TONOREF II Operators Manual Nov 2010

Original instructions

NIDEK CO., LTD. (Manufacturer) NIDEK CO., LTD. (Tokyo Office)

NIDEK INCORPORATED (United States Agent) NIDEK S.A. (EU Authorized Representative)

: 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan Telephone: +81-533-67-6611 Facsimile: +81-533-67-6610 : 3F Sumitomo Fudosan Hongo Bldg., 3-22-5, Hongo, Bunkyo-Ku, Tokyo 113-0033, Japan Telephone: +81-3-5844-2641 Facsimile: +81-3-5844-2642 : 47651 Westinghouse Drive, Fremont, California 94539, U. S. A. Telephone: +1-510-226-5700 Facsimile: +1-510-226-5750 : Europarc 13, rue Auguste Perret, 94042 Créteil, France Telephone: +33-1-49 80 97 97 Facsimile: +33-1-49 80 32 08

November 2010 15601-P902G Printed in Japan

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Use this device properly and safely.

BEFORE USE, READ THIS MANUAL. This operator’s manual contains information necessary for the operation of the NIDEK AUTO REF/KERATO/TONOMETER Model TONOREF II. This manual includes the operating procedures, safety precautions, and specifications. This manual is necessary for proper use. Especially, the safety precautions and operating procedures must be thoroughly understood prior to operation of the device. Keep this manual handy to verify use whenever necessary. The device complies with ISO 10342 subclause 4: 2010 (Ophthalmic instruments-Eye Refractometers) and ISO 8612: 2009 (Tonometer). The dioptric powers are indicated with reference wavelength λd = 587.56 nm. There are no parts within the device that requires servicing by the user other than printer paper. If you encounter any problems or have questions about the device, please contact NIDEK or your authorized distributor.

"CAUTION! Federal Law (US) restricts this device to sale by or on the order of a properly licensed practitioner."

Safety precautions In this manual, signal words are used to designate the degree or level of safety alerting. The definitions are as follows.

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 or property damage accident.

Even situations indicated by “ CAUTION” may result in serious injury under certain conditions. Safety precautions must be strictly followed at all times.

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Use precautions Before Use CAUTION • Do not use the device for other than the intended purpose.

NIDEK is not responsible for accidents or malfunctions caused by misuse.

• Be sure to read the manual prior to operation of the device to understand the safety precautions and operating procedures thoroughly. Use the components specified by NIDEK. Using the device for purposes other than specified in this manual may cause unexpected malfunctions and/or adverse events. • Never modify nor touch the internal structure of the device. Electric shock or malfunction may result. • Install the device in an environment that meets the following conditions. The following conditions must be maintained during use. Use conditions Temperature: 10 to 35°C (50 to 95°F) Humidity: 30 to 75% (Non-condensing) Pressure: 800 to 1060 hPa A dust-free location A place with little external light A level and stable surface free from vibration and shock If the device is not installed and used under the above conditions, the reliability of measured results is impaired, and malfunction may result. In addition, there is a possibility of injury if the device receives shock and falls down. • Avoid installing the device near sunny windows or directly under a light. Intense light entering the measuring window may interfere with proper measurement. • Install the device in a place that is not exposed to strong electromagnetic waves. • Install the device in an environment where no contaminants such as corrosive gas, acid, or salt are contained in the air. Corrosion or malfunction of the device may result. • Avoid installing the device where it is exposed to direct air-conditioning flow. Changes in temperature may result in condensation inside the device or adversely affect measurements. • Be sure to use a wall outlet which meets the power specification requirements. If the line voltage is too high or too low, the device may not perform properly. Malfunction or fire may occur. • Connect the power plug to a ground outlet. Or connect a grounding wire to a ground terminal. Not connecting to a ground outlet may result in electric shock or fire in the event of device malfunction or power leakage. • Completely insert the power plug into the outlet as far as the prongs will go. Fire may occur if the device is used with a loose connection.

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CAUTION • Never use a table tap or extension cable to supply the device with power. The electrical safety may be lowered.

