ENDOCAPSULE 10 System Instructions

Contents

Contents Labels and Symbols ... 1 Symbols ... 1 Labels ... 2

Important Information - Please Read Before Use ... 11 Intended use/Intended purpose ... 11 Contraindications ... 11 Clinical benefit ... 11 Instruction manual ... 11 User qualifications ... 13 Instrument compatibility ... 13 Repair and modification ... 14 Signal words ... 14 Dangers, warnings, and cautions ... 14 Danger, warning, and cautions for patients ... 25 Expiration date of the capsule endoscope ... 25 Color tone of the capsule endoscope image ... 26

Chapter 1 Checking the Package Contents ... 29 1.1

ENDOCAPSULE RECORDER SET (MAJ-2029) ... 29

1.2

ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET (MAJ-2027) ... 30

1.3

LEAD ANTENNA UNIT (MAJ-2294) ... 31

1.4

ANTENNA LEAD COVER (MAJ-1470) ... 31

Chapter 2 Nomenclature and Functions ... 33 2.1

System components ... 33

2.2

ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE (OLYMPUS EC-S10) ... 36

2.3

CAPSULE ACTIVATOR (MAJ-1478) ... 36

2.4

ANTENNA UNIT (MAJ-2031) ... 37

2.5

ENDOCAPSULE RECORDER (OLYMPUS RE-10) ... 38

2.6

CRADLE (MAJ-2032) ... 40

2.7

BATTERY PACK (MAJ-2030) ... 41

2.8

RECORDER HOLDER (MAJ-2033) ... 42

2.9

ANTENNA UNIT HOLDER (MAJ-2034) ... 43

2.10 LEAD ANTENNA UNIT (MAJ-2294) ... 44 2.11 ANTENNA LEAD COVER (MAJ-1470) ... 45 2.12 SERVER/CLIENT HARDWARE (MAJ-2037) ... 46 2.13 LCD MONITOR (MAJ-2041) ... 46 MAJ-2029, MAJ-2027, MAJ-2294, MAJ-1470 SYSTEM MANUAL

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Contents

2.14 ENDOCAPSULE SOFTWARE 10 ... 46

Chapter 3 Connection and Setup ... 47 3.1

Connecting the AC adapter and USB cable to the cradle ... 47

3.2

Attaching the battery pack to the recorder ... 49

Chapter 4 Preparation and Inspection ... 51 4.1

Preparation of the equipment ... 51

4.2

Inspection of the exterior ... 52 Inspection of the sterile container of the capsule endoscope ... 52 Inspection of the exterior of the antenna unit ... 52 Inspection of the exterior of the recorder ... 52 Inspection of the exterior of the cradle ... 53 Inspection of the exterior of the antenna unit holder ... 53 Inspection of the exterior of the recorder holder ... 53 Inspection of the exterior of the capsule activator ... 54 Inspection of the exterior of the lead antenna unit ... 54 Inspection of the exterior of the antenna lead cover ... 54

4.3

Inspection of function ... 54 Inspection of the charging function ... 54 Inspection of the power-on function ... 56

Chapter 5 Operation ... 61 5.1

Charging the recorder ... 61

5.2

Initialization of the recorder ... 65

5.3

Attaching the antenna unit and the recorder ... 68 Inserting the antenna sheet in the antenna cover ... 68 Selection of the belt of the antenna unit holder ... 70 Attaching the antenna unit holder ... 71 Attaching the recorder holder ... 75 Connecting the recorder and the antenna unit ... 75 Turning ON the recorder ... 76 Inserting the recorder in the recorder holder ... 79

5.4

Attaching the lead antenna unit and the recorder ... 81 Confirmation of antenna locations ... 81 Attaching the antenna lead cover ... 83 Attaching the lead antenna unit ... 85 Attaching the recorder holder ... 87 Connecting the recorder and the lead antenna unit ... 87 Turning ON the recorder ... 88 Inserting the recorder in the recorder holder ... 91

