NIDEK US-4000 Echoscan Ophthalmic Ultrasound Device Operator’s Manual

US-4000
ECHOSCAN
OPERATOR’S MANUAL
NIDEK CO., LTD.
(Manufacturer)
NIDEK CO., LTD
(Tokyo Office)
NIDEK INCORPORATED
(United States Agent)
: 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan
Telephone: (81-533) 67-6611
Facsimile: (81-533) 67-6610
: 3F Sumitomo Fudosan Hongo Bldg., 3-22-5, Hongo,
Bunkyo-Ku, Tokyo 113-0033, Japan
Telephone: (81-3) 5844-2641
Facsimile: (81-3) 5844-2642
: 47651 Westinghouse Drive, Fremont, California 94539, U. S. A.
Telephone: (510) 226-5700
Facsimile: (510) 226-5750
June 2007
14610-P902A
Printed in JAPAN
:
Use this device properly and safely.
BEFORE USE, READ THIS MANUAL.
This Operator’s Manual contains information necessary for the operation of the NIDEK
US-4000
ECHOSCAN.
This
manual
includes
the
operating
procedures,
safety
precautions, and specifications.
IEC standards are applied in this manual.
The safety precautions and operating procedures must be thoroughly understood prior
to operation of the device. Keep this manual handy for reference.
Use of the device is limited to ophthalmologists or personnel involved in medical practice
under the ophthalmologists’ instructions in accordance with the instructions in the
operator’s manual. The ophthalmologists are responsible for other applications of this
device.
Use of the device outside the scope of this maual may cause unexpected troubles and
adverse events.
If you encounter any problems or have questions about the device, please contact NIDEK
or your authorized distributor.
Safety precautions
In this manual, signal words are used to designate the degree or level of safety alerting. The definitions are as follows.
CAUTION
• Indicates a potentially hazardous situation which, if not avoided, may result in minor or
moderate injury or property damage accident.
Even situations indicated by “ CAUTION” may result in serious injury under certain conditions.
Safety precautions must be strictly followed at all times.
I
:
Use precautions
Before Use
CAUTION
• Never use the device for other than its intended purpose.
NIDEK will assume no responsibility for accident or malfunction caused by improper use.
• The safety precautions and operating procedures must be thoroughly understood
prior to operation of the device.
Use of the device outside the scope of this maual may cause unexpected troubles
and adverse events.
• Do not use the deviec if any abnormality is found in the visual check or operation
check before use.
If there is any abnormality in power output, communication, or operation, the device
may become unusable.
Intended effect cannot be obtained with a failured device and unexpected health
hazard may result from unexpected troubles and misdiagnosis.
• Never modify nor touch the internal structure of the device.
Electric shock or malfunction may result.
• Install the device in an environment that meets the following conditions. The
following conditions must be maintained during use.
Use conditions
Ambient temperature: +10ºC to +35ºC
Humidity: 30 to 75% (Non-condensing)
Atmospheric pressure: 800 hPa to 1060 hPa
Minimal dust in the air
Little influence of disturbance light
Level and stable surface free from vibration and bumping
If the device is not installed and used under the above conditions, the reliability of
measurement results is lowered, and malfunction may result. In addition, injury may
result if the device is bumped or falls down.
• Install the device in an environment where no contaminants such as corrosive
gas, acid, and salt are contained in the air.
Corrosion or malfunction of the device may result.
• Avoid installing the device where it is exposed to direct air flow from an air
conditioner.
Changes in temperature may result in condensation inside the device or adversely
affect measurement results.
• Be sure to use a power outlet which meets power requirements.
If the supplied voltage is too high or low, the device may not deliver full performance, and malfunction or fire may result.
• The power outlet must be equipped with a grounding terminal. If not, connect the
device to the protective earth ground using a ground conductor.
Electric shock or fire may result from current leakage caused by malfunction.
• Insert the mains plug into an outlet as far as the prongs of the plug will go.
Imperfect connection may result in fire.
II
:
CAUTION
• For supplying the device with the power, never use a table tap or an extension
cable.
There is a fear of reduction in electrical safety.
• Never use any power cord other than the speficied one or use the accessory power
cord for other instruments.
Malfunction or fire may result.
• Never crush or pinch the power cord with heavy objects.
Damage may result in electric shock or fire.
• Before connecting cables to the device, turn the device off and disconnect the
power cord from an outlet.
Malfunction may result.
• Before transporting the device, pack the device in the specified packing materials
to avoid impact from falling or other causes.
Excessive vibration and impact to the device may result in device failure.
Installation precautions
CAUTION
• In installation, be sure that the following conditions are satisfied:
- Protected form direct sunlight or ultraviolet rays
- Not exposed to rain or water
- Dust free environment with air containing no sulfur or salt
- Level and stable surface free form vibration and bumping
- The specified environmental conditions during use are satisfied
• Install the US-4000 in a place where there is no other devices such as laser
devices that radiate strong electromagnetic waves.
Strong electromagnetic waves may interfere with proper measurement.
If the US-4000 must be installed in the same place as any other device that radiates
strong electromagnetic waves, perform the measurement using the US-4000 after
stopping operation of the other device.
• Install the device so that the air vent on the cover of the main body is not blocked.
• Do not use this device in an operating room.
During Use
CAUTION
• Do not use the deviec if any abnormality is found in the visual check or operation
check before use.
Intended effect cannot be obtained with a failured device and unexpected health
hazard may result from unexpected troubles and misdiagnosis.
III
:
CAUTION
• In the event that a strange odor or smoke is noticed coming from the device, turn it
off and unplug the power cord immediately. After confirming that the smoke is no
longer being produced, contact NIDEK or your authorized distributor.
Continued use may result in electric shock or fire. In case of fire, use a dry chemical
(ABC) extinguisher.
• If the internal wires of the power cord are exposed, power to the device is
interrupted by moving the cord, or the plug or cord becomes extremely hot, this
indicates that the cord is damaged. Immediately replace the power cord.
Immediately remove the plug from the outlet and contact NIDEK or your authorized
distributor for replacement; otherwise, electric shock or fire may result.
• Never press the LCD screen with a hard object such as a ball-point pen. Keep
magnetic objects away from the LCD screen.
Malfunction may result.
• Do not operate the LCD screen with wet hands.
Water intrusion may result in malfunction of the device.
• There may be a few “constantly-lit”, “missing” or “dead” pixels in your LCD screen
which are a characteristic of the LCD screens, This does not represent a failure of
the LCD screen; continuously use the monitor.
• Do not use cables and accessories that are not specified for the device.
The electromagnetic compatibility (EMC) may be decreased and the device operation
may be affacted.
• Do not use the device near portable and mobile radio frequency communication
systems.
They may have an adverse effect on operation of the device.
• Do not use the device in the same room with other equipment such as life-support
equipment, other equipment that has major affects on the life of the patient and
results of treatment, or other measurement or treatment equipment that involves
small electric current.
• If the instrument is connected to a PC that does not comply with IEC60601-1 (except
one that uses an AC adapter that meets the Class II requirements of IEC60950-1),
supply power to the instrument and PC through isolation transformers.
Contact NIDEK or your authorized distributor for installing isolation transformers.
• Perform the measurements using appropriate sonic velocity values.
Accurate axial length and pachymetry cannot be obtained with inappropriate sonic
velocity values.
• This device uses a heat-sensitive printer paper. To keep the printed data for a long
period of time, make copies of the printouts.
The paper degrades over time and the printed data may become illegible.
IV
:
Probe
CAUTION
• Always hold the plug, not the cable, when connecting or disconnecting the probe.
If the cable breaks near the probe side, it is necessary to replace the whole probe.
• Disinfect the probe tip for every patient.
Failure to do so may cause infection of patient’s cornea.
• Before measurement, confirm that there are no scratches, chips, or cracks on the
surface of the probe tip.
If there are, proper measurement may not be possible.
• Before measurement, confirm that there are no scratches or chips on the surface of
the probe tip which contacts the cornea.
If there are, the cornea may be damaged.
• Pay attention not to bump the probe tip.
The probe tip may be deformed or chipped.
• Do not press the probe against the patient’s cornea with excessive force.
The measurement result becomes unstable and the patient’s eye may be damaged.
• After using the probe, put the protective cover on the probe and keep it in the case.
• Do not move the probe while it is in contact with the patient’s cornea.
The corneal epithelium may become damaged.
• Never perform autoclaving, EOG sterilization, or ultrasonic cleaning of the A-scan,
B-scan, or Pachymetry probe.
The probes may become damaged.
V
:
After use
CAUTION
• When the device is not in use, turn off power to it and place the dust cover over it.
Dust may affect the accuracy of measurements.
• Always hold the power plug, not the cord, to remove it from an outlet.
The metal core of the cord may be damaged and electric shock, malfunction, or fire
may result.
• Wipe between the prongs of the power plug periodically.
Dust that may settle between the prongs attracts moisture and could result in short
circuit, electric shock, or fire.
• If the device will not be used for a long period of time, disconnect the power cord
from the power outlet .
Fire may result.
• Maintain the surrounding temperature and humidity at the following ranges during
transportation and storage of the device.
Environmental conditions:
Ambient temperature: –10ºC to +55ºC
Humidity: 10 to 95% (non-condensing)
Minimal dust in the air
Protected from direct sunlight
• To transport the device, use the packing materials in which the device was
delivered to protect it from excessive vibration and bumping.
Excessive vibration or bumping may result in device failure.
VI
:
Maintenance and checks
CAUTION
• Only service personnel properly trained by Nidek are allowed to service the device.
Nidek assumes no responsibility for accidents resulting from improper servicing.
• When performing maintenance work, secure a sufficient maintenance space.
Maintenance work in an insufficient space may result in injury.
• When the device is sent back to NIDEK for repair or maintenance, wipe the surfaces
(especially, the parts that come into contact with the patients) of the device with a
clean cloth soaked with ethyl alcohol for disinfection.
• Each time the system starts, be sure to make a check of the device.
If not, accurate measurement values cannot be obtained.
• When replacing the printer paper, use the specified type.
Failure to do so may cause a malfunction of the printer.
• When replacing fuses, use the specified ones.
Failure to do so may cause a malfunction or a fire.
• When cleaning the cover of the device and touch screen, never use organic
solvents such as thinners or abrasive detergents.
The cover of the device and touch screen may be damaged.
• If the LCD screen becomes dirty, wipe it with a soft cloth or gauze soaked in with
ethanol.
Other cleaning methods may damage the touch screen.
After the cleaning, when the accessories are dry, be sure to visually check their exterior.
• Only service personnel properly trained by NIDEK are allowed to disassemble and
repair the device.
NIDEK assumes no responsibility for accidents caused by improper repair.
Disposal
CAUTION
• Follow local governing ordinances and recycling plans regarding disposal or
recycling of device components.
It is recommended to commission the disposal to a designated industrial waste disposal contractor.
• When disposing of packing materials, sort them by material and follow local
governing ordinances and recycling plans.
VII
:
Patient environment
The patient environment is the volume of space in which contact can occur between the patient and
any part of the device or between the patient and any other person(s) touching the device.
Use devices that comply with IEC6060-1 in the patient environment. If any device that does not
comply with IEC 60601-1 is to be used, use an isolating transformer or common protective grounding.
Radius of 1.5 m
2.5 m
1.5 m
VIII
1.5 m
Table of Contents
1. BEFORE USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Outline of Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.2 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.3 Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.4 Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
{ Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
{ Rear view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1.5 Screen Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
1.5.1
1.5.2
1.5.3
1.5.4
1.5.5
1.5.6
1.5.7
1.5.8
1.5.9
A-scan biometry screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
IOL power calculation screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
A-scan biometry utility screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
B-scan imaging screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
B-scan imaging utility screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Pachymetry screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Pachymetry utility screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Utility screen (1/2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Utility screen (2/2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
1.6 Labels and Indications on the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
1.7 Checking Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
2. OPERATING PROCEDURES . . . . . . . . . . . . . . . . . . . . . . 29
2.1 Operation flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
2.2 Device Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
2.2.1
2.2.2
2.2.3
2.2.4
2.2.5
Connecting power cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Connecting foot switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Attaching probe rest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Connecting probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
{ A-scan probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
{ Connecting B-scan probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
{ Connecting Pachymetry probe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Connecting Probe stand (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
{ Attaching A-scan probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
{ Attaching cable for fixation lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
2.3 Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
2.3.1
2.3.2
Adding new patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Setting physician data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
2.4 A-scan Biometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
2.4.1
2.4.2
2.4.3
2.4.4
Basic operation of A-scan biometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Cautions in A-scan biometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Manual gate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Calculation of IOL refractive power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
IX
:
2.4.5
2.4.6
Comparison in DUAL screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Setting A-scan biometry utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
{ Changing sonic velocity to calculate distance . . . . . . . . . . . . . . . . . . . . . . . . . . 58
{ Setting IOL formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
{ Setting normally used IOL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
{ Setting fixation light ON/OFF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
{ Setting print format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
{ Inputting IOL data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
{ Calculating personal value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
{ Setting IOL power calculation formula in specified axial length range . . . . . . . 69
2.5 B-scan Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
2.5.1
2.5.2
2.5.3
2.5.4
2.5.5
2.5.6
2.5.7
2.5.8
2.5.9
2.5.10
2.5.11
Basic operation of B-scan imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
Probe angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Changing observation depth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Changing display range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
CV mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Zoom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Four image display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Measuring area on B-scan imaging screen (Area screen) . . . . . . . . . . . . . . . . . . . 81
Measuring distance on B-scan image (Caliper screen) . . . . . . . . . . . . . . . . . . . . . 83
Moving image operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Setting B-scan imaging utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
{ Setting probe angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
{ Setting scan depth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
{ Setting scale color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
{ Changing gain curve pattern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
{ Setting Log scale range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
{ Setting printer mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
{ Setting data format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
{ Other settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
2.6 Pachymetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
2.6.1
2.6.2
Basic operation of pachymetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Setting pachymetry utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
{ Setting Pachymetry probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
{ Setting PRINT switch of foot switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
{ Setting printing of pachymetry results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
{ Setting corneal thickness sonic velocity to calculate distance . . . . . . . . . . . . . 97
{ Setting map selected at device power-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
2.7 UTILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
2.7.1
2.7.2
2.7.3
X
Displaying Utility screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
Setting Utility (1/2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
{ Setting backlight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
{ Setting Start Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
{ Setting Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
{ Setting date and time indication format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
{ Setting Auto OFF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
{ Setting sound volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
{ Setting save mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
Setting Utility(2/2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
{ Adjusting touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
{ Setting date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
:
{ Handling EEPROM parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
2.8 Completion of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
3. OPERATION WHEN PERIPHERAL DEVICES ARE CONNECTED . . 111
3.1 Connecting to Keratometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
3.1.1
3.1.2
3.1.3
Outline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Method of connection (example) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Operating procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
3.2 Connecting to Video Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
3.3 Connecting to USB Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
3.4 Connecting to LAN Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
4. CHECKS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
4.1 Checks Before Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
4.2 Usage of the Test Piece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
4.2.1
4.2.2
Usage of test piece for A-scan biometry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Usage of test piece for pachymetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
4.3 Check List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
5. MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
5.1 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
5.2 Various error codes and Suggested Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
5.3 Replacing Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
5.4 Replacing Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
5.5 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
5.5.1
5.5.2
5.5.3
Cleaning cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Cleaning printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Cleaning touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
5.6 Maintenance of Ultrasound Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
5.6.1
5.6.2
5.6.3
Cleaning ultrasound probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
Disinfecting ultrasound probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
Sterilizing ultrasound probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
5.7 List of Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
6. SPECIFICATIONS AND CONFIGURATION . . . . . . . . . 137
6.1 Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
XI
:
6.2 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
6.2.1
6.2.2
6.2.3
6.2.4
6.2.5
6.2.6
6.2.7
6.2.8
6.2.9
A-scan biometry/IOL power calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
B-scan imaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Pachymetry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Other functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Environemntal conditions (during use) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
Environmental conditions (during storage and shipping) . . . . . . . . . . . . . . . . . . . 140
Composition of parts that come into contact with human body . . . . . . . . . . . . . . 140
Others. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
6.3 Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
6.3.1
6.3.2
Standard accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Optional accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
7. IOL FORMULA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
7.1 Outline of IOL Formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
7.1.1
7.1.2
7.1.3
7.1.4
7.1.5
7.1.6
SRK Formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
SRK II Formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
SRK/T Formula. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Binkhorst Formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
Hoffer Q Formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
Holladay Formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
8. EMC & Acoustic output. . . . . . . . . . . . . . . . . . . . . . . . . 151
8.1 EMC (ELECTROMAGNETIC COMPATIBILITY) . . . . . . . . . . . . . . . . . . . . . . . . 151
8.2 Acoustic output reporting table(IEC 60601-2-37:2005) . . . . . . . . . . . . . . . . . . 156
8.2.1
8.2.2
8.2.3
8.2.4
8.2.5
8.2.6
A-scan probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
B-scan probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
45× angled probe with detachable tip. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
45× angled Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Pachymetry probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
GLOBAL ACOUSTIC OUTPUT LIMITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
9. Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
XII
1.
