Water Container Instructions

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 3 Intended use ... 3 Instruction manual ... 3 User qualifications ... 3 Instrument compatibility ... 3 Reprocessing and storage ... 3 Repair and modification ... 4 Signal words ... 4 Precautions ... 4

Chapter 1 Checking the Package Contents ... 5 1.1

Checking the package contents ... 5

Chapter 2 Instrument Nomenclature ... 7 2.1

Nomenclature and functions ... 7

Chapter 3 Preparation and Inspection ... 11 3.1

Precautions for preparation and inspection ... 11

3.2

Preparation and inspection ... 13

3.3

Adjusting the gas pressure ... 16

3.4

Connecting to the endoscope ... 17

3.5

Disconnecting from the endoscope ... 18

Chapter 4 Operation ... 21 4.1

Operation ... 21

4.2

Transportation ... 23

Chapter 5 Reprocessing ... 25 5.1

Instruction ... 25

5.2

General policy ... 26

5.3

Compatibility summary ... 27

5.4

List of the compatible methods ... 28

5.5

Detergent solution for manual cleaning ... 29

5.6

Disinfectant solution for manual disinfection ... 30

5.7

Water ... 31

5.8

Rinse water ... 31

5.9

Alcohol ... 31 MAJ-902 INSTRUCTION MANUAL

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Contents

5.10 Washer disinfector ... 32 5.11 Steam sterilization (autoclaving) ... 35 5.12 Signs of degradation from reprocessing and its number of times ... 37 5.13 Workflow ... 38 5.14 Prepare equipment for reprocessing ... 39 Equipment needed ... 39

5.15 Manually cleaning the water container ... 40 Equipment needed ... 42 Clean the external surface ... 42 Flush the tube with detergent solution ... 43 Immerse the water container in detergent solution ... 43 Remove detergent solution from the tube ... 43 Dry the water container ... 44

5.16 Manually disinfecting the water container ... 45 Equipment needed ... 46 Immerse the water container in disinfectant solution ... 46 Rinse the water container ... 47 (Optional) Alcohol flush ... 48 Dry the water container ... 48

5.17 Sterilizing the water container ... 49 Equipment needed ... 49

5.18 Reprocessing using a WD ... 50 WD ... 50 (Optional) Alcohol flush ... 50 Dry the water container ... 50

Chapter 6 Storage ... 51 6.1

Inspection before storage ... 51

6.2

Storage ... 51

6.3

Disposal ... 52

Appendix ... 53 Specifications ... 53 Environment ... 53 Specifications ... 53

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MAJ-902 INSTRUCTION MANUAL

Labels and Symbols

Labels and Symbols The meaning(s) of the symbol(s) shown on the package, the back cover of this instruction manual and/or this instrument are as follows:

 Front side

CE marking

Caution, refer to instructions.

Caution, refer to instructions.

MAJ-902 INSTRUCTION MANUAL

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Labels and Symbols

 Back cover of this instruction manual Symbol

Description Manufacturer

Authorized representative in the European Community

Translation

Importer (into European Union)

Date of manufacture

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MAJ-902 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use This instrument has been designed to be used with endoscopes (EVIS EXERA series videoscope, 40 series endoscope) to allow gas insufflation and water feeding from the endoscope. Do not use this 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 equipment 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.

 Instrument compatibility This instrument is compatible with endoscopes (EVIS EXERA series videoscope, 40 series endoscope). Using incompatible equipment can result in patient injury and/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 Chapter 5, “Reprocessing”. After using this instrument, reprocess and store it according to the instructions given in Chapter 5, “Reprocessing” and Chapter 6, “Storage”. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.

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Important Information - Please Read Before Use

 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.

 Signal words The following signal words are used throughout this manual:

DANGER

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

WARNING

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

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.

NOTE

Indicates additional helpful information.

 Precautions NOTE In case of any serious incident happens to User or Patient while operating the device, the incident should be reported to Olympus and the competent authority of the respective member state or country.

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MAJ-902 INSTRUCTION MANUAL

1.1 Checking the package contents

Chapter 1

1.1

Checking the Package Contents Ch.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 the instrument for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing”.

