TX-20 Operation Manual

Thank you for purchasing the Canon Full Auto Tonometer TX-20 (referred to as “TX-20” in this manual). Be sure to read this manual thoroughly before using the instrument, and apply the information that you learn.

Important • The TX-20 must only be used by a doctor or a legally qualified person. • The user is responsible for managing the usage and maintenance of medical equipment. We suggest that a dedicated individual is assigned responsibility for maintenance to ensure that the TX-20 is kept in good condition and can be used safely. • Rx Only (USA) Federal law restricts this device to sale by or on the order of a physician.

Disclaimers • Canon takes no responsibility for damage that occurs due to fires, earthquakes, third-party actions, other accidents, the user's deliberate misuse, negligence, experimentation, or use under other abnormal conditions. • Canon takes no responsibility for direct or consequential damages resulting from the use or the inability to use the TX-20. • Canon takes no responsibility for injuries or property damage that may occur if safety precautions are not followed or the instrument is used for something other than its intended purpose. • Medical examinations are the responsibility of a doctor. Canon takes no responsibility for diagnostic results. • The information in this manual may be changed without prior notice. • Although we have made every effort to ensure the accuracy of the information in this manual, if you have any questions regarding the contents, please contact your sales representative or local Canon dealer.

Installation • Request your sales representative or local Canon dealer to install the TX-20.

Trademarks • Canon and the Canon logo are trademarks of Canon Inc. • Other system names and product names that appear in this manual are trademarks of their respective companies.

Copyright • The copyright of this manual belongs to Canon Inc. • Unauthorized reproduction, duplication, or reprinting of this manual in whole or in part is prohibited.

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Contents 1 Introduction... 5 Features... 5 Indications for Use... 5 Components... 6 Conventions Used in This Manual... 7 2 Safety... 8 Regulatory Information... 8 Safety Precautions... 10 Notes on Using TX-20... 14 Labels and Symbols... 17 3 Names of Parts... 19 Main Unit (From the Examiner's Side)... 19 Main Unit (From the Patient's Side)... 20 Bottom Side... 21 Operation Panel... 22 Operation Lever... 23 Monitor Panel... 24 Measurement Screen... 25 PATIENT ID Screen... 27 DATA Screen... 28 MENU Screen... 29 Screen that Appears When Measurement Fails... 30 Anterior Segment Image Display Screen... 30 Anterior Segment Image and Intraocular Pressure Measurement Waveform Display Screen... 31 Other Screens... 32 USB Connection Check Screen... 32 Print Message Input Screen ... 32 User Name Input Screen... 33 Password Input Screen ... 33 Computer Name Input Screen... 34 Output Folder Name Input Screen ... 34 LCD Brightness Adjustment Screen . ... 35 Description of Printouts ... 36 4 Basic Operation... 37 Flow of Operations... 37 Connecting Cables . ... 38 Preparations Prior to an Examination... 40 Patient Setup... 41 Measuring... 43 Finishing an Examination... 47 Power Saving Mode... 48 Recovering from the Power Saving Mode... 48 5 Types of Measurements... 49 Measurement Screen... 49 Changing the Alignment Mode ... 49 Changing the Number of Measurements ... 50 Changing the Eye Fixation Lamp . ... 51 PATIENT ID Screen ... 51 Input Patient ID in the PATIENT ID Screen... 52 Input Patient ID from an External Device ... 56 MENU Screen . ... 57 MENU Screen Display and Functions of Buttons ... 57

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 Basic Operations on MENU Screen ... 58 Common Settings in Measurement Modes ... 61 Settings for Intraocular Pressure Measurements . ... 62 Settings for Printing ... 63 Settings for Patient ID Input Interface ... 64 Settings for Interface of Output of Measurements ... 64 Settings for Patient No. . ... 67 Settings for Patient ID ... 68 Setting the Time, Date, and Power Saving Mode... 69 Settings for the LCD ... 69 Checking Firmware ... 70 6 Maintenance... 71 Daily Inspections ... 71 Cleaning and Disinfection... 72 Refilling Chin Rest Paper... 74 Replacing Printing Paper... 74 Preparations for Packing and Transport . ... 76 7 Troubleshooting... 77 Symptom and Remedy... 77 Message and Remedy... 78 Appendix... 87 Specifications... 87 Stylesheet File... 88 EMC (Electromagnetic Compatibility)... 90 Warranty and Repair Service... 95

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1

Introduction

Features The Canon Full Auto Tonometer TX-20 has full auto-alignment for intraocular pressure measurement. The features of these products are shown below.

