NT-510 Operators Manual Aug 2008

Use this device properly and safely.

BEFORE USE, READ THIS MANUAL. This operator’s manual contains information necessary for the operation of the NIDEK NON CONTACT TONOMETER Model NT-510. 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 8612:2001 (Ophthalmic instruments-Tonometers). There are no user-serviceable parts inside the device except 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.

I



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. 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 35qC (50 to 95qF) Humidity: 30 to 90% (Non-condensing) Pressure: 800 to 1060 hPa A place not exposed to the water 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. • Install the device in an environment where no contaminants such as corrosive gas, acid, and 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. Electric shock or fire may occur 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. • Never use a table tap or extension cable to supply the device with power. The electrical safety may be lowered.

II

CAUTION • 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 an outlet. Malfunction may result. • Before carrying the device, put the device into the packing mode and lock the main body to the base with the locking lever. An accidental movement of the measuring unit during transportation may result in malfunction. • When the device is carried, avoid holding the forehead rest and the main body; hold the bottom of the base. If areas other than the base are held and the device falls, there is a fear of injury or malfunction. • Install the device in a place that is not exposed to high electromagnetic wave when in use. • In 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 affects 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 simultaneously with portable and mobile radio frequency communication systems because it 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 or the system and decrease the immunity of the device to electromagnetic disturbance. • The Electromagnetic Compatibility Directive sets the essential requirements for electrical and electronic equipment that may disturb, or be disturbed by, other equipment. The NT-510 complies with these requirements as tabled on pages 79 to 82. Follow the guidance in the tables for use of the device in an electromagnetic environment.

III



During Use WARNING • Before starting measurement, set 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 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 switching the right and left of the patient's eye. • Be sure to connect an interface cable, checking the symbols of input (IN: output (OUT:

) and

).

• 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. • Measure when fixation and alignment are sufficiently performed. Do not measure while misaligned. Proper measurement may not be performed. • Before or after use, and before measuring patients, 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 with a clean cloth dampened with rubbing alcohol. If chinrest paper is used, remove one piece for each patient. • 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 on the air nozzle. The measurement accuracy may decrease substantially.

IV

CAUTION • 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, then 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. This does not represent failure of the LCD; continuously use the display. • This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2: 2001+A1:2004, and Medical Device Directive 93/42/EEC. 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: 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. • Never use the device with cables or accessories other than the designated ones. Malfunction caused by improper electromagnetic compatibility (EMC) characteristics may result.

V



CAUTION • Never use portable or mobile radio frequency (RF) devices in the vicinity of this device.

These devices may adversely affect medical electrical equipment and malfunction may result. • When connecting the device to the PC* that is not corresponded to IEC60601-1, be sure to supply power through the isolation transformer. *Expect for the PC that adopts the class II AC adapter certificated with IEC609501. 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. • When using Intraocular Pressure Correction function, set the correction factors Param1 and Param2 beforehand. • The results obtained from the Intraocular Pressure Correction function are reference values only, so they should be used at the discretion of the user. • The device uses thermal paper for printer. When saving the printings, make a copy of it. Thermal paper may become difficult to read due to aged deterioration. • This device is classified as Group 1 set by ISO 15004-2:2007 Light Hazard and conforms to the standard.

VI

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. • During transportation or storage using dedicated packaging material, keep an environment that meets the following conditions. Environmental conditions: Temperature: –10ºC to 55ºC (14ºF to 131ºF) Humidity: 10 to 95% (non-condensing) Pressure: 700 hPa 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 • 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.

VII



Maintenance

CAUTION • Only NIDEK service representatives or hospital personnel trained by NIDEK should attempt to modify or touch the inside of the device and/or upgrade 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.

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. • When disposing of packing materials, sort them by material and follow local governing ordinances and recycling plans.

VIII

{ Patient environment The patient environment represents a space where there is a possibility of direct contact between the patient or the operator and third person. When another type of device is used in the patient environment, use a device that complies with IEC 60601-1. If the devices that do not comply with IEC 60601-1 are used, it is necessary to use an isolating transformer as a power supply or to connect the devices to additional protective grounding.

4CFKWUQH 1.5 m

2.5 m

1.5 m

1.5 m

IX



X

Table of Contents 1. BEFORE USE... 1 1.1 Outline of device...1 1.2 Indications for Use...2 1.3 Principles...3 1.4 Device Description...4 1.5 Measurement Screen Description...9 1.6 Labels and Indications on Device...12 1.7 Checking Contents...13 1.8 Before First Use...14

2. OPERATING PROCEDURES... 17 2.1 Operation Flow...17 2.2 Preparation for Measurement...18 2.3 Measurement...24 2.3.1

Measuring puffed air pressure check during startup...31

2.4 Completion of Measurements...33 2.4.1 2.4.2

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

2.5 Selecting Mode...35 2.5.1 2.5.2

Sleep mode...35 Eyelid detection mode...36

2.6 Printing...37 2.6.1 2.6.2

Printing measured data...37 Printing parameter settings...38

2.7 Parameter Settings...39 2.7.1 2.7.2 2.7.3 2.7.4

XI

Parameter tables...42 Setting Network function...48 Setting date and time...53 Entering comments...55

:

3. OPERATION WHEN PERIPHERAL DEVICES ARE CONNECTED... 57 3.1 Connecting to Computer... 57 3.1.1 3.1.2 3.1.3

Outline... 57 RS-232C connection... 58 Network connection (LAN)... 59

3.2 Connecting Barcode / Magnetic Card Reader... 60 3.2.1 3.2.2 3.2.3

Outline... 60 Connecting procedure... 60 Operating procedure of barcode / magnetic card reader... 60

