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OLYMPUS

OLYMPUS ENF TYPE VQ RHINO-LARYNGOFIBERSCOPE Instructions

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OLYMPUS Videoscope Systems

87 Pages

INSTRUCTIONS  RHINO-LARYNGO VIDEOSCOPE  OLYMPUS ENF TYPE VQ  (For PAL type only)   Contents  Contents Symbols...  1  Important Information — Please Read Before Use...  2  Intended use ...  2  Applicability of endoscopy ...   2  Instruction manual... 3  User qualifications ...   3  Instrument compatibility ...   3  Reprocessing before the first use/reprocessing and storage after use...  4  Spare equipment ...  4  Maintenance management ...  4  Prohibition of improper repair and modification ... 4  Signal words... 5  Warnings and cautions ...  5  Precaution for disappeared or frozen endoscopic image...  11  Examples of inappropriate handling... 12  Chapter 1  Checking the Package Contents... 13  Chapter 2  Instrument Nomenclature and Specifications ...   14  2...  Nomenclature... 14  2...  Endoscope functions...  16  2...  Specifications... 17  Preparation and Inspection ...   20  3...  Preparation of the equipment... 21  3...  Inspection of the endoscope ...  22  3...  Inspection and connection of ancillary equipment ...  25  3...  Inspection of the endoscopic system ... 27  Operation ...  28  4...  Insertion ...   31  4...  Withdrawal of the endoscope... 34  Reprocessing: General Policy...  35  5...  Notes for cleaning, disinfection, and sterilization ... 35  5...  Precautions ... 36  Chapter 3  Chapter 4  Chapter 5  RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ  i
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Page 1

INSTRUCTIONS

RHINO-LARYNGO VIDEOSCOPE

OLYMPUS ENF TYPE VQ

(For PAL type only)

Page 3

Contents

Contents

Symbols.........................................................................................

1

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

2

Intended use ............................................................................................

2

Applicability of endoscopy ........................................................................

2

Instruction manual.....................................................................................

3

User qualifications ....................................................................................

3

Instrument compatibility ...........................................................................

3

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

4

Spare equipment ......................................................................................

4

Maintenance management .......................................................................

4

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

4

Signal words..............................................................................................

5

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

5

Precaution for disappeared or frozen endoscopic image..........................

11

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

12

Chapter 1

Checking the Package Contents............................

13

Chapter 2

Instrument Nomenclature and Specifications ......

14

2.1

Nomenclature..................................................................................

14

2.2

Endoscope functions.......................................................................

16

2.3

Specifications..................................................................................

17

Preparation and Inspection ....................................

20

3.1

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

21

3.2

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

22

3.3

Inspection and connection of ancillary equipment ..........................

25

3.4

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

27

Operation .................................................................

28

4.1

Insertion ..........................................................................................

31

4.2

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

34

Reprocessing: General Policy................................

35

5.1

Notes for cleaning, disinfection, and sterilization ............................

35

5.2

Precautions .....................................................................................

36

Chapter 3

Chapter 4

Chapter 5

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

i

Page 4

Contents

Chapter 6

Recommended Reprocessing Methods

and Chemical Agents ..............................................

39

6.1

Compatibility summary....................................................................

39

6.2

Detergent solution ...........................................................................

42

6.3

Disinfectant solution ........................................................................

43

6.4

Rinsing water ..................................................................................

44

6.5

Automatic cleaning/disinfection.......................................................

44

6.6

Ethylene oxide gas sterilization.......................................................

45

Cleaning, Disinfection, and Sterilization

Procedures ...............................................................

47

7.1

Required reprocessing equipment ..................................................

48

7.2

Cleaning, disinfection, and sterilization procedures ........................

51

7.3

Precleaning .....................................................................................

53

7.4

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

55

7.5

Leakage testing...............................................................................

56

7.6

Manual cleaning ..............................................................................

61

7.7

Disinfection .....................................................................................

64

7.8

Rinsing and drying after disinfection ...............................................

66

7.9

Automatic cleaning/disinfection.......................................................

68

7.10 Sterilization .....................................................................................

69

Chapter 7

Chapter 8

Storage and Disposal ..............................................

70

8.1

Storage ...........................................................................................

70

8.2

Storage of reprocessing equipment and the leakage tester

(WA23070A) ...................................................................................

71

8.3

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

71

8.4

Disposal ..........................................................................................

71

Troubleshooting ......................................................

72

9.1

Troubleshooting guide ....................................................................

72

9.2

Withdrawal of the endoscope with any irregularity..........................

74

9.3

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

75

Appendix........................................................................................