Three alignment modes • In full auto mode, both eyes are measured and the results are printed automatically, shortening the time used for measuring. • In auto mode, auto-alignment and measurement are performed each time the measurement button is pressed. The examiner can monitor the condition of the patient’s eyes while measuring them. • In manual mode, measurements can be performed manually such as when the patient’s pupil is eccentric or cornea is deformed.

Compact, with superior operability More compact and more lightweight than the previous model. Upright operations, patient care, alignment operation have been greatly improved with a tiltable color LCD monitor and powered operation lever.

Enhanced external interface Measurement data can be exported via RS-232C connections or to a LAN. Patient ID can be input from a USB device.

Indications for Use For USA The Canon Full Auto Tonometer TX-20 is intended to be used for the measurement of intraocular pressure of the human eye.

For European Union The TX-20 measures the intraocular pressure detecting the change of the cornea surface and the result will be provided for diagnosis.

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1 Introduction

Components Full Auto Tonometer TX-20 Main unit

Chin rest paper 100 sheets provided.

Power cord Connects the TX-20 to an AC outlet (3m). USA and Canada only: Plug type: VM0275 HospitalGrade

Printing paper 2 rolls provided.

Nozzle cap Initially covers the nozzle.

Dust cover Use it to cover the TX-20 when the instrument is not being used.

Ferrite core If a LAN cable is being used, attach the ferrite core to it. Operation manual for the TX-20-this document Describes the handling precautions and operating instructions for the TX-20. Warranty Card (for USA model only) WEEE Directive Leaflet (for EU model only) Installation Report

Optional products Chin rest paper-500 sheets Printing paper-10 rolls

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1 Introduction

Conventions Used in This Manual This manual uses the following symbols to indicate precautions that are important for using the TX-20 safely. Always follow these safety precautions.

WARNING CAUTION CAUTION

A warning that incorrect operation may result in death or serious injury. A caution that incorrect operation may result in serious injury. A caution that incorrect operation may break the TX-20 or damage other devices. This symbol indicates actions that must not be taken (prohibited actions). This symbol indicates actions that must be taken. This symbol indicates important advice that we strongly recommend be followed while operating the TX-20. This symbol indicates supplementary explanations or advice for operating the TX-20.

References This manual uses the following style to indicate reference destination. Example: (see page 15)

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Safety

Regulatory Information The following sections list the classifications applicable to the TX-20 and the directives and standards that the TX-20 complies with.

Device Classification Type of protection against electric shock

Class I equipment

Degree of protection against electric shock

Type B applied parts (Chin rest, forehead rest)

Degree of protection against ingress of water

IPX0

Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide

Not suitable

Mode of operation

Continuous operation

Directives and Standards USA and Canada UL 60601-1:2003 CAN/CSA C22.2 No.601.1-M90 IEC 60601-1: 1988/A1: 1991/A2: 1995

Medical electrical equipment – Part 1: General requirements for safety

IEC 60601-1:2005

Medical electrical equipment - Part1: General requirements for basic safety and essential performance

IEC 60601-1-1: 2000

Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems

IEC 60601-1-2: 2001/A1:2004 IEC 60601-1-2:2007

Medical electrical equipment – Part 1-2: Collateral standard: Electromagnetic compatibility – Requirements and tests

IEC 60601-1-4: 1996/A1: 1999

Medical electrical equipment – Part 1-4: Collateral standard: Programmable electrical medical systems

IEC 62304: 2006

Medical device software – Software life-cycle processes

IEC 62366: 2007

Medical device – Application of usability engineering to medical devices

ISO 15004-1: 2006

Ophthalmic instruments – Part 1: General requirements applicable to all ophthalmic instruments