4. MAINTENANCE... 61 4.1 Troubleshooting... 61 4.2 Error Messages and Countermeasures... 63 4.3 Replacing Printer Paper... 66 4.4 Fixing Chinrest Paper... 68 4.5 Cleaning... 69 4.5.1 4.5.2 4.5.3

Cleaning air nozzle... 69 Cleaning printer... 70 Cleaning forehead rest and chinrest... 70

4.6 List of Replacement Parts... 71

5. SPECIFICATIONS AND ACCESSORIES... 73 5.1 Classifications... 73 5.2 Safety Features... 74 5.3 Specifications... 75 5.4 Standard Configuration... 77 5.4.1 5.4.2

Standard accessories... 77 Optional accessories... 77

6. EMC (ELECTROMAGNETIC COMPATIBILITY)... 79 7. GLOSSARY... 83 8. INDEX... 85

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1. BEFORE USE 1.1

Outline of device

1

NON CONTACT TONOMETER Model NT-510 is designed to non-contact tonometry measurement. The non-contact tonometry function measures the intraocular pressure without contacting the eye. Tonometry is performed for the early detection 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. In addition to the above, the device also offers the following features: • An auto-tracking mechanism is provided. The device automatically controls the up-anddown movements for alignment and focusing. • An auto-shooting 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 and LAN interface allows data export to computers etc.

1

BEFORE USEIndications for Use

1.2

Indications for Use The NON CONTACT TONOMETER NT-510 is a medical apparatus which performs measurement of intraocular pressure.

2

BEFORE USEPrinciples

1.3

Principles 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 o applanated surface o 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 Auto Complete 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.

3

1

BEFORE USEDevice Description

1.4

Device Description

{ Front view

Function buttons

LCD screen

Memory indicator

Start button

Joystick

Locking lever

Power button

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.

4

BEFORE USEDevice Description

•CLR button (

)

Used to clear the measured data. When the CLR button is pressed for about a second, all the measured data is erased. •Print button (

)

1

When this button is pressed while the memory indicator is lit, measured results are printed out. If this button is pressed when the memory indicator is turned off, the printer paper is fed.

LCD screen 5.7-inch color LCD screen. The LCD screen panel pops out when the lower portion of the panel is pulled toward you When operating the device in an upright position, tilt the panel so that the indications on the screen are clear. The panel is reset to its original position by magnet.

Memory indicator Indicates that measured data is being stored in memory. ON

Measured data is stored in the internal memory.

OFF

Measured data is not stored in the internal memory.

Blinking

Sleep mode

Start button When the start button is pressed, the measurement takes place regardless of the alignment and focusing status of the device. Joystick Used for alignment and focusing. Tilt the joystick to the right and left for alignment. Turn the joystick for alignment in the up and down directions. For focusing, push the joystick forward and pull it backward.

Locking lever Used to fix the main body to the base unit. To lock the main body, press the locking lever down.

Power button Used to turn on or off the power to the device. Printer cover Inside is the printer equipped with the auto cutter located. Open the printer cover for replacing printer paper by pressing the cover open button. Cover open button To open the printer cover, press the button.

5

BEFORE USEDevice Description

{ Rear view Eyelid detection LEDs Eye level marker

Forehead rest LED for Corneal Illumination

Chinrest up/down buttons

Air nozzle

Safety stopper Chinrest

Patient sensor

Forehead rest During measurements, the patient’s forehead should be gently placed over the forehead rest. Clean the forehead rest for each patient. (See “ During Use” (page IV) and “4.5.3 Cleaning forehead rest and chinrest” (page 70)).

Air nozzle Air is puffed out of the nozzle of the measuring unit. In this operator’s manual, the area containing the observation window around the air nozzle is referred to as the air nozzle.

Chinrest During measurements, the patient’s chin should be gently placed on the chinrest. Adjust the chinrest with the eye level marker as a guide to position the patient’s eye to the proper height for measurement. Clean the chinrest for each patient. (See “ During Use” (page IV) and “4.5.3 Cleaning forehead rest and chinrest” (page 78)).

Patient sensor The patient sensor detects whether the patient is seated in front of the device. The sensor, while detecting the patient, assumes that the patient’s chin is placed on the chinrest and the puffed air pressure check is not performed.

Eye level marker Used as a guide for the patient's eye level during measurements. The height of the chinrest should be adjusted so that the center level of the patient’s eye almost aligns with this line.

Chinrest up/down buttons ( Move up or down the chinrest.

6

,

)

BEFORE USEDevice Description

Safety stopper Used to provide a safety space so that the air nozzle does not touch the patient’s eye. Change the position of the stopper for each patient to keep the proper amount of the space for safety. While pressing the safety stopper, “RTN TO ORG” blinks on the screen, and the measuring unit automatically returns to the origin in the right, left, back and forth directions. (See “ During Use” (page IV) and Step 8 of “2.2 Preparation for Measurement” (page 24).)

1

• Materials composed of the parts that contact the patient during measurement are as follows: Function buttons: ABS resin Start button: ABS resin Joystick: ABS resin, Synthetic rubber Power switch: Polyamide resin Forehead rest: Elastomer Chinrest: ABS resin Chinrest up/down buttons: ABS resin Safety stopper: ABS resin

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