POWERSPIRAL CONTROL UNIT Instructions Feb 2020

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 7 Intended use ... 7 Contraindications ... 7 Applicability of endoscopy and endoscopic treatment ... 7 Instruction manual ... 8 User qualifications ... 8 Instrument compatibility ... 9 Repair and modification ... 9 Signal words ... 9 Precautions ... 10

Summary of Equipment Function ... 12

Chapter 1 Checking the Package Contents ... 13 1.1

Checking the package contents ... 13

Chapter 2 Nomenclature and Functions ... 15 2.1

PowerSpiral control unit (PSCU) ... 15

2.2

Force gauge (MAJ-2179) ... 18

2.3

PowerSpiral foot switch (MAJ-2181) ... 20

2.4

The force gauge display on the endoscopic image screen (PIP display) ... 21

Chapter 3 Installation and Connection ... 23 3.1

Precautions for installation and connection ... 23

3.2

Installation workflow ... 24

3.3

Install the PowerSpiral control unit and the ancillary equipment ... 25 Installation on the mobile workstation (WM-NP2, WM-DP2, WM-NP1, WM-WP1, or WM-DP1) ... 26 Installation in another location ... 26

3.4

Connection of the force gauge ... 27 Installation of the force gauge ... 27 Connection of the force gauge ... 29

3.5

Connection of the PowerSpiral foot switch ... 31

3.6

Connection of the video system center ... 32 CV-190 PLUS, CV-190 ... 32

3.7

Connection of the light source ... 34 CLV-290SL, CLV-190 ... 34

3.8

Connection of the endoscope position detecting unit (Only if the endoscope position detecting unit is used.) ... 36 UPD-3 ... 36 PSCU INSTRUCTION MANUAL

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3.9

Connection to the AC mains power supply ... 38 When the mobile workstation (WM-NP2, WM-DP2, WM-NP1, WM-WP1, or WM-DP1) is used ... 39 When a mobile workstation other than the WM-NP2 and WM-DP2, WM-NP1, WM-WP1, or WM-DP1 is used or when no mobile workstation is used ... 40

Chapter 4 Inspection ... 41 4.1

Warnings: inspection ... 41

4.2

Inspection workflow ... 42

4.3

Inspection of the initialization operation of the PowerSpiral control unit ... 42

4.4

Inspection of the single use PowerSpiral tube rotation function by the inspection mode ... 44 Inspection of the display of the force gauge ... 45 Inspection of the backward rotation ... 47 Inspection of the forward rotation ... 50 Inspection of the forced stop of the single use PowerSpiral tube rotation ... 50

Chapter 5 Operation ... 51 5.1

Precautions for operation ... 51

5.2

Operation workflow ... 53

5.3

Operation to rotate the single use PowerSpiral tube ... 54 Rotation of the single use PowerSpiral tube ... 54 Forced stop of the single use PowerSpiral tube rotation ... 56 Limit function and its release ... 57 Forced termination of the inspection mode ... 58

5.4

Turning OFF the PowerSpiral control unit ... 58

Chapter 6 Reprocessing, Storage, Disposal, and Transportation ... 59 6.1

Reprocessing ... 59 Surface disinfectant cleaner ... 61 Signs of degradation from reprocessing ... 61 Preparing equipment for Reprocessing ... 62 Reprocessing the PowerSpiral control unit (PSCU) and accessories ... 63

6.2

Storage ... 66

6.3

Disposal ... 66

6.4

Transportation ... 66

Chapter 7 Troubleshooting ... 67

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7.1

Troubleshooting ... 67

7.2

Troubleshooting guide ... 68

7.3

Returning the PowerSpiral control unit for repair ... 75

PSCU INSTRUCTION MANUAL

Contents

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

Specifications ... 79 Environment ... 79 Specifications ... 80

EMC information ... 85 License information of Open Source Software ... 90 GNU GPL ... 90 Others ... 91 newlib ... 92 Libhal_bsp ... 103

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Contents

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PSCU INSTRUCTION MANUAL

Labels and Symbols

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

 PowerSpiral control unit (PSCU)

Power ON/OFF

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).

Front panel

Fuse

Blue

Indicates to refer to the instruction manual for the cable to be connected. Refer to the instruction manual.

Manufacturer name

Serial number

Alternating current

Crossed-out wheeled bin’ symbol

Potential equalization terminal

Electrical rating The product name, rated voltage, and frequency are shown.