ISO 15004-2: 2007

Ophthalmic instruments – Part 2: Light hazard protection

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2 Safety

ISO 10993-1: 2009 ISO 10993-5: 2009 ISO 10993-10: 2010

Biological evaluation of medical devices – Evaluation and testing

ISO 8612: 2001 ANSI Z80.10-2003

Ophthalmic instruments – Tonometers

European Union 93/42/EEC

Medical Device Directive

EN 60601-1:2006

Medical electrical equipment - Part1:General requirements for basic safety and essential performance

EN 60601-1-2: 2007

Medical electrical equipment – Part 1-2: Collateral standard: Electromagnetic compatibility – Requirements and tests

EN 60601-1-6: 2010

Medical electrical equipment – Part 1-6: Collateral standard: Usability

EN 62304: 2006

Medical device software – Software life-cycle processes

EN 62366: 2008

Medical device – Application of usability engineering to medical devices

EN ISO 14971: 2009

Medical device – Application of risk management to medical devices

EN ISO 15004-1: 2009

Ophthalmic instruments – Part 1: General requirements applicable to all ophthalmic instruments

ISO 15004-2: 2007

Ophthalmic instruments – Part 2: Light hazard protection

EN ISO 10993-1: 2009 EN ISO 10993-5: 2009 EN ISO 10993-10: 2010

Biological evaluation of medical devices

ISO 8612: 2001

Ophthalmic instruments – Tonometers

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Safety Precautions To prevent injuries and data loss, operate the TX-20 correctly by following the safety precautions.

To avoid the risk of electric shock, this instrument must only be connected into a supply mains with protective earth.

WARNING

Do not damage the power cord. Prohibited

• Do not place anything heavy onto the power cord. • Do not damage or modify the power cord. • Do not forcibly bend, twist or pull the power cord. • Do not hold the power cord when removing it from the AC outlet. Be sure to hold the plug. Handle the power cord carefully. If the cord is damaged, contact your sales representative or local Canon dealer for a replacement. A damaged cord may result in fire or electric shock.

Do not use a multiple power strip and an extension cable. Prohibited

Connect the power cord directly to the AC outlet. Do not use a multiple power strip and an extension cable with it.

Do not disassemble or modify. Prohibited

A disassembled or modified instrument may result in fire or electric shock. Because the TX-20 incorporates high-voltage parts that may cause electric shocks, touching them may cause death or serious injury.

Do not leave alcohol, thinner, or any flammable chemicals near the instrument. Prohibited

Do not place near to a flammable solvent. Fire may result if the solvent spills or evaporates and makes contact with the internal electric parts. Some disinfectants are flammable. Be sure to take precautions when using them.

Stop using immediately if there is an abnormality or problem. If an abnormality occurs, immediately unplug the power plug and turn off the power of all the devices. • Smoke is emitted • An unusual smell • An unusual noise • Foreign matter gets inside • Damaged Fire or electric shock may result if you continue use in such conditions. Immediately turn off the power of TX-20, unplug the power plug and turn off the power of all connected devices. Then, contact your sales representative or local Canon dealer.

Do not place anything on top of the device. Prohibited

Fire or electric shock may result if water or any other liquid or a needle, paper clip or any foreign matter gets inside the TX-20.

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WARNING Prohibited

Do not use a power supply voltage other than the one specified on the rating label. Do not use any power cord other than the one supplied. Use the power voltage specified on the rating label. Otherwise, fire or electric shock may result. The supplied power cord is designed exclusively for this product. Do not use any other power cord.

Do not plug or unplug the power plug with wet hands. Prohibited

Do not plug or unplug the power plug or handle any other parts with wet hands. Otherwise, fire or electric shock may result.

Unplug the plug periodically and remove any dust or dirt around the plug and the AC outlet. If the cord is kept plugged in for a long time in a dusty, humid or sooty environment, dust around the plug will attract moisture, resulting in possible insulation failure that may result in a fire.

Insert the power plug completely. Insert the power plug completely into the AC outlet. If a pin of the power plug makes contact with metal or any conductive object, fire or electric shock may result.

