MAJ-1878 ENDOSCOPE POSITION MARKING PROBE Instructions Aug 2013

Contents

Contents Symbols ... 1 Important Information - Please Read Before Use ... 2 Intended use ... 2 Instruction manual ... 2 User qualifications ... 2 Instrument compatibility ... 3 Reprocessing before the first use/reprocessing and storage after use ... 3 Repair and modification ... 3 Signal words ... 3 Dangers, warnings, and cautions ... 4

Chapter 1 Checking the Package Contents ... 7 1.1

Checking the package contents ... 7

Chapter 2 Nomenclature and Functions ... 9 2.1

Nomenclature ... 9 Endoscope position marking probe (MAJ-1878) ... 9 Stopper (MAJ-961) ... 10

2.2

Specifications ... 11 Operating environment ... 11 Specifications ... 12

Chapter 3 Preparation and Inspection ... 13 3.1

The workflow of preparation and inspection ... 13

3.2

Preparation of the equipment ... 15

3.3

Preparation and inspection of the endoscope position marking probe (MAJ-1878) ... 16 Inspection of the endoscope position marking probe ... 16 Connection to the endoscope position detecting unit (UPD, UPD-3) ... 17 Inspection of the display of the endoscope model ... 18

3.4

Preparation and inspection of the stopper (MAJ-961) ... 22 Inspection of the stopper ... 22 Attaching the stopper to the endoscope position marking probe ... 23

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Contents

Chapter 4 Operation ... 29 4.1

Precautions ... 29

4.2

Insertion of the endoscope position marking probe (MAJ-1878) ... 30

4.3

Operating the endoscope position detecting unit ... 32

4.4

Withdrawal of the endoscope position marking probe (MAJ-1878) from the endoscope ... 32

4.5

Disconnecting the endoscope position marking probe (MAJ-1878) from the endoscope position detecting unit (UPD, UPD-3) ... 34

Chapter 5 Reprocessing ... 35 5.1

General policy ... 35

5.2

Compatible reprocessing methods and chemical agents ... 37 Compatibility summary ... 37 Water (for reprocessing) ... 38 Detergent solution ... 38 Disinfectant solution ... 38 Rinsing water ... 39 Alcohol ... 39 Ethylene oxide gas sterilization ... 39

5.3

Required reprocessing equipment ... 41 Preparing the equipment for reprocessing ... 41 Reprocessing equipment parts and functions ... 43

5.4

Reprocessing workflow for endoscope position marking probe ... 44 Workflow for high-level disinfection and sterilizing endoscope position marking probe ... 44

5.5

Precleaning of the endoscope position marking probe ... 45 Equipment needed ... 45 Wipe down the insertion section of the endoscope position marking probe ... 45

5.6

Leakage testing of the endoscope position marking probe ... 46 Equipment needed ... 46 Inspection of the seal ring (MAJ-1188) ... 46 Changing the seal ring (when necessary only) ... 47 Attaching the water-resistant cap ... 49 Performing the leakage test ... 50

5.7

Manually cleaning the endoscope position marking probe ... 53 Equipment needed ... 53 Immersion in detergent solution ... 54 Rinsing ... 54 Presoak for excessive bleeding and/or delayed reprocessing ... 55

5.8

Manually high-level disinfecting the position marking probe ... 56 Equipment needed ... 56 Immersion in disinfectant solution ... 57 Rinsing after high-level disinfection ... 57

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MAJ-1878 INSTRUCTION MANUAL

Contents

5.9

Sterilizing the endoscope position marking probe ... 59 Ethylene oxide gas sterilization ... 59

5.10 Reprocessing procedure for the stopper (MAJ-961) ... 61 Equipment needed ... 61 Cleaning ... 61 High-level disinfection ... 63 Rinsing after high-level disinfection ... 63 Ethylene oxide gas sterilization ... 65

Chapter 6 Reprocessing Endoscope Position Marking Probe and Accessories Using an Automated Endoscope Reprocessor ... 67 6.1

Placing the endoscope position marking probe in the reprocessor ... 67 Placing the endoscope position marking probe to be reprocessed in an OER-A reprocessing basin ... 68 Placing the endoscope position marking probe to be reprocessed in an OER-AW/OER-Pro reprocessing basin ... 69 Placing the stoppers in the reprocessor stopper setup ... 72

Chapter 7 Storage and Disposal ... 73 7.1

Storage of the endoscope position marking probe (MAJ-1878) ... 73

7.2

Storage of the stopper (MAJ-961) ... 74

7.3

Disposal ... 74

Chapter 8 Troubleshooting ... 75 8.1

Troubleshooting ... 75

8.2

Troubleshooting guide ... 76

Appendix ... 77 Combination equipment ... 77 System chart ... 77

EMC information ... 79

MAJ-1878 INSTRUCTION MANUAL

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Contents

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MAJ-1878 INSTRUCTION MANUAL

Symbols

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: Symbol

Description Refer to instructions.

Caution

TYPE BF applied part

Ch 2.8

Compatible with a ø 2.8 mm or larger instrument channel diameter.