• Do not use a power cord other than the one supplied. Also do not connect the supplied power cord to any other device. Failure or fire may result. • Do not place heavy objects on the power cord. The damaged power cord may cause fire or electric shock. • Before connecting cables to the device, turn the device off and disconnect the power cord from the outlet. Malfunction may result. • Install the device in area where the outlet that the mains plug is inserted into is easily accessible during use. In addition, ensure that the power cord can be disconnected without the use of a tool. Otherwise, it may interfere with disconnecting of the power from the input power source in case of abnormality. • Before carrying the device, put the device into the packing mode and lock the main body to the base with the locking lever. Accidental movement of the measuring unit during transportation may result in malfunction. • When the device is carried, two persons should hold (A) and (B) (both right and left sides). Avoid holding the forehead rest and the main body; hold the bottom of the base. If only one person carries the device, or areas other than the base are held and the device falls, there is a possibility of injury or malfunction. (A)

(B)

• This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2: 2001 + A1: 2004. These limits are designed to provide reasonable protection against harmful interference in a standard medical installation. This device generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to other devices, which can be determined by turning the device off and on, the user is encouraged to try to correct the interference by one or more of the following measures: - Reorient or relocate the receiving device. - Increase the separation between the devices. - Connect the device to an outlet on a circuit different from that to which the other device(s) are connected. - Consult the manufacturer or field service technician for help.

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CAUTION • The International Electrotechnical Commission sets the essential requirements for electrical and electronic equipment that may disturb, or be disturbed by, other equipment. The TONOREF II complies with these requirements as shown in the tables in “6 EMC (ELECTROMAGNETIC COMPATIBILITY) (page 139)”. Follow the guidance in the tables for use of the device in an electromagnetic environment.

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During Use WARNING • Before starting NT measurement, adjust the safety stopper for each patient to prevent the air nozzle from touching the patient’s eye.

Contact between the air nozzle and the eye may damage the cornea.

CAUTION • Before use, perform visual and operation checks. If abnormal conditions are encountered, stop using the device.

If the device is used under abnormal conditions, intended results may not occur. Also unexpected malfunctions or health hazards may occur due to improper measurement. • Refrain from use on patients who have corneal surface disorder or anamnesis. • Take extra care when measuring patients with acute keratoconjunctivitis or poor fixation. • Before measurement, explain the measurement purpose or method sufficiently to patients. ex) You will feel a puff of air on your eye. This is normal measurement and has no affect on the eye. • Be sure not to touch the patient’s face during alignment or when alternately examinating the patient’s right and left eye. • Be sure to connect an interface cable, checking the symbols of input (IN: output (OUT:

) and

).

Data transmission may not be performed properly. • Take care not to catch hands or fingers in moving parts (measurement part and chin rest). Be sure to give this caution to patients. Hands or fingers may be pinched and may result in injury. • Instruct the patient to fix on the fixation light with their eyes wide open. Start the measurement after confirming that the instruction is properly followed by the patient. Be careful not to perform the measurement while the device is misaligned to the patient’s eye. Proper measurement may not be performed. ex) - Instruct the patient not to blink their eyes during the measurement. (The patient’s blinking during the measurement can be prevented by having them blink just before the measurement then open their eyes wide.) - Instruct the patient to open both eyes during the measurement. (With one eye closed, the fixation is not stable and the other eye cannot be opened wide enough.) • When measuring, caution patients not to touch the NT measurement part. When switching from NT measurement to R/K measurement, the air nozzle recesses and the shutter closes at which time fingers may be caught in the shutter. (In this case, the cover stops immediately and does not result in injury.) • Before measuring patients and at the end of use, wipe the forehead rest and chin rest with a clean cloth such as gauze dampened with rubbing alcohol. For tough stains, do not repeatedly wipe with a dry cloth, rather use a clean cloth dampened with rubbing alcohol. If chinrest paper is used, remove one piece for each patient.

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CAUTION • After use on the patients with an infection, be sure to clean the air nozzle with a cotton swab dampened with rubbing alcohol. Infected tears may be scattered and come into contact with the air nozzle then scattered again, causing a secondary infection.