Do not clean the TX-20 with flammable solvent. Prohibited

For safety reasons, before cleaning the TX-20, be sure to turn off the power of all the devices and unplug the power cord from the AC outlet. Do not use alcohol that is not for cleaning, benzene, thinner or any other flammable solvent. Otherwise, fire or electric shock may result.

Turn off the power before inspection. For safety reasons, before inspecting the instrument or cables, be sure to turn off the power of all the devices. Otherwise, electric shock may result.

Do not measure an eye whose cornea is frail due to corneal disease or surgery. Prohibited

Otherwise, complications may occur.

Be sure to turn off the power before moving the TX-20. When moving the TX-20, always move the measurement unit to the packing position (see page 76), turn off the power, unplug the power cord, and disconnect any external equipment. Otherwise, the cable may be damaged, which may result in fire or electric shock.

Use the indentations for lifting and moving the TX-20. When lifting the TX-20, hold it on the bottom and keep it level. Do not hold it by the head rest, nozzle or LCD monitor, as they may come off and result in injury.

Do not touch conductive parts of non-medical equipment and the patient simultaneously. Prohibited

Otherwise, electric shock may result.

Do not install in locations exposed to water, steam, moisture or dust.

CAUTION Prohibited

Doing so may cause problems or malfunctions.

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2 Safety

Do not install in locations exposed to salt, sulfur or corrosive gas.

CAUTION Prohibited

Doing so may result in corrosion of the instrument, problems or malfunctions.

Do not install in locations that are unstable or exposed to vibration. Prohibited

The vibration may knock over the instrument or the instrument may become unbalanced and fall, resulting in a malfunction or injury.

Do not place anything near the power plug. Prohibited

To make it easy to unplug the power plug at any time, avoid putting any obstructions near the AC outlet. Fire or electric shock may result if the power plug is not unplugged during an emergency.

Do not block the vent holes. Prohibited

Doing so may cause the internal temperature to rise and result in fire.

Do not put your hands or fingers near the measurement unit. Prohibited

Your hand or fingers may be pinched and injured. Similarly, instruct the patient not to place his/her hands or fingers on the base.

Hold the TX-20 when connecting or disconnecting a cable. For safety reasons, when connecting or disconnecting the power cord or any cable be sure to hold the main unit. Otherwise, the main unit may fall over, possibly causing injury.

Ensure that the entire system conforms to IEC 60601-1-1. Use the computer and other equipment that conform to the system standard IEC 60601-1 or IEC 60950-1 for the Full Auto Tonometer TX-20. Be sure that the entire system conforms to IEC 60601-1-1. Be sure to also use an isolation transformer conforming to IEC 60601-1 when a computer conforming to IEC 60950-1 is used. Otherwise, electric shock may occur. Ask your sales representative or local Canon dealer to connect it to a computer.

Use an isolation transformer for LAN connections. If the LAN connector is being used to connect to a network, connect an isolation transformer for networks between the TX-20 and network devices (HUB etc.) and between network devices. If this is not done, there is a risk of short circuits or malfunctioning devices. Ask your sales representative or local Canon dealer to connect it to a network.

Turn off the power and unplug the power cord before connecting cables. Always turn off the power and unplug the power cord before connecting the cables of any external devices to the TX-20. If this is not done, there is a risk of damage.

Always disinfect the nozzle after measuring an infected patient’s eyes. A patient’s tears may get on the nozzle and cause a secondary infection. Always use a cotton swab or other appropriate material that has been treated with disinfectant ethanol to wipe the nozzle.

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2 Safety

Keep the forehead rest and chin rest clean.

CAUTION

To prevent the risk of infection, wipe the forehead rest with disinfectant ethanol for each patient. To ensure cleanliness, replace the chin rest paper for each patient. If the chin rest paper is not being used, be sure to disinfect the chin rest for each patient. For details on how to disinfect, consult a specialist. The forehead rest may be corroded if a disinfectant other than those above is used.