Manufacturer

Authorized representative in the European Community

Serial number

MAJ-1878 INSTRUCTION MANUAL

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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 endoscope and the endoscope position detecting unit (UPD, UPD-3) for detection and display of the location and/or shape of the inserted 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 for 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, contact Olympus.

 Terms used in this manual Endoscope model The endoscope model is a computer graphic image modeling the shape of the endoscope’s insertion tube.

 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 clinical endoscopic procedures, the physician and operator are requested to form judgements from their viewpoints as specialists.

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MAJ-1878 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Instrument compatibility Refer to “ System chart” on page 77 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.

 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 as described in Chapter 5, “Reprocessing”. After using this instrument, reprocess and store it as described in Chapter 5, “Reprocessing” and Chapter 7, “Storage and Disposal”. Improper and/or incomplete reprocessing or storage can pose 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.

 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.

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Important Information - Please Read Before Use

 Dangers, warnings, and cautions Follow the dangers, warnings, and cautions given below when handling this instrument. This information is to be supplemented by the dangers, warnings, and cautions given in each chapter.

DANGER • Never apply the instrument to the heart or any area near the heart. This could result in fatal accidents. • This instrument generates AC magnetic fields. To prevent critical effects on the patients, carefully observe the following points:  Never use the instrument on a patient with a pacemaker implant. The AC magnetic fields generated by the instrument may disturb the pacemaker and cause ventricular fibrillation or impair electronic pacemaker parts, which could result in fatal accidents.  Never use the instrument on pregnant women or on women observed of being pregnant. The effects of the AC magnetic field generated by the instrument on fetuses have yet to be determined.

WARNING • Always wear appropriate personal protective equipment. Patient debris adhering to the endoscope position marking probe could pose an infection control risk. • Use the endoscope position marking probe with the stopper (MAJ-961) attached. Otherwise, the probe’s distal end may extend from the endoscope’s distal end, which could result in patient injury. • When the endoscope position marking probe is inserted through the slit of the biopsy valve (MB-358), the slit could be widened. Should irregularities be detected, replace the biopsy valve with a new one as described in the endoscope’s instruction manual. If a damaged biopsy valve is used, the suction performance may deteriorate or debris may leak and splash on the operator and/or patient. • Do not prepare, inspect, or use this instrument with wet hands.

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MAJ-1878 INSTRUCTION MANUAL

Important Information - Please Read Before Use

CAUTION • Confirm that the endoscope that is used is compatible with this instrument. If the endoscope position marking probe is inserted into an incompatible endoscope, the probe cannot be withdrawn from the endoscope, or the endoscope and/or the probe could be damaged. • Do not touch the contact pins inside the endoscope position marking probe’s electrical connector as this may cause the equipment to malfunction. • Do not handle the endoscope position marking probe roughly as you may damage the equipment or injure yourself. • Do not apply excessive force during connection. Doing so may cause the equipment to malfunctions. • Do not coil the insertion section with a diameter of less than 20 cm. Equipment damage can result. • Do not pull, twist, or tightly coil the insertion section. Equipment damage can result. • The electrical connector of the endoscope position marking probe is not waterproof. Before immersing the instrument, always attach the water-resistant cap (MAJ-962). • Turn the endoscope position detecting unit (UPD, UPD-3) OFF before connecting or disconnecting the endoscope position marking probe to/from the unit. Otherwise, equipment damage can result. • Do not drop this instrument or apply shock to it. Equipment damage can result. • When using this equipment in domestic environments and connected to the public mains network, electromagnetic interference with other devices may occur. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this equipment, or shielding the location. The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment (when connected to UPD).

NOTE • It is highly desirable that a backup endoscope position marking probe be available to continue clinical procedures in case of a malfunction. • While the endoscope position marking probe is inserted into the endoscope, suction will be impaired or, at worst, disabled. Be sure to withdraw the endoscope position marking probe from the endoscope before performing suction.

MAJ-1878 INSTRUCTION MANUAL

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Important Information - Please Read Before Use

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MAJ-1878 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 this instrument for the first time, reprocess it as described in Chapter 5, “Reprocessing”.

 Endoscope position marking probe

Endoscope position marking probe (MAJ-1878) with water-resistant cap (MAJ-962)

 Accessories

Stopper (MAJ-961)

Probe holder

MAJ-1878 INSTRUCTION MANUAL

Instruction manual

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1.1 Checking the package contents

Ch.1

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MAJ-1878 INSTRUCTION MANUAL

2.1 Nomenclature

Chapter 2

2.1

Nomenclature and Functions

Nomenclature

 Endoscope position marking probe (MAJ-1878)

Ch.2

1

2 3 4

9 8

6

7

5

No.

Nomenclature

Description

1

Chain

Connects the water-resistant cap (MAJ-962) and the electrical connector.

2

Venting connector

Attach the leakage tester here.

3

Water-resistant cap Attach the water-resistant cap to the electrical connector before cleaning and/or (MAJ-962) disinfection procedure to avoid water penetration to the electrical connector Attach its chain to the electrical connector so that the cap cannot get lost.

4

Insertion section

This section is inserted into the instrument channel.

