CHF- Type CB30L and CB30S CHOLEDOCHO FIBERSCOPE Instructions Dec 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...

7

Checking the package contents...

7

Instrument Nomenclature and Specifications ...

8

2.1

Nomenclature...

8

2.2

Endoscope functions...

11

2.3

Grasping forceps 5 mm O.D. T1079 functions...

12

2.4

Specifications...

12

Preparation and Inspection ...

15

3.1

Preparation of the equipment...

16

3.2

Preparation and inspection of the endoscope...

17

3.3

Preparation and inspection of accessories ...

19

3.4

Preparation and inspection of the grasping forceps 5 mm O.D. T1079 20

3.5

Preparation, inspection and connection of the ancillary equipment

23

3.6

Inspection of the endoscopic system ...

24

Operation ...

26

4.1

Insertion ...

28

4.2

Using endo-therapy accessories...

33

4.3

Withdrawal of the endoscope...

34

4.4

Transportation of the endoscope ...

35

Reprocessing: General Policy...

36

5.1

Instructions...

36

5.2

Precautions ...

37

1.1

Chapter 2

Chapter 3

Chapter 4

Chapter 5

Chapter 6

Compatible Reprocessing Methods and Chemical

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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Contents

Agents ...40 6.1

Compatibility summary...

40

6.2

Detergent solution ...

42

6.3

Sterilant solution ...

42

6.4

Rinsing water ...

42

6.5

ETO gas sterilization ...

43

6.6

Steam sterilization (autoclaving) of accessories ...

45

Cleaning and Sterilization Procedures ...

46

7.1

Required reprocessing equipment ...

46

7.2

Cleaning and sterilization procedures ...

52

7.3

Precleaning ...

53

7.4

Leakage testing...

55

7.5

Manual cleaning ...

57

7.6

Sterilization ...

61

7.7

Cleaning and sterilization procedures for removable parts and cleaning equipment ... 64

7.8

Cleaning and sterilization procedures for grasping forceps 5 mm O.D. T1079 ... 67

Chapter 7

Chapter 8

Cleaning Equipment ...

71

Chapter 9

Storage ...

73

Storage ...

73

Chapter 10 Troubleshooting ...

74

10.1 Troubleshooting guide ...

74

10.2 Withdrawal of the endoscope with an abnormality...

76

10.3 Returning the endoscope for repair...

76

Appendix...

77

System chart ...

77

9.1

ii

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

1

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 TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct and hepatic duct). Applicable routes of access include percutaneous, open surgical, postsurgical through a fistula tract and translaparoscopic. Therapeutic endoscopic procedures using various kinds of accessories are also possible and include the ability to extract or fragment stones within these organs. Do not use the instrument for any purpose other than its intended use. Grasping forceps 5 mm O.D. T1079 has been designed for grasping the insertion portion of the CHF-CB30L/S and manipulating it under endoscopic observation. 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.

2

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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 sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning and Sterilization Procedures”. After using this instrument, reprocess and store it according to the instructions in Chapter 5 through Chapter 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 user injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 10, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 10, contact Olympus.

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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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 dangers, warnings and cautions described below when handling this instrument. This information is supplemented by the dangers, 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 insert or withdraw the endoscope’s insertion tube while the UP/DOWN angulation lock is fixed. Patient injury or equipment damage can result.

•

Never perform angulation control, insert/withdraw the endoscope or manipulate endo-therapy accessories without viewing the endoscopic image. Patient injury can result.

•

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.

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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.

•

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.

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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Important Information - Please Read Before Use

•

While in use, do not pull the universal cord. 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 coil the insertion tube with a diameter of less than 6 cm. Equipment damage can result.

•

Do not apply shock to the distal end of the insertion tube, particularly the objective lens surface of the distal end. Visual abnormalities may result.

•

Do not twist or bend the bending section. Equipment damage may result.

•

Do not squeeze the bending section forcefully. The covering of the bending section may stretch or break causing water leaks.

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.

•

Inserting and using endo-therapy accessories without a clear endoscopic view may cause patient injury.

•

Patient injury may be caused by: − inserting or withdrawing the endoscope, applying suction without a clear endoscopic view − withdrawing the endoscope with the angulation controls locked − forcefully bending and pulling, twisting or rotating the endoscope’s tip

6

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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 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 and Sterilization Procedures”.