76

System chart ............................................................................................

76

EMC information........................................................................................

79

Chapter 9

ii

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 5

Symbols

Symbols

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

cover of this instruction manual, and/or this instrument are as follows:

Refer to instructions.

TYPE BF applied part

Endoscope

Manufacturer

Authorized representative in the European Community

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

1

Page 6

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, monitor, and other ancillary

equipment for endoscopic diagnosis within the ear, nasal lumens and airway

anatomy.

Do not use this instrument for any purpose other than its intended use.

Applicability of endoscopy

If there is an official standard on the applicability of endoscopy that is defined by

the hospital’s administration or other official institutions such as academic

societies on endoscopy, follow that standard. Before starting endoscopy

thoroughly evaluate its properties, purposes, effects, and possible risks (their

natures, extent, and probability). Perform endoscopy only when its potential

benefits are greater than its risks.

Fully explain to the patient the potential benefits and risks of the endoscopy as

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

the endoscopy only after obtaining the consent of the patient.

Even after starting the endoscopy continue to evaluate the potential benefits and

risks, and immediately stop the endoscopy and take proper measures if the risks

to the patient become greater than the potential benefits.

2

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 7

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

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.

NBI (Narrow Band Imaging) observation

This is a special observation using the narrow band observation light.

User qualifications

If there is an official standard on the qualification of endoscopy that is defined by

the medical administration or other official institutions such as the academic

society on endoscopy, follow the standard. If there is no official qualification

standard, 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 otorhinolaryngology, etc.). The medical safety manager of the

hospital or person in charge of the department should select a physician who is

performing the planned endoscopy safely by following the official guidelines set

by the academic society of endoscopy, etc.

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 and/or equipment damage.

This instrument complies with the EMC standard for medical electrical

equipment; edition 2 (IEC 60601-1-2: 2001). However, when connecting 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 (see “EMC information” on page 79 for EMC compliance level).

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

3

Page 8

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 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 Chapter 5, “Reprocessing: General Policy” through Chapter 8, “Storage

and Disposal”. 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 interruption of the examination

due to equipment failure or malfunction.

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 that an irregularity is

observed should not be used, but should be inspected by following Section 9.1,

“Troubleshooting guide” on page 72. 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 user injury and/or

equipment damage can result. Some problems that appear to be malfunctions

may be correctable by referring to Chapter 9, “Troubleshooting”. If the problem

cannot be resolved using the information in Chapter 9, contact Olympus.

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.

4

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 9

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.

•

Push the video connector until it clicks into the video system

center, then confirm that the video connector is securely

attached by pulling it gently. Improper connection will

damage the CCD. A damaged CCD will display no image

and make the distal end hot, which could cause operator

and/or patient burns.

•

After using this instrument, reprocess and store it according

to the instructions given in Chapter 5, “Reprocessing:

General Policy” through Chapter 8, “Storage and Disposal”.

Using improperly or incompletely reprocessed or stored

instruments may cause patient cross-contamination and/or

infection.

•

Failure to properly clean and sterilize endoscopic equipment

after each procedure can compromise patient safety. To

minimize the risk of transmitting diseases from one patient to

another, after each procedure the endoscope and the

equipment must undergo thorough manual cleaning followed

by sterilization, following the description in Chapter 7,

“Cleaning, Disinfection, and Sterilization Procedures”.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

5

Page 10

Important Information — Please Read Before Use

6

•

Never insert or withdraw the endoscope’s insertion tube while

the angulation is locked. Patient injury and/or equipment

damage can result.

•

Never perform angulation control forcibly. Never forcefully

pull, twist, or rotate the angulated bending section. Patient

injury can result.

•

Never insert or withdraw the endoscope’s insertion tube

forcibly and press it forcefully against the walls of internal

organs, as trauma may occur and/or equipment damage may

result.

•

Never perform angulation control, insertion/withdrawal of the

endoscope without viewing the endoscopic image. Patient

injury can result.

•

Never operate the bending section, insert or withdraw the

endoscope’s insertion tube while the image is frozen. Patient

injury, bleeding, and/or perforation 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 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.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 11

Important Information — Please Read Before Use

•

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 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 insertion immediately. Otherwise, patient injury can

result or the endoscope could become lodged and 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.

•

Do not strike, bend, hit, pull, twist, or drop the endoscope’s

distal end, insertion tube, bending section, and control

section with excessive force. The endoscope may be

damaged and could cause patient injury, such as burns,

bleeding, and/or perforation. It could also cause parts of the

endoscope to fall off inside the patient.