1.1
BEFORE USE
Outline of Device
1
The NIDEK US-4000 Echoscan is an ultrasonic device to visualize the shape and properties of the
eye interior and provide the image information to be used for diagnosis. It also measures the axial
length and corneal thickness and provides the information to be used for diagnosis.
Axial length is one of the parameters used to determine the refractive power of an IOL prior to cataract
surgery. By inputting the measured axial length with other parameters, the refractive power of an IOL
can be calculated.
Corneal thickness is a necessary parameter when considering the clinical influence of surgery, drugs
and contact lenses upon endothelium tissue. Pachymetry is now commonly performed prior to and
after corneal refractive surgery using devices such as the excimer laser.
The US-4000 is comprised of a touch screen, main body with a built-in printer, an A-scan probe, a Bscan probe, a Pachymetry probe, and a foot switch. Items such as a video printer are also available
as optional accessories.
1.2
Indications for Use
The NIDEK US-4000 Echoscan is a medical device used for measuring the axial length, anterior
chamber depth, corneal thickness, lens thickness, and vitreous body thickess, for calculating IOL
power, and for observing the interior of the eye in B-scan imaging.
1
BEFORE USE: Principles
1.3
Principles
Ultrasonic waves are the sound waves pitched above the range of human hearing whose frequency is
20,000 Hz or more. In the medical field, ultrasonic waves of frequencies between 1 and 15 MHz are
applied, and these types of high sound waves have the following characteristics similar to light:
They have a high tendency to travel in a straight direction.
They have characteristics such as reflection and refraction at the boundaries of media which
have different acoustic impedances.
(Acoustic impedance = Density of medium × Sonic velocity in the medium)
Special material is adopted to transmit and receive the ultrasonic pulses. Electrodes are placed on
both sides of a thin piece of material, and the thickness of the material is changed by the fluctuation of
voltage when a voltage is applied between them. The material vibrates with its inherent frequency
when voltage is applied, and transmits the ultrasonic pulses. Conversely, when this material vibrates
by the impact of the ultrasonic pulses, voltage of the same frequency is generated on both electrodes
and it becomes possible to register the ultrasonic pulses as electrical signals. This phenomena is
called the “Piezo effect”, and the converter, which electrically generates the ultrasound waves and
changes them into voltage, is called a transducer.
In A-scan biometry, the ultrasonic pulse travels inside the eye when the probe is put on the eyeball. A
portion of the pulses is reflected from the boundary of the cornea, anterior chamber, lens, vitreous
body and retina, and their echoes are received at the same probe. The received echoes are converted
to the electronic acoustic signals and indicated on the LCD as an amplitude. In addition, the time difference of each echo is measured and the size of each area of tissue (anterior chamber depth, lens
thickness, vitreous body length and axial length) is calculated according to the time difference and
known inherent sonic velocity through each kind of tissue.
In B-scan imaging, touching the mechanical sector scan probe with a built-in transducer to the eye
emits the ultrasonic pulses that travel inside the eye. These pulses are reflected at boundaries of the
cornea, anterior chamber, anterior chamber, crystalline lens, vitreous body, and retina. The reflected
pulses (echoes) are received by the same mechanical sector scan probe to be converted to electrical
signals. Then the amplitude of the electrical signals is converted to brightness to display the twodimensional static and dynamic images of the eye interior on the screen.
In pachymetry, the ultrasonic pulses are transmitted when the probe is put on the cornea. A part of the
pulses is reflected at the front and rear surface of the cornea. When the probe receives the reflected
echoes, the time difference of each echo is measured and the corneal thickness is calculated according to the time difference and known inherent sonic velocity through the cornea.
If the directions of the ultrasonic waves are not perpendicular to each boundary surface in both axial
length and pachymetry, the echoes become weak and may not return to the probe. Therefore, it is
very important to coincide the direction of the ultrasonic wave with the visual axis in order to achieve
accurate measurement.
2
BEFORE USE: Device Description
1.4
Device Description
{ Front view
1
LCD touch screen
A 8.4-inch color LCD that is used as a touch screen for data input.
The LCD touch screen can be tilted for the operator's convenience.
Knob 1
Used to change the TGC (Time Gain Control) or area of magnification.
Knob 2
Used to change the gain or area of magnificaiton.
Probe rest
Used to keep the probes when not in use.
USB port
Used to connect the USB flash drive to save images, measurement data, and device parameters.
Pilot lamp
Illuminates when power is supplied to the device.
3
BEFORE USE: Device Description
{ Rear view
Probe holder
Place for keeping the probe.
Cover open button
Pressed to open the printer cover.
Printer cover
Used cover the internal printer with an automatic paper cutter. The printer cover is opened by pressing the
Cover open button when replacing the printer paper.
Probe connector (P)
Used to connect a Pachymetry probe (45° angled probe, 45° angled probe with detachable tip, or straight
probe).
Probe connector (BIO)
Used to connect the A-scan probe.
Probe connector (B)
Used to connect the B-scan probe.
Power switch
Pressed to turn ON and OFF power to the device.
4
BEFORE USE: Device Description
External fixation lamp connector
When using the probe stand, power for its fixation lamp is supplied from this connector.
Foot switch connector
The cable plug of the foot switch is connected here.
1
LAN port
Used to connect the US-4000 with an external device (PC) using a LAN cable for data transmission.
External communication connector
An RS-232C interface connector used to connect the US-4000 with an external device such as a PC for data
transmission. When the US-4000 is connected to a NIDEK Keratometer, data obtained by the Keratometer
can be imported to the US-4000.
Video output terminal
Used to connect the video printer (optional) to print images.
Remote connector
Used to connect the remote cable for the video printer (optional).
Fuse holder
Contains fuses. The fuses are blown when overcurrent flows to the device.
Inlet
Used to connect the power cord.
5
BEFORE USE: Device Description
Stylus
Used to manipulate the screen.
B-scan probe
A-scan probe
A solid probe with a built-in fixation lamp
FRAGILE
Pachymetry probe
45° Probe
A solid probe for pachymetry
(4#)+.'
45° probe (with detachable tip)
A solid probe for pachymetry with a detachable tip
(4#)+.'
Straight probe
A straight-type solid probe for pachymetry
(4#)+.'
6
BEFORE USE: Device Description
Foot switch
Used for A-scan biometry, pachymetry, and B-scan imaging.
24+06
1
Test piece
(for A-scan biometry)
(for pachymetry)
For 45° probe
For straight probe
Printer paper (3 rolls)
Ultrasound gel
Applied to the eyelid for B-scan imaging.
Dust cover
7
BEFORE USE: Screen Description
1.5
1.5.1
Screen Description
A-scan biometry screen
Patient switch
Pressed to register patient information and display the physician's name and the patient ID.
Measurement value
Displays axial length, anterior chamber depth, and lens thickness.
Mode switch
Pressed to display the desired screen among the A-scan biometry, B-scan imaging, and Pachymetry
screens.
Date and time switch
Displays the current date and time. Pressed to display the A-scan biometry utility screen.
EYE TYPE switch
Pressed to select the type of the eye to be measured.
•Phakic: Phakic Eye
The axial length is converted from the average sonic velocity. Then the anterior chamber depth and the lens
thickness are converted from their respective sonic velocities.
8
BEFORE USE: Screen Description
•Phakic2: Phakic Eye
The axial length is calculated by adding the anterior chamber depth, lens thickness, and vitreous body length that
are converted from their respective sonic velocities.
•APhakic: APhakic Eye
•IOL: Pseudophakic Eye
1
MODE switch
Pressed to change the measurement method.
Auto: The measurement is completed when acceptable measurement conditions continue for a determined
duration.
Speedy: The measurement is completed automatically and the acceptability of the waveform is determined by the
device.
Manual: The measurement is performed by depressing the foot switch.
DENSE CAT switch
OFF: A normal eyes are measured.
ON: An eye with a dense cataract are measured.
(The parameters are changed as follows: THRESHOLD to "Flat Low," gain to 100%, Axial Velocity to 1548 m/s and
Lens Velocity to 1629 m/s. These parameters can be changed in the Utility screen.)
* This switch is not displayed when the Eye Type is Aphakic or IOL.
THRESHOLD switch
Pressed to change the programmed threshold which automatically determines the measurement value of
each intraocular part. Each time this switch is pressed, the threshold indication below the switch changes
among “Normal,” “Low,” and “Flat Low.”
* Generally set to “Normal”. If the measurement cannot be performed with an eye with mature cataract even
by increasing the gain, the measuerment may become possible by changing the threshold to “Low” or “Flat
Low.”
Measurement data list indication area
Up to 10 measurement values (three times of three measurement values (nine times in total) in Speedy
mode) for axial length and each intraocular part are indicated. Whenever the measurement data is obtained,
the average (Avg) and standard deviation (SD) in the list are calculated and indicated.
* The measurement value of each intraocular part varies according to the selected Eye Type as shown in the
table below.
Axial length
Anterior
chamber
depth
Lens
thickness
Vitreous body
length
Phakic
O
O
O
O
Phakic2
O
O
O
O
APhakic
O
-
-
-
IOL
O
O
-
O
Eye type
Gate display
The specified gate can be moved using Knob 1.
9
BEFORE USE: Screen Description
Gain display
Displays the gain during the A-scan biometry.
The gain is adjusted with Knob 2.
PRINT switch
Pressed to print the data being displayed.
Data save switch
Pressed to save data.
CLEAR switch
Pressed to delete the measurement data in the measurement data list. Once the data is deleted, it cannot be
restored.
DUAL switch
Pressed to display the DUAL window where data (waveform and measurement data) is read from the
internal memory, USB flash drive, or the PC.
DELETE switch
Pressed to delete the measurement data in the list.
To delete data, highlight the data to delete by pressing it with the finger or stylus, then press the DELETE switch.
When the DELETE switch is pressed, it changes to the RECALL switch which restores the deleted data.
SELECT switch
Pressed to decide the measurement data to be used for IOL power calculation.
When this switch is pressed, the "*" mark is attached to the selected data which is to be used for IOL power
calculation.
If this function is not used, the average data is used for IOL power calculation.
* The A-scan biometry data to be used for IOL power calculation can also be input in the IOL power calculation
screen.
BIO/IOL Select switch
Pressed to switch the A-scan biometry screen and IOL power calculation screen.
Gate display switch
Pressed to toggle display of each gate between ON and OFF.
Gate switch
Pressed to select the desired gate and enable or disable the manual gate function for each gate. Four gate
types are available: Cornea, Lens-F (anterior), Lens-B (posterior), and Retina.
FREEZE/LIVE switch
Pressed to start or stop the A-scan biometry.
OD/OS switch
Pressed to change the eye to be measured.
10
BEFORE USE: Screen Description
1.5.2
IOL power calculation screen
1
A-scan biometry data
A-scan biometry data is automatically input. The data also can be input manually.
Keratometer reading
Corneal curvature radius (mm) and/or corneal refractive power (D) are input.
Target
Target postoperative refractive power is input.
Formula switch
Pressed to select the desired IOL formula.
IOL Select switch
Pressed to select IOLs to be used.
IOL power calculation result table
Displays the IOL power calculation results when the values required for the calculation are input. For each
IOLs, IOL powers that are closest to the calculation result and the expected postoperative refractive power
with those IOL powers are displayed. The highlighted row shows the values closest to the target
postoperative refractive power.
IOL Select switch
Pressed to select the IOL to be used for surgery from IOL1 to IOL3.
The selected IOL is highlighted (white characters on a dark background) on the calculation result printout.
