MAJ-2301 Foot Switch Instructions

Contents

Contents Labels and Symbols ... 1 Important Information - Please Read Before Use ... 4 Intended use / Intended purpose ... 4 Patient selection criteria ... 4 Contraindications ... 4 Clinical Benefit ... 4 Instruction manual ... 4 User qualifications ... 5 Instrument compatibility ... 5 Prohibition of improper repair and modification ... 5 Signal words ... 6 Precautions ... 6 EMC ... 9

Summary of Equipment Functions ... 10

Chapter 1 Checking the Package Contents ... 11 1.1

Checking the package contents ... 11

Chapter 2 Nomenclature and Functions ... 13 2.1

Symbols and descriptions ... 13

2.2

Foot switch ... 14

2.3

Wireless unit ... 16

2.4

Foot switch hanger ... 16

2.5

Foot switch cable ... 17

2.6

Pairing stickers ... 17

Chapter 3 Installation and Connection ... 19 3.1

Precautions for installation and connection ... 19

3.2

Installation procedure workflow ... 20

3.3

Connection of wireless unit ... 21

3.4

Connection of foot switch hanger ... 24

3.5

Insertion of batteries into the foot switch ... 26

3.6

Pairing ... 31

3.7

Assign the functions of the switches ... 35

3.8

Storage of foot switch ... 36

MAJ-2301 INSTRUCTION MANUAL

i

Contents

Chapter 4 Inspection ... 37 4.1

Precautions of workflow ... 37

4.2

Inspection workflow ... 38

4.3

Inspection of remaining battery power (for wireless control) ... 38

4.4

Inspection of foot switch cable (for wired control) ... 41

4.5

Inspection of foot switch operation ... 43

Chapter 5 Operation ... 45 5.1

Operating precautions ... 45

5.2

Wireless control of foot switch ... 46

5.3

Wired control of foot switch ... 48

Chapter 6 Reprocessing, Storage, Disposal, and Transportation ... 51 6.1

Reprocessing, storage, disposal, and transportation ... 51

Chapter 7 Troubleshooting ... 53 7.1

Troubleshooting ... 53

7.2

Troubleshooting guide ... 54

7.3

Returning this instrument for repair ... 57

Appendix ... 59 Combination equipment ... 59 System chart ... 59

Specifications ... 61 Environments ... 61 Specifications ... 61

EMC information ... 63 Cautions on 2.4 GHz band radio wave equipment ... 68

ii

MAJ-2301 INSTRUCTION MANUAL

Labels and Symbols

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

 Foot switch

Battery compartment

Product plate

Product plate details

CE marking

Ukraine Radio Law Certification mark Crossed-out wheeled bin’ symbol Non-ionizing radiation marking Ingress protection rating Product plate

Inside of battery compartment

Battery insertion orientation indication The applicable battery type and the orientation for inserting the batteries are indicated.

MAJ-2301 INSTRUCTION MANUAL

The product name, power rating, non-ionizing radiation marking, and Ingress protection rating are indicated.

Rechargeable battery inhibition indication This marking inhibits the use of rechargeable batteries.

1

Labels and Symbols

 Wireless unit

Wireless unit

Serial number plate Manufacturing date Product plate Date of manufacture

Product plate details

CE marking

Ukraine Radio Law Certification mark  

    

Non-ionizing radiation marking Product plate

Crossed-out wheeled bin’ symbol

2

MAJ-2301 INSTRUCTION MANUAL

The product name, manufacturer name, power rating, and non-ionizing radiation marking are indicated.

Labels and Symbols

 Back cover of this instruction manual Symbol

Description

Symbol

Description

Manufacturer

Authorized representative in the European Community

Translation

Importer (into European Union)

 Package Symbol

Description Date of manufacture

95% 10%

Symbol 70C –20C

1060hPa

Humidity limit

Description Temperature limit

Atmosphere limit

700hPa

Unique device identifier

Catalogue number

Serial number

MAJ-2301 INSTRUCTION MANUAL

3

Important Information - Please Read Before Use

Important Information - Please Read Before Use

 Intended use / Intended purpose This instrument has been designed to be used with Olympus Surgical Microscope for use in controlling it.

 Patient selection criteria None known.

 Contraindications None known.