•

When the endoscopic image does not appear on the monitor,

the CCD 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 touch the metal plug of the light guide connector

immediately after removing it from the light source because it

is extremely hot. Operator or patient injury can result.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

7

Page 12

Important Information — Please Read Before Use

•

Although the illumination light emitted from the endoscope’s

distal end is required for endoscopic observation it may also

cause alteration of living tissues such as protein denaturation

of living tissue and perforation of the tissue by inappropriate

use.

Observe the following warnings on the illumination.

− Always set the minimum required brightness.

Please note that the brightness of the image on a monitor

may differ from the actual brightness at the distal end of

the endoscope.

− Pay special attention to the brightness level setting of the

light source, particularly when operating the electrical

shutter function of a video system center. When using a

light source and video system center that are compatible

with the light source’s automatic brightness control

function, make sure to use this function. The automatic

brightness control function can keep the illumination light

properly. Refer to the instruction manuals for the light

source and the video system center for further details.

− Do not continue observation in the proximity to tissue or

keep the distal end of the endoscope in contact with living

tissue for a long time.

− When the endoscope will not be used for a long period, be

sure to turn OFF the light source or activate the light

shield function (standby mode, etc.) so that the

endoscope is not illuminated unnecessarily.

•

8

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.

Carefully withdraw the endoscope from the patient and

remove blood or mucus to restore optimum illumination and

to ensure the safety of the examination. If you continue to

use the endoscope with its obstructed distal end, the

temperature at the distal end may rise and cause mucosal

burns to the patient. It may also cause patient and/or

operator injury.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 13

Important Information — Please Read Before Use

•

Generally reprocessing agents∗1 are aggressive and might

effect the distal end of the endoscope when the inner lenses

mist up, resulting in a foggy video image. Any further use of

the endoscope under this condition might lead to the lens

coming off. Before inserting the endoscope into a patient,

check that the video image is clear, and if necessary wipe the

outer surface of the lens at the distal end with a soft cloth. If a

foggy image appears, stop using the endoscope immediately.

•

For reasons described below, do not rely on the NBI∗2

imaging modality alone for primary detection of lesions or to

make a decision regarding any potential diagnostic or

therapeutic intervention.

− It has not been demonstrated to increase the yield or

sensitivity of finding any specific mucosal lesion.

− It has not been demonstrated to aid in differentiation or

establishing the presence or absence of dysplasia or

neoplastic changes within mucosa or mucosal lesions.

•

Be sure to prepare a secondary endoscope to avoid that the

examination be interrupted due to equipment failure or

malfunction of the primary endoscope.

∗1

Contact Olympus for the names of specific brands that have

been tested for compatibility with the endoscope.

∗2

NBI stands for Narrow Band Imaging. For more details, refer

to the instruction manual for the video system center CV-180

or OTV-S7Pro.∗3

∗3

This product may not be available in some areas.

•

Do not pull the universal cord during an examination. The

light guide connector will be pulled out from the output socket

of the light source and the endoscopic image will not be

visible.

•

Do not pull the video cable during an examination. The

endoscopic image may not be visible anymore.

•

Do not coil the insertion tube, universal cord, or 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.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

9

Page 14

Important Information — Please Read Before Use

•

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 it may

cause water leaks.

•

Do not insert the video connector while the electrical contacts

are wet and/or dirty. 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.

•

Do not attempt to bend the endoscope’s insertion tube with

excessive force. Otherwise, the insertion tube may be

damaged.

•

Be sure that this instrument is not used adjacent to or

stacked with other equipment (other than the components of

this instrument or system) to avoid electromagnetic

interference.

•

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.

•

This endoscope contains a memory chip that stores

information about the endoscope and communicates this

information to the video system center CV-180 or

OTV-S7Pro∗1.

∗1 This product may not be available in some areas.

10

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 15

Important Information — Please Read Before Use

Precaution for disappeared or frozen endoscopic

image

•

If the endoscopic image unexpectedly disappears or the

frozen image cannot be restored during an examination,

immediately withdraw the endoscope from the patient.

Continued use of the endoscope in such condition may

cause patient injury, such as 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 video connector to the video system center

completely by pushing the video connector into the video

system center until it clicks. Otherwise, faulty contact can

result.

− Make sure that the video connector and its electrical

contacts are completely dry before connecting the video

connector to the video system center. Wet contacts could

cause the equipment to malfunction.

− 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 the CCD cable can result.

− If air bubbles emerge from the endoscope continuously

during the leakage test, do not use the endoscope. Water

may enter the instrument and cause a short circuit. This

may result in breakage of the switch and CCD.