Water container (MAJ-902)

MAJ-902 INSTRUCTION MANUAL

Instructions

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1.1 Checking the package contents

Ch.1

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MAJ-902 INSTRUCTION MANUAL

2.1 Nomenclature and functions

Chapter 2 2.1

Instrument Nomenclature

Nomenclature and functions

Ch.2

MAJ-902 INSTRUCTION MANUAL

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2.1 Nomenclature and functions

3 4 11

3

Ch.2 14

2 1

5

15

6

12 13

7

10 8 9

8

10

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MAJ-902 INSTRUCTION MANUAL

2.1 Nomenclature and functions

No.

Nomenclature

Description

1

Caution tag

Shown cautions of gas supply

2

Tip receptacle

Insert the metal tip and hold it.

3

Lid

Attach to the container opening.

4

Gas tube connector

Connect the gas tube connector

5

Hook

Attach this instrument to a the light source

6

Lot No.

Lot No. of this instrument

7

Specified water level marks

The upper and lower limit lines for the amount of sterile water to be put into the container.

8

Container

Put in sterile water.

9

Lowest water level line

If the sterile water level falls below this line, water feeding may not be possible.

10

Container protector

Protect the bottom of the container.

11

Tube

Air/water supply channel

12

Metal tip

Connect to the air and water supply connector on the endoscope

13

Cleaning cap

Attach to the metal tip for reprocessing

14

Water tube

Send sterile water from the container to the scope.

15

O-ring

Used to seal the container with the lid.

MAJ-902 INSTRUCTION MANUAL

Ch.2

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2.1 Nomenclature and functions

Ch.2

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MAJ-902 INSTRUCTION MANUAL

3.1 Precautions for preparation and inspection

Chapter 3 3.1

Preparation and Inspection

Precautions for preparation and inspection WARNING • Some national or professional guidelines recommend reprocessing endoscopes and accessories prior to their first use of the day or when a certain time passes after disinfecting/sterilizing, or in case the storage time recommended by the national authorities is exceeded.

Ch.3

• Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment to be used with this instrument as described in the respective instruction manuals. Should the slightest irregularity be suspected, do not use this instrument; contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage.

CAUTION • 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”. Failure to do so could pose an infection control risk and cause tissue irritation. • Never drop the water container or subject it to impacts. The container could become damaged, which could make air and/or water feeding impossible. • The water container is a consumable item. If inspection of the water container reveals any irregularities, use a new water container. • Do not bend, twist or pull the tube excessively. The tube could become damaged, which could make air and/or water feeding impossible. • The O-ring is subject to wear. Replace it with a new one whenever you detect damaged or deformed areas. Otherwise air and/or water feeding might be impossible.

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3.1 Precautions for preparation and inspection

CAUTION • To remove the O-ring, pull out the portion that lies in the notch along the container’s rim. Attempting to pry the O-ring out of its groove could damage the O-ring and/or the container. Notch Groove

Container

Ch.3

Figure 3.1 •

Do not bend, pull or twist the water tube on the underside of the lid with excessive force. Doing so could damage the water tube, making water feeding impossible.

Water tube

Figure 3.2 • Never detach the water tube from the lid (see Figure 3.2). Doing so could damage the water tube, making water feeding impossible.

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MAJ-902 INSTRUCTION MANUAL

3.2 Preparation and inspection

3.2

Preparation and inspection 1 Referring to Chapter 2, “Instrument Nomenclature”, inspect the water container and all of its components. Confirm that all components free of damage or irregularities. WARNING Securely fasten the gas cylinder and other equipment as instructed by the manufacturer. Equipment that has not been securely fastened may fall and cause disconnections and damage.

Ch.3 NOTE • The gas cylinder, valve, regulator, relief valve, pressure gauge, flow meter, gas tube connector and tubes are not shipped with this product, and are generally delivered non-sterile. Clean, disinfect and/or sterileze these items as required before use. • Install a bactericidal filter between the flow meter and gas tube connector, if necessary. • Always prepare a spare gas cylinder for quick replacement in case the primary cylinder becomes empty during the procedure.