 Clinical Benefit Supports to achieve the clinical benefit of OME-V200 by providing wireless or wired operation function.

 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 the related equipment and use the equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions about any information in this manual, contact Olympus.

 Terms used in this manual Surgical microscope (OME-V200) The surgical microscope designated by Olympus to be used in combination with this instrument.

4

MAJ-2301 INSTRUCTION MANUAL

Important Information - Please Read Before Use

Pairing Action of giving one-to-one correspondence between the wireless unit connected to the surgical microscope and the foot switch for holding wireless communication between them.

View field movement Function that moves the positioning of observation using the foot switch.

 User qualifications 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 clinical procedures of microsurgery using surgical microscope. This manual, therefore, does not explain or discuss the details of microsurgery using surgical microscope. For details of microsurgery using a surgical microscope, the physician and operator are requested to judge from their viewpoints as specialists.

 Instrument compatibility This instrument should be used in combination with the ancillary equipment shown in “ System chart” on page 59. Using incompatible equipment can result in patient or operator injury and/or equipment damage as well as malfunction. This instrument complies with EMC standard for medical electrical equipment edition 4 (IEC 60601-1-2: 2014).

 Prohibition of improper repair and modification Never allow a person other than Olympus-qualified personnel to disassemble or modify the instrument, as this may result in injury of the patient or operator as well as damage to the equipment. Olympus will not assume any liability for human accident or equipment damage occurred due to repair by a person other than Olympus-qualified personnel.

MAJ-2301 INSTRUCTION MANUAL

5

Important Information - Please Read Before Use

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

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

WARNING • Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock.  Do not souse or spill a liquid such as water over the wireless unit. If a liquid is spilt on it, immediately wipe it. Should a liquid penetrate the wireless unit, immediately stop using it and contact Olympus.  Do not prepare, inspect, or use the foot switch with wet hands.  Should a liquid enter the foot switch during the battery replacement, for example, immediately remove the batteries to prevent a fire or electric shock hazard. Once a liquid has entered the foot switch, do not use it because the equipment may have been damaged. • Never install and operate the foot switch in locations where:  The concentration of oxygen is high;  Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere;  Flammable gases are present in the atmosphere;  Flammable liquids are near. Otherwise, explosion or a fire may result because the foot switch is not explosion-proof. • Do not use for purposes other than those described in “ Intended use / Intended purpose” on page 4, as this may result in injury of the patient or operator as well as damage to the equipment.

6

MAJ-2301 INSTRUCTION MANUAL

Important Information - Please Read Before Use

WARNING • This instrument should be used under the conditions specified in “ Environments” on page 61. Otherwise, imperilment of safety or failure of equipment may result as well as malfunction.

CAUTION • Since this instrument has a wireless function, it may affect peripherals to be used at the same time. • Handle batteries by strictly observing the following. Incorrect use of batteries may cause fluid leak, heat generation, which would lead to equipment damage.  Use batteries specified for this instrument.  Do not use rechargeable batteries.  Insert batteries by observing the (+) and (–) polarity.  Use only batteries of the same brand.  Do not use a battery with a broken coating.  Do not use a battery deformed by dropping or other impact.  Do not use a battery if any irregularity, including fluid leak, discoloration, and deformation, is observed. • Do not use this instrument in any place where it may be subject to strong electromagnetic radiation (for example, in the vicinity of a microwave therapeutic equipment, MRI, wireless set, short-wave therapeutic equipment, cellular/portable phone, etc.). This may impair the performance of this instrument. • Do not use this instrument in any place with strong magnetic force, or bring magnetized equipment or magnets closer. This may impair the performance of this instrument. • Do not apply excessive force to a switch of this instrument or press it with a sharp or hard object. Otherwise, the switch damage may result. • Connect various connectors in a dry state without contamination of electrical contacts. Also, do not touch the electrical contacts inside the connector directly. If the electrical contacts are dirty or used under wet conditions, the equipment may cause malfunction. • Do not apply excessive force or strong impact to this instrument, ancillary equipment, and cables. Otherwise, equipment damage or failure may result. • Remove batteries when they are exhausted or not to be used for a long period. If batteries are left inside the instrument, over-discharge may cause fluid leak, which may eventually lead to a failure of this instrument. • Remove dust and dirt from batteries before use. If the (+) or (–) pole is dirty or dusty, a contact failure may result. MAJ-2301 INSTRUCTION MANUAL

7

Important Information - Please Read Before Use

NOTE • Startup display icons are displayed on four corners of the observation monitor screen for ten to twenty seconds after the power is turned ON on the surgical microscope. Afterwards the icons will disappear. These icons are displayed until the setup of the surgical microscope has completed and does not mean malfunction.

