AFC-330 Operators Manual Feb 2014

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

February 2014 15411-P902-H Printed in Japan C 2011 NIDEK CO., LTD.

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Use this device properly and safely.

BEFORE USE, READ THIS MANUAL. This operator’s manual includes operating procedures, safety precautions, and specifications for the NIDEK Non-mydriatic auto fundus camera, AFC-330. Cautions for safety and operating procedures must be thoroughly understood before using this device. Keep this manual handy for reference. Use of the device outside the scope of this manual may cause unanticipated adverse events or adverse device effects. There are no parts within the device that requires servicing by the user. If you encounter any problems or have questions about the device, please contact NIDEK or your authorized distributor.

Safety precautions In this manual, a signal word is used to designate the degree or level of safety alerting. The definition is as follows:

WARNING • Indicates a potentially hazardous situation which, if not avoided, may 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.

15411-P902-H

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Usage precautions Safety of LED CAUTION • The device is a Class 1 LED product in accordance with IEC60825-1: 1993+A1:

1997+A2: 2001 and the LED used for the device is safe in expected use conditions including situations such as looking into the LED using an optical system. However, it is recommended to observe the following precautions when using the device: 1)Do not direct LED beams to human eyes when unnecessary. 2)Do not look into the objective lens (aperture) for a long period of time for observation. 3)If the device cannot be used properly or any device problem cannot be solved, immediately stop using the device, then contact NIDEK or your authorized distributor.

Before Use WARNING • Be sure to use a grounded power outlet.

Electric shock or fire may result in the event of malfunction or power leakage.

CAUTION • Never use the device for other than its intended purpose. NIDEK will not assume responsibility for accidents or malfunction caused by misuse. • Before use of the device, read this manual. Especially, the cautions for safety and operating procedures must be thoroughly understood. Do not use accessories that are not specified by NIDEK for the device. Use of the device outside the scope of the specified use may result in unexpected troubles and adverse events. • Never modify or touch the internal structure of the device. Electric shock or malfunction may result. • When unpacking the device, secure a sufficient space. When the outer box is lifted to be moved, it may hit the wall, ceiling, or objects around. • Install and use the device under the following conditions: Ambient temperature: 10 to 35ºC (50 to 95ºF) Humidity: 30 to 90% (Non-condensing) Atmospheric pressure: 800 to 1,060 hPa Protected from exposure to water Minimal dust in the air Protected from extraneous light sources Level and stable surface free from vibration and bumping The room can be darkened to the degree that a newspaper can barely be read The reliability of image capture results is lowered, and malfunction may result. In addition, injury may result if the device is bumped or topples over. • Do not install the device where it is exposed to strong electromagnetic waves during operation. Images may not be captured properly, or malfunction may result.

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CAUTION • Install the device in an environment where no contaminant such as corrosive gas, acid, or salt is contained in the air.

Corrosion or malfunction of the device may result. • Avoid installing the device where it is exposed to direct air flow from an air conditioner. Changes in temperature may result in condensation inside the device or adversely affect image capture results. • Be sure to use a power outlet which meets the specified power requirements. If the supplied voltage is too high or low, the device may not perform up to specifications, and malfunction or fire may result. • Never use power strips or extension cables for the power supply of the device. Overloading the electric outlet may cause overheating and fire. • Insert the power cord plug fully into the power outlet. Imperfect connection may result in fire. • Do not use any power cord other than the one provided. Do not use the provided power cord for any other instrument. Malfunction or fire may result. • Before connecting any cables to the device, be sure to turn off power to the device and unplug the power cord. Malfunction may result. • Never crush or pinch the power cord with heavy objects. Damage may result in electric shock or fire. • Be sure to securely connect cables to specific connectors without applying excessive force (with their port shapes matching the plug shape). Failure may result. • Do not connect anything other than the optional external fixation lamp unit to the external fixation lamp connector. Failure, electric shock, or fire may result. • When carrying the device to another location, its base should be held by two hands from both sides by two persons as indicated by (A) and (B) in the figure shown to the right. Never hold any parts other than the base such as the forehead rest, chinrest, joystick, or image capturing unit. If any parts other than the base are held, the device may fall and injury or failure may result.

(A)

How to hold

(B)

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CAUTION • Before carrying the device to another location, disconnect all the cords and cables.

If the cords and cables get caught or stepped on, the device may fall, resulting in injury or failure.