11
BEFORE USE: Screen Description
Print switch
Pressed to print the calculation results.
BIO/IOL Select switch
Pressed to switch the A-scan biometry and IOL power calculation screens.
OD/OS switch
Pressed to switch the eye to be measured.
12
BEFORE USE: Screen Description
1.5.3
A-scan biometry utility screen
1
Physician switch
Pressed to select the physician (1 to 5) and register the Physician data.
Conditions set in
,
,
and
to
can be set for each physician.
Velocity input area
Pressing each switch displays the ten-key window and the sonic velocity to calculate distance can be input.
Pressing the Default switch resets all the values to the default values.
Formula area
The IOL formula to be used in the IOL power calculation is selected. (Multiple formulas can be selected.)
Mode switches
Pressed to display the desired screen among the A-scan biometry, B-scan imaging, and Pachymetry utility
screens.
IOL area
The IOLs used for IOL1, 2, and 3 are selected.
Utility switch
Pressed to display the Utility screen.
13
BEFORE USE: Screen Description
Setting switches
IOL switch: Pressed to register IOLs.
Personal switch: Pressed to calculate the Personal value.
Auto switch: Pressed to perform calculation for the selected IOL within the specified axial length.
Fixation Light switches
Pressed to toggle the fixation light in the A-scan probe between ON and OFF.
Foot Switch switches
Pressed to toggle the function of the PRINT switch between printing and changing of the measurement
mode.
Print Format switches
Pressed to select the desired print format.
Exit switch
Pressed to return to the A-scan biometry screen.
PRINT switch
Pressed to print the A-scan biometry utility settings.
Save switch
Pressed to save the A-scan biometry utility settings.
Load switch
Pressed to return the A-scan biometry utility settings to the saved ones.
Default switch
Pressed to return the A-scan biometry utility settings to the default.
14
BEFORE USE: Screen Description
1.5.4
B-scan imaging screen
1
Patient switch
Pressed to register patient information and display the physician's name and the patient ID and name.
Mode switches
Pressed to display the desired screen among the A-scan biometry, B-scan imaging, and Pachymetry
screens.
Date and time switch
Displays the current date and time. Pressed to display the B-scan imaging utility screen.
Probe angle switch
Displays the angle of the probe on the eye to be measured. The default value is "90°" and each pressing of
the switch increases the angle by 45°.
Observation depth switch
Pressed to switch the observation depth (from the tip of the probe).
Norm (35 mm) ⇔ Long (50 mm)
Display range switch
Pressed to change the display range.
Enabled when the gain curve pattern is set to "Log." The display range can be selected among 10, 20, 30, 40, and
50 dB.
15
BEFORE USE: Screen Description
CV (Cross Vector) mode switches
The triangle switches are pressed to move the cross ventor line. The CV switch in the center is pressed to
toggle the CV mode between ON and OFF.
Zoom switch
Pressed to magnify the image on the screen to "×2.5" or "×5."
In the magificination screen, the image navigator "Zoom Navi" is displayed.
Area/Caliper screen switch
Pressed to display the Area/Caliper screen.
Four-image display switch
Pressed to display the Four-image display screen.
The Four-image display screen cannot be displayed if no data is saved in the internal memory.
Print switch
Pressed to print the data being displayed.
Data save switch
Pressed to save the measurement data to an external (USB flash drive or PC) or the internal memory.
Data read switch
Pressed to display the FILE window and read the data from the stored location.
Moving image operation switches
Pressed to play the moving image of about 20 seconds (200 frames) just before the FREEZE switch is
pressed.
The saved moving image is deleted in the following cases:
When the LIVE condition is resumed
When power to the device is turned off
When a New Patient is added
LIVE/FREEZE switch
Pressed to start (LIVE) or stop (FREEZE) the measurement. The same operation can be performed with the
foot switch.
OD/OS switch
Pressed to switch the eye to be measured.
Measurement condition display
Displays the B-scan imaging conditions.
B-scan image display
Displays the B-scan image and cross-vector line.
16
BEFORE USE: Screen Description
1.5.5
B-scan imaging utility screen
1
Physician switch
Pressed to select the desired physician (1 to 5) or register Physician data.
Conditions set in
to
, and
to
can be set for each physician.
Mode switches
Pressed to display the desired screen among the A-scan biometry, B-scan imaging, and Pachymetry utility
screens.
Utility switch
Pressed to display the Utility screen.
Scan Depth switches
Pressed to select the scan depth at the time of device power-up. (This setting can be changed in the B-scan
imaging screen.)
Setting switches
Pressed to set the sonic velocity to calculate distance in B-scan imaging, TGC and GAIN at the time of
device power-up, and the times of averaging (1 to 5) of the B-scan images.
Scale Color switches
Pressed to toggle the scale color between multiple colors and gray scale.
Print Mode switches
17
BEFORE USE: Screen Description
Pressed to toggle the printer for B-scan images between the built-in printer and an external printer.
Ext. Resolution switches
Pressed to toggle the resolution of an external printer between VGA (640 × 400) and SVGA (800 × 600).
Ext. Size switches
Pressed to toggle the area to be printed between Full (Entire screen) and Image (only waveform).
Exit switch
Pressed to return to the B-scan imaging screen.
PRINT switch
Pressed to print the B-scan imaging utility settings.
Save switch
Pressed to save the B-scan imaging utility settings.
Load switch
Pressed to return the B-scan imaging utility settings to the saved ones.
Default switch
Pressed to return the B-scan imaging utility settings to the default.
Save Format switches
Pressed to select the format of the data to be saved between "Raw (raw data)" and "Jpeg (Joint
Photographic Experts Group)", or both.
Log Scale Range switches
Pressed to select the range level for when the scale type (gain curve) at the time of device power-up is
"Log." (This setting can be changed in the B-scan imaging screen.)
Scale Type switches
Pressed to select the gain curve to be used among “Log,” “Linear,” and “S-curve.”
Probe Angle switches
Pressed to set the probe angle at the time of device power-up. (This setting can be changed in the B-scan
imaging screen.)
18
BEFORE USE: Screen Description
1.5.6
Pachymetry screen
1
Patient switch
Pressed to register patient information and display the physician's name and the patient ID and name.
Mode switches
Pressed to display the desired screen among the A-scan biometry, B-scan imaging, and Pachymetry
screens.
Date and time switch
Displays the current date and time. Pressed to display the Pachymetry Utility screen.
Waveform display area
Displays the waveform during pachymetry.
AUTO MODE switch
Pressed to toggle the measurement mode between "Auto" and "Speedy."
BIAS switch
Pressed to change the displays of the pachymetry value.
Non: The measurement value is displayed as it is.
µm: The measurement value is displayed with a bias amount (-999 to 999 µm) added.
%: The measurement value is displayed multiplied by a bias rate (10 to 200%).
19
BEFORE USE: Screen Description
DELETE switch
Pressed to delete the selected data in the list.
To delete data, highlight the data to delete by pressing it with the finger or stylus, then press the DELETE
switch.
When the DELETE switch is pressed, it changes to the RECALL switch that restores the deleted data.
VALUE switch
Pressed to input the bias value. The bias values are not displayed when the BIAS switch is "Non."
CLEAR switch
Pressed to delete the measurement data at each measurement point.
ALL CLEAR switch
Pressed to delete all the measurement data of the measurement map.
Point display
The specified measurement point can be moved using Knob 1.
Gain display
Displays the gain during pachymetry measurement.
The Knob 2 is used to adjust the gain.
Print switch
Pressed to print the data being displayed.
Measurement value list
Displays the corneal thickness at the specified measurement point.
Displays the Measurement values and their average (Avg) and standard deviation (SD).
MAP switch
Pressed to change the measurement map.
Pressing this switch changes the Map number from 1 to 6.
* Six types of measurement maps are available.
LIVE/FREEZE switch
Pressed to start (LIVE) or stop (FREEZE) the measurement. The same operation can be performed with the
foot switch.
OD/OS switch
Pressed to switch the eye to be measured.
Measurement point display
Displays the measurement points. The measurement point can be moved by pressing the desired point on
the screen.
Corneal thickness display
Displays the average and standard deviation of the measurement value list.
20
BEFORE USE: Screen Description
1.5.7
Pachymetry utility screen
1
Physician switch
Pressed to select the desired physician (1 to 5) or register Physician data.
Conditions set in
,
,
, and
and the Map No. selected in
can be set for each physician.
Mode switch
Pressed to display the desired screen among the A-scan biometry, B-scan imaging, and Pachymetry utility
screens.
Utility switch
Pressed to display the Utility screen.
Print ON and OFF switches
Pressed to enable or disable printing of the pachymetry results.
Foot switch switches
Pressed to toggle the function of the PRINT switch of the foot switch between “Print (printing)” and “Next
(moving to the next measurement point)."
Exit switch
Pressed to return to the Pachymetry screen.
PRINT switch
Pressed to print the Pachymetry utility settings.
21
BEFORE USE: Screen Description
Save switch
Pressed to save the Pachymetry utility settings.
Load switch
Pressed to return the Pachymetry utility settings to the saved ones.
Default switch
Pressed to return the Pachymetry utility settings to the default.
Map switch
Pressed to set the map number for at the time of device power-up. (This setting can be changed in the
Pachymetry screen.)
Velocity switch
Pressed to set the sonic velocity to calculate distance.
Probe switch
Pressed to select the type of the Pachymetry probe.
22
BEFORE USE: Screen Description
1.5.8
Utility screen (1/2)
1
Mode switch
Pressed to display the desired screen among the A-scan biometry, B-scan imaging, and Pachymetry utility
screens.
Utility switch
Pressed to display the Utility (2/2) screen.
Date Format switches
Pressed to select the desired date display format.
Auto OFF switches
Pressed to set the maximum time of the LIVE condition.
Sound switches
Pressed to change the sound pitch. The sound can be turned off as well.
Save Mode switches
Pressed to toggle the location to save data between the internal or extermal memories.
Ext. Save switches
Pressed to toggle the external location to save data between "USB (USB flash drive)" and LAN (PC)."
Network switch
Pressed to set the network.
23
BEFORE USE: Screen Description
Exit switch
Pressed to return to the measurement screen.
Print switch
Pressed to print the utility setting.
Save switch
Pressed to save the utility setting.
Load switch
Pressed to return the settings to the ones saved in the Utility screen.
Default switch
Pressed to return the utility setting to the default.
Communication switches
Pressed to select communicaiton with the device (PC) that is connected using the external communication
connector.
Start Mode switches
Pressed to set the screen (A-scan biometry, B-scan imaging, and Pachymetry) for at the time of device
power-up.
LCD backlight switches
Pressed to select the brightness of the backlight.
24
BEFORE USE: Screen Description
1.5.9
Utility screen (2/2)
1
Mode switch
Pressed to display the desired screen among the A-scan biometry, B-scan imaging, and Pachymetry utility
screens.
Utility switch
Pressed to display the utility (1/2) screen.
Date and time switches
Used to set the data and time by pressing the arrow switches.
Exit switch
Pressed to return to the measurement screen.
Parameter switches
Pressed to restore or backup the specified settings.
Touch Panel switch
Pressed to adjust the displayed screen and the coordinates of the touch screen.
25
BEFORE USE: Labels and Indications on the Device
1.6
Labels and Indications on the Device
To call the operator’s attention, the device is provided with labels and indications.
If labels are curling up or characters are faded and become barely legible, contact NIDEK or your
authorized distributor.
Indicates that important descriptions are contained in the operator’s manual and that the
operator must refer to the operator's manual prior to operation.
Indicates that the degree of protection against electric shock is of a Type B Applied Part.
Indicates that when the switch is pressed to this symbol side, power is not supplied to the
device.
Indicates that when the switch is pressed to this symbol side, power is supplied to the device.
Indicates that the device must be supplied only with alternating current.
Indicates the fuse rating.
Indicates that the u pedal is to be connected to this port.
Indicates the connector for the fixation lamp cable of the probe stand.
Indicates the manufacturer.
Indicates the date of manufacture.
Indicates that this product shall be disposed of in a separate collection of electrical and
electronic equipment in EU.
26
BEFORE USE: Labels and Indications on the Device
Rear view
INPUT
100-120V㨪 50/60Hz
70VA
SER.NO.
3NNNN
XXXX
1
8TGIKQPU
34-14 Maehama Hiroishi-cho Gamagori Aichi Japan
MADE IN JAPAN
14610-M103-A
8TGIKQPU
8TGIKQPU
INPUT
SER.NO.
230V㨪
50/60Hz
4NNNN
70VA
XXXX
34-14 Maehama Hiroishi-cho Gamagori Aichi Japan
MADE IN JAPAN
INPUT
100-120V㨪 50/60Hz
70VA
SER.NO.
3NNNN
XXXX
14610-M104-A
8TGIKQPU
34-14 Maehama Hiroishi-cho Gamagori Aichi Japan
MADE IN JAPAN
REMOTE
VIDEO
OUT
14610-M103-A
LAN
RS-232C
Left side view
+2:
27
BEFORE USE: Checking Contents
1.7
Checking Contents
Unpack the contents from the shipping carton and check if all the necessities are included.
The following is included into the standard configuration:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
28
Main body
B-scan probe
A-scan probe
Pachymetry 45° probe
Foot switch
Test piece (for A-scan biometry)
Test piece (for pachymetry)
Printer paper
Power cord
Stylus
Ultrasonic gel
Dust cover
Spare fuses
Probe rest
Operator's manaul
2.