Figure 1 • In case any serious incident happens to user or patient while operating the device,that incident should be reported to Olympus and the competent authority of the respective member state or country.

8

MAJ-2301 INSTRUCTION MANUAL

Important Information - Please Read Before Use

 EMC • For safety, always use this instrument in combination with equipment compliant to the EMC standard. Otherwise, interference from or to other equipment may result. • The foot switch and wireless unit radiate RF energy to achieve their intended use (control of the surgical microscope). This means that they could produce electromagnetic interferences when they are placed in the proximity of equipment carrying the symbol marking below or mobile and portable RF communications equipment such as a cellphone. If an electromagnetic interference occurs, a relief measure such as displacement of interfered equipment will be required.

• The foot switch and wireless unit incorporate the radio communication function as shown in the following table. Consequently, they may be affected by electromagnetic interference from nearby equipment that uses the same frequency band as them. Before using them, make sure that there is no risk of electromagnetic interference from nearby equipment. Frequency band with potential risk of extraneous interference

2400 – 2483.5 MHz

Modulation method

Primary modulation: FSK Secondary modulation: FHSS

Antenna power

1.0 mW

Table 1

MAJ-2301 INSTRUCTION MANUAL

9

Summary of Equipment Functions

Summary of Equipment Functions This instrument is designed to be connected to the Olympus-designated surgical microscope. By pairing between the foot switch and wireless unit, the control signals of the surgical microscope can be transmitted with either wireless or wired connection. The function incorporated in this instrument is outlined below. Note that only one foot switch can be pairing with a wireless unit.

 Pairing of foot switch and wireless unit Pairing of the foot switch and wireless unit enables wireless communication between them. Pairing can be set using the foot switch cable provided with this instrument. Wireless control of the functions of the surgical microscope is possible by controlling the foot switch. Refer to Section 3.6, “Pairing”.

 Wired connection of foot switch In case the wireless signal is weak or the batteries are exhausted, the foot switch can be connected directly to the Olympus-designated surgical microscope using the provided foot switch cable. When the foot switch is connected through the foot switch cable, the functions of the surgical microscope can be controlled from the foot switch even when it contains no batteries in it. Refer to Section 5.3, “Wired control of foot switch”.

NOTE • The foot switch cannot control the microscope functions unless the provided wireless unit is connected to the microscope. Be sure to connect the wireless unit to the surgical microscope even before the wired control operation. • Wireless communication is not performed when wired connection.

10

MAJ-2301 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, such as the foot switch, wireless unit, and accessories, 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.

 Foot switch and Wireless unit

Foot switch (MAJ-2301)

Wireless unit

 Accessories

Foot switch hanger

Foot switch cable

Pairing stickers (No.1 – No.10)

Retaining screws (M4 × 5 mm) (× 4)

Retaining screws (M4 × 12 mm) (× 2)

Allen screwdriver (3 mm width across flats)

MAJ-2301 INSTRUCTION MANUAL

11

Ch.1

1.1 Checking the package contents

Instruction manual (This book)

EU DECLARATION OF CONFORMITY

DECLARATION OF CONFORMITY for Ukraine Radio Law

NOTE

Ch.1

This instrument does not come with batteries. Before use, prepare three “C”-size 1.5 V alkaline batteries separately.

12

MAJ-2301 INSTRUCTION MANUAL

2.1 Symbols and descriptions

Chapter 2

Nomenclature and Functions

This chapter is intended to explain the names and functions of the parts of the foot switch.

2.1

Symbols and descriptions

 Foot switch Symbol

Ch.2 Description

Symbol

Description

Communication status marking

Battery power marking

Battery insertion orientation indication

Rechargeable battery inhibition indication

Foot switch 1

Foot switch 2

Foot switch 3

Foot switch 4

Foot switch 5

Foot switch 6

Medical device

Model number

 Wireless unit Symbol

Description Foot switch marking

MAJ-2301 INSTRUCTION MANUAL

Symbol

Description Serial number

13

2.2 Foot switch

2.2

Foot switch

 Upper surface 1

2

3

4

5

6 (6)

6 (5)

Ch.2 6 (3) 6 (4)

No.