• Do not expose the LCD touch-screen to direct sunlight or intense ultraviolet rays. The LCD touch-screen may become damaged. • Before carrying the device to another location, set it to Packing mode and ready to be packed, and lock the main unit to the base with the main unit locking knob. The main unit may move during the transport and the device may fail. For details of the locking knob, see “5. Locking knob” (Page 7) in “1.4 Device Configuration”. Do not lock the main unit to the base with the locking knob when transporting the device in the packing material. (For details of Packing mode, see “2.4.2 Finishing operation in order to transport the device: Packing mode” (Page 68).) • Perform visual and operational checks before using the device. Do not use the device if any error is found. Use of a malfunctioning device will not produce the expected results and may cause troubles or lead to inappropriate diagnoses that may induce health hazards. • This device has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2: 2007. 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 system 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 system and other 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. • The International Electrotechnical Commission sets the essential requirements for electrical and electronic equipment that may disturb, or be disturbed by, other equipment. The device complies with these requirements as shown in the tables in “6.1 EMC (Electromagnetic Compatibility)” (Page 165). Follow the guidance in the tables for use of the device in an electromagnetic environment.

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During Use CAUTION • Be sure to use accessories specified by NIDEK.

Use of the accessories not specified by NIDEK may cause malfunctions or adverse events.

• When turning off power to the device, do not turn off (

) the power switch at first.

Be sure to turn off the device power with the procedure described in “2.4.1 Usual finishing of operation” (Page 67). If the power switch is turned off ( ) at first without observing the correct procedure, corruption of data or software, or failure of the device may result. • When restarting the device, turn on power to it at least three seconds after turning power off. The device may malfunction. • Caution should be exercised when deciding to apply this device to treat a very young child or a patient with aphakic eye or ocular disease. Risk of trouble increases • Prior to image capture, explain the purpose and method sufficiently to the patient. • Set the amount of the light emitted from the device to the minimum level required. Be sure to return the light amount to the minimum level after every patient. Large amount of light not only may cause dizziness but also may cause thermal or optical damage to the patient’s retina. The light amount depends on the duration and intensity with which the light is radiated on the retina. • Take care not to catch hands or fingers in moving parts such as between the image capturing unit and the main unit, between the main unit and the base, and the chinrest. Hands or fingers may be pinched and result in injury. • Take care not to let the image capturing unit contact the patient’s face when moving it close to the patient’s face. Injury may result. • Be sure to pull the image capturing unit to toward the operator using the joystick before moving it to the other eye. Injury may result. • Be sure to perform image capture with sufficient eye fixation and eyelid opening. Eyelid, eyelashes, or insufficient eye fixation may interfere with capturing of proper images. • Make sure that the patient does not stand up while holding device parts such as the forehead rest after image capture. The device may topple over.

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CAUTION • Before and after use, and before every patient, clean the parts that come into contact

with the patient such as the forehead rest and chinrest with clean gauze or cloth dampened with rubbing alcohol. For severe stains, wipe with a clean cloth dampened with rubbing alcohol instead of wiping them repeatedly with a dry cloth. If the chinrest papers are used, remove a sheet after each patient.

• If the periphery of the objective lens is contaminated by contact with the patient’s eyelashes or exposure to their tears, clean the periphery with rubbing alcohol before the next patient. • Before use, check that the objective lens is clean without dust, dirt, or fingerprints. If the objective lens is not clean, the quality of captured images is substantially affected. • If the objective lens is not clean, be sure to clean it before the next patient. Do not use rubbing alcohol to clean the objective lens. For cleaning of the objective lens, see “4.3 Cleaning Objective Lens” (Page 155). • In the event of smoke or strange odors, immediately turn off the device and disconnect the power plug from the outlet. Once it is determined that the smoke will not become more serious, contact NIDEK or your authorized distributor. Continued use may result in electric shock or fire. In case of fire, use a dry chemical (ABC) extinguisher. • Immediately replace the power cord if the internal wires are exposed, the power turns on or off when the power cord is moved, or the cord or plug is too hot. Immediately remove the plug from the power outlet and contact NIDEK or your authorized distributor for replacement. Failure to do so may result in electric shock or fire. • Do not operate the LCD touch-screen with wet hands. If water enters inside the device, the device may fail. • There may be a few “constantly-lit”, “missing” or “dead” pixels in the LCD touchscreen which are a characteristic of the LCD touch-screen manufacturing process. This does not represent a failure of the LCD touch-screen, and the monitor can be used with no problem. • Never touch the LCD touch-screen with any hard pointed object such as a ball-point pen. Keep magnetic objects away from the LCD touch-screen. The monitor may be damaged.