Endoscope Forceps/irrigation plug (MAJ-891)

Channel cleaning brush (BW-15SH)

Channel-opening cleaning brush (MH-507)

Channel cleaning brush (BW-7B)∗1

Single use single-ended cleaning brush (BW-400B)∗1

ETO cap (MB-156)

Instruction manual (This manual)

Instruction manual (Forceps/irrigation plug)

Grasping forceps 5 mm O.D (T1079) Biopsy valve (MAJ-579, 10 pcs)

∗1 These products may not be available in some areas. CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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Chapter 2 Instrument Nomenclature and Specifications

Chapter 2 Instrument Nomenclature and Specifications 2.1

Nomenclature Endoscope

Universal cord

7. Forceps/irrigation plug 1. Eyepiece frame

Irrigation port Forceps port 6. Instrument channel port

2. Eyepiece 3. Diopter adjustment ring

5. UP/DOWN angulation lock Locking ring

4. UP/DOWN angulation control lever

Eyepiece section

8

Control section

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

Boot

Chapter 2 Instrument Nomenclature and Specifications

11. ETO cap

9. Venting connector

Serial No.

8. Light guide connector

Flexible tube

Distal end

Instrument channel

10. Bending section

Insertion portion (Working length) Light guide lens

Objective lens Distal end (enlarged)

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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Chapter 2 Instrument Nomenclature and Specifications

Grasping forceps 5 mm O.D. T1079

2. Cap (MH-365) Reprocessing port

Hook

Slit in handle

Sheath

3. Grasping section Manipulation rod

Insertion portion (Working length) Hook Distal opening 1. Handle

Sheath Silicone tip

10

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

Chapter 2 Instrument Nomenclature and Specifications

2.2

Endoscope functions 1. Eyepiece frame Video adapter (AR-TL08E etc.) can be attached to the eyepiece frame. AR-TL12S, etc. can be attached after removing the eyepiece frame. Refer to the “System chart” in Appendix to ensure compatibility. 2. Eyepiece The viewfinder mask is seen with an index mark indicating the UP direction of the bending section. 3. Diopter adjustment ring The diopter adjustment ring is turned to adjust the focus. For photography, set the ring to the click stop position before mounting the camera. 4. 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. 5. UP/DOWN angulation lock Pushing the UP/DOWN angulation lock in the “F ” direction frees angulation. Pushing the lock in the opposite direction locks the bending section at any desired position. 6. Instrument channel port The instrument channel port functions as: channel for insertion of endo-therapy accessories: irrigation channel. 7. Forceps/irrigation plug Accessories are inserted through the forceps port. Fluid can be fed through the irrigation port. 8. Light guide connector The light guide connector connects to the light source and transfers light from the light source to the operative site. 9. Venting connector The venting connector accepts the ETO cap or leakage tester. 10. Bending section The bending section moves the distal end of the endoscope by operating the UP/DOWN angulation control lever. 11. ETO cap The ETO cap must be installed prior to ETO 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.).

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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Chapter 2 Instrument Nomenclature and Specifications

2.3

Grasping forceps 5 mm O.D. T1079 functions 1. Handle The handle is grasped to project the hook from the sheath. 2. Cap The cap prevents air from leaking. 3. Grasping section The grasping section grasps the endoscope’s flexible tube in the distal opening between the hook and the silicone tip.

2.4

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)

12

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

Chapter 2 Instrument Nomenclature and Specifications

Specifications  Endoscope Optical system

Field of view Direction of view

Insertion portion

0° (Forward Viewing)

Depth of field

2.5 – 50 mm

Distal end outer diameter

ø 2.7 mm

Flexible tube outer diameter

ø 2.8 mm

Working length Instrument channel

75°

700 mm (type L), 450 mm (type S)

Channel inner diameter

ø 1.2 mm

Minimum visible distance

1.5 mm

Direction from which endo-therapy accessories exit the endoscope when observing the endoscopic image Bending section

Angulation range

Total length

UP 120°, DOWN 120° 1010 mm (type L), 760 mm (type S)

 Grasping forceps Insertion portion

Grasping section outer diameter

ø 5 mm

Sheath outer diameter

ø 5 mm

Working length

330 mm

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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Chapter 2 Instrument Nomenclature and Specifications

Medical Devices Directive

Year of manufacture

This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a 1012345 The year of manufacture is given in the second digit of the serial number.

Degree of protection against electric shock

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CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

TYPE BF applied part

Chapter 3 Preparation and Inspection

Chapter 3 Preparation and Inspection •

Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment that is 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. Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.

•

This instrument was not sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning and Sterilization Procedures”.

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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Chapter 3 Preparation and Inspection

3.1

Preparation of the equipment Prepare the equipment shown in Figure 3.1 (for compatibility, see “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 the respective instruction manuals for each piece of equipment.

Endoscope

Grasping forceps 5 mm O.D. (T1079) Guiding tube (A5490)

Light source

Endo-therapy accessories

Figure 3.1

16

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

Forceps/irrigation plug

Chapter 3 Preparation and Inspection

3.2

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

Inspection of the endoscope 1. Visually inspect the control section and the light guide connector for excessive scratching.

2. Visually inspect the boot and the flexible tube near the boot for bends and twists or other irregularities.

3. Visually inspect the surface of the insertion portion for dents, bulges or other irregularities.

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

Figure 3.2

CHOLEDOCHOFIBERSCOPE CHF-CB30L/S

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