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Nidek Medical YC-1800 Operator's Manual
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Nidek Medical YC-1800 Operator's Manual

Nidek Medical YC-1800 Operator's Manual

Ophthalmic yag laser system
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OPHTHALMIC YAG LASER SYSTEM
OPHTHALMIC YAG LASER SYSTEM
OPERATOR'S MANUAL
OPERATOR'S MANUAL
YC-1800
YC-1800

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Summary of Contents for Nidek Medical YC-1800

  • Page 1 OPHTHALMIC YAG LASER SYSTEM OPHTHALMIC YAG LASER SYSTEM YC-1800 YC-1800 OPERATOR’S MANUAL OPERATOR’S MANUAL...
  • Page 2 Original instructions NIDEK CO., LTD. : 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, JAPAN (Manufacturer) Telephone: +81-533-67-6611 URL: https://www.nidek.com/ NIDEK INC. : 2040 Corporate Court, San Jose, CA 95131, U.S.A. (United States Agent) Telephone: +1-800-223-9044 (USA Only) URL: https://usa.nidek.com/ NIDEK S.A. : Europarc, 13 rue Auguste Perret, 94042 Créteil, FRANCE (EU Authorized Representative) Telephone: +33 1 49 80 97 97...
  • Page 3 TO UNDERSTAND THE OPERATING PROCEDURES AND MAINTENANCE. This Operator's Manual contains information necessary for the operation of the NIDEK OPHTHALMIC YAG LASER SYSTEM, YC-1800. This manual includes the operating procedures, cautions for safety, specifications and maintenance instructions. This manual is required to correctly use the device.
  • Page 4 Table of Contents § 1 Page INTRODUCTION ......................1-1 1.1 Outline ........................1-1 1.2 Principle ........................1-1 1.3 Intended Use ......................1-1 1.4 Classifications ......................1-2 1.5 Symbol Information ....................1-3 1.6 Precautions in Patient Selection ................... 1-5 1.7 Troubles and Adverse Events ..................1-5 §...
  • Page 5 Page 5.5 Cleaning ........................5-4 5.5.1 Cleaning exterior ....................5-4 5.5.2 Cleaning optical parts ..................5-5 5.6 Aligning Optical Axes of Laser Beams and Illumination ..........5-5 5.6.1 Checking alignment ................... 5-6 5.6.2 Aligning optical axis of laser beam ..............5-7 5.6.3 Aligning YAG laser beam to aiming beam ............
  • Page 6 Since the Nd:YAG laser used in the YC-1800 is an invisible infrared ray (wavelength: 1,064 nm), a red diode laser (wavelength: 635 nm (typ.)) is used for the aiming beam. The laser system was so designed...
  • Page 7 [Degree of protection against electric shock] The YC-1800 is classified as a system with Type B applied parts. A system with Type B applied parts provides an adequate degree of protection against electric shock particularly regarding leakage current and protective grounding (if any).
  • Page 8 1 - 3 1.5 Symbol Information This symbol means that the system is classified as a system with type B applied parts. The applied parts are the forehead rest and chinrest. See 3. SYSTEM DESCRIPTION (p.3-1). This symbol on the power switch of the motorized table indicates that power is supplied to the motorized table.
  • Page 9 1 - 4 This symbol indicates that the focal point of the YAG laser has shifted from the aiming beam toward the posterior. This symbol indicates that the COUNTER display is located on the left. This symbol indicates that the counter on the COUNTER display will be reset with a press of the switch.
  • Page 10 1 - 5 1.6 Precautions in Patient Selection Caution should be exercised when selecting patients with the following conditions to be treated with the YC-1800: When performing posterior capsulotomy after inserting the IOL Patients with progressive eye disease Patients who have difficulty in eye fixation due to nystagmus or condition that may induce...
  • Page 11 SAFETY PRECAUTIONS § 2 In this manual, Signal Words are used to designate a degree or level of safety alerting. The definitions are as follows. DANGER: Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. WARNING: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
  • Page 12 2 - 2 CAUTION • In installation of the system, observe the instructions below. - To avoid troubles from condensation, let the system sit until the condensation dissipates before installation. - To avoid malfunction from change in temperature and condensation, do not install the system where it is exposed to direct flow of air conditioning.