CE marking

POWERSPIRAL CONTROL UNIT MODEL PSCU POWER INPUT 220 – 240V 50/60Hz 70 VA

Rear panel PSCU INSTRUCTION MANUAL

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Labels and Symbols

 Force gauge (MAJ-2179) Displays that the endoscope needs to be replaced or repaired.

Displays the endoscope’s available time until the endoscope needs to be replaced or repaired.

Front panel CE marking

Crossed-out wheeled bin’ symbol

Manufacturer name

Authorized representative in the European Community

Serial number

Wendenstrasse 14-18, 20097 Hamburg, Germany

Rear panel Date of Manufacture

YYYY-MM-DD

Bottom

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PSCU INSTRUCTION MANUAL

Labels and Symbols

 The force gauge display on the endoscopic image screen (PIP display)

Displays the endoscope’s available time until the endoscope needs to be replaced or repaired.

Displays that the endoscope needs to be replaced or repaired.

Caution

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Labels and Symbols

 Force gauge cable (MAJ-2180) CE marking

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PSCU INSTRUCTION MANUAL

Labels and Symbols

 PowerSpiral foot switch (MAJ-2181) Date of Manufacture

Serial number

CE marking

YYYY-MM-DD

Wendenstrasse 14-18, 20097 Hamburg, Germany

Crossed-out wheeled bin’ symbol

Manufacturer name

Authorized representative in the European Community

Bottom

CATEGORY AP marking

Top

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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)

 Package Symbol

Description Handle with care

Keep dry

Keep away from direct sunlight

This way up

Stacking limit by number

70C –25C

Temperature limitation

95%

Humidity limitation 10%

1060hPa

Atmospheric pressure limitation 700hPa

Date of Manufacture

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PSCU INSTRUCTION MANUAL

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use This PowerSpiral control unit is intended to facilitate the insertion of the Olympus-designated intestinal endoscope by rotating the single use PowerSpiral tube clockwise and counterclockwise.

 Contraindications As a TYPE BF applied part, the endoscope connected to this instrument must never be applied directly to the heart. Leakage current from the TYPE BF applied part may be dangerous and cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following:  Never apply the endoscope connected to this instrument to the heart or any area near the heart.  Never allow an EndoTherapy accessory or another endoscope applied to or near the heart to come in contact with the endoscope connected to this instrument.

 Applicability of endoscopy and endoscopic treatment If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the healthcare facility’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risk (their natures, extent, and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient. Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.

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Important Information - Please Read Before Use

 Instruction manual This instruction manual contains essential information on using the PowerSpiral control unit 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 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, contact Olympus.

 Terms used in this manual Hospital grade wall mains outlet: The hospital grade wall mains outlet is a wall AC mains power outlet socket having the exclusive terminal for grounding.

Force gauge: The force gauge is a term for the functions and device of displaying the direction in which the single use PowerSpiral tube is rotating, the electric current to the motor within the endoscope, the endoscope’s available time, the replacement time of the covering of the endoscope’s rotation part, and the device fails (error code).

Limit function: The limit function stops the rotation of the single use PowerSpiral tube to protect the endoscope’s rotation part when the electric current to the motor on the endoscope exceeds a setting value.

Single use PowerSpiral tube: The single use PowerSpiral tube is attached to Olympus endoscopes before use.

 User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that 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 healthcare facility or person in charge of the department (department of internal medicine, etc.). The physician should be qualified to operate and perform safely the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures.

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PSCU INSTRUCTION MANUAL

Important Information - Please Read Before Use

 Instrument compatibility Refer to “ System chart” on page 77 to confirm that the PowerSpiral control unit is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment damage and makes it impossible to obtain the expected functionality. This instrument complies with the EMC standard for medical electrical equipment, edition 4 (IEC 60601-1-2: 2014).

 Repair and modification The PowerSpiral control unit does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or operator injury, equipment damage and/or the impossibility to obtain the expected functionality can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 7, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 7, contact Olympus. This instrument is to be repaired by Olympus technicians only. Olympus is not liable for any injury or damage that occurs as a result of repairs attempted by non-Olympus personnel.

 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

 Precautions Follow the warnings and cautions given below when handling the PowerSpiral control unit. This information is to be supplemented by the warnings and cautions given in each chapter.

