NIDEK OPHTHALMIC SURGICAL SYSTEM
Model CV-24000 OPERATOR’S MANUAL
* Specifications are subject to change without notice for improvement.
NIDEK CO., LTD. (Manufacturer) NIDEK CO., LTD (Tokyo Office)
NIDEK INCORPORATED (United States Agent) NIDEK SOCIETE ANONYME (Authorized Representative)
: 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan Telephone: (0533) 67-6611 Facsimile: (0533) 67-6610 : 6th Floor, Takahashi Bldg., No.2, 3-chome, Kanda-jinboucho Chiyoda-ku, Tokyo 101-0051, Japan Telephone: (03) 3288-0571 Facsimile: (03) 3288-0570 Telex: 2226647 NIDEK J : 47651 Westinghouse Drive Fremont, California 94539, U. S. A. Telephone: (510) 226-5700 Facsimile: (510) 226-5750 : Europarc 13, rue Auguste Perret, 94042 CRETEIL, France Telephone: (01) 49 80 97 97 Facsimile: (01) 49 80 32 08 2005. 3 18214-P902I Printed in JAPAN
BEFORE USE OR MAINTENANCE, READ THIS MANUAL. THIS MANUAL CONTAINS ONLY INFORMATION TO UNDERSTAND THE OPERATING PROCEDURES AND MAINTENANCE. The Operator’s Manual contains information necessary for the operation of the NIDEK OPHTHALMIC SURGICAL SYSTEM Model CV-24000. This manual includes the operating procedures, cautions for safety, specifications and maintenance instructions. This manual complies with IEC 60601. This manual is required to correctly use this system. Especially, the cautions for safety and operating procedures must be thoroughly understood before using the instrument. Keep this manual handy to verify use whenever necessary. Use of this system is limited to the cataract and vitreous surgery by qualified physicians only. The physicians are responsible for the application of this system to various surgical techniques. If you encounter any problems or have questions about the instrument, contact NIDEK or your authorized distributor.
[NOTE] There are 3 types of the CV-24000. To make a distinction, each system is abbreviated according to the specifications and abbreviated names such as A type (or A), AP type (or AP), and P type (or P) are used in this manual to simplify descriptions (see below). In addition, it is possible to select the language indicated on the screen between English and Japanese, however, in this manual, English version is presented.
Model name CV-24000
For cataract surgery
A type (or A)
For cataract and vitreous surgeries
AP type (or AP)
For vitreous surgery
P type (or P)
Table of Contents §1 INTRODUCTION ... 1-1 1.1 Outline ... 1-1 1.2 Principles ... 1-2 1.3 Classifications ... 1-4 1.4 Symbol Information ... 1-5
§2 SAFETY ... 2-1 2.1 Storing, Transport, and Installation ... 2-1 2.2 Wiring and Connection ... 2-3 2.3 During Use ... 2-4 2.3.1 In general ... 2-4 2.3.2 Sterilization ... 2-5 2.3.3 About the US handpiece and US tip ... 2-6 2.3.4 About ultrasound oscillation ... 2-7 2.3.5 About use of the diathermy function ... 2-8 2.3.6 About use of the vitreous cutter ... 2-9 2.4 After Use, Maintenance, and Check ... 2-9 2.4.1 Cleaning and sterilization ... 2-9 2.4.2 Others ... 2-10 2.5 Disposal ... 2-11 2.6 Safety Devices ... 2-12 2.7 Labels ... 2-13
§3 SYSTEM DESCRIPTION ... 3-1 §4 OPERATING PROCEDURES ... 4-1 4.1 Preparation Before Surgery ... 4-1 4.1.1 Sterilization of instruments ... 4-1 4.1.2 Setup... 4-3 4.2 Setting and Testing Each Cassette ... 4-5 4.2.1 For anterior single cassette --For A and AP types... 4-5 4.2.2 For anterior dual cassette -- For A and AP types ... 4-14 4.2.3 For anterior/posterior dual cassette --For AP type ... 4-18 4.2.4 For posterior dual cassette (Posterior setting) --For AP type ... 4-26 4.2.5 For posterior dual cassette (ANT/POST setting) --For AP type ... 4-32 4.2.6 For posterior dual cassette (Dual setting) --For P type ... 4-39 4.2.7 For posterior dual cassette (Single setting) --For P type ... 4-45 4.2.8 Selectable mode after test ... 4-49 4.2.9 switch ... 4-49