  • Page 13 2 - 3 2.2 Wiring and Connection WARNING • Be sure to connect the power plug to a gounded outlet. - Electric shock or fire may occur in the event of malfunction or power leakage. CAUTION • In handling the power cord and cables, observe the following instructions: - To avoid break of cable that may cause short circuit or fire, always pull the plug, not the cord, when unplugging the power cord or do not coil the cord tightly or put it under heavy objects.
  • Page 14 2 - 4 WARNING • In handling of the system, observe the instructions below. - Only service technicians properly trained by NIDEK may install and configure the system. Only qualified physicians may perform emission of the YAG laser beam for treatment. - To avoid hazardous radiation exposure, do not perform operation which is not described or different from the procedure specified in the operator’s manual.
  • Page 15 2 - 5 CAUTION • In use of the YC slit lamp, observe the instructions below. - To avoid damage to the retina of the patient, only trained physician may perform observation using the YC slit lamp. Do not emit unnecessarily intense YAG laser beam. - To avoid the blue hazard, set the illumination for observation to the minimum level initially, and then increase it until the desired intensity can be obtained.
  • Page 16 2 - 6 2.4 After Use, Maintenance, and Checks CAUTION • After use of the system, observe the instructions below. - To avoid fire caused by moistened dust around the power plug, disconnect the power cord from the grounded power outlet if the system will not be used for a long period of time. - To maintain the performance of laser emission, turn off the power and put dust cover over it after use of the system.
  • Page 17 2 - 7 2.6 Safety Devices [Key switch] Only the designated key can be used for the system in order that use of the system is restricted to qualified physicians only. If the key switch is set to the (ON) position, the key cannot be removed. Whenever the system is not in use, remove and store the key in a secure place.
  • Page 18 The Nominal Ocular Hazard Distance (NOHD) is the distance along the axis of the unobstructed beam from the laser aperture where the exposure or irradiance falls below the applicable exposure limit. The nominal ocular hazard distance (NOHD) of the YC-1800 is as follows: In the single mode:NOHD = 3.5 m...
  • Page 19 2 - 9 2.8 Labels In order to draw the physician’s attention, the appropriate warning labels are affixed to the specified positions on the main unit. Ｙ Ｃ −１ ６ ０ ０/１ ８ ０ ０ Ｐ ＯＷＥ Ｒ  Ｓ Ｕ Ｐ Ｐ Ｌ Ｙ Ｉ...
  • Page 20 2 - 10 [For the USA and its commonwealth and other territories] ＹＣ−１６００/１８００ ＰＯＷＥＲ ＳＵＰＰＬＹ ＩＮＰＵＴ １００−２４０Ｖ〜 ５０／６０Ｈｚ １００ＶＡ ＩＤ １３７０４−Ｅ０２０ 13706-M808-A4 35465-M260-A0 35465-M253-A0 11828-M008-B3 OPHTHALMIC YAG LASER SYSTEM MODEL YC-1800 Y162**** DATE MMMM YYYY CAUTION:Federal law restricts this device to sale by or on the order of a licensed physician. This product complies with FDA radiation performance standards,21 CFR Subchapter J. Manufacturer: 34-14 MAEHAMA HIROISHI-CHO GAMAGORI AICHI 443-0038 JAPAN MADE IN JAPAN 13706-M802-C2...
  • Page 21 2 - 11 2.9 Other Considerations There has been a report that neovascular glaucoma may occur in patients with diabetic retinopathy after YAG laser posterior capsulotomy.
  • Page 22 SYSTEM DESCRIPTION § 3 [Front view of the system] Eyepieces Fixation lamp Forehead rest Chinrest elevation control Eye Level marker Control panel Base fixing knob Grips [Top view of the system] Laser head connector Tonometer holder...
  • Page 23 3 - 2 Grips Laser head connector Ask the patient to hold these grips during the The cable plug of the laser head is connected operation in order to keep him/her in a steady here. position. Tonometer holder Chinrest elevation control When an applanation tonometer is used, the Used to adjust the height of the patient’s chin by tonometer mount is attached to this holder.