2.1
OPERATING PROCEDURES
Operation flow
Connecting accessories
2
"2.2 Device Setup (Page 32)"
"2.2.1 Connecting power cord (Page 32)"
"2.2.2 Connecting foot switch (Page 33)"
"2.2.3 Attaching probe rest (Page 33)"
“{ A-scan probe (Page 34)”
“{ Connecting B-scan probe (Page 35)”
“{ Connecting Pachymetry probe (Page 35)”
"2.2.5 Connecting Probe stand (optional) (Page 36)"
Preparing for measurement
"2.3 Preparation (Page 37)"
"2.3.1 Adding new patient data (Page 39)"
"2.3.2 Setting physician data (Page 41)"
Starting measurement
A-scan biometry
"2.4 A-scan Biometry (Page 44)"
"2.4.1 Basic operation of A-scan biometry (Page 44)"
"2.4.2 Cautions in A-scan biometry (Page 50)"
"2.4.3 Manual gate (Page 51)"
"2.4.4 Calculation of IOL refractive power (Page 53)"
"2.4.5 Comparison in DUAL screen (Page 56)"
"2.4.6 Setting A-scan biometry utility (Page 58)"
“{ Changing sonic velocity to calculate distance (Page 58)”
“{ Setting IOL formula (Page 60)”
“{ Setting normally used IOL (Page 61)”
“{ Setting fixation light ON/OFF (Page 62)”
“{ Setting print format (Page 63)”
“{ Setting printer mode (Page 89)”
“{ Inputting IOL data (Page 64)”
“{ Calculating personal value (Page 66)”
“{ Setting IOL power calculation formula in specified axial length range
(Page 69)”
29
OPERATING PROCEDURES: Operation flow
B-scan imaging
"2.5 B-scan Imaging (Page 71)"
"2.5.1 Basic operation of B-scan imaging (Page 71)"
"2.5.2 Probe angle (Page 73)"
"2.5.3 Changing observation depth (Page 73)"
"2.5.4 Changing display range (Page 74)"
"2.5.5 CV mode (Page 76)"
"2.5.6 Zoom (Page 77)"
"2.5.7 Four image display (Page 79)"
"2.5.8 Measuring area on B-scan imaging screen (Area screen) (Page 81)"
"2.5.9 Measuring distance on B-scan image (Caliper screen) (Page 83)"
"2.5.10 Moving image operation (Page 85)"
"2.5.11 Setting B-scan imaging utility (Page 86)"
“{ Setting probe angle (Page 86)”
“{ Setting scan depth (Page 87)”
“{ Setting scale color (Page 87)”
“{ Changing gain curve pattern (Page 88)”
“{ Setting Log scale range (Page 89)”
“{ Setting printer mode (Page 89)”
“{ Setting data format (Page 90)”
Pachymetry
"2.6 Pachymetry (Page 91)"
"2.6.1 Basic operation of pachymetry (Page 91)"
"2.6.2 Setting pachymetry utility (Page 95)"
“{ Setting Pachymetry probe (Page 95)”
“{ Setting PRINT switch of foot switch (Page 96)”
“{ Setting printing of pachymetry results (Page 96)”
“{ Setting corneal thickness sonic velocity to calculate distance (Page 97)”
“{ Setting map selected at device power-up (Page 97)”
End of operation
"2.8 Completion of Operation (Page 109)"
30
OPERATING PROCEDURES: Operation flow
Initial setting
"2.7 UTILITY (Page 98)"
"2.7.1 Displaying Utility screen (Page 98)"
"2.7.2 Setting Utility (1/2) (Page 100)"
“{ Setting backlight (Page 100)“
“{ Setting Start Mode (Page 100)”
“{ Setting Communication (Page 101)”
“{ Setting date and time indication format (Page 101)”
2
“{ Setting Auto OFF (Page 102)”
“{ Setting sound volume (Page 102)”
“{ Setting save mode (Page 103)”
"2.7.3 Setting Utility(2/2) (Page 107)"
“{ Adjusting touch screen (Page 107)”
“{ Setting date and time (Page 107)”
31
OPERATING PROCEDURES: Device Setup
2.2
Device Setup
2.2.1
Connecting power cord
1
2
Turn off the power switch.
Securely connect the power cord to the inlet on the rear side of the device while adjusting the direction of the plug to the inlet.
3
Position the power cord so that it does not interfere with operation.
4
Securely connect the plug of the power cord to a wall outlet with a protective ground.
* Be sure to connect the power cord to the power outlet with a protective ground.
Plug
32
OPERATING PROCEDURES: Device Setup
2.2.2
Connecting foot switch
1
2
3
Set the foot switch in a convenient position, and position the cable so that it does not
interfere with operation.
Align the notch of the foot switch cable plug, and connect it to the connector on the rear
side of the device.
2
Rotate the knurled ring of the plug clockwise to secure.
Plug
2.2.3
Attaching probe rest
1
Attach the probe rest to the main body of the device.
Attach the probe rest so that it fits the shape of the main body.
33
OPERATING PROCEDURES: Device Setup
2.2.4
Connecting probe
{ A-scan probe
1
2
Align the red mark of the cable plug of the probe with that of the probe connector (BIO)
on the front side of the device, and insert the plug as far as it goes.
Place the probe on the probe rest of the device.
Probe
Probe
Plug
Probe
34
OPERATING PROCEDURES: Device Setup
{ Connecting B-scan probe
1
Connect the probe and the plug of the probe cable.
Probe
2
3
Plug
Align the red mark of the cable plug of the probe with that of the probe connector (B) on
the front side of the device, and insert the plug as far as it goes.
Place the probe on the probe rest of the device.
Probe
Probe
Plug
Probe
{ Connecting Pachymetry probe
1
2
Align the red mark of the cable plug of the probe with that of the probe connector (P) on
the front side of the device, and insert the plug as far as it goes.
Place the probe on the probe rest of the device.
Probe
Probe
Plug
Probe
35
2
OPERATING PROCEDURES: Device Setup
2.2.5
Connecting Probe stand (optional)
{ Attaching A-scan probe
1
2
Hold the probe holder of the probe stand with one hand so that it does not move.
Insert the probe held by the other hand from the physician’s side of the probe holder. At
this time, pay attention not to contact the probe tip with the probe holder.
Hook
3
4
Fasten the probe cable on the hook with the probe holder moved to the patient’s side. At
this time, loop the probe cable twice on the hook while leaving enough slack.
Connect the probe to the device referring to "{ Attaching A-scan probe (Page 36)."
{ Attaching cable for fixation lamp
1
2
3
36
Position the illumination cable so that it does not interfere with the operation.
Align the notch of the other side of the plug to the connector for the external fixation lamp
connector on the rear side of the device.
Insert the plug directly, and turn the knurled ring of the plug clockwise to secure.
OPERATING PROCEDURES: Preparation
2.3
Preparation
1
Turn ON ( | ) the power switch on the right side of the device.
The pilot lamp on the front side of the device lights up with a beep sound, and the opening
screen appears.
After a few seconds, the screen becomes the A-scan biometry screen automatically.
If it is hard to see the indications on the screen, rotate the legs to adjust the inclination of the
device.
CAUTION
2
• Remove the USB flash drive when turning ON power to the US-4000.
Data may become corrupted.
Check the system.
Check the device referring to "4.1 Checks Before Use (Page 117)".
After checks, record each result in the list "4.3 Check List (Page 121)".
3
Disinfect the probe.
Disinfect the probe with the power switch of the device OFF.
Before measurement, be sure to disinfect the probe for every patient.
When using the probe stand, disinfect the forehead rest and chinrest with gauze dampened
with ethanol.
1) If the tip of the probe is contaminated, clean it as necessary.
37
2
OPERATING PROCEDURES: Preparation
2) Soak the probe tip (max. 20mm) in the following or for 10 minutes.
Within 20 mm
0.1% Chlorhexdine Gluconate Solution
Ethanol for disinfection
3) Wipe the probe tip, which was soaked in the disinfection solution, with the disinfected
absorbent gauze dampened with ethanol.
4) Dry the probe.
4
Prepare the patient.
For A-scan biometry or pachymetry
1) Apply the surface anesthesia to the patient’s eye to be measured.
2) Ask the patient to take a posture suitable for the measurement.
3) Apply the corneal protection agent to the probe tip if necessary.
Be sure not to apply too much corneal protection agent to avoid interference with measurement.
For B-scan imaging
1) Apply the ultrasound gel to the patient’s eyelid.
38
OPERATING PROCEDURES: Preparation
2.3.1
Adding new patient data
New patients can be added in the A-scan biometry, B-scan imaging, IOL power calculation, and
Pachymetry screens.
1
Pressing the Patient switch displays the screen shown in Step 2.
2
2
To add a new patient to the Patient list, press the New Patient switch.
Pressing this switch deletes the saved patient information and measurement results and
blanks the fields beside the switches.
3
Press the ID switch to input or change the patient's ID. Then press the Enter switch.
Pressing the ID switch enables input of characters using the keyboard window.
39
OPERATING PROCEDURES: Preparation
* A maximum of 14 characters can be input.
4
Press the Name switch to input or change the patient's name. Then press the Enter
switch.
Pressing the Name switch enables input of characters using the keyboard window.
* A maximum of 14 characters can be input.
5
Press the Sex switch select the sex of the patient.
Pressing the Sex switch displays "MALE" and "FEMALE" alternately in the field beside the
switch.
6
Press the Age switch to input or change the patient's age. Then press the Enter switch.
Pressing the Age switch enables input of characters using the ten-key window.
* Numerical characters can be input in the range from 0 to 200.
7
Press the Memo switch to input or change the comments on the patient. Then press the
Enter switch.
Pressing the Memo switch enables input of characters using the keyboard window.
* A maximum of 34 characters can be input.
8
40
Press the Exit switch to return to the measurement screen.
OPERATING PROCEDURES: Preparation
2.3.2
Setting physician data
A maximum of five physicians can be saved with individual settings.
1
Press the switch that displays the date and time in the A-scan biometry, IOL power calculation, B-scan imaging, or Pachymetry screen.
2
2
Press the Physician switch to display the setting of the physician to check or change.
Each time the Physician switch is pressed, the next physician number and the settings are
displayed.
3
Holding down the Physician switch displays the keyboard window. If necessary, input or
change the physician's name and press the Enter switch.
41
OPERATING PROCEDURES: Preparation
* A maximum of 14 characters can be input.
4
If necessary, change the sonic velocity to calculate distance.
Pressing the switches listed below displays the ten-key window that can be used to input
and change the sonic velocity to calculate distance required for the calculation in the A-scan
biometry, pachymetry, and IOL power calculation.
Pressing the Default switch returns all the settings to the default.
The switches and their default input value and input range are as shown in the table below.
Switch
Input value
Default value
Input range
Axial (Aphakic)
Axial length average sonic
velocity to calculate distance
1550 m/s
(1532 m/s)
1000 to 2000 m/s
ACD
Anterior chamber sonic
velocity to calculate distance
1532 m/s
1000 to 2000 m/s
Lens sonic velocity to
calculate distance
1641 m/s
(1629 m/s)
1000 to 2000 m/s
Vitreous
Vitreous body conversion
sonic velocity
1532 m/s
500 to 2000 m/s
IOL
IOL sonic velocity to calculate
distance (acrylic)
2060 m/s
500 to 3000 m/s
Cornea
Cornea sonic velocity to
calculate distance
1640 m/s
1000 to 2000 m/s
IOL Thk
IOL thickness
0.80 mm
0.02 to 5.00 mm
VD
Vertex distance
12.00 mm
0.00 to 20.00 mm
Lens
(DENSE CAT ON)
* If the Eye Type is "Aphakic" (aphakic eye), the measurement is performed with the sonic
velocity to calculate distancesonic velocity to calculate distance as specified with the
switches above.
* If the DENSE CAT is "ON", the measurement is performed with the sonic velocity to calculate distance as specified with the switches above.
5
If necessary, change the IOL formula used for IOL power calculation.
Select the desired IOL formula under "Formula."
42
OPERATING PROCEDURES: Preparation
6
If necessary, input or change the IOL data used for IOL power calculation.
Pressing the IOL switch displays the screen for presetting the IOL data to be used for IOL
power calculation.
When the IOL settings are present in this screen, the IOL power can be calculated soon
after A-scan biometry.
* For details, see "{ Inputting IOL data (Page 64).”
7
If necessary, calculate the Personal value.
Pressing the Personal switch displays the Personal value calculation screen where the physician inputs various data for the preoperative and postoperative measurement to be calculated.
8
If necessary, change the print format.
Change the print format by pressing any of the switches next to “Print Format”: OFF, 1, 2, or
3.
For details of the print format, see "{ Setting print format (Page 63).”
9
Press the Save switch to save the settings.
To reset to the previous data, press the Load switch.
* If the Save switch is not pressed, the settings in this screen are not saved in the device.
10
If necessary, press the Print switch to print the various data in the screen.
11
To confirm or change the data setting for other physicians, return to Step 2.
12
Press the Exit switch to return to the measurement screen.
43
2
OPERATING PROCEDURES: A-scan Biometry
2.4
A-scan Biometry
2.4.1
Basic operation of A-scan biometry
1
Press the BIO switch to display the A-scan biometry screen.
2
Press the OD/OS switch to select the right or left eye to be measured.
Each time the switch is pressed, the eye to be measured indicated above the switch is toggled between “OD/R” (right eye) and “OS/L” (left eye).
3
Press the EYE TYPE switch to specify the patient’s eye type.
Each time the switch is pressed, the patient’s eye type indicated above the switch is
changed in the order of “Phakic”, “Phakic2”, “Aphakic”, “IOL” and “Phakic”.
* When the patient’s eye type is changed, contents of the sonic velocity to calculate distance
indicated on the left side of the switch are also changed. The patient’s eye type and sonic
velocity to calculate distance are as follows:
Phakic: sonic velocity to calculate distance of average (Axial V.), anterior chamber depth
(ACD V.) and lens thickness (Lens V.)
44
OPERATING PROCEDURES: A-scan Biometry
Phakic2: sonic velocity to calculate distance of anterior chamber depth (ACD V.), lens thickness (Lens V.) and vitreous length (Vit V.)
Aphakic: sonic velocity to calculate distance of aphakic eye (Axial V.)
IOL: sonic velocity to calculate distance of anterior chamber depth (ACD V.), IOL (IOL V.)
and vitreous length (Vit V.) and IOL thickness (IOL Thk.)
2
4
Press the MODE switch to specify the measurement mode.
Each time the switch is pressed, the measurement mode indicated above the switch is
changed among “Auto,” “Speedy,” and “Manual.”
Auto: The measurement conditions are evaluated when the measurement is started.
When the measurement conditions are acceptable, a beep sounds and data sampling is performed. The stability of the measurement data is continuously evaluated during the data sampling.
When ten sets of data with the stability of ±0.1 mm are obtained, a beeping sounds and the measurement is automatically stopped.
Speedy: Data sampling begins when the measurement is started. The measurement
automatically stops when three sets of data is obtained.
The measurement data of the past three times are listed. If the measurement is performed more
than three times, the oldest three sets of data is deleted.
Manual: The physician performs data sampling when the measurement is started.
The measurement automatically stops when 10 sets of data are obtained.