4.3 Operation Screens ... 4-50 4.3.1 Anterior mode screen (main screen) --For AP and P types ... 4-50 4.3.2 Dia mode screen (anterior mode) --For AP and P types ... 4-53 4.3.3 Irr mode screen (anterior mode) --For A and AP types ... 4-55 4.3.4 US mode screen (anterior mode) --For A and AP types ... 4-56 4.3.5 US Propedal mode screen (anterior mode) --For A and AP types ... 4-59 4.3.6 I/A mode screen (anterior mode) --For A and AP types ... 4-64 4.3.7 I/A Propedal mode screen (anterior mode) --For A and AP types ... 4-67 4.3.8 Vit mode screen (anterior mode) --For A and AP types ... 4-70 4.3.9 Posterior mode screen (main screen) For AP and P types ... 4-72 4.3.10 Dia mode screen (posterior mode) --For AP and P types ... 4-75 4.3.11 Vit mode screen (posterior mode) --For AP and P types ... 4-77 4.3.12 Asp mode screen (posterior mode) --For AP and P types ... 4-80 4.3.13 US PPL mode screen (posterior mode) --For AP type ... 4-82 4.3.14 Scis mode screen (posterior mode) --For AP and P types ... 4-85 4.3.15 Small screens ... 4-87 22.214.171.124 FGX small screen ... 4-88 126.96.36.199 Illum1, Illum2 small screen ... 4-89 4.3.16 Custom setting screen ... 4-90 4.3.17 Program contents screen ... 4-94 188.8.131.52 Changing settings on the anterior screen ... 4-95 184.108.40.206 Changing settings on the posterior screen ... 4-105 4.3.18 File screen ... 4-111 4.4 Cleaning the Instruments ... 4-114
§5 TROUBLESHOOTING ... 5-1 5.1 Error During Cassette Test ... 5-1 5.2 Error During System Test ... 5-3 5.3 Error During Use ... 5-8
§6 MAINTENANCE ... 6-1 6.1 List of Consumables and Maintenance Parts ... 6-1 6.2 Replacement of Printer Paper ... 6-1 6.3 Replacement of Halogen Lamp ... 6-2 6.4 Replacement of Fuses... 6-3 6.5 Cleaning ... 6-5 6.5.1 Cleaning the exterior ... 6-5 6.5.2 Cleaning the LCD touch panel ... 6-6
§7 SPECIFICATIONS ... 7-1 7.1 Specifications of Each Part ... 7-1 7.2 Power Requirements and Others ... 7-5
§8 ACCESSORIES... 8-1 8.1 Configurations for A Type... 8-1 8.2 Configurations for AP Type ... 8-2 8.3 Configurations for P Type ... 8-3 8.4 Option ... 8-4 8.4.1 Anterior mode ... 8-4 8.4.2 Posterior mode ... 8-4 8.4.3 Foot pedal ... 8-4 Words in this manual ... end of the manual
§1 INTRODUCTION 1.1 Outline NIDEK OPHTHALMIC SURGICAL SYSTEM Model CV-24000 is a system for cataract and vitreous surgeries and has 3 available types, for cataract surgery, for cataract and vitreous surgeries, and for vitreous surgery. The system for cataract surgery (A type) has the functions such as the irrigation control, vacuum pressure/aspiration flow control, ultrasound power control, anterior vitrectomy, and diathermy. The system for cataract and vitreous surgeries (AP type) has the functions such as the posterior vitrectomy, fluid/gas exchange, intraocular scissors driving, and intraocular illumination in addition to the functions of the system for cataract surgery. The system for vitreous surgery (P type) has the functions such as the vacuum pressure/aspiration flow control, posterior vitrectomy, fluid/gas exchange, intraocular scissors driving, intraocular illumination, and diathermy. These 3 systems are comprised of a main body, foot pedal, and accessories. To enhance the usability of each function of the system, the CV-24000 adopts the followings: (1) A color LCD touch panel and infrared wireless remote control*1 achieve easy input of setting values and check of the system condition. (2) An automatic loading-type tube cassette enables you to perform quick setting and cleaning of tubes. (3) A built-in printer makes it possible to print surgery data of US Time/US Energy, vacuum pressure, etc. The CV-24000 is the user-friendly system whose functions of cataract and vitreous surgeries and their operabilities are successfully combined.
*1 An infrared wireless remote control is for A and AP types only, not for P type.