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CAUTION • 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 as other electronic equipment such as lifesupport equipment, equipment that has major effects on the life of the patient and results of treatment, or any other measurement or treatment equipment that involves small electric current. - Do not use the system with portable and mobile radio frequency communication systems because that may have an adverse effect on operation of the device. - Do not use cables or 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. • The base and image capturing units are equipped with a cooling fan for each. Fan noise does not indicate a failure of the device or interfere with operation of the device. • If the device fails, disconnect the power cord from the power outlet, then contact NIDEK or your authorized distributor without touching the interior of the device. • If the device is connected to a PC that does not comply with IEC60601-1 (except one that uses an AC adapter that meets the Class II requirements of IEC60950-1), supply power to the device and PC through isolation transformers. Contact NIDEK or your authorized distributor for installing isolation transformers. • Each time before connecting a USB flash drive to the device, be sure to check it for viruses. If the device is infected with a virus and any problem occurs, NIDEK does not assume responsibility or compensate for damages. • Users are responsible for managing captured image data. NIDEK will not assume any responsibility for loss of data. • Equipment connected to the analog or digital interfaces must be certified according to the representative appropriate national standards (such as EN 60601-1 and IEC 60601-1). Further more, all configurations shall comply with the system standard IEC 60601-1. 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. If in doubt, consult the technical service department of your local representative. • This device is classified as Group 1 according to “4.4 Optical radiation hazard with fundus cameras” in ISO 10940: 2009 Ophthalmic instruments-Fundus cameras, 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 or between the patient and any other person(s) touching the device. 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 isolation transformer or common protective grounding.

1.5 m in radius

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 power to the device and protect the objective lens from dust by covering it with the lens cap, then place the dust cover over the unit.

• When disconnecting the power plug from the power outlet, turn off power to the device, then remove it making sure to always hold the power plug, not the cord. The metal core of the cord may be damaged and electric shock, malfunction, or fire may result. • If the device will not be used for an extended period of time, disconnect the power cord from the power outlet. Failure to do so may leave the device vulnerable to electric disturbances which may result in fire. • Occasionally clean the prongs of the power plug with a dry cloth. If dust settles between the prongs, the dust could collect moisture, and short circuit or fire may occur. • If the device is used after a long period of disuse, check for any abnormality before use. • Store and transport (when the device is packed) under the following conditions: Ambient temperature: −10 to 55ºC (14 to 131ºF) Humidity: 10 to 95% (non-condensing) Atmospheric pressure: 700 to 1,060 hPa Protected from exposure to water Minimal dust in the air Protected from direct sunlight • When transporting the device, set it to Packing mode and ready to be packed, and store it in a specific packaging material without locking the main unit using the locking knob. The device may fail from excessively hard vibration or bumping. For details of Packing mode, see “2.4.2 Finishing operation in order to transport the device: Packing mode” (Page 68). For details of the locking knob, see “5. Locking knob” (Page 7) in “1.4 Device Configuration”.

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Maintenance CAUTION • When the halogen lamp for eye observation, or the xenon flash lamp for image capture needs to be replaced, contact NIDEK or your authorized distributor.

The device incorporates extremely high-voltage components. Opening the lamp house cover or replacing the lamp may result in electric shock. For replacement of parts, see “ Parts to be maintained by service personnel” (Page 157). • The manager of this device must see that maintenance and preventive inspection are performed at least once a year. For details of the inspection and maintenance, contact NIDEK or your authorized distributor. If the periodical inspection and maintenance cannot be performed by the user, entrust them to NIDEK or your authorized distributor. • Only service personnel trained by NIDEK are allowed to repair and service the device. NIDEK assumes no responsibility for any adverse events resulting from improper servicing. • When performing maintenance work, secure a sufficient maintenance space. Maintenance work in an insufficient space may result in injury. • When cleaning the device exterior or the LCD touch-screen, do not use organic, abrasive cleaner such as thinner. The device exterior or the LCD touch-screen may be corroded or damaged. • Do not use the device beyond its service life. Even with proper maintenance and check, after time, the device reliability or safety may begin to fail to achieve the target values. • Before returning the device to NIDEK for repair or maintenance, wipe the exterior of the device (especially the parts that come into contact with patients) with a cloth dampened with rubbing alcohol for disinfection.