45
OPERATING PROCEDURES: A-scan Biometry
5
Press the FREEZE switch or the MEASURE switch of the foot switch to start A-scan
biometry.
The indication of the switch becomes “LIVE”, and A-scan biometry starts.
6
Put the A-scan probe on the center of the cornea.
1) A-scan waveform appears, and A-scan biometry is performed according to the selected
measurement mode.
2) Adjust the gain by rotating Knob 2 so that a proper A-scan waveform can be obtained.
The gain can be changed in the range between 0 and 100 in 10 dB increments.
* The most recently selected gain is indicated in this screen after the device power is
turned ON again.
46
OPERATING PROCEDURES: A-scan Biometry
3) To measure eyes with hypermature cataract, press the DENSE CAT switch.
2
4) If necessary, press the THRESHOLD switch to change the programmed threshold
among “Normal,” “Low,” and “Flat Low” with which the program determines the acceptability of the measurement value of each intraocular part.
* If there is an additional echo near the threshold preceding any of the valid echoes, redo the measurement referring to "2.4.3 Manual gate (Page 51)".
• When the patient’s eye type is Aphakic, the anterior chamber depth (ACD), lens thickness
(Lens) and vitreous length (Vitreous) are not measured. For IOL implanted eyes, the lens
thickness (Lens) is not measured and the value between the cornea and the front surface of
the IOL is indicated as the anterior chamber depth (ACD).
• The Auto mode is an auxiliary function to facilitate the A-scan biometry operation. It is not
intended for clinical judgement. When using the values obtained in Auto mode for IOL
power calculation, physicians have to examine the obtained values.
7
Repeat Step 5.
Repeat Step 5 several times to ensure validity of the obtained data.
Up to 10 sets of data of the axial length and each intraocular part can be indicated on the list.
8
Arrange the data if necessary.
To delete data due to fluctuations comparied to other data, arrange the data according to the
procedure below.
47
OPERATING PROCEDURES: A-scan Biometry
To delete one set of data, highlight the data with the stylus or finger and press the DELETE
switch.
To undo deletion of a set of data, highlight the No. of the deleted data with the stylus or finger and press the RECALL switch.
To delete all the measured data on the list, press the CLEAR switch. (However, this deletion
cannot be undone. Care should be taken when data is deleted in this manner.)
* Each time the data is deleted and the deletion is undone, the average (Avg) and standard
deviation (SD) are recalculated.
48
OPERATING PROCEDURES: A-scan Biometry
9
If necessary, select the measured data used for IOL power calculation.
To use the measurement data in the data list, highlight the data with the stylus or finger, and
press the SELECT switch to enter. (The “*” mark is indicated next to the No. of the selected
data.)
* If this setting is not performed, the average value is used for IOL power calculation.
2
10 Press the Data save switch to save the data obtained in the A-scan biometry screen.
In this window, a maximum of 12 sets of measurement data displayed in the A-scan biometry screen can be saved (to the internal memory) with the date and patient's name. A maximum of 1000 sets of measurement data can be saved in an external memory.
49
OPERATING PROCEDURES: A-scan Biometry
2.4.2
Cautions in A-scan biometry
To carry out A-scan biometry smoothly and accurately, pay attention to the following:
(1) Instruct the patient not to move their eyes.
If the patient is nervous, instruct them to relax.
(2) Confirm that the probe is in contact with the center of the cornea.
Contact between the probe and the cornea is an important factor in obtaining accurate Ascan biometry values. Change the probe contact angle so that a proper A-scan waveform is
obtained.
A proper A-scan waveform means that it has echoes from the following three parts: the cornea, and the anterior and posterior surfaces of the lens. An proper A-scan waveform has
also a large retinal echo which rises sharply accompanying a small scleral echo.
When the echoes of the retina and sclera are not separated, rotate Knob 2 to decrease the
gain.
(3) Check the following points before freezing the obtained A-scan biometry value:
a) Has a proper A-scan waveform been obtained?
b) Is the probe in contact with the cornea properly?
c) Is the patient’s eye fixed?
d) Are the obtained values stable? (Is the variations in the obtained values within ±0.05 mm?)
* If the A-scan biometry is performed hurriedly, accurate values cannot be obtained. Take enough
time for the A-scan biometry.
(4) In Auto mode, if the display does not stop (FREEZE) even when the obtained values are indicated,
the retinal echo may have not risen properly or there is no lens echo or it is too weak.
Change the contact and angle of the probe so that a proper waveform as shown below is
obtained.
ٕ
ٕ
50
ٕ
ٕ
Proper
Improper
OPERATING PROCEDURES: A-scan Biometry
2.4.3
Manual gate
If there is an additional echo near the threshold value preceding any of the valid echoes, this additional echo is mistakenly considered a valid echo. This Manual Gate function is used to eliminate the
influence of extraneous echoes. This function is also used if there are many multiple echoes in the
measurement of an eye with an IOL implanted.
The Manual Gate can be displayed by selecting a gate type (Cornea, Lens-F (anterior), Lens-B (posterior), or Retina) and pressing the ON/OFF switches. Then the displayed gate position can be
adjusted.
1
2
In the FREEZE screen, confirm that no improper A-scan waveform or intraocular biometry values are found.
1) Press the MEASURE switch of the foot switch or the LIVE switch to stop the A-scan
biometry operation.
2) In the FREEZE screen, observe the A-scan waveform and intraocular biometry values.
If the A-scan biometry values are improper due to extraneous echoes, go to Step 2.
2
Adjust the Manual Gate position.
1) Select the gate type by pressing the GATE switch and press the ON/OFF switch to display the Manual Gate.
* There are gates for Cornea, Lens-F (anterior), Lens-B (posterior), and Retina. Move each
gate to the respective echo.
2) Turn Knob 1 and move each gate just to the left side of the respective echoes.
* The gate can also be moved using the stylus or finger.
51
OPERATING PROCEDURES: A-scan Biometry
3
Restart the A-scan biometry operation and confirm the change of the values of each
intraocular part by the Manual Gate.
1) Press the MEASURE switch on the foot switch or the FREEZE switch to restart the measurement.
2) Check whether the values of each intraocular part are changed.
Echoes on the left side of the set manual gate are no longer considered valid echoes, and all
intraocular values are changed by the Manual Gate function.
* Since an extraneous echo in the A-scan biometry may indicate an intraocular lesion, it is recommended to check for such a possible lesion using other methods (such as B-scan imaging).
52
OPERATING PROCEDURES: A-scan Biometry
2.4.4
Calculation of IOL refractive power
Pressing the IOL switch after the A-scan biometry displays the IOL power calculation screen in which
the IOL power is calculated. The calculation is performed when the necessary data is input, and the
calculated results of the selected IOL type are listed. The IOL data must be input in advance referring
to “{Inputting IOL data (Page 64).”
1
After the A-scan biometry, press the BIO/IOL switch to display the IOL power calculation screen.
2
2
3
Press the OD/OS switch to select the eye in which to implant an IOL.
Press the R1 and R2 switches to input the corneal curvature radius (mm) and/or corneal
refractive power (D).
Pressing any of the R1 and R2 switches displays the ten-key window. After inputting the values using the ten-key, press the Enter switch.
4
Press the Formula switch to select the IOL formula used to calculate the IOL power.
Each time the switch is pressed, the IOL formula registered in the physician setting screen is
indicated in order.
The selected IOL formula is indicated on the switch.
Auto: An IOL formula is automatically selected based on the axial length.
Comparison: The IOL power is calculated with all the IOL formula.
* The most recently selected IOL formula is indicated in this screen after the device power is
turned OFF and then ON again.
53
OPERATING PROCEDURES: A-scan Biometry
5
Press any of the IOL 1, IOL 2, and IOL 3 switches to display the IOL list window. Select
up to three IOL types to be used for the IOL power calculation.*2
1) Press the IOL number to be changed to display the IOL list window.
2) Select the IOL in the list with the stylus or finger.
* If there is no desired IOL, register a new one.
3) Press the OK switch to determine the IOL used for the calculation and close the window.
* To close the IOL list window without any changes, press the Cancel switch.
4) To change the IOL selected with other switches, repeat Steps 1) to 3).
* The same IOL cannot be selected with multiple switches.
6
If necessary, temporarily change the IOL constant selected in Step 5.*3
1) Press the Aconst switch (such as ACD and SF) just below the IOL whose IOL constant is
the item to be changed to display the numeric key window.
* The indicated switch is one of “Aconst,” “SF,” and “ACD” according to the IOL formula to
be used.
*2 If three types of IOLs are not necessary for the IOL refractive power calculation, leaving the IOL model name blank deletes the registered IOL data, and the deleted IOLs
are not used for the calculation. (For the inputting method, see “{ Inputting IOL data
(Page 64).” Unless this setting is saved in the IOL data input screen, the blank IOL
model name is returned to the original once power to the device is turned off.
54
OPERATING PROCEDURES: A-scan Biometry
*3 Changes made in this step are temporary, and the values return to the original once
power to the device is turned off.
2) Input a new IOL constant using the ten-key window, and press the Enter switch.
* The following lists the switches and ranges of each constant. Values cannot be input
outside the ranges:
Aconst (A constant) (Aconst switch) ........100 to 130
ACD (Predicted postoperative anterior chamber depth) (ACD switch)..... 1.6 to 9.99
SF (Surgeon factor) (SF switch)... 0 to 9.99
* Each time the BS switch is pressed, the input numerical values are deleted from the
right end.
* To close the ten-key window without any changes, press the Cancel switch.
3) To change the IOL constant of the other two IOLs, repeat Steps 1) to 2).
7
Input the obtained data of each intraocular part to carry out the IOL power calculation.
1) Select either the right (OD/R) or left (OS/L) eye to enter data first.
2) Press the Axial switch to display the ten-key window, and input the axial length.
* When the A-scan biometry is completed, the average or measured data with a “
mark has already been input.
”
3) Press the R1/R2 switch to display the ten-key window, and input the corneal curvature or
refractive power.
* The following are the ranges of corneal curvature and corneal refractive power, and the
values cannot be input outside the ranges:
Corneal curvature: 5.00 to 19.99 mm
Corneal refractive power: 20.00 to 60.00 D
* When the NIDEK Keratometer is connected, the corneal curvature or refractive power
that was obtained with the Keratometer has been already input.
4) Press the Target switch to display the ten-key window, and input the desired postoperative refractive power.
* The range of the desired postoperative refractive power is between -10.00 D and +10.00 D, and
the value cannot be input outside the range.
5) The IOL powers for each set of input data are calculated.
The IOL power which is the closest to the desired postoperative refractive power is highlighted in
the middle row on the calculation list.
6) Input the data for the other eye in the same manner as Steps 2) to 4) to calculate the IOL
power for it.
8
Press the Print switch to print the calculation results.
55
2
OPERATING PROCEDURES: A-scan Biometry
2.4.5
Comparison in DUAL screen
1
2
3
56
Press the DUAL switch in the A-scan biometry screen to display the DUAL screen.
Press the Data Read switch below the table on the left side of the screen to display the
file list.
Select the desired file from the list to be displayed on the left side (1) of the screen by the
stylus or finger, and press the Display switch.
OPERATING PROCEDURES: A-scan Biometry
4
Press the Data Read switch below the table on the right side of the screen to display the
file list.
2
5
Select the desired file from the list to be displayed on the right side (2) of the screen by
the stylus or finger, and press the Display switch.
6
Press the LIST/WAVE switch to display the lists.
7
Select appropriate data from the list by the stylus or finger.
8
Press the LIST/WAVE switch to display the waveform and confirm that it is appropriate.
9
Press the IOL switch to calculate the IOL power.
57
OPERATING PROCEDURES: A-scan Biometry
2.4.6
Setting A-scan biometry utility
1
Press the switch that indicates the date and time in the A-scan biometry screen to display the A-scan biometry utility screen.
{ Changing sonic velocity to calculate distance
1
58
Press any of the Axial, ACD, Lens, Vitreous, and IOL switches to change the sonic
velocity to calculate distance. To change other values, press the IOL Thk or VD switch.
OPERATING PROCEDURES: A-scan Biometry
2
Input the sonic velocity to calculate distance and other values and press the Enter switch.
2
Switch
Input value
Default
value
Axial
(Aphakic)
Axial length average sonic
velocity to calculate distance
1550 m/s
1000 to 2000 m/s
(1532 m/s)
ACD
Anterior chamber sonic
velocity to calculate distance
1532 m/s
Lens sonic velocity to
calculate distance
1641 m/s
1000 to 2000 m/s
(1629 m/s)
Lens
(DENSE CAT ON)
Input range
1000 to 2000 m/s
Vitreous
Vitreous body sonic velocity to
1532 m/s
calculate distance
500 to 2000 m/s
IOL
IOL sonic velocity to calculate
distance (PMMA)
2060 m/s
500 to 3000 m/s
IOL Thk
IOL thickness
0.80 mm
0.02 to 5.00 mm
V.D.
Vertex distance
12.00 mm
0.00 to 20.00 mm
* If the Eye Type is "Aphakic" (aphakic eye), the measurement is performed with the sonic
velocity to calculate distance as specified with the switches above.
* If the DENSE CAT is "ON", the measurement is performed with the sonic velocity to calculate distance as specified with the switches above.
Pressing the Default switch resets all the settings to the default values.
3
Press the Save switch to save the data.
59
OPERATING PROCEDURES: A-scan Biometry
{ Setting IOL formula
1
Select the IOL formula(s) to be used for the IOL power calculation.
Auto: An IOL formula is automatically selected based on the axial length.
2
60
Press the Save switch to save the setting.
OPERATING PROCEDURES: A-scan Biometry
{ Setting normally used IOL
1
Press any of the IOL1, 2, or 3 switches to display the IOL list.
2
2
Select the desired IOL from the IOL list, and press the OK switch.
3
Press the Save switch to save the setting.
61
OPERATING PROCEDURES: A-scan Biometry
{ Setting fixation light ON/OFF
Toggle the fixation light inside the A-scan probe between lit and unlit.
62
1
Select "ON" or "OFF."
2
Press the Save switch to save the setting.
OPERATING PROCEDURES: A-scan Biometry
{ Setting print format
Set the print format in the A-scan biometry.
1
Select the print format from "Off," "1," "2," and "3."