1.2 Principles (a) Phacoemulsification When a voltage is applied to an oscillator inside the US handpiece, the oscillator is vibrated according to the amplitude and frequency of the AC voltage. The obtained vibration is transmitted to the US tip via a trumpetlike part called as a horn. In phacoemulsification, the AC voltage is applied to the oscillator at a ultrasound range of frequency, and the obtained ultrasound vibration is amplified by the horn and transmitted to the US tip. Then, the end of US tip fragmentates the lens nucleus and the emulsification is achieved. (b) Irrigation The irrigation solution flows into the eye via a tube and handpiece by gravitation. Because the irrigation pressure changes according to the height between the eye to be operated and the fluid level of the irrigation bottle, the pressure can be controlled by raising or lowering the motorized pole, which the irrigation bottle is hung on, with the switch operation. Furthermore, the built-in pinch valve supplies and stops the irrigation solution. (c) Aspiration When the peristaltic pump rotates, the fluid inside the aspiration tube is pressed out by the roller, the vacuum pressure is generated, and substance inside the eye is aspirated. In other words, as the volume of pressed-out fluid is equal to the flow rate, it can be controlled by the rotation speed of pump. In addition, the pressure sensor monitors and controls the vacuum pressure. (d) Vitrectomy When the air pressure generated by the built-in air compressor or external compressed air source is intermittently supplied to the vitrectomy cutter, the inner blade at the tip of the cutter is vibrated. The cutting speed is controlled by the intermittent period of the supplied air pressure which is controlled by the special solenoid valve. (e) Intraocular scissors The scissors are opened or closed when the air pressure generated by the built-in air compressor or external compressed air source is intermittently supplied to the intraocular scissors. The cutting speed is controlled by the intermittent period of the supplied air pressure which is controlled by the special solenoid valve. It is also possible to open or close the scissors by the air pressure according to the pressing amount of foot pedal.
1-3 (f) Fluid/gas exchange When the compressed air adjusted by the built-in small pump is conveyed to the inside of the eye via sclera, the air pressure presses the fluid out of the vitreous cavity and the pressed-out fluid is drained. Then, the fluid is exchanged with gas. (g) Intraocular illumination The illumination adopts the halogen lamp as a light source, whose infrared ingredients are eliminated by the filter inside the illumination unit in advance. The illumination is led to the inside of the eye by the acrylic light guide probe. (h) Diathermy The Joule heat is generated when the electrical current is applied to tissue. Diathermy is to dehydrate, coagulate the tissue with the Joule heat, stop bleeding, or prevent bleeding of the incised area. (i) Fragmentation This is used for the pars plana lensectomy. From the incision made at the pars plana, the special US tip is inserted into the vitreous cavity and the lens is fragmented and aspirated by the ultrasound oscillation of the US tip.
1.3 Classifications [Protection method against electric shock] Class I CV-24000 is classified into a Class I system. A Class I system is a system in which the protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in such a way that means are provided for the connection of accessible conductive parts to the protective (earth) conductor in the fixed wiring of the installation in such a way that accessible conductive parts cannot become live in the event of a failure of the basic insulation. [Degree of protection against electric shock] Type BF applied part, Type B applied part The diathermy of CV-24000 is classified into a Type BF applied part and others are classified into a Type B applied part. A Type BF applied part is isolated from other parts of the medical/electrical equipment to such a degree that no current higher than the patient leakage current allowable in single fault condition flows if 1.1 times of maximum rated supply voltage is applied between the applied part and earth. A Type B applied part contains an internal electrical power source providing an adequate degree of protection against electric shock particularly regarding; - allowable leakage currents - reliability of the protective earth connection (if present) [Degree of protection by the enclosure] The main body of the CV-24000 is classified as IP20, and the foot switch is classified as IPX8. An IP20 system is protected against an ingress of solid foreign objects, such as a finger having a diameter of 12.5mm or greater, however, it is an ordinary system without protection against an ingress of liquids. Be careful not to get water on the main body and control box. An IPX8 system is a waterproof system provided with an enclosure preventing the effects caused by immersion in water. [Sterilization methods recommended by the manufacturer] Non-sterilized instruments of CV-24000 should be autoclaved under 132ºC. [Degree of safety in the presence of flammable anesthetics and/or flammable cleaning agents] CV-24000 should be used in an environments where no flammable anesthetics and/or flammable cleaning agents are present. [Mode of operation] CV-24000 is an intermittent operation system. [Classification by transference] CV-24000 is classified into a transportable system.
1.4 Symbol Information This symbol indicates that important descriptions related to operation or maintenance are contained in the operator’s manual and that an operator must refer to the operator’s manual prior to operation and maintenance. This symbol indicates that the degree of protection against electric shock is a type B applied part. This symbol indicates that the degree of protection against electric shock is a type BF applied part. This symbol indicates that the applied part is non-grounding type according to the high frequency. This symbol indicates that the system should be operated only with alternating current. This symbol indicates the master switch setting. When the switch is flipped to the symbol side, the power is not supplied to the system. This symbol indicates the master switch setting. When the switch is flipped to the symbol side, the power is supplied to the system. This symbol indicates the fuse rating. This symbol indicates the function to raise or lower the irrigation pole. This symbol indicates the slot where the memory card is inserted. When inserting the memory card, align the symbol on the memory card with the one on the main body. This symbol indicates the connector to which the foot pedal shall be connected. This symbol indicates the switch to eject a cassette. This symbol indicates the switch to display the Dia mode screen.