• Before and after use, check that there are no contaminations like dust or fingerprints on the air nozzle or the measuring window. The measurement accuracy may decrease substantially. • In the event of smoke or strange odors, immediately turn off the device and disconnect the power plug from the outlet. After you are sure that the smoke has stopped, contact NIDEK or your authorized distributor. Usage of the device under such abnormal conditions may cause fire or electric shock. In case of fire, use a dry chemical (ABC) extinguisher to extinguish the fire. • Immediately replace the power cord if the internal wires are exposed, the device turns on or off when the power cord is moved, or the cord and/or plug are too hot to be held with hands. This may result in electric shock or fire. In the event of malfunction, disconnect the power cord from the wall outlet. Never touch the inside of the device and contact NIDEK or your authorized distributor. • Never press the LCD display with a hard object such as a ball-point pen. Keep magnetic objects away from the LCD display. The device may be damaged. • Do not operate the LCD display with wet hands. Water seeping into the device may result in failure of the device. • There may be a few constantly-lit, missing, or dead pixels in your LCD which are a characteristic of the LCD manufacturing process. This does not represent failure of the LCD; continuously use the display. • When connecting the device to a PC* that does not correspond to IEC60601-1, be sure to supply power through an isolation transformer. *PC adopting a class II AC adapter correspond to IEC60950-1. Electric shock may occur. For installation of the isolation transformer, consult NIDEK or your authorized distributor. • When connecting to peripheral equipment like a PC with LAN connector via a medical facility network, insert or connect the isolation transformer between medical electrical equipment and networked device (HUB etc.), or networked device and other electrical equipment. Depending on the types or numbers of other electrical equipment connected to the network, electric shock or malfunction/failure of the electrical equipment may occur. For installation of the network isolation transformer, consult NIDEK or your authorized distributor.

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CAUTION • Accessory equipment connected to the analog and digital interfaces must be certified according to the representative appropriate national standards (for example, UL

60950-1 for Data Processing Equipment, UL 60601-1 for Medical Equipment, and CSA C22.2 No. 601-1, EN 60601-1, and IEC 60601-1.) Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Anyone who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult the technical service department or your local representative. • The device uses thermal paper for printer. When archiving the printings, make a copy of it. Thermal paper may become difficult to read due to age deterioration. • If the device is used after a long period of disuse, check for any abnormality before use. • In the event of malfunction, disconnect the power cord from the wall outlet. Do not touch the inside of the device and contact NIDEK or your authorized distributor. • During installation and operation of the device, observe the following instructions about EMC (electromagnetic compatibility): - Do not use the device simultaneously with other electronic equipment to avoid electromagnetic interference with the operation of the device. - Do not use the device near, on, or under other electronic equipment to avoid electromagnetic interference with the operation of the device. - Do not use the device in the same room with other equipment such as life-support equipment, other equipment that has major effects on the life of the patient and results of treatment, or other measurement or treatment equipment that involves small electric current. - Do not use the device with portable and mobile radio frequency communication systems because that may have an adverse effect on operation of the device. - Do not use cables and accessories that are not specified for the device because that may increase the emission of electromagnetic waves from the device and decrease the immunity of the device to electromagnetic disturbance. • This device is classified as Group 1 set by ISO 15004-2: 2007 Light Hazard and conforms to the standard.

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Patient environment The patient environment is the volume of space in which contact can occur between the patient and any part of the device (including connected devices) or between the patient and any other person(s) touching the device (including connected devices). Use devices that comply with IEC60601-1 in the patient environment. If any device that does not comply with IEC 60601-1 is to be used, use an isolating transformer or common protective grounding.

Radius of 1.5 m

2.5 m

1.5 m

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1.5 m

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After Use CAUTION • When the device is not in use, turn off the power switch and put the dust cover over the device.

If not, dust may affect the measurement accuracy. • Do not yank the power cord to disconnect it from a wall outlet but hold the plug. This can damage the metal core of the cord and may result in fire, short circuit or electric shock. • Occasionally clean the prongs of the main plug with a dry cloth. If dust settles between the prongs, the dust will collect moisture, and short circuit or fire may occur. • If the device will not be used for a long time, disconnect the power cord from the wall outlet. Fire may occur. • Maintain the surrounding temperature and humidity at the following ranges during transportation and storage of the device. Environmental conditions: Temperature: –10 to 55ºC (14 to 131ºF) Humidity: 10 to 95% (non-condensing) Pressure: 700 to 1060 hPa A place not exposed to the water No large amount of dust is contained in the air Vibration- and shock-free, level and stable surface without vibration and shock A place not exposed to direct sunlight No chemicals or organic solvents are present, or a place where corrosive gas may be generated • To transport the device, use the special packing materials to protect from shock and impact. Excessive vibration or impact may cause device malfunction. • When transporting, set the mode to Packing mode and pack the main body in the original packing material with the fixing lever unlocked. It may result in failure when excessive vibration and shock are applied.

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Maintenance CAUTION • Only service technicians properly trained by NIDEK can repair the device or update the software.