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Contents

5.5

Turning ON the capsule endoscope ... 92 Confirmation of start of the capsule endoscope ... 92 Confirming reception ... 94 Confirming image ... 94 Locking the button operation ... 97

5.6

Ingesting the capsule endoscope ... 98

5.7

Removing the antenna unit and the recorder ... 101

5.8

Removing the lead antenna unit and the recorder ... 105

5.9

Downloading image data ... 109

Chapter 6 Functions ... 111 6.1

Screen transition ... 111

6.2

Displaying the real time image ... 115

6.3

Displaying the recorded image ... 115

6.4

Capturing an image ... 118 Capturing an image on the Real Time View screen ... 118 Capturing an image on the Playback View screen ... 119

6.5

Displaying the captured image ... 120

6.6

Deleting a captured image ... 122

6.7

Giving messages to a patient ... 123

6.8

Confirming the messages ... 124

6.9

Handling the recorder when the message is given ... 125

6.10 Locking the button operation ... 126

Chapter 7 Reprocessing, Storage, Disposal, and Transportation ... 127 7.1

Reprocessing ... 127

7.2

General policy ... 128 Precautions ... 128

7.3

Compatible Reprocessing Methods ... 131 Compatibility summary ... 131 List of compatible methods ... 132

7.4

Detergent solution for manual cleaning ... 134

7.5

Surface disinfectant cleaner ... 135

7.6

Water ... 135

7.7

Signs of degradation from reprocessing ... 136

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Contents

7.8

Reprocessing workflow for Endocapsule recorder set (MAJ-2029) and Lead antenna unit (MAJ-2294) ... 136 Summary of reprocessing workflow ... 136 Workflow for Endocapsule recorder set (MAJ-2029) and Lead antenna unit (MAJ-2294) ... 137

7.9

Preparing equipment for reprocessing ... 138

7.10 Reprocessing the Endocapsule recorder set (MAJ-2029) ... 139 7.11 Manually cleaning the lead antenna unit (MAJ-2294) ... 141 Dry accessories ... 147

7.12 Washing the recorder holder (MAJ-2033) and antenna unit holder except for plates (MAJ-2034) ... 148 7.13 Storage ... 150 7.14 Disposal ... 152 7.15 Transportation ... 152

Chapter 8 Troubleshooting ... 153 8.1

Troubleshooting ... 153 Recorder error messages ... 155 Recorder messages ... 157

8.2

Returning the system for repair ... 158

Appendix ... 159 Combination equipment ... 159 System chart ... 160

Specifications ... 162 Specifications ... 162 Environment ... 171

EMC information ... 175

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Labels and Symbols

Labels and Symbols Safety-related labels and symbols are attached at the locations shown below. If labels or symbols are missing or illegible, contact Olympus.

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

Blue

Description

Symbol

Description

Caution

Refer to instructions.

Refer to instructions.

When this equipment is in the proximity of portable RF (Radio Frequency) communication devices, electromagnetic interference that affects cardiac pacemakers may occur. Users of cardiac pacemakers must maintain a sufficient distance from the equipment.

Power switch (ON/OFF)

Use by (expiration date)

Sterilized using ethylene oxide

Sterilization lot number

TYPE BF applied part

Single use only

Do not resterilize

Do not use if package is damaged

Manufacturer

Serial number

Authorized representative in the European Community

Importer (into European Union)

Translation

Medical device

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Labels and Symbols

Symbol

Description

Symbol

Description

Single sterile barrier system with protective packaging inside

 Labels  ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE

Product name Model name

TYPE BF applied part marking

Sterilization lot number

Refer to instructions. Single use only

Expiration date Single sterile barrier system with protective packaging inside Sterilized with ethylene oxide CE marking

Do not use if package is damaged

Do not resterilize Protection against fluid

Manufacturer name Country of manufacture

Refer to the separate leaflet “Radio Act Certification Country Marking List” on page 30 to confirm the countries requiring the Radio Act marking not printed on the sealing paper of the OLYMPUS EC-S10 sterile container.