2 Prepare the gas cylinder, valve, regulator, relief valve, pressure gauge, flow meter, gas tube connector and tubes for connecting equipment. Connect all equipment as shown in Figure 3.3 and in accordance with their respective instruction manuals. Valve

Gas tube

Relief valve Valve

Flow meter

Regulator Pressure gauge Gas tube connector

Gas cylinder

Figure 3.3

3 Adjust the gas pressure as described in Section 3.3, “Adjusting the gas pressure”.

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3.2 Preparation and inspection

WARNING • Never fill in the container with sterile water while holding it over electrical equipment. If water is spilled on or into the equipment, electrical shock or damage can result. • Use sterile water only. Using non-sterile water can result in growth of bacteria or channels clogging, and this could pose an infection control risk and tissue irritation.

NOTE Fill the container with sterile water to within the specified water level marks. If the container is not filled between these marks, water feeding will be inadequate.

Ch.3

4 Fill the container with sterile water until the water level is within the water level marks specified on the outside of the container.

Specified water level marks

Figure 3.4

CAUTION If the O-ring is not correctly attached and the lid is not closed properly, gas insufflation and water feeding may not be possible. (See Figure 3.5)

5 Attach the lid to the container. Screwing the lid onto the container, the torque for screwing may grow. After that, screw the lid 180° clockwise.

O-ring

Container

Figure 3.5

6 Attach the container protector to the bottom of the container. 14

MAJ-902 INSTRUCTION MANUAL

3.2 Preparation and inspection

CAUTION Hang the hook of the water container on the water container holder of the light source or mobile workstation. Otherwise, the water container may fall and sterile water could be spilled on surrounding equipment. This could result in equipment damage and/or malfunction.

7 Hang the hook of the water container on the water container holder of the light source or mobile workstation.

8 Securely connect the gas tube to the gas tube connector on the lid of the water container.

9 Connect the metal tip of the water container to the endoscope as described in

Ch.3

Section 3.4, “Connecting to the endoscope”.

10 Turn the light source ON and set the air flow regulator switch on the light source to “0” or “OFF”. Confirm that no air is being fed from the light source.

11 Cover the small hole in the endoscope’s air/water valve with a finger wearing sterile gloves. Gradually open the regulator until the gas flow rate reaches 1000 cm3/min (1 l/min).

12 Inspect gas insufflation and water feeding as described in the endoscopic instruction manuals.

13 Close the regulator. NOTE To disconnect the metal tip of the water container from the endoscope, perform the procedure as described in Section 3.5, “Disconnecting from the endoscope”.

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3.3 Adjusting the gas pressure

3.3

Adjusting the gas pressure DANGER Do not allow the pressure to exceed the preselected value of 50 kPa at any time during the procedure, and always monitor the pressure during the procedure. Otherwise, excess pressure can build up within the patient’s body cavity and cause injury. It can also damage the water container and/or the endoscope.

Adjust the gas pressure in accordance with the following procedure.

Ch.3

1 After confirming that the regulator and relief valve are closed, open the gas cylinder’s valve.

2 Cover the gas tube connector opening with your fingers wearing sterile gloves. Gradually open the regulator until a pressure between 60 and 70 kPa is reached.

3 Keeping the gas tube connector opening covered, gradually open the relief valve until the pressure of 50 kPa is reached.

4 Turn the valve off at the regulator, but leave the gas tube connector open.

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MAJ-902 INSTRUCTION MANUAL

3.4 Connecting to the endoscope

3.4

Connecting to the endoscope CAUTION • Never drop the water container or subject it to impacts. The container could become damaged, which could make gas insufflation and water feeding impossible. • Do not bend, twist or pull the tube excessively. The tube could become damaged, which could make gas insufflation and water feeding impossible. • Connect the metal tip slowly and carefully. Otherwise, the metal tip could become damaged, which could make gas insufflation and water feeding impossible. • Push the metal tip straight onto the water supply connector on the endoscope. If connection to the endoscope is excessively angled, the metal tip may be damaged.

Connect the metal tip of the water container to the endoscope connector as described below. (See Figure 3.6)

1 Push the metal tip’s water supply channel gently onto the water supply connector on the endoscope at an angle of 90° to the connector. (See Figure 3.6)

2 Turn the metal tip 90° clockwise to align the air supply channel with the air supply connector of the endoscope. (See Figure 3.6)

3 Gently press the metal tip to confirm that it is securely connected to the endoscope. Endoscope 1.

2.

3.

Turn 90° clockwise Air supply connector Water supply connector

Air supply channel Water supply channel

Metal tip

Figure 3.6

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Ch.3