1-6 This symbol indicates the switch to display the Irr mode screen. The symbol on the cassette indicates the connection line with the irrigation bottle. This symbol indicates the switch to display the US mode screen. The symbol on the cassette indicates the connection line with the US handpiece. This symbol indicates the switch to display the I/A mode screen. The symbol on the cassette indicates the connection line with the I/A handpiece. This symbol indicates the switch to display the Vit mode screen. This symbol indicates the switch to display the Asp mode screen. This symbol indicates the switch to display the Scis mode screen. This symbol indicates the switch to indicate the setting of the intraocular illumination. This symbol indicates the switch to indicate the setting of the gas exchange. This symbol indicates the effective number of use and means the prohibition of reuse. This symbol indicates the method of sterilization and means that the radiation sterilization has been performed. This symbol indicates the time period over which the part can be used safely.
§2 SAFETY In this manual, Signal Words are used to designate a degree or level of safety alerting, whose definitions are as follows. WARNING: CAUTION:
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury or property damage accident.
Some items described in WARNING and CAUTION may cause a serious accident according to the circumstances. Follow all the instructions mentioned below since they are very important.
2.1 Storing, Transport, and Installation CAUTION • Prior to storage, verify that the storage area meets the following conditions: - Not exposed to ultraviolet rays and direct sunlight. - Not splashed with rain or water. - No chemical agents and organic solvent are present. - No salt, sulfur content, toxic gas or large amounts of dust is contained in the air. - Level and stable without vibration and shock. - The following environmental conditions in storage and transport ( packed condition) specified in the specification are met. Temperature: -10 to 60ºC / Humidity: 30 to 90% (non-condensing) Atmospheric pressure: 700 to 1060 hPa • Lower the irrigation pole to the lowest position before transporting the system. In addition, fold the irrigation hook and store it inside the pole. Failure to do so may bump the pole or catch the hook. • Transport the system after hanging the foot pedal and cords on their special hooks on the stand. If the system is transported without the foot pedal and cords properly stored, the cords may be caught causing a fall of system and break of cords.
CAUTION • Hold the handle on the stand when transporting the system. Avoid sudden operation at the start/stop of transportation. Otherwise, the system may fall down and an injure or system malfunction may result. • Never drag the system by holding the power cord or cable of the foot pedal when transporting the system. Otherwise, the system may fall down and an injure or system malfunction may result. • If the temperature differs substantially before and after the transport, condensation may occur in the system. After transport, confirm that the system is at room temperature before turning on the power of the system. If the power is turned on while the condensation is happening, malfunction or electric shock may result from short-circuit. • Prior to installation, verify that the installation area meets the following conditions: - Level and stable without vibration and shock. - Not exposed to liquids such as water. - No flammable gases (including anesthetic gas) or solvents is present. - No large amount of dust is contained in the air. - Not exposed to direct air-conditioning flow. - Not exposed to direct sunlight or ultraviolet rays. - The following environmental conditions in installation (unpacked condition) are met. Temperature: 10 to 30ºC / Humidity: 30 to 75% (non-condensing) Atmospheric pressure: 860 to 1060 hPa • Install the system where it is not exposed to strong electromagnetic waves during operation. Strong electromagnetic waves may cause the system to malfunction. • Install the system so as not to block the ventilation hole on the cover of the main body. The cooling fan cannot radiate heat properly and the system may be adversely affected.
2.2 Wiring and Connection CAUTION • Use a grounded power outlet which meets the power requirements labeled on the system. Otherwise, the system may not perform sufficiently or may be damaged. If the power outlet is not a grounded type and a leakage of current occurs because of a system malfunction, an electric shock may result. Moreover, it may cause electromagnetic interference for other devices or hum noise. • Do not overload the electrical outlet. Abnormal heat generation may occur and result in fire. • Always pull the plug, not the cord, when unplugging the power cord. The cable core may break, and an ignition or electric shock due to a short-circuit may result. • Be sure not to get the power cord pinched under a heavy object such as the system. The cable sheath may break, and a short-circuit or electric shock may result. • If the inside wires of the power cord are exposed, do not continue using the system but unplug the power cord and contact NIDEK or your authorized distributor. An electric shock or fire may occur. • Never remove the cover that holds the power cord except in order to replace the fuse. If the power cord is disconnected during the operation, the result of the surgery may be seriously affected. • After inserting the cable plug of the foot pedal, lock the plug with the ring to hold it. If the cable plug becomes loose during the operation, the result of the surgery may be seriously affected. • Securely connect the plug of connecting cables for the handpiece, etc. and the luer connector for the tube, etc. following the instructions on this operator’s manual. Otherwise, the system may not work normally and an accident or malfunction may occur. • Hold the plug, not the cable or cord, to when connecting or disconnecting the US handpiece or diathermy cord. If the inside wires of the cable or cord break, ultrasound oscillation and diathermy become impossible.
