 130, DOWN 130 635 mm

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

Chapter 2 Instrument Nomenclature and Specifications

Medical Devices Directive

EMC

(For PAL type only)

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

Applied standard; IEC 60601-1-2: 2001

This instrument complies with the standards listed in the left column.

(For PAL type only) CISPR 11 of emission: Group 1, Class B This instrument complies with the EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connecting to 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. Year of manufacture

2312345 The last digit of the year of manufacture is the second digit of the serial number.

Degree of protection against electric shock

TYPE BF applied part

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

15

Chapter 3 Preparation and Inspection

Chapter 3 Preparation and Inspection Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment used with this instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use this instrument and see Chapter 10, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 10, contact Olympus.

16

•

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 Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”.

•

Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

Chapter 3 Preparation and Inspection

3.1

Preparation of the equipment Prepare the equipment shown in Figure 3.1 (for compatibility, see the “System chart” in the Appendix) and personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves, before each use. Refer to their respective instruction manuals for each piece of equipment.

Biopsy valve Suction valve

Endo-therapy accessories

Endoscope

Suction pump

• Paper towels

Light source

• Trays

Display monitor

• Lint-free cloths

Video system center

• Personal protective equipment

Figure 3.1

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT

17

Chapter 3 Preparation and Inspection

3.2

Inspection of the endoscope Clean and disinfect or sterilize the endoscope as described in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection and Sterilization Procedures”.

Inspection of the endoscope 1. Inspect the control section, the light guide connector and the video connector for excessive scratching.

2. Inspect the boot and the insertion tube near the boot for bends, twists or other irregularities.

3. Inspect the surface of the insertion tube for dents, bulges, swelling, peeling or other irregularities.

4. Carefully run your fingertips over the entire length of the insertion tube. Inspect for any protruding objects or other irregularities (see Figure 3.2).

Figure 3.2

5. Inspect the covering of the bending section for sagging, swelling, cuts, holes or other irregularities.

6. Gently hold the midpoint of the bending section and at a point 10 cm from the distal end. Push and pull gently to confirm that there is no play.

7. Inspect the objective lens at the distal end of the endoscope’s insertion tube for scratching, cracks, stains, gaps around the lens or other irregularities.

18

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT