Nidek CV-24000 Operators manual

NIDEK

OPHTHALMIC SURGICAL SYSTEM

Model CV-24000

OPERATOR’S MANUAL

* Specifications are subject to change without notice for improvement.

NIDEK CO., LTD. : 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan
(Manufacturer) Telephone: [phone]

Facsimile: (0533) 67-6610

NIDEK CO., LTD : 6th Floor, Takahashi Bldg., No.2, 3-chome, Kanda-jinboucho
(Tokyo Office) Chiyoda-ku, Tokyo 101-0051, Japan

Telephone: [phone]
Facsimile: [phone]
Telex: 2226647 NIDEK J

NIDEK INCORPORATED : 47651 Westinghouse Drive Fremont, California 94539, U. S. A.
(United States Agent) Telephone: [phone]

Facsimile: [phone]

NIDEK SOCIETE ANONYME : Europarc 13, rue Auguste Perret, 94042 CRETEIL, France
(Authorized Representative) Telephone: [phone]

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 Types Abbreviations

For c a taract s urgery A type (or A)

CV-24000

For c atarac t and vit reous s urgeri es AP ty pe (or AP)

For vitreous surgery P type (or P )

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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

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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 A P 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 V it mode screen (anterior mode) --For A and AP types....................................4-70

4.3.9 Posterior mode screen (main screen) For A P and P types.................................4-72

4.3.10 Dia mode screen (posterior mode) --For A P 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 A P 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

4.3.15.1 FGX small screen..............................................................................4-88

4.3.15.2 Illum1, Illum2 small screen .................................................................4-89

4.3.16 Custom setting screen.................................................................................... 4-90

4.3.17 Program contents screen ...............................................................................4-94

4.3.17.1 Changing settings on the anterior screen .............................................4-95

4.3.17.2 Changing settings on the posterior screen .........................................4-105

4.3.18 File screen .................................................................................................. 4-111

4.4 Cleaning the Instruments ......................................................................................... 4-114

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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

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7

SPECIFICATIONS ...................................................................................................... 7-1

7.1 Specifications of Each Part ......................................................................................7-1

7.2 Power Requirements and Others .............................................................................. 7-5

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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

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1

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.

INTRODUCTION

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*

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 Ener gy, 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

achieve easy input of setting

*1 An infrared wireless remote control is for A and AP types only , not for P type.

1 - 2

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.

(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

1 - 4

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.

1 - 5

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.

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2

In this manual, Signal Words are used to designate a degree or level of safety alerting,
whose definitions are as follows.

WARNING: Indicates a potentially hazardous situation which, if not avoided,

could result in death or serious injury.

CAUTION: Indicates a potentially hazardous situation which, if not avoided,

may result in minor or moderate injury or property damage accident.

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

SAFETY

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.

2 - 2

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.
T emperature: 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 W iring 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.

2 - 3

• 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 - 4

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.

T o do so may cause an electric shock or system malfunction.

• This system is provided with a T ype B applied part. A void 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.

T ouching 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.

2 - 5

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 - 6

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.

2 - 7

• 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 - 8

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 - 9

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.

- T o avoid rust, use only enzyme detergent for cleaning. (Refer to the user’s guide attached to
the detergent before use.)

- T o avoid rust, wash the cleaned parts sufficiently and dry them as quickly as possible.

• Observe the following points in the first sterilization after use:

- T o 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.)

- T o 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.

2 - 10

CAUTION

• Observe the following points in the cleaning and sterilization of the US handpiece and diathermy
cord:

- T o 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.

- T o 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.

2 - 11

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.

2 - 12

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.

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)]

2 - 13

450

For AC 100V/AC 115V

For AC 230V

550

2 - 14

[Bottom side of the foot pedal]

[Rear side of the remote control (AP type)]

2 - 15

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§

SYSTEM DESCRIPTION

3

[Front side of the main body (AP type)]

LCD touch panel

Photodetector of
remote control

Switch panel

Plugs for light guide

Speaker

Tray

Tray UP/DOWN knob

Storage box

Caster lock

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.

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 .

Type Available m ode s

A type Dia, Irr, US, I/A, Vit

AP type

P type

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.

T ray

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.

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

Volume control

PRINT/FEED switch

Printer cover

Hook for foot pedal cable

Hook for foot pedal

Hook for power cord

Connector for external

pressure source

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.

Foot pedal connector
Pilot lamp

Power switch

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.