2.3 During Use 2.3.1 In general CAUTION • Never use this system for purposes other than cataract surgery. If any accident occurs because of use for other purposes, NIDEK assumes no responsibility. • Prior to the first use of the system each day, perform the system test and function checks referring to the Pre-operation check manual (18214-P912A). NIDEK assumes no responsibility if failure occurs during the operation of each mode without performing the test and checks. • If any abnormality occurs to the system, do not touch the inside of the system. Unplug the power cord from the power outlet and contact NIDEK or your authorized distributor. • In case of failure of the system, take backup measures for the surgery to be performed. • Do not modify or touch the inside of the system. To do so may cause an electric shock or system malfunction. • This system is provided with a Type B applied part. Avoid the combined use of this system and other systems which contact the patient during use. • Do not touch the LCD touch panel with anything other than fingers during operation. Do not touch 2 or more places at the same time. Touching with a hard or sharp object (such as ball-point pen) may scratch the panel. If 2 or more places are touched at the same time, a system malfunction may occur. • Make sure that the LCD touch panel is not exposed to the direct sunlight or ultraviolet rays during operation. The LCD touch panel may be damaged. • Contents of cassette pack and connection set are disposable items. Never open the package until just before use. Be sure to dispose of them after use and never reuse them. • Use the specified infusion tube (another package including the cassette pack) only. Using unspecified infusion tube may cause an insufficient irrigation flow and the anterior chamber or eyeball to collapse. • When using the optional I/A tip (φ 0.5mm), pay special attention to the aspiration pressure so that it does not become so high. If the I/A tip (φ 0.5mm) is used at the setting of the aspiration pressure over 300 mmHg, the anterior chamber may become shallow at the time of aspiration.
CAUTION • Never let a hard substance contact the ends of tips (especially US tip), diathermy forceps, vitrectomy cutter and intraocular scissors. They may be deformed or cannot be used any longer. • The height of IV pole indicated on the screen is intended for use of a 500 mL glass bottle. Using other bottles may cause a gap between the indication and actual heights. • Never splash water onto the main body. Besides, be sure not to splash water onto the foot pedal as much as possible. Otherwise, a system malfunction or electric shock may result. • Tray is to place the surgical instruments such as handpiece, etc. during surgery. Do not place heavy objects or rest your weight on the tray. Otherwise, it may be deformed or the system may fall down.
2.3.2 Sterilization WARNING • Be sure to sterilize all accessories that need to be sterilized before the surgery. Otherwise, the physician, patient or assistant may be infected.
CAUTION • Sterilize the accessories according to the specified method. (For details, refer to “4.1.1 Sterilization of instruments” (p.4-1).) If not, they may be deformed or damaged. • Confirm that no dirt or foreign object is on the instruments before sterilization. If dirt or foreign object is found, remove it be cleaning. (For the details of cleaning, see “4.4 Cleaning the Instruments” (p.4-109).) • Autoclave the parts observing their useful lifetime and the number of times they can be used that are written on the package. If the useful lifetime or the number of uses is exceeded, the parts may have problems and may interfere with the surgery.
2.3.3 About the US handpiece and US tip CAUTION • Never modify the US handpiece or the US tip by bending, cutting, or engraving them. The US handpiece or the US tip may break or malfunction. • When autoclaving the US handpiece, always use a vacuum drying type sterilizer. Using a sterilizer other than that of a vacuum drying type may damage or accelerate the deterioration of the US handpiece. • Use only the NIDEK US tip for the US handpiece. Never use the I/A tip or other manufacturers’ US tips. Normal ultrasound oscillation may not be achieved. NIDEK assumes no responsibility for accidents caused by use of unspecified tips. • Confirm that the plug of the US handpiece is completely dry before connecting it to the US connector. Failure to do so may cause an electric shock and damage to the US handpiece. • Connect the US tip to the US handpiece, and the cable plug of the US handpiece to the US connector of the main body securely. Insecure connections may cause ultrasound oscillation failure and poor electrical contact. • Never immerse the US handpiece and plug in a liquid. Ultrasound oscillation failure or poor electrical contact may result. • Use the US handpiece at ordinary temperatures. After autoclaving, leave it for approximately 15 minutes or more and check that it has cooled down before use. Otherwise, burns may occur. • If abnormal heat is generated from the US handpiece or US tip, do not touch the internal structure of the system. Disconnect the US handpiece from the system and contact NIDEK or your authorized distributor. The untrasound may not be oscillated and burns may occur to the patient or the user.