  • Page 24 3 - 3 [Right side view of the system] Magnification change control Slit rotation control Chinrest Hole for focusing rod Energy control Slit width control Focus shift control Illumination arm fixing knob Aiming rotation control Microscope arm fixing knob...
  • Page 25 3 - 4 Aiming rotation ( ) control* Slit rotation control* Used to switch the arrangement (vertical or hori- Used to rotate the slit 90º to left and right from zontal) of the aiming spots. Select by turning the the vertical position. A scale is provided above control.
  • Page 26 3 - 5 [Right side view of main unit] [Right side view of joystick] Hand switch S-switch Grip [Top view of Part A] Brake lever Emergency stop switch Key switch LINE indicator Illumination control [Right side view of Part B] DC input connector Foot switch connector Remote connector...
  • Page 27 3 - 6 Hand switch LINE indicator When this switch is pressed in the READY ( ) The indicator illuminates when power is supplied mode, the YAG laser beam will be emitted. to the system from the AC adapter. *As the trigger switch, either the hand switch or the foot switch (optional) can be used.
  • Page 28 3 - 7 [Control panel] EMISSION indicator YAG FOCUS SHIFT Focus shift indicator display COUNTER display Reset switch PULSE NUMBER Burst switch display Aiming switches Aiming level indicator ENERGY display STATUS indicator STATUS switch...
  • Page 29 3 - 8 STATUS indicator EMISSION indicator Illuminates to show whether or not the YAG la- Illuminates while the key switch is turned to the ser beam can be emitted. ON position ( ) and the system is operational. “ ” : READY mode The indicator goes off in the event of a system (Laser beam can be emitted.) failure.
  • Page 30 3 - 9 [AC adapter] Power cable For 100 V For 200 V Connecting cable Connecting cable Power cable This cable is connected to the DC input connec- The main plug at the end of the cable is con- tor on the switch box. The cable transmits elec- nected to a grounded power outlet.
  • Page 31 3 - 10 [Motorized table (optional)] Master switch Table control lever Caster locks Fuse holder Master switch Caster locks Used to turn on and off power to the motorized Used to lock the motorized table by depressing table. Pressing the side (ON) powers the mo- the levers when installing the system and the mo- torized table.
  • Page 32 OPERATING PROCEDURES § 4 4.1 Connection [Attaching the fixation lamp] Hold the fixation lamp so that the Fixation lamp electrode prongs are orientad as the illustration below and insert it Clamping ring into the connector for the fixation lamp. Then rotate the clamping Connector for ring clockwise to fix the connec- fixation lamp...
  • Page 33 4 - 2 4.2 Operation Flow Connecting the power cord ..[4.3 Starting System, Step 1] (p.4-3) Wearing safety goggles ..... [4.3 Starting System, Step 2] (p.4-3) Turning key switch to ON ( ) ..[4.3 Starting System, Step 3] (p.4-3) Cleaning contacted parts ....
  • Page 34 4 - 3 4.3 Starting System 1. Connect the power cord of the AC adapter to a grounded outlet. The LINE indicator on the top of the switch box lights up. LINE indicator NOTE • When the system is installed on the motorized table, connect the power cord of the table to a grounded outlet, and turn on ( ) the master switch of the table.
  • Page 35 4 - 4 4.4 Preparing for Treatment 1. Set the focusing rod and adjust the diopter scale and pupillary distance (hereafter called PD) for the operator. Focusing rod 1) Remove the plug from the hole for mounting the focusing rod. Mount the focusing rod so that its flat surface faces the microscope.
  • Page 36 4 - 5 2. Press and hold the aiming switch to turn “ ” indicator off the aiming beam. The “ ” indicator lights up. Aiming switch 3. Clean all parts that the patient’s skin touches. Forehead rest Wipe the forehead rest, chinrest and grips with clean gauze or absorbent cotton dampened with Chinrest alcohol.
  • Page 37 4 - 6 9. Manipulate the joystick to bring the illumination onto the patient’s eye. 10. Turn the illumination control to adjust intensity of the illumination. 11. Manipulate the joystick so that the illumination is focused on the patient’s cornea. 12.