Printed item
A-scan biometry
Off
1
2
3
Patient data
-
O
O
O
Physician's name
-
O
O
O
Operation conditions
-
O
O
O
Eye (left or right)
-
O
O
O
Measurement data list, the average value
(Avg) and the standard deviation (SD)
-
O
-
-
A-scan biometry value used for IOL power
calculation
Value with "*" in the IOL list on the screen
-
O
O
O
Selected A-scan waveform
-
O
O
-
Print date and time
-
O
O
O
Off
1
2
3
Patient data
-
O
O
O
Physician's name
-
O
O
O
Operation conditions
-
-
-
O
IOL formula
-
O
O
O
Eye (left or right)
-
O
O
O
A-scan biometry value used for IOL power
calculation
Value with "*" in the IOL list on the screen
-
-
-
O
Selected A-scan waveform
-
-
-
O
Input axial length
-
O
O
O
Corneal curvature radius (mm)/ Refractive
power (D)
-
O
O
O
Target postoperative refractive power
-
O
O
O
IOL data, optimal IOL value, and selectable
IOL and refractive power
(Selectable range of IOL: ± 1.0D or ± 1.5D)
-
O
(± 1.5D)
O
1.0D)
O
1.0D)
Print date and time
-
O
Printed item
IOL power calculation
2
(±
O
(±
2
O
Press the Save switch to save the setting.
* If the Save switch is not pressed, the setting is reset to the original once power to the
device is turned off.
63
OPERATING PROCEDURES: A-scan Biometry
{ Inputting IOL data
When the IOL data is preset in this screen, it becomes possible to calculate the IOL power to be used
for the surgery soon after the A-scan biometry. (A maximum of 16 sets of IOL data can be input.)
64
1
Press the switch with the date and time indications in the A-scan biometry screen.
2
Press the IOL switch.
OPERATING PROCEDURES: A-scan Biometry
3
Press the box to input (or change) with the stylus or finger.
If any box in the Model and Manuf column is pressed, the keyboard window is displayed. If
any box in the Aconst, SF, and ACD columns is pressed, the ten-key window is displayed.
2
4
Input (or change) the IOL data.
The switches and changeable contents are as follows:
Model: Model of the IOL
Manuf.: Manufacturer
Aconst: A constant
SF: Surgeon factor
ACD: Predicted postoperative anterior chamber depth
* If three types of IOLs are not necessary for the IOL refractive power calculation, leaving the
IOL model name blank deletes the registered IOL data, and the deleted IOLs are not used
for the calculation.
5
Press the Save switch to save the data.
65
OPERATING PROCEDURES: A-scan Biometry
{ Calculating personal value
The values such as the IOL constant can be calculated by inputting the corneal curvature radius/
refractive power, axial length, IOL power and postoperative refractive power.
1
Press the switch that indicates the date and time to display the A-scan biometry utility
screen.
2
Press the Personal switch.
3
Input the postoperative refractive power.
Pressing any of the postoperative power switches displays the ten-key window which
enables inputting the refractive power required to calculate the IOL constant.
The following lists the switches (setting items) and ranges of the refractive power. Values
cannot be input outside the ranges:
Sphere switch (postoperative spherical power) - 20.00 to + 20.00 D
66
OPERATING PROCEDURES: A-scan Biometry
Cylinder switch (postoperative cylindrical power) - 20.00 to +20.00 D
2
4
Press the Axial switch to input the axial length of the eye to be treated.
Pressing this switch displays the ten-key window which enables inputting of the axial length.
The input range of axial length is between 12.00 and 40.00 mm, and the axial length cannot
be input outside the range.
5
Press the R1/R2 switches to input the corneal curvature radius or corneal refractive
power of the eye to be treated.
Pressing this switch displays the ten-key window which enables inputting of the corneal curvature radius or corneal refractive power.
The input ranges of corneal curvature radius and corneal refractive power are described
below, and the values cannot be input outside the ranges. In addition, the units (mm or D)
are automatically changed according to the input value.
Corneal curvature 5.00 to 19.99 mm
Refractive power 20.00 to 60.00 D
6
Press the Implanted IOL Power switch to input the implanted IOL power.
Pressing this switch displays the ten-key window which enables inputting the implanted IOL
power.
The input range of the implanted IOL power is between -40.00 and +40.00 D, and the value
cannot be input outside the range.
67
OPERATING PROCEDURES: A-scan Biometry
When the necessary data is input, the IOL constant is automatically calculated, and Aconst
(A constant), SF (surgeon factor) and ACD (predictable postoperative anterior chamber
depth) are indicated in the boxes under “Personal Value”.
68
7
If necessary, press the Print switch to print the data on this screen.
8
Press the Exit switch twice to return to the A-scan biometry screen.
OPERATING PROCEDURES: A-scan Biometry
{ Setting IOL power calculation formula in specified axial length range
1
In the A-scan biometry utility screen, press the Auto switch to display the Auto screen.
2
2
3
Press the Min Max switch to display the ten-key window. Input the axial length range
(values) using the ten-key. (Unit: mm)
Pressing any of the Formula switches displays the Formula select screen. Select the
desired IOL formula for each axial length range.
69
OPERATING PROCEDURES: A-scan Biometry
4
Press the Save switch to save the setting.
Press the Load switch to reset the settings to the saved ones. Pressing the Default switch resets the
settings to the default.
70
5
If necessary, press the Print switch to print the setting.
6
Press the Exit switch twice to return to the A-scan biometry screen.
OPERATING PROCEDURES: B-scan Imaging
2.5
B-scan Imaging
2.5.1
Basic operation of B-scan imaging
1
Press the B switch to display the B-scan imaging screen.
2
2
Press the OD/OS switch to select the right or left eye for which the B-scan imaging is to
be performed.
Each time the switch is pressed, the eye indication above the switch changes between "OD/
R" (right eye) and "OS/L" (left eye).
71
OPERATING PROCEDURES: B-scan Imaging
3
4
5
6
7
72
Press the FREEZE switch or the MEASURE switch of the foot switch to start the image
observation.
Apply the B-scan probe on the eyelid of the patient.
As necessary, change the settings such as TGC (-20 to 0 dB), GAIN (0 to 90 dB), probe
angle, observation depth, display range, and display color. Then start the image observation.
When the desired image is captured, press the LIVE switch or press the MEASURE
switch of the foot switch to FREEZE the image.
If necessary, press the PRINT or Data Save switch to save the necessary data.
OPERATING PROCEDURES: B-scan Imaging
2.5.2
Probe angle
The angle of the probe touching the eyelid is displayed. Each pressing of the switch rotates the angle
by 45° clockwise.
(ex.: 0° → 45° → 90° → 135° → 180° → 225° → 270° → 315° → 0° → 45° → ...)
2
2.5.3
Changing observation depth
Press the Depth switch to change the observation depth.
73
OPERATING PROCEDURES: B-scan Imaging
2.5.4
Changing display range
The Range switch is available when the gain curve is set to "Log." Each pressing of the Range switch
changes the value as "50 → 40 → 30 → 20 → 10 → 50dB..."
The B-scan image is displayed in 256 gray scales within the range of the echo intensity (50 dB).
The range of the echo intensity can be changed as necessary. For example, when the range is
changed to 30 dB, the echo intensity is displayed in 256 gray scales within the range of 30 dB. By
adjusting the range of 30 dB to the desired echo intensity, the image of the selected echo intensity can
be displayed in clear and emphatic contrast.
・Range: 50 dB
Brightness
F$
Echo intensity
・Range: 30 dB Middle intensity echoes are displayed clearly
Brightness
F$
Echo intensity
74
OPERATING PROCEDURES: B-scan Imaging
・Range: 30 dB Low intensity echoes are displayed clearly
Brightness
2
F$
Echo intensity
・Range: 30 dB High intensity echoes are displayed clearly
Brightness
F$
Echo intensity
75
OPERATING PROCEDURES: B-scan Imaging
2.5.5
CV mode
1
2
Press the "CV:OFF" switch.
Pressing the triangle switches moves
the cross-vector line. The A-scan waveform for the cross-vector line and the
entire B-scan image are displayed
together. The cross-vector line also can
be moved with the stylus or finger.
Cross-vector line
A-scan waveform
76
OPERATING PROCEDURES: B-scan Imaging
2.5.6
Zoom
1
Press the Zoom switch in the B-scan imaging screen to display the Zoom screen.
2
2
Press the Draw Ratio switch to toggle the magnification between x2.5 and x5.
77
OPERATING PROCEDURES: B-scan Imaging
3
Rotate Knob 1 and 2 to move the area of magnification in the up, down, left, and right
directions.
A square appears in the Zoom Navi display to indicate the area of magnification. The area of
magnification can be moved by touching the desired part in the Zoom Navi display with the
stylus or finger.
78
4
Press the Print switch to print the image on the screen.
5
Press the Exit switch to return to the B-scan imaging screen.
OPERATING PROCEDURES: B-scan Imaging
2.5.7
Four image display
1
Press the Quad switch in the B-scan imaging screen to display the four image display
screen.
If the desired data is stored in an external storage device, import the data by pressing the
Data Read switch.
2
2
3
Press the image or the MemNo. switch to select an image. Pressing the
and
switches displays 12 saved images consecutively (three consecutive sets of four images).
Press the Display switch to display only one image.
79
OPERATING PROCEDURES: B-scan Imaging
80
4
Press the Delete switch to delete the selected image.
5
Press the Exit switch to return to the B-scan imaging screen.
OPERATING PROCEDURES: B-scan Imaging
2.5.8
Measuring area on B-scan imaging screen (Area screen)
1
Press the Area/Caliper switch in the B-scan imaging screen to display the Area/Caliper
screen.
2
2
3
Press the Area/Caliper switch in the Area/Caliper screen to display the Area screen.
Move the "×" mark on the image to the desired start point by turning Knob 1 and 2, or
specify the start point with the stylus and confirm it by pressing the Set switch.
81
OPERATING PROCEDURES: B-scan Imaging
4
Repeat Step 3 to specify the desired range.
To change the position of the previous point, press the Back switch.
To clear all the points, press the All Clear switch.
5
82
Specify the end point to the same position as the start point, and press the Calculation
switch to calculate the area.
6
Press the Print switch to print the image in the screen.
7
Press the Exit switch to return to the B-scan imaging screen.
OPERATING PROCEDURES: B-scan Imaging
2.5.9
Measuring distance on B-scan image (Caliper screen)
1
Press the Area/Caliper switch in the B-scan imaging screen to display the Area/Caliper
screen.
2
2
Press the Area/Caliper switch in the Area/Caliper screen to display the Caliper screen.
3
Select the desired marker (+, +, x, or x).
83
OPERATING PROCEDURES: B-scan Imaging
4
5
Move the selected marker using Knob 1 and 2 or specify the desired point using the stylus.
Select the marker paired with the selected one (+ and + /
tion as in Step 4.
x and x) and specify its posi-
The distance is displayed when the marker positions are specified.
84
6
Press the Print switch to print the image in the screen.
7
Press the Exit switch to return to the B-scan imaging screen.
OPERATING PROCEDURES: B-scan Imaging
2.5.10 Moving image operation
Play a moving image of 20 seconds’ LIVE condition just before the FREEZE switch was pressed.
2
Play switch: Plays a moving image of about 20 seconds’ LIVE condition just before the FREEZE
switch was pressed.
Stop switch: The Play switch becomes the Stop switch while the moving image is played.
Scroll backward and forward switches: 1 image
Skip backward and forward switches: 5-image jumps
85
OPERATING PROCEDURES: B-scan Imaging
2.5.11 Setting B-scan imaging utility
1
Press the switch that indicates the date and time in the B-scan imaging screen to display
the B-scan imaging utility screen.
{ Setting probe angle
1
Select the desired probe angle for at the time of device power-up.
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
86
OPERATING PROCEDURES: B-scan Imaging
{ Setting scan depth
1
Select the desired scan depth for at the time of device power-up.
2
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original.
{ Setting scale color
1
Select the desired scale color.
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
87
OPERATING PROCEDURES: B-scan Imaging
{ Changing gain curve pattern
1
Set the gain curve to be used.
Types and characteristics of the gain curves are as described below.
1.LOG:
The brightness of the image is in proportion with the logarithm of the echo intensity.
In the range width of 50 dB, the whole image can be observed from the parts of weak to strong echoes. The desired part can be magnified by changing the display range.
2.Linear:
The brightness of the image is in proportion with the echo intensity.
Areas of echo intensity a little higher than the middle intensity are displayed in high contrast.
Areas of high echo intensity are displayed in white.
3.S-curve:
Areas of the echo intensity a little lower than the middle intensity are displayed in high contrast.
The other areas are displayed in low contrast.
High
Display concentration
S-curve
Log
Linear
Low
Low
High
Echo intensity (logarithmic scale)
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
88
OPERATING PROCEDURES: B-scan Imaging
{ Setting Log scale range
1
Set the range level at the time of device power-up when the scale type (gain curve) is
"LOG."
2
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
{ Setting printer mode
1
2
Select the printer for B-scan imaging between the built-in printer (Int.) and an external
printer (Ext.).
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
89
OPERATING PROCEDURES: B-scan Imaging
{ Setting data format
1
Select the data format in which the data is to be saved from "Raw (raw data)", "Jpeg
(Joint Photographic Experts Group)", or both.
If “Jpeg” is selected, the saved data cannot be read by the US-4000 again.
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
○Other settings
1
2
3
Press the Velocity, TGC, and GAIN switches to set those values at the time of device
power-up.
Press the Average switch to set the times (1 to 5) of averaging of the B-scan waveform.
Press the Save switch.
Unless the Save switch is pressed, the settings above at the time of device power-up return
to the original once power to the device is turned off.
90
OPERATING PROCEDURES: Pachymetry
2.6
Pachymetry
2.6.1
Basic operation of pachymetry
1
2
Press the PACHY switch to display the Pachymetry screen. (If the Pachymetry probe is
not connected, a warning message appears and the Pachymetry screen cannot be displayed.)
Press the OD/OS switch to specify the eye to be measured between the right or left.
Each time the OD/OS switch is pressed, the eye being selected is changed between “OD/R”
(right eye) and “OS/L” (left eye).
3
Press the Map No. switch to select the desired map.
Six types of maps are available. Each map is indicated with a number from “1” to “6” on the
left side of the switch.
Each time the Map No. switch is pressed, the map number and corresponding map are
changed in order.
91
2
OPERATING PROCEDURES: Pachymetry
* The point with the color different from the background is the measurement point of this
map.