NIDEK is not responsible for any accidents resulted from improper servicing. • When performing maintenance work, secure sufficient maintenance space. Maintenance work in an insufficient space may result in injury. • When the device is sent back to NIDEK for repair or maintenance, wipe the surfaces (especially, the area where patients contact) of the device with a clean cloth dampened with ethyl alcohol for disinfection. • Contact NIDEK or your authorized distributor to check whether the device needs measurement accuracy calibration if the AR-measured results are substantially different from subjectively measured results. • To maintain the performance, ask NIDEK to conduct yearly inspection. Inspection items: Calibration of measurement value Equipment component operation check

Disposal CAUTION • Follow local governing ordinances and recycling plans regarding disposal or recycling of device components. The device contains the circuit board with a lithium

battery mounted. Because the disposal method of lithium batteries varies according to the local government, follow the local governing ordinates and recycling plans when disposing of the circuit board with the lithium battery. It is recommended to commission the disposal to a designated industrial waste disposal contractor. Inappropriate disposal may contaminate the environment. • When disposing of packing materials, sort them by material and follow local governing ordinances and recycling plans. Inappropriate disposal may contaminate the environment.

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Table of Contents 1. BEFORE USE... 1 1.1 Outline of the Device...1 1.2 Intended Use...2 1.3 Principles...3 1.4 Device Description...4 1.5 Measurement Screen Description...9 1.5.1 1.5.2

R/K measurement screen...9 NT measurement screen...14

1.6 Labels and Indications on the Device...16 1.7 Checking Contents...17 1.8 Before First Use...18

2. OPERATING PROCEDURE... 23 2.1 Operation Flow...23 2.2 Preparation for Measurement...24 2.2.1 2.2.2

Measuring window check for soiling and puffed air pressure check during startup 29 Switching between R/K measurement and NT measurement...31

2.3 Finishing the Measurements...33 2.3.1 2.3.2

Normal shutoff...33 Shutoff before transporting the device...34

2.4 Selecting the Mode...35 2.4.1 2.4.2

Switching to manual mode...37 Sleep mode...38

2.5 AR (refractive error) and KM (corneal curvature radius) Measurements . . .39 2.5.1 2.5.2 2.5.3 2.5.4 2.5.5 2.5.6 2.5.7

AR (refractive error) and KM (corneal curvature radius) measurements: AR/KM measurement mode...40 AR (refractive error) Measurement: AR Measurement Mode...50 KM (corneal curvature radius) Measurement: KM Measurement Mode...52 CS (Corneal Size) Measurement...54 PS (Pupil Size) Measurement...57 PD (Pupillary Distance) Measurement...60 Measuring Hard Contact Lenses...62

2.6 NT (Tonometry) Measurement: NT Mode...64 2.6.1

Eyelid detection mode...74

2.7 Printing...75 2.7.1 2.7.2 2.7.3

Printing measured data...75 Eyeprint...78 Printing parameter settings...79

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2.8 Parameter Settings... 80 2.8.1 2.8.2 2.8.3 2.8.4

Parameter tables... 83 Setting Network function... 94 Setting the date and time... 99 Entering comments... 101

3. OPERATION WHEN PERIPHERAL DEVICES ARE CONNECTED... 103 3.1 Connecting to the NIDEK Motorized Refractor (RT)... 104 3.1.1 3.1.2 3.1.3

Outline... 104 Connecting procedure... 105 Operating procedure... 105

3.2 Connecting to the NIDEK Auto Lensmeter (LM)... 106 3.2.1 3.2.2 3.2.3

Outline... 106 Connecting procedure... 106 Operating procedure... 107

3.3 Connecting to Computer... 108 3.3.1 3.3.2 3.3.3

Outline... 108 RS-232C connection... 109 Network connection (LAN)... 110

3.4 Connecting to the Eye Care Card System... 112 3.4.1 3.4.2 3.4.3 3.4.4

Outline... 112 Method of connection... 112 Transferring data with the EyeCa-RW... 113 Erasing data on the Eye Care card... 114

3.5 Connecting Barcode / Magnetic Card Reader... 115 3.5.1 3.5.2 3.5.3

Outline... 115 Connecting procedure... 115 Operating procedure of barcode / magnetic card reader... 115

4. MAINTENANCE... 117 4.1 Troubleshooting... 117 4.2 Error Messages and Countermeasures... 119 4.3 Replacing Printer Paper... 123 4.4 Fixing Chinrest Paper... 125 4.5 Checking the AR/KM Measurement Accuracy... 126 4.6 Cleaning... 128 4.6.1 4.6.2 4.6.3

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Cleaning the measuring window... 128 Cleaning the air nozzle... 130 Cleaning the printer... 131