  • Page 38 4 - 7 13. As necessary, perform the following operations. a) Select the magnification of the microscope with the magnification change control. b) Adjust the slit width with the slit width control. c) Adjust the diaphragm and slit length with the diaphragm selection disk. d) Adjust the slit angle with the slit rotating control.
  • Page 39 4 - 8 4.5 Operation for Treatment CAUTION • Confirm that the irradiation conditions are correctly set and then emit the laser beam. 1. Set the following conditions for radiation. All the conditions for radiation are displayed on the control panel. Reset switch Burst switch Aiming switches...
  • Page 40 4 - 9 [c. Aiming level] Pressing the aiming switches ( / ) changes intensity of the aiming beam. Pressing decreases the intensity, and pressing increases it. The aiming switch is turned off “ ” by pressing and holding [d. Energy of the YAG laser beam] Adjust the energy of the YAG laser beam by turning the energy control or moving the S-switch right and left.
  • Page 41 4 - 10 4. When the target is determined, press the trigger switch to emit the YAG laser beam. Every time the YAG laser beam is emitted, an electrical beep sounds and the number of YAG YAG FOCUS SHIFT display laser pulses is shown on the Counter display.
  • Page 42 4 - 11 4.6 Indications of Misoperation As soon as emission of the YAG laser beam is disabled because of improper operation, an electronic beep sounds, and an abbreviation for the cause is shown on the YAG FOCUS SHIFT Abbreviation display on the control panel.
  • Page 43 4 - 12 4.8 Other Functions 4.8.1 Changing trigger switch Both the hand switch and foot switch (optional) are available as the trigger switch. Use of the hand switch and foot switch can be toggled with a simple operation as shown below. 1.
  • Page 44 4 - 13 4.8.2 Attaching applanation tonometer Rise of intraocular pressure is a commonly known postoperative complication of the YAG laser treatment. The system is designed so that an applanation tonometer can be attached to measure preoperative and postoperative intraocular pressure. * Attachable applanation tonometer: R900 Type, HAAG-STREIT CO., LTD.
  • Page 45 MAINTENANCE § 5 5.1 List of Consumable and Maintenance Parts Article Unit of order Order No. Chinrest paper 1 pack (400 sheets) 34131-M545 2 fuses (125VAC, T10A) 804-02-02148 Fuses (for 100V regions) (for motorized table) 2 fuses (250VAC, T5A) 804-02-02043 (for 200V regions) Illumination bulb 1 bulb (6V, 20W: PG22)
  • Page 46 5 - 2 5.3 Replacing Fuses of Motorized Table (Optional) If the master switch of the motorized table (optional) does not illuminate by turning it ON even though the power cord is connected, fuses of the motorized table may be blown. In such a case, replace the fuses with new ones following the procedure below.
  • Page 47 5 - 3 5.4 Replacing Illumination Lamp The illumination lamp may be blown if the illumination cannot be projected even if the key switch of the system is turned to the ON ( ) position, the illumination control is not turned fully counterclockwise, and slit shutters are not closed.
  • Page 48 5 - 4 4. While holding the lamp house cover closed with one hand, tighten the knob with the other. 5. Insert the power cord into the grounded power outlet. 6. Check whether the illumination is projected. Turn the key of the system to the ON ( ) position, open the slit shutters and confirm that the lamp is illuminated.
  • Page 49 5 - 5 5.5.2 Cleaning optical parts If an incision can be made only with high radiant energy, or intensity of the illumination is not high enough even though the illumination control is fully set at the maximum, the objective lens or prism head may be dirty or dust may have settled on those parts.
  • Page 50 5 - 6 WARNING • During the calibration, all personnel in the room should wear safety goggles of OD 4 or above to filter out the wavelength of 1064nm. • Pay attention not to expose skin or clothing to the laser beam. Severe burns or fire may result.
  • Page 51 5 - 7 5.6.2 Aligning optical axis of laser beam NOTE • For adjusting the optical axis of the laser beam, prepare the following items: - Phillips screwdriver - Hexagonal wrench (Nominal diameter: 1.5 mm) 1. Loosen the set screws on the lid on top of the Set screws microscope.
  • Page 52 5 - 8 5.6.3 Aligning YAG laser beam to aiming beam NOTE • For aligning the YAG laser beam to the aiming beam, prepare the following items. - Phillips screwdriver, - Hexagonal wrench (Nominal diameter: 1.5, 2.5 mm) Energy control 1.