Be sure to turn off the power when not in use. For safety reasons, be sure to turn off the power of all the devices when the TX-20 is not being used. Also, remove the power plug from the AC outlet and put on the cover when the TX20 is not going to be used for a long time. Otherwise, dust or any foreign matter may accumulate and result in fire.

Make sure to select the position where the nozzle stops for each patient. Look from the side of the patient when setting the stop position to see that the patient’s forehead and chin are firmly against the forehead rest and chin rest. If the stop position is not set correctly, the nozzle may contact the patient’s eye and result in injury.

Do not touch the cutter for the printer. Prohibited

Do not touch the cutter for the printer. Similarly, instruct the patient not to touch the cutter for the printer. Otherwise, it may result in injury.

Do not touch the area around the printer or open the paper cover during or immediately after printing. Prohibited

The printer’s thermal head and the surrounding area are very hot during and immediately after printing. To prevent burns, wait for the printer to cool before opening the paper cover to replace paper.

Do not touch the measurement unit and the chin rest while they are moving. Prohibited

CAUTION

The measurement unit and the chin rest move when the power is turned on, full auto is set, or the CHIN REST button is pressed. Do not touch the measurement unit or the chin rest while they are moving. Keep the patient’s chin away from the chin rest.

Use the product’s packaging to transport it. Use the TX-20 packing materials to protect it from vibration and shocks when it is transported on a cart, in a vehicle, or if shipped over long distances. Vibration or shock may cause a breakdown or damage the TX-20. For details, contact your sales representative or local Canon dealer.

Inspect daily and periodically. For safety reasons, before using the TX-20, be sure to perform the daily inspection. Have a periodically inspection performed for the TX-20 at least once a year by a Canon designated representative to maintain its performance and reliability.

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2 Safety

Notes on Using TX-20 Before Use • Sudden heating of the room in cold areas will cause condensation to form on the optical component of the nozzle and on optical parts inside the instrument. In this case, wait until condensation disappears before performing a measurement.

During Measurement • Describe to the patient what to expect during measurement so he/she will not be surprised by the sudden air puff. Demonstrate the intensity of the air puff by having the patient place a finger in front of the nozzle and then press the CHECK button. • The measurement unit automatically moves after the power is turned on. Do not prevent movement of the measurement unit by holding it or placing something near it. Do not let the patient place his/her chin on the chin rest until the measurement unit stops. • It is recommended that a hard copy of the printout be made if you wish to store it for a long time, because printouts on thermal paper are apt to deteriorate.

After Use • Turn off the power, put the cap over the optical component of the nozzle in order to prevent dust from attaching to it, and place the dust cover over the instrument.

During Cleaning and Disinfection • If the surface of the optical component of the nozzle is wiped when dust or dirt is on it, it will be scratched. Also, do not wipe the optical component with alcohol, including disinfectant ethanol or silicone-coated paper. Otherwise, the surface will be corroded or stained. • Use neutral detergent for cleaning the outside of the TX-20. Do not use neutral detergent for cleaning the LCD monitor. See below for LCD cleaning instructions.

LCD Monitor • Approximately 99.99% of the dots in high-technology LCD monitors are functional. About 0.01% of the dots may be missing or might appear as a bright spot. This is not a malfunction. • The polarization plate on the surface of the monitor is very fragile. Be careful when handling it and do not press or rub any hard objects against it. • Wipe water or saliva from the polarization plate on the monitor’s surface immediately; leaving it for a long time may cause distortion or discoloration. • If the surface is dirty, use something soft, such as an absorbent cotton cloth, with a small amount of ethanol, and lightly wipe it.

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Environment of Use • Use, store, and transport the TX-20 in an environment that is within the range of the following conditions. Use the original packaging to store or ship it. Temperature Environment of use

Humidity

Atmospheric pressure

10 to 40°C

30 to 90% RH (no condensation)

600 to 1060 hPa

Storage and transportation –30 to 50°C environment

10 to 95% RH (no condensation)

600 to 1060 hPa

• Do not install, store, or leave the TX-20 in a very hot or humid environment. Also, do not use the TX-20 outside. Doing so may cause a malfunction or misoperation. • After many years of usage, airborne dust in the room may get on the nozzle as well as the optical parts in the main unit and prevent accurate measurement. • When the TX-20 is not being used, attach the nozzle cap and place the dust cover over the TX-20.