2.3.4 About ultrasound oscillation CAUTION • Never touch the US tip during ultrasound oscillation. Injuries may occur. • Never let the end of the US tip contact other medical devices (instrument for nuclear segmentation, etc.) during ultrasound oscillation. The US tip or other medical devices may break and generate pieces of metal. • Before ultrasound oscillation, check the setting values (ultrasound output power, aspiration pressure, aspiration flow rate, US control mode, etc.). During ultrasound oscillation, observe the motion of the US tip. Otherwise, the US tip may be damaged beyond repair. • When oscillating the ultrasound, make sure that the US tip operates with sufficient irrigation and aspiration (the US tip must be in the test chamber filled with the irrigation solution or in the eye). Ultrasound oscillation without irrigation and aspiration may damage the US tip beyond repair. • During ultrasound oscillation, do not move the US tip close to a side of the incision or perpendicular to the dome of the cornea. The area around the incision may be burned. • If the ultrasound is oscillated while the US tip is in the viscoelastic, the viscoelastic blocks the irrigation flow. It causes insufficient cooling of the US tip and, as a result, a burn. Create a space filled with the irrigation solution between the lens and the viscoelastic in advance. Perform ultrasound oscillation with the irrigation and aspiration ports in the space. • In phacoemulsification, a phenomenon, known as cavitation, may occur in which the ultrasonic vibration forms bubbles from the gas in the irrigation solution that flows through the US handpiece. If this bubbles enter the patient’s eye, they may obstruct the physician’s view and interfere with surgery. To control the formation of bubbles, use the pulse mode or other methods not to use ultrasound more than necessary. If the bubbles enter the patient’s eye, aspirate them using the devices such as the US tip to secure the physician’s view.
2.3.5 About use of the diathermy function WARNING • When using the diathermy function for patients with a cardiac pacemaker or its electrode implanted, consult the cardiac surgeon or manufacturer of the pacemaker. The function of the pacemaker may be affected or the pacemaker may be damaged.
CAUTION • The diathermy forceps and pencil, and the cord that are standard accessories can be used exclusively for the CV-24000. Do not connect them to unspecified terminals or other manufacturer’s bipolar/monopolar device. Especially, if the diathermy cord is connected to the monopolar output terminal, unexpected output voltage may be generated and serious adverse events may occur. • Never modify the diathermy forceps, pencil, or cord by bending, cutting, or engraving them. The diathermy forceps, pencil, or cord may break or malfunction. • Connect the diathermy forceps or pencil and the cord securely. Insecure connections may cause coagulation failure and poor electrical contact. • When using the diathermy function, observe the following conditions to avoid a burn or electric shock: - Use the diathermy forceps and pencils, and the cords that are in the standard accessories. - Make sure that the diathermy cord is not deformed (change in shape or cracks). - Flammable gas should not be in the air. - The diathermy power selected should be as low as possible for the intended purpose. - The patient should not come into contact with metal parts which are earthed or which have an appreciable capacitance to earth (for example operating table supports, etc.). - The diathermy cord should be positioned in such a way that contact with the patient or other cords is avoided. - When physiological monitoring equipment is used simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from the patient’s eye. - Use monitoring systems incorporating high frequency current-limiting devices.
2.3.6 About use of the vitreous cutter CAUTION • Observe the following points when using the vitreous cutter to avoid trouble during the surgery: - Confirm the connections of the drive/aspiration tube and the leur adapter beforehand. - Before using the vitreous cutter, put the needle part in the water and check the operation. If it malfunctions, replace it. • Even after the check described above, performance of the vitreous cutter may decrease due to failure of the system infrequently. Before moving the tip of the cutter away from the incision, check that the incision has been made completely. If the tip of the cutter is moved away from the incision when the incision is incomplete, retinal tear may result.
2.4 After Use, Maintenance, and Check 2.4.1 Cleaning and sterilization CAUTION • Observe the following points in the first cleaning after use: - Use distilled water for the first cleaning instead of tap water to avoid rust or stain. - To avoid rust, use only enzyme detergent for cleaning. (Refer to the user’s guide attached to the detergent before use.) - To avoid rust, wash the cleaned parts sufficiently and dry them as quickly as possible. • Observe the following points in the first sterilization after use: - To avoid rust, use only glutaral preparation for cleaning. Do not use other preparations such as phtharal preparation. (Refer to the user’s guide attached to the preparation before use.) - To avoid inflammation by touching the sterilized parts, wash them sufficiently and dry them as quickly as possible. (Refer to the user’s guide attached to the preparation before use.) • Observe the following points in the ultrasonic cleaning: - Do not subject the US handpiece and diathermy cord to the ultrasonic cleaning to avoid break of terminal or deterioration of the electrical characteristics that may occur depending on the conditions. - To protect the ends of the US tip, I/A tip, and diathermy forceps, put the rubber cap on them before using the ultrasonic cleaning for them.