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Labels and Symbols

 ANTENNA UNIT Antenna unit (front panel) TYPE BF applied part marking

Antenna unit (rear panel)

Serial number

Label

RCM marking Product name RNZ marking Model name Crossed-out wheeled bin’ symbol

Refer to instructions. Manufacturer name

CE marking Country of manufacture

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Labels and Symbols

 ENDOCAPSULE RECORDER Recorder (rear panel) Power switch

Label Medical device Product name Model name RCM marking Electrical rating/ Input power

RNZ marking

Refer to instructions.

Crossed-out wheeled bin’ symbol

CE marking Manufacturer

Manufacturer name

Authorized representative in the European Community

Country of manufacture

Date of Manufacture

Recorder (front panel)

UDI label The UDI label is required by some countries’ regulations regarding the identification of a medical device also known as Unique Device Identification (UDI).

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Serial number

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Labels and Symbols

 CRADLE Cradle (rear panel)

Serial number

Label

Product name Model name Electrical rating/ Input power

Crossed-out wheeled bin’ symbol

Refer to instructions. Manufacturer name

CE marking

Country of manufacture

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Labels and Symbols

 BATTERY PACK (Front)

Label

Model name

UKCA marking

Lot number

Product name

UL marking Voltage rating, Battery pack capacity, Battery pack type

CE marking Recycle marking Crossed-out wheeled bin’ symbol

Caution

EAC marking Warnings Battery recycling mark (for Taiwan)

Manufacturer name

Serial number

Country of manufacture

Model name Lot number

Product name Voltage rating, Battery pack capacity, Battery pack type

UL marking

RCM marking

Caution

Serial number

Warnings

Manufacturer name

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Country of manufacture

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Labels and Symbols

 BATTERY PACK (Back)

Label

Caution

Warnings

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Labels and Symbols

 RECORDER HOLDER Country of manufacture Refer to instructions.

Model name

CE marking

Do not dry clean Do not iron Do not tumble dry Do not bleach Label

Maximum washing temperature 40°C normal process

 ANTENNA UNIT HOLDER Country of manufacture Refer to instructions.

Model name

CE marking

Label

Do not dry clean Do not iron Do not tumble dry Do not bleach Maximum washing temperature 40°C normal process

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Labels and Symbols

 LEAD ANTENNA UNIT (MAJ-2294) LEAD ANTENNA UNIT (front panel) TYPE BF applied part marking

LEAD ANTENNA UNIT (rear panel) Label

Serial number

Product name

RCM marking

Model name

RNZ marking

Crossed-out wheeled bin’ symbol

Refer to instructions.

CE marking

Manufacturer name Country of manufacture

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Labels and Symbols

 ANTENNA LEAD COVER (MAJ-1470)

Label

Product name Model name Single use only

Number of pieces

CE marking

Lot number

Refer to instructions Non-sterile marking

Expiration date

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

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Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use/Intended purpose The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM is intended for visualization of the small intestine mucosa. • It may be used in the visualization and monitoring of lesions that may indicate Crohn's disease not detected by upper and lower endoscopy. • It may be used in the visualization and monitoring of lesions that may be a source of obscure bleeding (either overt or occult) not detected by upper and lower endoscopy. • It may be used in the visualization and monitoring of lesions that may be potential causes of iron deficiency anemia (IDA) not detected by upper and lower endoscopy. The OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM may be used as a tool in the detection of abnormalities of the small intestine.

 Contraindications None known.

 Clinical benefit Supports to achieve the clinical benefit of connected Capsule Endoscope by providing function to receive and record image from Capsule Endoscope.

 Instruction manual This instruction manual contains essential information on using the system safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment that will be used during the procedures, and use the equipment as instructed. Note that the complete instruction manual for this system consists of the following parts: this manual, the “WORKSTATION MANUAL”, and the “Cautions for capsule endoscopy patients”. 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.

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Important Information - Please Read Before Use

 Terms used in this manual DC magnetic field Magnetic field formed by permanent magnets or electromagnets that are used in health devices and audio speakers.