Installation • Request your sales representative or local Canon dealer to install the TX-20. • A strong shock to the TX-20 may put it out of alignment. Please handle the unit carefully.

Transportation • Be sure to turn off the TX-20’s power switch, remove the AC plug from the outlet, and disconnect any cables connected to other equipment. • When moving the TX-20, perform the specified operation to move the measurement unit to the transport position (see page 76). • Remove the paper from the printer before moving the TX-20. • Carry the TX-20 by the indentations for lifting at its front and rear, and keep it level. • Do not hold anything except the indentions for lifting when lifting the TX-20. • The TX-20 needs to be protected from vibration and shocks when it is transported on a cart, in a vehicle, or if shipped over long distances. Always use the original packaging. For details, contact your sales representative or local Canon dealer.

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2 Safety

Disposal Disposal of this product in an unlawful manner may have a negative impact on human health and on the environment. Therefore, when disposing of this product, be absolutely certain to follow the procedure which is in conformity with the laws and regulations applicable to your area.

European Union (and EEA*) only This symbol indicates that this product is not to be disposed of with your household waste, according to the WEEE Directive (2002/96/EC) and your national law. This product should be handed over to a designated collection point, e.g., on an authorized one-for-one basis when you buy a new similar product or to an authorized collection site for recycling waste electrical and electronic equipment (EEE). Improper handling of this type of waste could have a possible negative impact on the environment and human health due to potentially hazardous substances that are generally associated with EEE. At the same time, your cooperation in the correct disposal of this product will contribute to the effective usage of natural resources. For more information about where you can drop off your waste equipment for recycling, please contact your local city office, waste authority, approved WEEE scheme or your household waste disposal service. For more information regarding return and recycling of WEEE products, please visit www.canon-europe.com/WEEE. * EEA: Norway, Iceland and Liechtenstein

For California, USA Only The battery in this device contains perchlorate material. Special handling may apply. See http://www.dtsc.ca.gov/hazardouswaste/perchlorate

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2 Safety

Labels and Symbols The position and contents of the label attached on the TX-20 are shown below.

USA and Canada

European Union

The following table describes the symbols and indications on the TX-20.

USA and Canada Alternating current Type B Caution: Check the documentation provided. MEDICAL EQUIPMENT WITH RESPECT TO ELECRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1 AND CAN/CSA C22.2 NO. 601.1 41C4 Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Year and month of manufacture

Example: October 2010

Serial number in SIX digits

Example: 123456

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2 Safety

European Union Alternating current Type B Caution: Check the documentation provided. Product that WEEE directive, Directive on Waste Electrical and Electronic Equipment, 2002/96/EC, requires separate collection. This symbol shows compliance of the equipment with Directive 93/42/ EEC. This symbol indicates that a User’s Manual is supplied with this equipment. Manufacturer’s name and address Serial number in SIX digits

Example: 123456

Year and month of manufacture

Example: October 2010

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3

Names of Parts

Main Unit (From the Examiner's Side)

1 2 3

5 6

4

7

1

Measurement unit

5

Measurement is done at this part.

2

Height adjustment mark Align the patient's eye with this mark.

3

Printer Prints the measurement results.

6 7

Operation lever Indentation for lifting

LCD monitor The patient's eye and various screens appear here.

4

Operation panel Operations such as setting the nozzle position, chin rest height, and printing are done from here.

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3 Names of Parts

Main Unit (From the Patient's Side)

1

5

2 3

6

4

7

1

Forehead rest

5

Patient rests his/her forehead here to prevent patient's eye from moving.

2

Nozzle Blows air for observing or measuring the patient's eye.

3 4

Head rest Power switch Turns on the power for the main unit.

External eye fixation lamp Used if it is difficult to fix the patient's eye by using the internal eye fixation lamp. Fix on the eye that is not being measured.

6

Chin rest The patient’s chin is placed here. Raise or lower the chin rest to set the appropriate height for the patient’s eye(s).

7

Indentation for lifting

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