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CAUTION • Observe the following points in the cleaning and sterilization of the US handpiece and diathermy cord: - To avoid contact failure from short circuit or rust, do not immerse the parts in the detergent or sterilizing solution. - Wipe the exterior of the US handpiece and the diathermy cord with gauze or absorbent cotton soaked in the detergent or sterilizing solution and wrung sufficiently. Do not wipe them with excessive force. - To avoid break of wire, wipe the areas where the cable and cord are attached with special care. - To avoid break of wire, do not press or pull the cables and cords forcefully when wiping them.
2.4.2 Others CAUTION • If the system will not be used for a long period of time, unplug the power cord from the power outlet. If dust settles on the plug of the power cord, the dust absorbs moisture and may cause a short-circuit and fire. • If the system is not being used, turn OFF the power and put the dust cover on the system. Dust settles on the system and makes it dirty. • Use the specified fuses only. Otherwise, the system may not perform sufficiently and a system malfunction or fire may result. • Use the specified lamp for intraocular illumination. Otherwise, the system may not perform sufficiently and a system malfunction or fire may result. • Use the specified printer paper. Otherwise, data cannot be printed out or the printer paper may be jammed.
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CAUTION • When sending the system back to NIDEK for repair or maintenance, wipe the surface of the system (except the LCD touch panel) with a gauze dampened with glutaral preparation. Wipe the LCD touch panel with a gauze dampened with alcohol. Then, wipe the part which has been cleaned with glutaral preparation with a gauze dampened with sodium hypochlorite. Failure to do so may cause personnel who repair or preform maintenance to become infected. • Ask NIDEK for inspection of the system once a year. According to the frequency of use, the part which drives the irrigation pole may need to be greased. • Only service technicians properly trained by NIDEK can modify and repair the system. NIDEK assumes no responsibility for accidents caused by improper repair.
2.5 Disposal CAUTION • Follow local governing ordinances and recycling plans regarding disposal or recycling of device components when disposing of the system. Especially, the disposing method of lithium batteries varies according to the government. This system has electric circuit boards with lithium batteries in the main body. When disposing of the board, follow the instruction of the government. • When disposing of packing materials, sort them by the materials and follow local governing ordinances and recycling plans. • When disposing of the main body and foot pedal, wipe the surface of them with a gauze dampened with rubbing solution such as glutaric aldehyde. Failure to do so may cause personnel who are involved in the disposal to become infected. • When disposing of accessories such as tips, tubes, handpiece, forceps and scissors, follow the recommended disposal procedure for medical wastes such as needles from an injection or blood infusion tubes as specified by your local medical institution and ordinances against environmental pollution.
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2.6 Safety Devices [TEST mode] This mode is to check the conditions of each part of the system before surgery, and performing this test prevents troubles from occurring during surgery. CV-24000 automatically checks the following items according to the inserted cassette by pressing each switch in the “Test” box indicated on the LCD touch panel. • Cataract surgery... Motion check of irrigation and aspiration * When the US handpiece is connected to the system, ultrasound output is also checked. • Vitreous surgery ... Motion check of aspiration * When the US handpiece is connected to the system, ultrasound output is also checked. • Cataract & Vitreous surgeries ... Anterior screen: Motion check of irrigation and aspiration * When the US handpiece is connected to the system, ultrasound output is also checked. Posterior screen: Motion check of aspiration * When the US handpiece is connected to the system, ultrasound output is also checked. If an abnormality is found by checking these items, error and contents are indicated on the display. [Self-diagnostic function] The system automatically checks the connecting condition of each part and own functions even during surgery. If an abnormality occurs, error and contents are indicated on the display and the beep sound is produced. (The beep sound stops by pressing the part indicated as an error.) [Aspiration pump] A peristaltic pump system which controls the aspiration flow rate by pressing the aspiration tube is adopted in order to achieve the ease of operation and stable aspiration.