  • Page 53 5 - 9 5.7 Calibration of Laser Beams WARNING • Only personnel trained by NIDEK or a NIDEK distributor are allowed to calibrate the laser power and energy output. • During the calibration, all personnel in the room should wear safety goggles of OD 4 or above to filter out the wavelength of 1064nm.
  • Page 54 5 - 10 5.7.1 Calibrating power output of aiming beam 1. Attach the power meter to the system for measuring the aiming beam. 1) Fasten the stand of the detector to the chinrest Detector of the slit lamp with a tape or the equivalent. 2) Connect the power meter and detector.
  • Page 55 5 - 11 [B. Measuring minimum power output] 5) If the measured value is within the tolerance (0.5 ± 0.3 μW = 0.2 to 0.8 μW), the minimum power output does not need adjustment. Proceed to Step 10 (p.5-12). 6) Press and hold the aiming switch and turn off the aiming beam.
  • Page 56 5 - 12 2) Press the Aiming switch to change the parameter setting. (Pressing increases the setting. Pressing decreases the setting.) * The parameter setting on the ENERGY display is the percentage of the measured value. For example, to make the measurement value 25 μW when the measured value is 22 μW and the parameter setting is 100, set the parameter to 113 or 114 as obtained from the following formula: 25 ÷...
  • Page 57 5 - 13 3. Align the aiming spot with the light-receptive surface of the detector. 1) Turn off the illumination. 2) Press the aiming switch on the control panel to emit the aiming beam. 3) Manipulate the joystick or chinrest elevation control so that two aiming spots of the largest possible sizes are projected on the light-receptive surface of the detector.
  • Page 58 5 - 14 5. Set the system to the adjustment mode. 1) Reset the key to the OFF ( ) position, and stop the system. Abbreviation of the parameter 2) Turn the key to the ON ( ) position while pressing the following three switches: Aiming Parameter number switches...
  • Page 59 5 - 15 8. Stop the system once and turn it on again. Turn the key to the OFF ( ) position to stop the system once, turn the key to the ON ( ) position again. The system enters the STANDBY mode ( ) in about 10 seconds. 9.
  • Page 60 CHECKS § 6 6.1 Checks Before Use Before using the system, check the items below. (1) Appearance Check the appearance of the system and the motorized table for deformation and stains which hinder a physician from operating them correctly. Stains produced by chemical agents may cause a system malfunction.
  • Page 61 6 - 2 (4) Energy control / S-switch Can the radiant energy be set in the range of 0.3 to 10.0 mJ with the control? Is the test fire executed automatically after the setting? (5) STATUS switch / S-switch Does the mode change between STANDBY ( ) and READY ( ) modes with every pressing of the STATUS/S-switch? * If the (OFF) indicator for the aiming level indicator illuminates, the system do not enter the...
  • Page 62 TROUBLESHOOTING GUIDE § 7 The system is provided with a self-diagnostic function which constantly monitors the working state during operation. If any failure occurs in the system, the laser beam will be blocked by the safety shutter, the system produces alarm sounds intermittently, and the “EMISSION”...
  • Page 63 SPECIFICATIONS AND CONFIGURATION § 8 8.1 Specifications 8.1.1 Specifications of system 1. Treatment laser 1-1. Type of laser: Nd: YAG laser 1-2. Wavelength: 1,064 nm 1-3. Pulsing method: Q-switching 1-4. Mode structure: Fundamental 1-5. Pulse duration: 4 nsec (typ.) 1-6. Energy output: 0.3 to 10.0 mJ (per pulse) <<Tolerance: ±...
  • Page 64 8 - 2 3-4. Pupil distance: 55 to 75 mm (continuously changed) 3-5. Diopter: ±8D 3-6. Diaphragm / Slit length: 15 mm, 10 mm, 6.3 mm, 0.4 mm / 2 to 13.8 mm (continuously changed) 3-7. Slit width: 0 to 15 mm (continuously changed) 3-8.