Disposal CAUTION • Follow local governing ordinances and recycling plans regarding disposal or

recycling of device components. The device contains a circuit board with a lithium battery mounted. Because the disposal method of lithium batteries varies according to the local government, follow the local governing ordinances and recycling plans when disposing of the circuit board with the lithium battery. It is recommended to entrust 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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Connection to Network CAUTION • When connecting to peripheral equipment like a PC with LAN connector via a medical

facility network, insert or connect an isolation transformer between medical electrical

equipment and the networked device (such as HUB), or the networked device and any 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 a network isolation transformer, consult NIDEK or your authorized distributor. • If the PC of this system is connected by a LAN to other devices such as an external computer via a network of the medical facility, do not connect the system to a network that can connect to the Internet. Be sure to configure the local network only with PCs for NIDEK's image filing software (such as NAVIS-EX). NIDEK will not assume responsibility or compensate for damages caused by any virus infection and development. • When connecting the device with other equipment in a medical facility through the network, be sure that the connection does not pose any danger to the patient, operator, or any other third persons. When any devices are additionally connected to or disconnected from the network, updated or upgraded, be sure that those changes do not pose any danger to the patient, operator, or any other third persons.

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Table of Contents 1. BEFORE USE... 1 1.1 Device Outline...1 1.2 Intended Use...2 1.3 Principle...2 1.4 Device Configuration...3 1.5 Screen Configuration...10 1.6 Labels and Symbols...41 1.7 Packed Contents...45 1.8 Device and Software Setup...46

2. OPERATING PROCEDURE... 53 2.1 Operation Overview...53 2.2 Image Capture Preparation...55 2.3 Image Capture (Normal Photography Mode [Auto shot, No blink])...58 2.3.1 2.3.2

Image Capture with auto shot...58 Image Capture without automatic functions...65

2.4 Image Capture Shutdown Procedure...67 2.4.1 2.4.2

Usual finishing of operation...67 Finishing operation in order to transport the device: Packing mode...68

2.5 Photography Mode Other Than Normal Photography Mode...70 2.5.1 2.5.2 2.5.3 2.5.4 2.5.5

Stereo photography mode...70 Panorama photography mode...72 Anterior eye photography mode...74 Small pupil photography mode...76 Low-light photography mode...79

2.6 Optional functions...80 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.6.6

Anterior eye monitor...80 Auto shot...80 Alignment area change...82 High-sens tracking: fixation shift...83 Split indicator...83 Image Capture interval...84

2.7 Registering, editing, and searching patient information...85 2.7.1 2.7.2

Registering patient in the screen...85 Registering patient information using CSV file...99

2.8 Photography settings menu...100 2.8.1 2.8.2

Fixation lamp mode...101 Camera setting...103

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2.8.3

Focus bar... 103

2.9 Control Menu... 104 2.9.1 2.9.2 2.9.3

Main unit settings... 105 Photography settings... 111 External settings and Other settings... 121

3. OPERATION FOR WHEN PERIPHERAL DEVICES ARE CONNECTED... 139 3.1 Connection of USB devices... 139 3.1.1 3.1.2

Connection, disconnection, and use of USB flash drive... 140 Connection, disconnection, and use of printer... 143

3.2 Connection of PC... 144 3.2.1

Network connection (LAN)... 144

4. MAINTENANCE... 147 4.1 Troubleshooting... 147 4.2 Error Messages and Remedies... 150 4.3 Cleaning Objective Lens... 155 4.4 Attaching Chinrest Paper... 156 4.5 Cleaning Exterior... 157 4.6 Consumables and Maintenance Parts List... 157

5. SPECIFICATIONS AND ACCESSORIES... 159 5.1 Classifications... 159 5.2 Specifications... 161 5.3 Configuration... 163 5.3.1 5.3.2