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2.7 Labels In order to call the operator’s attention, the appropriate warning labels are affixed to the designated locations on the system. [Rear side of the main body (AP type)]
For AC 100V/AC 115V
For AC 230V
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[Rear side of the remote control (AP type)]
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§3 SYSTEM DESCRIPTION [Front side of the main body (AP type)]
LCD touch panel
Photodetector of remote control
Plugs for light guide
Tray UP/DOWN knob
3-2 LCD touch panel Displays various operation screens, setting values of each mode, and present system conditions. By pressing the indicated operation switch, it is possible to change the mode and input/ change the setting value. Photodetector of remote control Receives the infrared signal from the remote control. Do not block the anterior part of this photodetector. (P type does not have this function.) Switch panel Indicates available modes for each system type. By pressing these switches on this panel, the corresponded mode is selected. Available modes for each system are as follows. Type A type AP type P type
Available modes Dia, Irr, US, I/A, Vit Dia, Irr, US, I/A, Vit, Scis, Illum1, Illum2, ON/OFF of FGX Dia, Asp, Vit, Scis, Illum1, Illum2, ON/OFF of FGX
Plugs for light guide For AP and P types, the connector of the light guide for intraocular illumination is inserted here. Speaker This is for a voice guidance, operation sound, and beep sound. Tray The remote control, each handpiece for US, I/A, and irrigation, vitrectomy cutter, intraocular scissors, and light guide probe are placed here. Be sure not to place heavy object or rest your weight on this tray.
Tray UP/DOWN knob Used to adjust the height of tray. While raising this knob with one hand, adjust the height of tray by holding the tray arm with the other hand. Releasing this knob fixes the adjusted height. Storage box The door of this storage box can be opened and closed with the knob. Caster lock Used to transport the system and fix the position of the system. The caster is locked by lowering the lever, and it is released by raising the lever.
3-3 [Rear side of the main body (AP type)] Back light control Irrigation pole
Irrigation pole height fixing knob Irrigation pole UP/DOWN switch
Memory card slot Printer cover
Hook for foot pedal cable
Hook for foot pedal
Hook for power cord
Connector for external pressure source
Foot pedal connector Pilot lamp
Inlet with fuse
Inlet with fuse Inlet with the built-in fuse carrier. The power cord is connected here. When the power is not supplied to the system, there is a fear that fuses inside the carrier may be burnt.
Connector for external pressure source When using a compressed air or nitrogen gas cylinder as a driving source for the vitrectomy cutter and intraocular scissors with AP or P type, the external pressure source is connected here.
3-4 Memory card slot A memory card for storing data of surgery conditions is inserted here. Irrigation pole UP/DOWN switch Used to adjust the height of irrigation pole. By pressing the side, the irrigation pole is raised, and it is lowered by pressing the side. Irrigation pole height fixing knob When the adjustable range of the height is not enough with the irrigation pole UP/DOWN switch, loosen this knob and adjust the height of irrigation pole. Irrigation pole This is for hanging an irrigation bottle. The height of bottle can be adjusted with the electric switch. The irrigation bottle is hung on the hook at the top of this pole. Back light control Used to adjust the light quantity of the back light for LCD touch panel. Turning this control clockwise brightens the back light, and turning this control counterclockwise darkens the back light. Volume control Used to adjust the volume of speaker. Turning this control clockwise turns up the volume, and turning this control counterclockwise turns down the volume. PRINT/FEED switch When the PRINT switch is pressed, the surgery data displayed on the LCD touch panel is printed out. When the FEED switch is pressed, the printer paper is fed. This switch is also used when the printer paper is replaced.
Printer cover A printer is built in this cover. When “PUSH OPEN” at the top of this cover is pressed, the cover opens and it becomes possible to replace the printer paper. Hook for foot pedal cable A foot pedal cable is hung on here when the system is transported and stored. Hook for foot pedal A foot pedal is hung on here when the system is transported and stored. Hook for power cord A power cord is hung on here when transporting and storing the system. Foot pedal connector A connector of the foot pedal is connected here. Pilot lamp Lights up when the power is supplied to the system by turning ON ( | ) the power switch. Power switch Used to turn ON/OFF the power of the system. Pressing the “ | ” side turns ON the power, and pressing the “ ” side turns OFF the power.
3-5 [Left side of the main body (AP type)]
DIA connector FGX connector VIT connector Cassette slot US connector CASSETTE EJECT switch TESTING CASSETTE indicator
3-6 TESTING CASSETTE indicator Blinks during a test. CASSETTE EJECT switch To eject the cassette, press this switch. After the lock of cassette is unloaded, the cassette can be pulled out. Cassette slot A cassette is inserted here. FGX connector When fluid/gas used with AP or P type is exchanged, a tube connector for fluid/gas exchange is connected here via a microfilter. DIA connector A banana plug of the diathermy connecting cord is connected here. VIT connector A connector of the tube for driving the vitrectomy cutter is connected here. US connector A connector plug of the connecting cable for US handpiece is connected here when the US handpiece is used with A or AP type. SCIS connector When the intraocular scissors is used with AP or P type, a connector for driving the intraocular scissors is connected here.