•

Turn the 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.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

11

Page 16

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 can be ensured through

appropriate handling by the physician and the medical facility. Examples of

inappropriate handling are given below:

Inserting or withdrawing the endoscope or operating the bending section

without a clear endoscopic image may cause patient injury, bleeding, and/or

perforation.

12

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 17

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 cleaned, 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

ETO cap (MB-156)

Instruction manual

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

13

Page 18

Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature

and Specifications

2.1

Nomenclature

5. ETO Cap

1. Light guide connector

Universal cord

4. Venting connector

Serial number

Light guide

Video cable

3. UP mark

Electrical contacts

2. Video connector

14

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 19

Chapter 2 Instrument Nomenclature and Specifications

7. UP/DOWN angulation lock

6. UP/DOWN angulation

control lever

Control section

9. Remote switches

Boot

Insertion tube/working length

Flexible tube

Distal end

9. Remote switches

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

8. Bending section

15

Page 20

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 output socket of the video

system center so that the endoscopic image become visible.

The endoscope contains a memory chip that stores information about the

endoscope and communicates this information to the video system center

CV-180 or OTV-S7Pro∗1. For more details, refer to the instruction manual

for the CV-180 or OTV-S7Pro∗1.

∗1 This product may not be available in some areas.

3. UP mark

When the video connector is connected to the video system center, this

mark is facing upward.

4. Venting connector

Attach the ETO cap or leakage tester here.

5. ETO Cap

The ETO cap must be installed prior to ethylene oxide gas sterilization and

aeration and removed prior to immersion or clinical examination. The cap

must also be attached when the endoscope is transported outside the

hospital (shipment, return for repairs, etc.).

6. 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.

7. UP/DOWN angulation lock

Pushing this lever in the “F ” direction frees angulation. Pushing the lever

in the opposite direction locks the bending section at any desired position.

8. Bending section

This bending section moves the distal end of the endoscope when the

UP/DOWN angulation control lever is operated.

9. Remote switches “1” to “4”

The functions of remote switches “1” to “4” can be selected on the video

system center. When selecting functions, refer to the instruction manual for

the video system center.

16

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 21

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)

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)

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

17

Page 22

Chapter 2 Instrument Nomenclature and Specifications

Specifications

 Endoscope

Model

Optical system

ENF-VQ

Direction of view

Insertion tube

90°

Field of view

0° (Forward viewing)

Depth of field

5 – 50 mm

Distal end outer

diameter

ø 3.9 mm

Distal end enlarged

1. Objective lens

2. Examination light outlet

UP

1.

2.

2.

DOWN

Bending section

Flexible tube outer

diameter

ø 3.6 mm

Working length

300 mm

Angulation range

UP 130°, DOWN 130°

Total length

528 mm

NBI∗1

Available

∗1 NBI stands for Narrow Band Imaging. For more details, refer to the

instruction manual for the video system center CV-180 or OTV-S7Pro∗2.

∗2 This product may not be available in some areas.

18

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 23

Chapter 2 Instrument Nomenclature and Specifications

Medical Device

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.

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

2001234

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

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

19

Page 24

Chapter 3 Preparation and Inspection

Chapter 3 Preparation and Inspection

Before each case, prepare and inspect this instrument as instructed below.

Inspect other equipment to be used with this instrument as instructed in their

respective instruction manuals. If this instrument malfunctions, do not use it.

Return it to Olympus for repair as described in Section 9.3, “Returning the

endoscope for repair” on page 75. If any irregularity is observed after inspection,

follow the instructions given in Chapter 9, “Troubleshooting”.

20

•

Using an endoscope that is not functioning properly may

compromise patient or operator safety and may result in

more severe equipment damage.

•

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

Chapter 5, “Reprocessing: General Policy” through Chapter

7, “Cleaning, Disinfection, and Sterilization Procedures”.

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

Page 25

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.

Endoscope

Monitor

• Paper towels

Light source

• Trays

• Lint-free cloths

Video system center

• Personal protective equipment

Figure 3.1

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

21

Page 26

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, video connector, and light guide connector

section for excessive scratching, deformation, or other irregularities.

2.

Inspect the boot and the insertion tube near the boot for bends, twists, or

other irregularities.

3.

Inspect the external surface of the entire insertion tube for dents, bulges,

swelling, peeling, or other irregularities.

4.

Holding the insertion tube gently with one hand, carefully run your fingertips

over the entire length of the insertion tube in both directions. Inspect for any

protruding objects or other irregularities. Also confirm that the insertion tube

is not abnormally rigid (see Figure 3.2).

Figure 3.2

22

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VQ

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