RTC (Real time clock) The recorder’s internal clock.

Capsule endoscope ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE (OLYMPUS EC-S10)

Recorder ENDOCAPSULE RECORDER (OLYMPUS RE-10)

ENDOCAPSULE SOFTWARE 10 ENDOCAPSULE SOFTWARE 10 SERVER-CLIENT (MAJ-2038), ENDOCAPSULE SOFTWARE 10 CLIENT (MAJ-2039), ENDOCAPSULE SOFTWARE 10 (MAJ-2188), ENDOCAPSULE SOFTWARE 10 LIGHT (MAJ-2189), or ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE (MAJ-2190).

Workstation The PC on which ENDOCAPSULE SOFTWARE 10 has been installed and the LCD monitor recommended by Olympus.

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Important Information - Please Read Before Use

 User qualifications This instrument should be used by persons trained in the use of this instrument. The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must be qualified to operate and perform safely in capsule endoscopy procedures. This manual, therefore, does not explain or discuss capsule endoscopy procedures. Physicians performing capsule endoscopy should: − have completed a formal training program that includes training in the recognition and management of small intestinal diseases − have competency and privileges to perform gastrointestinal endoscopy − be familiar with the ENDOCAPSULE 10 SYSTEM hardware and software − have formal training in capsule endoscopy that includes hands-on training and supervised review of initial cases by a competent capsule endoscopist − meet pertinent local healthcare facility requirements and professional society credentialing guidelines.

 Instrument compatibility Refer to “ System chart” on page 160 to confirm that the system 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 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.

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Important Information - Please Read Before Use

 Repair and modification This system does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it. Doing so may result in patient or user injury and/or equipment damage. Some problems that appear to be malfunctions may be correctable by referring to Chapter 8, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 8, contact Olympus.

 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.

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

 Dangers, warnings, and cautions about the examination DANGER • This system is contraindicated to patients with the following conditions. − Patients with cardiac pacemakers or other implanted electronic devices (e.g. defibrillators) Cardiac pacemakers or other implanted electronic devices may malfunction due to the RF (radio frequency) interference. − Patients who are nonsurgical candidates Open surgery is required if the capsule endoscope is retained in the patient’s body.

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Important Information - Please Read Before Use

− Patients with known intestinal strictures, adhesions, diverticulum, obstruction, or fistulas that may block the passage of the capsule endoscope Patients with these physical features risk retention of the capsule endoscope. − Patients with significant gastrointestinal tract delay Long-term retention of the capsule endoscope may be observed in patients with known radiation enteritis due to intestinal strictures or adhesions. − Patients diagnosed with radiation enteritis Long-term retention of the capsule endoscope may be observed in patients with known radiation enteritis due to intestinal strictures or adhesions. − Patients with known dysphagia Patients with dysphagia may have a risk of aspiration into the tracheal branches and could have difficulty ingesting the capsule endoscope. − Patients with significant difficulty in swallowing a tablet as large as capsule endoscope Patients that may have difficulty ingesting a capsule as large as the capsule endoscope risk getting the capsule lodged in their throat. − Patients who are pregnant Use of the capsule endoscope has not yet been proven to be safe on pregnant patients. • Instruct the patient to stay away from equipment that generates strong electromagnetic fields (such as MRI equipment), between ingestion and excretion of the capsule endoscope. Otherwise, injury within the body cavity may occur. If the excretion of the capsule endoscope has not been confirmed within 2 weeks after ingestion, attempt to locate the capsule endoscope within the patient’s body by X-ray examination. • Do not use this system for any purpose other than its intended use.

WARNING • Do not use this endocapsule recorder set and accessories for any purpose other than its indications for use. Patient or operator injury and/or equipment damage may result. • The capsule endoscope may cause unexpected intestinal obstruction. In the worst case, surgical operation may be required. • The capsule endoscope must be ingested under the supervision of the physician or medical personnel authorized by the physician. • The physician should explain to the patient the risks of retention in the examination and obtain the patient’s informed consent before the examination.

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