  • Page 65 Within 50/60 Hz ±1Hz 2-3. Power consumption: 1000 VA or less (including the outlet) 3. Environmental conditions * Same as the environmental conditions for the YC-1800. 4. Dimensions and mass 4-1. Dimensions: 600 (W) × 450 (D) × 653 to 851 (H) mm 600 (W) ×...
  • Page 66 8 - 4 8.2 Configuration 8.2.1 Standard configuration • YC-1800 ....................1 • AC adapter ....................1 • Standard accessories .................. 1 Head belt ....................1 Arm rest....................1 Focusing rod ................... 1 Dust cover ....................1 Chinrest paper (1 pack [400 sheets]) ............1 Operator’s manual...................
  • Page 67 § 9 ADMINISTRATION 9.1 Cautions on Administration Appoint personnel to be in charge of storage and administration for the area the ophthalmic YAG laser system is used. One qualified manager and one sub-manager are needed. Please observe the following: • The manager should appoint the personnel who use the system. •...
  • Page 68 9 - 2 9.2 Management List (1) Qualified manager and sub-manager Post Name Qualified manager Sub-manager (2) Registration list of the personnel who use the system Post Name...
  • Page 69 9 - 3 (3) Functional check list Item Focus Burst Aiming Energy STATUS Trigger Optical Emergency shift switch switches control / switch / switch axis of stop switch control S-switch S-switch the laser beam Date ・　　・ ・　　・ ・　　・ ・　　・ ・　　・ ・　　・...
  • Page 70 9 - 4 (4) Calibration output list Maximum power output Minimum power output of Maximum energy output Minimum energy output Item of aiming beam aiming beam of YAG laser beam of YAG laser beam ( W) ( W) (mJ) (mJ) Pre- After Pre-...
  • Page 71 TECHNICAL INFORMATION § 10 10.1 Light Hazard Provision of information on the avoidance of light hazard from the optical device is required in ISO 15004- 2: 2007 “Ophthalmic instruments - Fundamental requirements and test methods -”. CAUTION • The light emitted from this device is potentially hazardous. The longer the exposure time is, the greater the risk of ocular damage becomes.
  • Page 72 10 - 2 O Maximum intensity and fractions of maximum intensity Aiming beam level Slit light volume angle (degree)
  • Page 73 10 - 3 10.2 EMC (Electromagnetic Compatibility) The device complies with the International Electrotechnical Commission standards (IEC 60601-1-2: 2007). WARNING • Use the specified accessories, optional accessories, and cables. - Otherwise, increased emissions or decreased immunity of the device may result. •...
  • Page 74 10 - 4 Guidance and manufacturer's declaration - electromagnetic emissions The YC-1800 is intended for use in the electromagnetic environment specified below. The customer or the user of the YC-1800 should assure that it is used in such an environment.
  • Page 75 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the YC-1800 is used exceeds the applicable RF compliance level above, the YC-1800 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the YC-1800.
  • Page 76 Recommended separation distances between portable and mobile RF communications equipment and the YC-1800 The YC-1800 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the YC-1800 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the YC-1800 as recommended below, according to the maximum output power of the communications equipment.
  • Page 77 10 - 7...
  • Page 78 Words in this manual To understand the contents of this manual easily, the following words are used. Before reading this manual, grasp the meaning of the following words. Focus shift ...... To shift the focal point of the YAG laser beam and aiming beam. Mainly in treatment of secondary cataract, this function is used to avoid cracking the IOL by shifting the focal point of the YAG laser beam from the aiming beam toward the posterior.
  • Page 79 are reserved by NIDEK or the owner of the Third-Party- IMPORTANT—READ CAREFULLY Software. The license granted herein will not be intended as, or construed to be, any assignment of the rights of THIS AGREEMENT APPLIES TO THE NIDEK SOFT- NIDEK or the owner of the Third-Party-Software. The WARE AND ACCOMPANYING DOCUMENTS.
  • Page 80 Agreement with immediate effect. Upon termination of provisions of this Agreement will continue in full force this Agreement due to the breach of this Agreement, and effect. NIDEK reserves all the rights to claim damages resulting 11. SURVIVAL from such breach. 11.1.The provisions of 2, 3, 4, 6, 7, 8, 9, 10, 12, 13, 14, 15, 6.2.