Standard Configuration... 163 Optional accessories... 163

6. EMC (ELECTROMAGNETIC COMPATIBILITY)... 165 6.1 EMC (Electromagnetic Compatibility)... 165

7. GLOSSARY... 169

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1. BEFORE USE 1.1

Device Outline 1 The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using a built-in color CCD camera without the use of mydriatic agents. The AFC-330 is useful not only for ophthalmology but also for fundus photography in medical examinations such as for diabetes. With this single device, registration of patient information, image capture, and viewing of captured images are possible. In addition, captured images can be output to a USB flash drive, and printed using a printer. By connecting a personal computer (PC) to the device via a LAN and installing the optional image filing system software, images captured by this device can be transferred to the PC at high speed, and viewed and managed on the PC. The device has the following features: • Auto shot (automatic image capture) for executing image capture simply by aligning the device to the patient’s eye • Alignment assist functions such as triple axis auto tracking (up, down, right, left, forward, and backward), auto focus, eyelid/required pupil diameter detection, and motorized chinrest • Small pupil photography mode for pupils as small as 3.3 mm in diameter (angle of view: 33º) in addition to the usual photography mode for pupils of 4 mm or larger in diameter (angle of view: 45º) • Anterior eye photography mode for easy anterior eye image capture • Stereo photography mode, and Panorama photography mode for easy stereo and panorama image capture that may be operated automatically • 8.4-inch, color LCD touch-screen that displays buttons for easy operation and image capture while observing the high quality fundus image, and allows evaluation of the image quality after image capture • USB2.0 for storing captured images to a USB flash drive, or for direct printing of images with a printer without using a PC • LAN connection for high-speed transfer of captured images to the PC

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BEFORE USE: Intended Use

1.2

Intended Use The NIDEK Non-Mydriatic Auto Fundus Camera Model AFC-330 is an ophthalmic camera that is indicated for use in capturing images of the retina and the anterior segment of the eye. *

When the device is used with NAVIS-EX, for which a separate operator’s manual is provided, the functions for image review, image processing, and exporting are available. The filed images provide information for reference purposes.

1.3

Principle

 Alignment 1. Anterior eye observation Alignment is performed while observing the anterior eye under the anterior eye illumination LED (infrared light) on the LCD touch-screen. When proper alignment is achieved, the fundus observation screen is automatically displayed. 2. Fundus observation A bundle of light rays from the halogen lamp passes through the infrared filter and becomes infrared light to illuminate the fundus. Alignment and focusing of the device is performed while observing the illuminated fundus on the LCD touch-screen.

 Image capture White light from the xenon flash lamp irradiates the anterior eye and fundus. The light reflected from those eye portions forms an image, and the image is captured by the built-in color CCD camera for fundus image capture.

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BEFORE USE: Device Configuration

1.4

Device Configuration

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LCD panel 1. LCD touch-screen 2. Pilot lamp Image capturing unit

3. Release button

Main unit

4. Joystick 5. Infrared filter lever Operation panel

Base unit

1. LCD touch-screen An 8.4-inch color LCD touch-screen that allows operation of various functions with the buttons displayed on it. For the displayed contents, see “1.5 Screen Configuration” (Page 10). The LCD touch-screen can be tilted at various angles by pulling its bottom. If the operator uses the device in a standing posture, tilt the screen at a suitable angle. To return the screen to the original position, raise it as high as it goes (about 45°), then slowly lower it. • If two or more disparate positions on the LCD touch-screen are touched at the same time, the operation may not be recognized properly.

2. Pilot lamp Lights up when the device power is on (

).

Blinks when the device is in Sleep mode*1.

*1.

The device enters Sleep mode when it is not operated for the specified period of time. Select the time from 5, 10, and 15 minutes in “Main unit settings” of “Control menu”. The factory setting is 5 minutes. (For details of setting, see “ Main unit settings” (Page 105).) To restore the device from Sleep mode, press any button or switch the eye by moving the joystick.

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BEFORE USE: Device Configuration

3. Release button Provides the following four functions: • Execution of image capture The flash is fired and the eye image is captured by the built-in CCD camera. • The same function as the OK/Auto transfer button or the retry button in the preview screen • Enabling of image capture with the same conditions (the same eye [left eye if the selected image is left eye] in the same image capture mode) as used for the image selected in the thumbnail screen (same function as the retry button

)

• Enabling of image capture with the same conditions as used for the latest image capture when the release button is pressed without selecting any image in the thumbnail screen (same function as the image capture button

)

For details of operation in the preview and thumbnail screen, see “[Preview screen]” (Page 24) and “[Thumbnail screen]” (Page 26).

4. Joystick Used to move the image capturing unit to the desired position. Tilting the joystick moves the image capturing unit to left, right, forward, and backward. Rotating the grip of the joystick moves the image capturing unit up and down. It is also used to select the OK/Auto transfer button or the retry button in the preview screen, and to advance images in the thumbnail screen. Rotate the grip of the joystick to advance images. For details of the operation in the preview screen, see “[Preview screen]” (Page 24). 5. Infrared filter lever Used when cleaning the objective lens. The infrared filter inside the device can be removed by pulling this knob so that the cleanliness of the objective lens can easily be checked. When the knob is pulled, the message “Would you like to clean the objective lens?” appears. For details, see “4.3 Cleaning Objective Lens” (Page 155).

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