4
Press the AUTO MODE switch to toggle between "Auto" and "Speedy."
5
Press the BIAS switch to set the bias indication and bias amount.
(A) To indicate an unbiased value
Press the BIAS switch until “Non” is indicated below the switch.
* Non: The measurement value is displayed as it is.
92
OPERATING PROCEDURES: Pachymetry
(B) To indicate a biased value
Press the BIAS switch until “µm” or “%” is indicated below the switch.
When “µm” or “%” is indicated, the VALUE switch appears below the indication.
When the bias setting is anabled, the biased average value shown on each measurement point in
the map is the result of averaging after adding the bias value to each measurement value of the
measurement point. Therefore, the shown biased average value may differ from one that is
obtained by simply adding the bias value to the average vale.
* µm : The biased value (measurement value + bias value) is indicated in as the measurement value.
% : The biased value (measurement value × bias value) is indicated as the measure-
ment value.
[Bias setting]
Both in the case of “µm” and “%”, press the VALUE switch to display the ten-key window to input
the bias amount. The following is the ranges of bias amount, and the value cannot be input outside
the ranges:
µm : - 999 to 999 µm
6
% : 10 to 200 %
Press the MEASURE switch of the foot switch or the FREEZE switch to start the measurement.
The indication of the FREEZE switch changes to “LIVE,” and pachymetry is started..
7
Put the probe tip on the point of the cornea corresponding to the highlighted measurement point on the map.
Each time the measurement starts, a short beep sounds, and the average measurement value is
indicated on the highlighted measurement point. In the list, the measurement values, average
value, and standard deviation of each measurement are indicated. In the waveform display above
the list, the current waveform is indicated.
Highlighted row in the list indicates the currently-measured data, and the highlighted row moves
down a row as each measurement is finished.
When the Auto-measurements for the set times are finished, a beeping sounds, and the indication
on the LIVE switch changes to “FREEZE.”
93
2
OPERATING PROCEDURES: Pachymetry
8
Release the probe tip from the cornea.
9
If necessary, manipulate the measured data on the list.
If the dispersions in the measurement data is great compared to other data, manipulate
the data with the procedures below.
To delete a set of data in the list, highlight the data with the stylus or finger, and press the
DELETE switch.
To restore the deleted data, highlight the deleted data with the stylus or finger, and press
the RECALL switch.
To delete all the measurement data in the list, press the ALL CLEAR switch, then the OK
switch. (If the measurement data is deleted in this method, the deleted data cannot be
restored even by pressing the RECALL switch. Care should be taken when deleting the
measurement data.)
* Each time a set of measurement data is deleted or restored, the average value (Avg)
and standard deviation (SD) are recalculated.
10Press the PRINT (NEXT) switch of the foot switch or press the next measurement point
with the finger to change the highlighted measurement point.
11Press the MEASURE switch of the foot switch or the FREEZE switch to start measurement at the new measurement point.
12Repeat Steps 7) to 11) until the measurement of all the measurement points on the map
are completed.
94
OPERATING PROCEDURES: Pachymetry
2.6.2
Setting pachymetry utility
1
Press the switch that indicates the date and time in the Pachymetry screen to indicate
the Pachymetry utility screen.
2
{ Setting Pachymetry probe
1
Select the type of the Pachymetry probe to be used.
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
95
OPERATING PROCEDURES: Pachymetry
{ Setting PRINT switch of foot switch
1
2
Toggle the function of the PRINT switch of the foot pedal between "PRINT (printing)" and
"Next (moving to the next measurement point)."
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
{ Setting printing of pachymetry results
1
Toggle printing of the pachymetry results between "ON" and "OFF."
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
96
OPERATING PROCEDURES: Pachymetry
{ Setting corneal thickness sonic velocity to calculate distance
1
Press the Cornea switch.
2
2
Input the sonic velocity to calculate distance.
3
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
{ Setting map selected at device power-up
1
Press the Map switch.
2
Select the desired map.
3
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
97
OPERATING PROCEDURES: UTILITY
2.7
UTILITY
2.7.1
98
Displaying Utility screen
1
Press the switch that indicates the date and time in each measurement screen.
2
Press the Utility switch.
OPERATING PROCEDURES: UTILITY
3
Change the settings in the Utility (1/2) screen.
2
4
Press the Utility switch.
5
Change the settings in the Utility (2/2) screen.
6
Press the Exit switch to return to the measurement screen.
99
OPERATING PROCEDURES: UTILITY
2.7.2
Setting Utility (1/2)
{ Setting backlight
1
2
Press the desired LCD backlight switch (Low, Mid, or Hi) to set the brightness of the LCD
backlight. The default setting is ”Hi."
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
{ Setting Start Mode
1
Select the initial screen after device power-up among "BIO," "B," and "Pachy."
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
100
OPERATING PROCEDURES: UTILITY
{ Setting Communication
1
Select the method of data transmission to other connected devices.
Toggle bewteen "OFF" and "NIDEK." The default setting is "OFF."
2
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
{ Setting date and time indication format
1
Select the format of the date and time indication. The default setting is "Y/M/D."
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
101
OPERATING PROCEDURES: UTILITY
{ Setting Auto OFF
1
2
Press the Probe switch to input the maximum time of the LIVE (measurement) condition.
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
{ Setting sound volume
1
Select the desired sound pitch.
In a noisy environment, setting “Hi” increases the audibility of the sound.
2
Press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
102
OPERATING PROCEDURES: UTILITY
{ Setting save mode
1
Toggle the location to save the data between the internal memory (Memory) and an
external storage device (Ext.).
2
2
If the internal memory (Memory) is selected, press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
If the internal memory is selected, the saved data is deleted once power to the device is
turned off.
3
To use an external storage device, select "USB" or "LAN."
4
If "USB" is selected, press the Save switch.
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
5
If "LAN" is selected, press the Network switch.
6
Obtain the following information from the network administrator. (IP Address of the US-4000)
TCP/IP
IP Address, Subnet Mask
PC CIFS
User Name, Pass word, Domain
103
OPERATING PROCEDURES: UTILITY
7
Input the information obtained from the network administrator.
Input a fixed IP address in the IP Address box. DHCP is not supported.
8
Confirm the computer name and domain in the Syetem Properties window on the PC.
(Ask the network administrator for detailed procedures.)
9
104
Create a folder for saving data on the PC.
OPERATING PROCEDURES: UTILITY
10 Select "Share this folder" under the Sharing tab in the Properties window of the created
folder. Press the Permissions switch and set the access permission. Then press the OK
switch.
2
11 Input the names of the PC and the folder for saving data.
12 Press the Save switch.
13Press the Exit switch to return to the Utility (1/2) screen.
14Press the Save switch.
105
OPERATING PROCEDURES: UTILITY
If the Save switch is not pressed, the setting is reset to the original once power to the device
is turned off.
106
OPERATING PROCEDURES: UTILITY
2.7.3
Setting Utility(2/2)
{ Adjusting touch screen
1
Press the Touch Panel switch in the Utility screen to display the screen shown below.
Press the centers of the four red crosses with the stylus.
2
• If any place other than the center of the red cross is touched with the stylus and the position
of the screen is adjusted improperly, turn ON power to the device while pressing Knob 2.
The touch screen can be adjusted again.
{ Setting date and time
1
Set the date and time with the arrow mark switches. The setting is reflected in the Utility
switch.
The date and time is set without pressing the Save switch.
107
OPERATING PROCEDURES: UTILITY
{ Handling EEPROM parameters
Loading backup of various settings (from USB flash drive)
1) Connect the USB flash drive that contains the backup data to the USB port of the device.
2) Press the Restore switch.
Saving various settings to USB flash drive
1) Connect the backup USB flash drive to the USB port of the device.
2) Press the Backup switch.
108
OPERATING PROCEDURES: Completion of Operation
2.8
Completion of Operation
When the A-scan biometry, IOL power calculation, B-scan imaging, and pachymetry are finished,
complete the operation following the procedure below.
1
Measure any additional patients.
To measure an additional patient, go back to"2.3 Preparation (Page 37)".
2
3
2
After the last patient is measured, turn OFF the power switch on the right side of the
device.
Clean the used probes.
Remove any contamination by wiping the probe lightly with a soft cloth soaked with water or
rubbing alcohol and wrung out. (See "5.6.1 Cleaning ultrasound probe (Page 133)".)
4
Disinfect the used probe and store it in the special case.
Perform the sterilization if necessary. (See "5.6.2 Disinfecting ultrasound probe (Page
134)".)
1) Soak the probe tip (max. 20mm) in the following disinfentant solutions:
0.1% Chlorhexdine Gluconate Solution
Ethanol for disinfection
2) Wipe the probe tip with the disinfected absorbent gauze dampened with ethanol.
3) Leave the probe sit until the tip is dry.
4) Put the cap on the probe tip, disconnect the probe from the device, and store it in the
special case.
5
Clean the exterior of the device and touch screen if necessary.
Clean them referring to "5.5 Cleaning (Page 131)".
6
Put the dust cover on the device to keep dust out.
The operation of the device is completed.
109
OPERATING PROCEDURES: Completion of Operation
110
3.
OPERATION
WHEN PERIPHERAL DEVICES ARE CONNECTED
The US-4000 can export the measurement data to a connected external device such as a PC. When
the US-4000 is connected to a NIDEK Keratometer, data (R1 and R2) obtained by the Keratometer
can be imported to the US-4000.
CAUTION
• Before connecting cables to devices, turn the devices off and disconnect all power
cords from outlets.
Malfunction may result.
3.1
3
Connecting to Keratometer
3.1.1
Outline
The US-4000 can be connected to devices such as the Auto Ref/Keratometer (ARK-530 series and
ARK-700 series), Keratometer (KM-500, etc.), Handy Auto Ref/Keratoemter (ARK-30, etc.), OPDSCAN (ARK-9000, etc.), and Auto Ref/Kerato/Tonometer (RKT-7700, etc.).
• The measurement data obtained by the KM is transmitted through the RS-232C
interface.
3.1.2
Method of connection (example)
1
The US-4000 and the data output connector of the Keratometer is connected with a
communication cable (optional).
Connect the RS-232C connectors at the back of the US-4000 and the Keratometer.
RS-232C cable (optional)
INPUT
100-120V㨪 50/60Hz
70VA
SER.NO.
3NNNN
XXXX
34-14 Maehama Hiroishi-cho Gamagori Aichi Japan
MADE IN JAPAN
REMOTE
VIDEO
OUT
14610-M103-A
RS-232C
111
OPERATION WHEN PERIPHERAL DEVICES ARE CONNECTED: Connecting to Video Printer
3.1.3
Operating procedure
1
After measurement with a keratometer, displaying the IOL power calculation screen with
the US-4000 automatically transfers the measurement data from the keratometer to the
US-4000.
• To disconnect the interface cable, press the
button on the connector.
Button
When the cable is connected, the button is
located on the underside of the connector.
3.2
Connecting to Video Printer
The US-4000 can be connected to a video printer for printing B-scan images.
Use a video printer that complies with IEC60601-1.
1
2
3
4
5
6
7
In the B-scan imaging utility screen, set "Print Mode" to "Ext."
Select the resolution (VGA/SVGA) of the video printer.
Select the information to be printed (Full (all the information in the screen) / Image (only
the waveform)).
Press the Save switch to save the setting.
Connect the remote terminal of the US-4000 and the remote control terminal of the video printer.
Connect the video output terminal of the US-4000 and the VIDEO IN connector of the
video printer.
Press the Print switch in the B-scan imaging screen to print the B-scan image.
* For use of the video printer, refer to its operator's manual.
112
OPERATION WHEN PERIPHERAL DEVICES ARE CONNECTED: Connecting to USB Port
3.3
Connecting to USB Port
A USB memory key is connected to the US-4000 to save measurement images and values by selecing "USB" in the file setting in the B-scan imaging or A-scan biometry screen.
Use one of the recommended USB flash drives listed below. Other USB flash drives may not be used.
Recommended USB flash drives:
IO-DATA . . . . . . TB-B512, TB-B1G, TB-B2G, TB-BH4G/G
BUFFALO. . . . . RUF-C512ML/U2, RUF-C1GL-B/U2, RUF-Q16/4P,
SanDisk . . . . . . SDCZ6-1024-J65
TRANSEND . . . TS1GJFV10
1
2
In the B-scan imaging utility screen, select "Save Format" to "Raw," "Jpeg," or "Both,"
and press the Save switch.
In the Utility (1/2) screen, set "Save Mode" to "Ext.," and "Ext.Save" to "USB," and press
the Save switch.
CAUTION
• Do not remove the USB flash drive from the US-4000 during data transfer.
• Remove the USB flash drive prior to turning ON power to the US-4000.
113
3
OPERATION WHEN PERIPHERAL DEVICES ARE CONNECTED: Connecting to LAN Port
3.4
Connecting to LAN Port
1
2
3
114
In the Utility (1/2) screen, set "Save Mode" to "Ext." and "Ext. Save" to "LAN”, and press
the Save switch.
Press the Network switch to display the Network Utilty screen.
Press the IP Address and Subnet Mask switches and input the IP address and subnet
mask.
OPERATION WHEN PERIPHERAL DEVICES ARE CONNECTED: Connecting to LAN Port
4
Press the User Name, Password, Domain, Machine Name, and Folder Name switches
and input the respective information.
3
5
Press the Save switch to save the settings.
6
Turn OFF power to the US-4000.
7
Connect a LAN cable to the US-4000.
8
Turn ON power to the US-4000.
115
OPERATION WHEN PERIPHERAL DEVICES ARE CONNECTED: Connecting to LAN Port
116
4.
4.1
CHECKS
Checks Before Use
Before using the device, be sure to check the following items. Record each result in the list on
"Check List (Page 121)".
(1)Appearance
Check the appearance of the device for damage and/or stains which hinder the operation of
the device. Stains produced by chemical agents may lead to a malfunction of the device.
(2)Power cord
Check whether the power cord is properly connected to a wall outlet with a protective ground
whose type is single-phase of the specified voltage.
(3)Start-up
When the power switch is turned ON ( | ), the pilot lamp lights up and a beep sounds, as the
opening screen appears. Confirm that the initial screen (set in the Utility screen) displayed
after the device power-up appears a few seconds later.
(4)Probe
Check the surface of the A-scan, B-scan, and Pachymetry probes for scratches, chips, and/
or cracks. Also check if the probe connectors are loose.