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4.6.4

Cleaning forehead rest and chinrest... 131

4.7 List of Replacement Parts... 132

5. SPECIFICATIONS AND ACCESSORIES... 133 5.1 Classifications... 133 5.2 Safety Features... 134 5.3 Specifications... 135 5.4 Standard Configuration... 138 5.4.1 5.4.2

Standard accessories... 138 Optional accessories... 138

6. EMC (ELECTROMAGNETIC COMPATIBILITY)... 139 7. GLOSSARY... 143 8. INDEX... 147

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1. BEFORE USE 1.1

Outline of the Device

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AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objective refraction, corneal shape measurement, and non-contact tonometry measurement by incorporating a standard auto ref/keratometer and non-contact tonometer into one unit. The objective refraction function measures spherical powers, cylindrical powers and cylinder axis. The corneal shape measurement function measures the radius of corneal curvature (corneal refractive powers), the direction of the steepest meridian, and the amount of corneal astigmatism. The non-contact tonometry function measures the intraocular pressure without contacting the eye. Refraction is mainly performed as a reference for lens prescription for correction of visual acuity using spectacles and contact lenses. The corneal curvature radius measurement is performed mainly for the following purposes: • To prescribe lenses for correction of visual acuity using contact lenses • To determine the power of intraocular lenses to be implanted after cataract surgery • To conduct postoperative follow-up of corneal shape Tonometry is performed for screening of glaucoma, and for preoperative examination and postoperative care in ophthalmology. This device is an integral type with a main body mounted on a base. A chinrest is mounted on the base on the patient’s side. An LCD panel, control buttons, joystick and a printer are attached on the main body to conduct alignment and perform operations. Inside the device are units for performing AR/KM and NT measurements, which can be operated by simply pressing a button/switch. In addition to the above, the device also offers the following features: • A space-saving concept that allows AR/KM and NT measurements to be performed by a single device which saves space and eliminates the need for the patient to move between two devices. • An auto-tracking mechanism is provided. The device automatically controls the up-anddown and right-and-left movement for alignment and focusing. • An auto shot function is provided. Measurements take place automatically when the device is best aligned and in focus. • An APC function that measures the intraocular pressure with the minimum necessary pressure of puffed air. • A motorized up-and-down chinrest allows the operator to adjust the height of the chinrest. • A built-in RS-232C/LAN interface allows data export to computers etc.

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BEFORE USE: Intended Use

1.2

Intended Use The AUTO REF/KERATO/TONOMETER TONOREF II is intended to be used for the measurement of the refractive errors of the eye, corneal radius of curvature and intraocular pressure.

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BEFORE USE: Principles

1.3

Principles

1. Objective refraction Fine measurement beams are projected on the fundus of the patient’s eye by a projecting optical system and then computation is performed by capturing the reflected beams as a ring image to measure the refractive errors (SPH, CYL, AXIS) of the patient’s eye. 2. Corneal curvature radius measurement Four near-infrared rays area projected onto the cornea and the ray reflected by the cornea is detected. From the detected signals, the corneal curvature radius (refractive power) and the direction of the steepest meridian are measured. 3. Measurement of intraocular pressure (NT measurement) Based on the Imbert-Fick principle (W = Pt × A), the intraocular pressure is calculated by dividing the amount of air pressure into the area of applanated surface. The device increases the air pressure puffed onto the cornea in proportion to time. The shape of the cornea changes gradually in the order of convex surface → applanated surface → concave surface. This change is optically detected and the device calculates the time required to make the pressed area flat after air is puffed on it. The air pressure used to make the cornea flat is calculated by time, and finally the intraocular pressure is obtained. APC (Automatic Puff Control) function The intraocular pressure measurement is performed with the air pressure as low as possible. When the measurement range is set to “APC 40” or “APC 60”, in the first measurement, the automatic shut-off function, which stops puffing air as soon as the light reflected from the cornea is detected, activates in order to eliminate excessive puffing. In subsequent measurements, the APC function activates to perform the measurement with the minimum air pressure based on the former measurement data. As the patient's eye is protected from excessive air pressure, discomfort of the patient can be decreased and continuous measurement can be performed smoothly.

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BEFORE USE: Device Description

1.4

Device Description

{ Front view

Function buttons

LCD screen

Memory indicator

Start button

Joystick

Locking lever

Power switch

Cover open button Printer cover

Function buttons Used to set the device and to switch the screen. Functions assigned to the function buttons are displayed by icon next to each switch on the screen. Lower two buttons on the left of the screen have unique functions when the measurement screen is displayed.

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