WARNING • Do not use this instrument for any purpose other than its “ Intended use” on page 7. • Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of electric shock.  When the PowerSpiral control unit is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components. Such contact may cause unintended current flow to the patient.  Keep fluids away from all electrical equipment. If fluids are spilled on or into the unit, stop operation of the PowerSpiral control unit immediately and contact Olympus.  Do not prepare, inspect, or use the PowerSpiral control unit with wet hands. • Never install and operate the PowerSpiral control unit in locations where:  The concentration of oxygen is high.  Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere.  Flammable anesthetics are present in the atmosphere.  Flammable liquids are near. Otherwise, explosion or fire may result because the PowerSpiral control unit is not explosion-proof. • Never insert anything into the ventilation grills of the PowerSpiral control unit. It can cause an electric shock and/or fire. • The PowerSpiral control unit may interfere with other medical electronic equipment used in combination with it. Before use, refer to the Appendix to confirm the compatibility of the PowerSpiral control unit with all equipment to be used. • Do not use the PowerSpiral control unit in locations exposed to strong electromagnetic radiation (for example, in the vicinity of a microwave therapeutic device, MRI, wireless set, short-wave therapeutic device, cellular/portable phone, etc.). This may impair the performance of the PowerSpiral control unit. • Use only the power cord specified by Olympus. Otherwise, equipment malfunction and/or power cord burns may result. Also, never use it for other equipment. Contact Olympus.

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PSCU INSTRUCTION MANUAL

Important Information - Please Read Before Use

CAUTION • Turn OFF the PowerSpiral control unit when connecting or disconnecting the endoscope. If the endoscope is connected or disconnected while the PowerSpiral control unit is turned ON, the motor within the endoscope may be damaged. • Do not touch the electrical contacts inside the PowerSpiral control unit’s connectors. • Do not apply excessive force to the connectors. Otherwise, damage and/or malfunction can occur. • Be sure that the PowerSpiral control unit is not used adjacent to or stacked with other equipment (other than the components of the PowerSpiral control unit or system) to avoid electromagnetic interference. • Electromagnetic interference may occur to the PowerSpiral control unit when it is placed near equipment marked with the following symbol or other portable and mobile RF communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary, such as reorienting or relocating the PowerSpiral control unit or shielding the location.

NOTE In case 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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Summary of Equipment Function

Summary of Equipment Function The functions of the PowerSpiral control unit described below are enabled only when the required equipment is connected to the PowerSpiral control unit. For more details, refer to the instruction manuals for the PowerSpiral control unit and the other instruments connected.

 Operation to rotate the single use PowerSpiral tube Operating the PowerSpiral foot switch causes the single use PowerSpiral tube to rotate.

 Display of the force gauge The force gauge indicates the following operations and/or information: • The direction in which the single use PowerSpiral tube is rotating. • The electric current to the motor within the endoscope. • The displaying of error code when the device fails. • The displaying of the endoscope’s available time and the replacement time of the covering of the endoscope’s rotation part.

 Display of the electric current to the motor within the endoscope The force gauge displays the number of the level bar indicators according to the electric current applied to the motor within the endoscope to estimate the magnitude of the torque acting occurred inside the endoscope’s insertion section and the rotational load on the patient’s body cavity.

 Display of the force gauge on the endoscopic image screen The force gauge information can be displayed on the monitor using the PIP function of the video system center.

 Limit function The limit function stops the rotation of the single use PowerSpiral tube when the electric current to the motor on the endoscope exceeds a setting value.

 Inspection mode The inspection mode checks that each function works normally before the examination when the PowerSpiral control unit is connected to the endoscope with the single use PowerSpiral tube.

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PSCU INSTRUCTION MANUAL

1.1 Checking the package contents

Chapter 1

1.1

Checking the Package Contents

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.

 PowerSpiral control unit

PowerSpiral control unit (PSCU)

 Accessories

Force gauge (MAJ-2179)

Force gauge cable (MAJ-2180)

Force gauge fastener (2 pcs.)

Binder

Communication cable 1.8M (MAJ-1948)

Y/C cable (MH-985)

CLV-UPD cable (MAJ-1898)

PowerSpiral foot switch (MAJ-2181)

Instruction manual

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Ch.1

1.1 Checking the package contents

Ch.1

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PSCU INSTRUCTION MANUAL

2.1 PowerSpiral control unit (PSCU)

Chapter 2

2.1

Nomenclature and Functions

PowerSpiral control unit (PSCU)

 Front panel Ch.2

1

No.

2

Nomenclature

Description

1

Power switch

Press to turn the PowerSpiral control unit ON or OFF.

2

Power indicator

Lights up when the PowerSpiral control unit is ON.

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