5

Boot

Prevents the junction between the insertion tube and the electrical connector from bending.

6

Projection

These projections show the position to connect the water-resistant cap to the electrical connector.

7

Electrical connector Connects the UPD cable (MAJ-966, MAJ-1881) to the electrical connector.

8

Index

This index shows the position to connect the UPD cable to the electrical connector.

9

Seal ring

Protects the electrical connector from water penetration when the water-resistant cap is attached.

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2.1 Nomenclature

 Stopper (MAJ-961) Attach the stopper to the endoscope position marking probe so that the probe’s distal end does not protrude from the endoscope’s distal end. 2

1

Ch.2

3

No.

Nomenclature

1

Cap

Fixes the endoscope position marking probe when the stopper is attached.

2

Main body

This is attached to the endoscope position marking probe when the endoscope position marking probe's distal end reaches the distal end of the endoscope.

3

Spacer portion

Adjusts the distal end of the endoscope position marking probe not to extend from the endoscope's distal end.

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Description

MAJ-1878 INSTRUCTION MANUAL

2.2 Specifications

2.2

Specifications

 Operating environment Operating environment

Ambient temperature 10 – 40C (50 – 104F)

Standard storage environment (e.g. within the hospital)

Relative humidity

30 – 85%

Atmospheric pressure

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

Ch.2

Ambient temperature 5 – 40C (41 – 104F) Relative humidity

10 – 95%

Atmospheric pressure

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

Transportation environment (conditions during transportation and short-term storage)

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)

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2.2 Specifications

 Specifications Item Size

Ch.2

Compatible Olympus endoscopes (All of these parameters should be met)

Specification

Maximum insertion portion diameter (mm)

ø 2.55

Working length (mm)

3500 mm

Detection length (mm)

940 mm

Model

CF, PCF, SIF (Except endoscopes with a biopsy elevator, or position detecting function.)

Channel inner diameter ø 2.8 mm or larger (mm) ø 3.7, ø 4.2 (Orange), ø 2.8, ø 3.2 (Yellow) (color code)

Compatible Olympus endoscope position detecting units

UPD, UPD-3

Medical Devices Directive

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

Applied standard

IEC 60601-1-2: 2001 IEC 60601-1-2: 2007 IEC 60601-1-2: 2014 IEC 60601-2-18: 1996 IEC 60601-2-18: 2009 • This instrument complies with the EMC standard for medical electrical equipment, edition 4 (IEC 60601-1-2: 2014). When connecting to an instrument that complies with a previous edition of the EMC standard for medical electrical equipment edition, the EMC characteristics could be vulnerable. • CISPR 11 of emission: Group 1, Class B (when connected to UPD-3) Group 1, Class A (when connected to UPD)

Year of manufacture

The last digit of the year of manufacture is the second digit of the serial number. In this example, the year is 2013.

Ex. 2301234 (serial number) Degree of protection against electric shock

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TYPE BF applied part

MAJ-1878 INSTRUCTION MANUAL

3.1 The workflow of preparation and inspection

Chapter 3 3.1

Preparation and Inspection

The workflow of 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. Should any irregularity be observed, do not use this instrument and refer to Chapter 8, “Troubleshooting”. If the irregularity is still observed after consulting Chapter 8, contact Olympus.

WARNING

Ch.3

• Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage. • Always inspect the instrument wearing sterile gloves in a clean environment. Failure to do so could pose an infection control risk. • This instrument was not reprocessed before shipment. Before using this instrument for the first time, reprocess it as described in Chapter 5, “Reprocessing”. • Only use the endoscope position marking probe with the stopper attached. Otherwise, the probe can be advanced or extended from the endoscope’s distal end. This could result in patient injury. • Place the endoscope position marking probe in a clean area during preparation and inspection. Failure to do so could pose an infection control risk.

CAUTION Do not use an endoscope that gives resistance to the insertion of the endoscope position marking probe. This could result in damage to the endoscope and/or the probe.

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3.1 The workflow of preparation and inspection

1 2

Preparation of the equipment Section 3.2 on page 15

Preparation and inspection of the endoscope position marking probe Section 3.3 on page 16

3

Preparation and inspection of the stopper Section 3.4 on page 22

Ch.3

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MAJ-1878 INSTRUCTION MANUAL

3.2 Preparation of the equipment

3.2

Preparation of the equipment

Prepare the instruments shown in Figure 3.1 (for compatibility, refer to “ System chart” on page 77) 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. Also prepare the equipment as described in Chapter 5, “Reprocessing” for immediate reprocessing after use.

 Endoscope system and endoscope position marking probe 1

7 2 8

3 4

9

1 Video monitor 2 Video system center 3 Light source 4 Water container 5 Suction pump 6 Endoscope 7 Endoscope position detecting unit (UPD-3) 8 UPD cable 9 Endoscope position marking probe 10 Stopper

5

10

6

 Personal protective equipment (e.g.)

Eyewear

Face mask

Moisture-resistant clothing

Chemical-resistant gloves

 Other • Paper towels

• Trays

• Lint-free cloths

Figure 3.1

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Ch.3