7 (C)

7 (D)

7 (A)

7 (B)

6 (1)

6 (2)

Name

Description

1

Handle

To be held when carrying the foot switch. It can also be hooked on the foot switch hanger when storing the foot switch.

2

Pairing indicator

Indicates pairing with the combined wireless unit. Refer to Section 3.6, “Pairing”.

3

Joystick

Used to control the movement by the joystick on the foot switch of the surgical microscope.

4

Communication status indicator

The green LED lights when the communication status is good and flashes when it deteriorates. Refer to Section 5.2, “Wireless control of foot switch”.

5

Battery power indicator The amber LED lights or flashes according to the remaining battery power level. Refer to Section 3.5, “Insertion of batteries into the foot switch”.

6

Foot switches 1 to 6

The functions of the surgical microscope can be assigned to these switches. The function assignment is performed from the surgical microscope.

7

Foot switches A to D

Used to control the focusing and zooming functions of the surgical microscope. The functions of the four switches are assigned from the surgical microscope.

NOTE For the function assignment of the switches, refer to the instruction manual for the surgical microscope.

14

MAJ-2301 INSTRUCTION MANUAL

2.2 Foot switch

 Rear and front surface 4 1 2

5

8

6 View when battery compartment cover is opened

3

7

7 Rear surface

Terminal surface

Ch.2

Close-up view of connection terminal

No.

Name

Description

1

Battery compartment cover

Opened or closed for inserting or removing batteries.

2

Finger hook

Insert your fingertip for opening the battery compartment cover.

3

Locks

Used to lock or unlock the battery compartment cover.

4

Battery compartment

Insert three “C”-size 1.5 V alkaline batteries.

5

Packing

Prevents water penetration inside the battery compartment.

6

Ribbon

To be pulled for removing batteries from the foot switch.

7

Connection terminal

Connect the FOOTSWITCH connector (on the side marked “FOOTSWITCH”) of the foot switch cable.

8

Terminal cover

Lid for protecting the connection terminal. To be opened when connecting the foot switch cable to the terminal.

MAJ-2301 INSTRUCTION MANUAL

15

2.3 Wireless unit

2.3

Wireless unit 1 2

2 3

Ch.2 No.

Name

Description

1

Connection terminal

Means of electrical connection to the surgical microscope.

2

Attaching holes

Used to attach the wireless unit to the surgical microscope using the provided retaining screws (M4 × 5 mm).

3

Pairing sticker attaching part

Attach the pairing sticker.

2.4

Foot switch hanger 1

2 4

3

No.

Name

Description

1

Attaching section

Used when attaching to the movement handle of the surgical microscope.

2

Attaching holes

Used to attach the foot switch hanger to the surgical microscope using the provided retaining screws (M4 × 12 mm).

3

Hook

Used to hook the foot switch.

4

Cable hook

Used to hook the cable when storing it.

16

MAJ-2301 INSTRUCTION MANUAL

2.5 Foot switch cable

2.5

Foot switch cable 2

1

3

4

5

6

7

No.

Name

1

FOOTSWITCH connector

Connect this connector to the connector on the foot switch when using it with wired connection.

2

Index

Connect the cable to the terminal on the foot switch so that this marking is visible on the top.

3

FOOTSWITCH marking

Indicates that the FOOTSWITCH connector is to be connected to the foot switch on this side.

4

MICROSCOPE marking

Indicates that the MICROSCOPE connector is to be connected to the surgical microscope on this side.

5

Index

Connect the cable to the footswitch terminal on the surgical microscope so that this marking is visible on the top.

6

MICROSCOPE connector

Connect this connector to the foot switch terminal on the surgical microscope.

7

Lock

Used for removing from a foot switch or surgical microscope.

2.6

Description

Pairing stickers 1

No.

Name

1

Pairing stickers No.1 – No.10

Description Attach the sticker matching the pairing indication on the paired foot switch onto the wireless unit. Refer to Section 3.6, “Pairing”.

MAJ-2301 INSTRUCTION MANUAL

17

Ch.2