(5)Operation of A-scan biometry and the measured value
Measure the axial length using the test piece, and verify that the operation is normal and that
the measured value is within the range indicated on the test piece.
(Refer to “4.2.1 Usage of test piece for A-scan biometry” (Page 118).)
(6)B-scan imaging operation
Start the measurement in the B-scan imaging screen.
Confirm that the transducer at the tip of the B-scan probe is vibrating and that the B-scan
waveforms are displayed.
(7)Pachymetry operation/value
Press the Pachy switch to display the Pachymetry screen. Measure the pachymetry using
the test piece to check whether the operation is normal and the measured value is within the
range indicated on the test piece.
(See “4.2.2 Usage of test piece for pachymetry” (Page 119).)
(8)Printer operation
Print the result of items (5) or (6) by pressing the Print switch. Confirm that there are no misaligned and blurred areas on the printout.
117
4
CHECKS: Usage of the Test Piece
4.2
Usage of the Test Piece
Before using the device be sure to check the operation using the test piece, and record the results
on “4.3 Check List” (Page 121).
• When the test piece is at a high temperature, the measured value cannot be indicated due
to the attenuation of ultrasonic waves.
In such a case, cool down the test piece.
4.2.1
Usage of test piece for A-scan biometry
1
2
Turn ON(|) the power switch tand display the A-scan biometry screen.
Confirm that the patient’s eye type is “Aphakic” and the sonic velocity to calculate distance is 1532 m/s.
a) If the patient’s eye type is not “Aphakic”, press the Eye Type switch to set it to “Aphakic”.
b) If the sonic velocity to calculate distance is not 1532 m/s, refer to “2.3.2 Setting physician
data” (Page 41) to set it to 1532 m/s.
3
Wet the probe tip with water, and put it vertically on the test piece as shown in the figure
below.
Be sure not to let in bubbles between the probe tip and test piece.
4
Press the FREEZE switch on the screen or the MEASURE switch of the foot switch to
start the measurement.
The measurement value and A-scan waveform are indicated. (They are not frozen automatically.)
5
Confirm that the measured value is within the range indicated on the test piece.
Test piece
A-scan probe
118
CHECKS: Usage of the Test Piece
4.2.2
Usage of test piece for pachymetry
1
Prepare the test piece.
1) Place the test piece on a dish (such as petri dish) as illustrated.
2) Pour water into the port and fill the dish of the lower part of the test piece with water by
using an injector or the equivalent.
Take care not to let in bubbles under the transparent plastic plate.
Test piece
Plastic plate
Port
Plastic plate
Dish
4
For straight probe
2
For 45° probe
Wet the probe tip with water, and insert the probe into the test piece so that the tip vertically comes into contact with the plastic plate inside the test piece.
For straight probe
For 45° probe
3
Turn ON ( | ) the power switch to show the A-scan biometry display.
4
Press the Pachy switch to display the Pachymetry screen.
5
Confirm that the sonic velocity to calculate distance is 1640 m/s.
If the sonic velocity to calculate distance is not 1640 m/s, refer to “2.6.2 Setting pachymetry
utility” (Page 95) to set to 1640 m/s.
119
CHECKS: Usage of the Test Piece
6
Press the FREEZE switch in the screen or the MEASURE switch of the foot switch to
start the measurement.
When the measurement value cannot be obtained, check the following points:
- Is the probe tip wet?
- Are there no bubbles under the plastic plate of the test piece?
7
120
Confirm that the measurement value is within the range indicated on the test piece.
CHECKS: Check List
4.3
Check List
Record the result of items in “4.1 Checks Before Use” (Page 117) on the list below.
Check items
Date
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
Appearnce Power cord
Start up
Probe
appearance
A-scan
biometry
B-scan
imaging
Pachymetry
Printer
4
121
CHECKS: Check List
122
5.
5.1
MAINTENANCE
Troubleshooting
If any problem occurs with the device, refer to the following table before requesting repair.
Problem
Suggested action
• The power cord may not be connected properly.
The LCD does not turn on.
Reconnect it securely.
• The power switch may not have been turn on. Check the power switch.
• Check the printer paper. If the printer is short of paper, set a new printer
paper roll.
The device cannot print out data.
• The Print Format or Print setting in the A-mode utility or Pachymetry utility
screen may be set to “Off.”
Reset the parameter.
The printer does operate, however, the
printout does not come out.
• The printer paper roll may be set with the wrong side up.
Set it with the correct side up.
• Check if the printer cover is closed securely.
5
Open the printer cover and close it securely.
The indication "Printer Error" is displayed
• The Print switch may have been pressed too soon after the printer cover
by pressing the Print switch, even when
was closed.
the printer paper is set.
After the printer cover is closed, it takes several seconds until the printer
becomes ready for use.
The printer paper is stuck and cannot be
ejected properly.
• The printer paper roll may be set at an angle or shifted to one side.
Open the printer cover and check whether the printer paper roll is set
properly.
Contact NIDEK or your authorized distributor if the above suggestions do not eliminate the corresponding problem.
123
MAINTENANCE: Various error codes and Suggested Actions
5.2
Various error codes and Suggested Actions
If any of the following error codes is displayed in the screen or printed, follow the suggestions in
the “Cause and suggested action” column.
When contacting NIDEK or your authorized distributor for servicing, report the device serial number, the Message number, and the symptom for proper servicing.
Message number
Cause and suggested action
• EEPROM writing error.
The device is shut off while data is being written to EEPROM, or a malfunction of
No.001 EEPROM
electric circuit board or EEPROM on the electric circuit board is probable.
Error
• If the same error code is displayed even after the device is turned on again, shut off the
device and contact NIDEK or your authorized distributor.
Shortage of clock IC hold voltage
No.002 Time may Correct the time in the Utility screen. If the same error code is displayed even after the
device is turned on again, shut off the device and contact NIDEK or your authorized
have shifted.
distributor.
No.003 EEPROM
File Checksum
Error.
Error in reading EEPROM file
The EEPROM file is corrupted or has been rewritten.
If the same error code is displayed even after the device is turned on again, shut off the
device and contact NIDEK or your authorized distributor.
No.010 BIO no
signal detection.
BIO signal detection timeout
If the same error code is displayed even after the device is turned on again, shut off the
device and contact NIDEK or your authorized distributor.
No.020 B no
signal detection.
B-scan probe is not connected.
Connect the B-scan probe. If the same error code is displayed again, shut off the device
and contact NIDEK or your authorized distributor.
Pachymetry signal detection timeout
No.030 Pachy no
If the same error code is displayed even after the device is turned on again, shut off the
signal detection. device and contact NIDEK or your authorized distributor.
No.031 Pachy
Probe No
Connection
The Pachymetry probe is not connected.
Connect the Pachymetry probe. If the same error code is displayed, shut off the device
and contact NIDEK or your authorized distributor.
No.064 RS232C
No Connection
The communication cable is not connected, or the other end of communication is not
ready for communication.
Confirm that the communication cable is connected to the external communication
connector securely. If the same error code is displayed, shut off the device and contact
NIDEK or your authorized distributor.
No response is received during the communicaiton. The communication cable is not
connected properly.
No.065 Com Time
Confirm that the communication cable is connected to the external communication
Up Error
connector securely. If the same error code is displayed, shut off the device and contact
NIDEK or your authorized distributor.
No.100 Printer
Error.
124
Printer error (Failure of the printer)
If the same error code is displayed, shut off the device and contact NIDEK or your
authorized distributor.
MAINTENANCE: Various error codes and Suggested Actions
Message number
No.101 Initialize
Error.
Cause and suggested action
Printer initialization error (Failure of the printer)
If the same error code is displayed, shut off the device and contact NIDEK or your
authorized distributor.
Printer data transmission error (Failure of the printer)
No.102 Send Data
If the same error code is displayed, shut off the device and contact NIDEK or your
Error.
authorized distributor.
No.103 Head
Voltage Error.
Printer head voltage error (Failure of the printer)
If the same error code is displayed, shut off the device and contact NIDEK or your
authorized distributor.
No.140 Reset
Error.
Printer reset error (Failure of the printer)
If the same error code is displayed, shut off the device and contact NIDEK or your
authorized distributor.
Printer connection error (Printer connection error or failure)
No.141 Hardware
If the same error code is displayed, shut off the device and contact NIDEK or your
Error.
authorized distributor.
No.144 No Paper.
There is no printer paper. (The printer cover is open.)
Supply a new roll of printer paper. (Close the printer cover.)
No.145 Head Up. The printer cover is open. Close the printer cover.
No.146 Head
Temperature
Error.
The printer head temperature is excessively high (in continuous image printing).
Start printing again after a while.
5
USB flash drive read data format error (Data has been edited outside the USB flash
No.201 Invalid
drive. Data is corrupted.)
Information Data. If the same error code is displayed, shut off the device and contact NIDEK or your
authorized distributor.
No.202 Invalid
RAW Data.
USB flash drive read waveform data format error
Data has been edited outside the USB flash drive.
Data is corrupted.
No.203 USB
Memory Error.
USB flash drive error
An error regarding the USB flash drive occurred.
(ex.: File deletion error that occurs when any file is deleted while it is being transferred.)
No.250 Can't
Access USB
memory.
The USB flash drive is not connected.
Connect the USB flash drive.
No.251 Can't
Write USB
memory.
USB flash drive writing error
The USB flash drive is write-protedted or full.
Disable the write protection or check the free space of the USB flash drive.
There is no raw data file.
No.252 There is
Only Jpge files are saved or Raw data files are deleted.
no Raw Data File. In the B-scan imaging utility screen, select "Raw" in "Save Format."
No.253 Can't
Display All USB
Data.
All the data in the USB flash drive cannot be displayed in the list.
Only a maximum of 1000 sets of data in the USB flash drive can be displayed.
More than 1000 data sets cannot be displayed.
125
MAINTENANCE: Various error codes and Suggested Actions
Message number
Cause and suggested action
No.254 Can't
Delete USB
Memory.
Data cannot be deleted.
The USB flash drive is write-protected.
Disable the write protection.
No.255 Can't
Read USB
Memory.
Data cannot be read.
Data is corrupted or does not exist.
No.300 CIFS
Error.
Windows file sharing error
No.301 Invalid
Network read data format error
Information Data. Data has been edited outside, or corrupted.
No.302 Invalid
RAW Data.
Network read waveform image data format error
Waveform image data has been edited outside, or corrupted.
IC error
No.303 Hardware IC was damaged by any cause such as electrostatic discharge.
If the same error code is displayed even after the device is turned on again, shut off the
Error.
device and contact NIDEK or your authorized distributor.
No.350 Can't
Access Network.
Network cannot be accessed.
Enabling access to the network may take a while after the device start-up.
Check the LAN cable connection and the IP address and subnet mask in the Network
setting in the Utility screen.
No.351 Can't
Write Network.
Network writing error (Write-protection is enabled or no free space is left.)
Check if the Write permission is granted to the destination folder in the PC and sufficient
free space is left.
There is no Raw data file. (Only the Jpeg file has been saved or the Raw data file has
No.352 There is
been deleted.)
no Raw Data File. In the B-scan imaging utility screen, select "Raw" for "Save Format."
No.353 Can't
Display All PC
Data.
All the data sets in the PC cannot be displayed in the list. (Only a maximum of 1000 data
sets can be displayed.)
More than 1000 data sets cannot be displayed.
No.354 There is The PC of the specified name does not exist.
no Machine Name The PC name specified in "Machine Name" in "Ext. Save" in the Utility screen, or the LAN
connection is not established.
in this Network.
No.355 Read Only Read-only attribute (Writing of data was tried to a folder with the read-only attribute.)
Write-protection is enabled on the destination PC folder. Disable the write-protection.
Folder.
No.356 Can't
Logon PC.
Logging on to the PC is not allowed. (The user name or password is incorrect.)
The User Name or Password input in the Utility screen are incorrect.
The shared folder does not exist. (The name of the shared folder is incorrect.)
No.357 There is
The folder specified in "Folder Name" in "Ext. Save" in the Utility screen does
no Shared Folder.
not exist or is not shared.
No.358 Network
Timeout.
126
Time out (The PC did not finish the process in a specified time.)
MAINTENANCE: Various error codes and Suggested Actions
Message number
No.359 Can't
Delete PC Data.
Cause and suggested action
The data cannot be deleted. (Deletion was tried on the data with the read-only
attribute.)
Write-protection is enabled on the destination PC folder. Disable the writeprotection.
No.360 Network The network is being initialized. (The initialization takes a while after the device
Initializing. Please startup.)
Retry.
Retry access to the Network later.
No.361 Access
Denied.
Access is not allowed. (Folder sharing setting is improper.)
Check the setting of "PC CIFS" in "Ext. Save" in the Utility screen.
No.362 Account
Disabled.
The account is disabled. (The user setting is improper.)
Check the setting of "ECHOSCAN" in "Ext. Save" in the Utility screen.
5
127
MAINTENANCE: Replacing Printer Paper
5.3
Replacing Printer Paper
Red lines on the edges of the printer paper indicates that the paper is running short.
When the red lines are printed, stop using the printer and set a new roll of printer paper.
• Do not run the printer while the printer paper is not set.
The printer head may become damaged.
• Do not pull the paper forcefully from the printer.
Printer malfunction may result.
1
Press the Cover open button until a click is heard, and open the printer cover.
Cover open button
2
Take out the roll of printer paper.
Printer paper
CAUTION
• When replacing the printer paper, take care not to touch the printer head at the
upper part of the printer inside the cover.
The printer head remains heated for a while after printing. Touching it may cause
burn.
128
MAINTENANCE: Replacing Printer Paper
3
Set a new roll of printer paper.
Set a new roll of printer paper as shown in the figure below.
Pull out the edge of the paper so that it comes out of the printer cover.
Printer paper
• If the printer paper roll is set in such a way that the paper becomes upside down, data is
not printed on the paper.
• Confirm that the roll of printer paper is not set at an angle or shifted to one side.
The printer paper may not come out properly.
5
4
Close the printer cover.
Press both edges of the printer cover to close it securely.
• Confirm that the cover is closed securely.
If the cover is not clsoed securely, the automatic paper cutter may not function properly. Pressing
the Print switch may display "No.144 No Paper." or "No.145 Head Up." and printing may not be
performed.
129
MAINTENANCE: Replacing Fuses
5.4
Replacing Fuses
When the pilot lamp does not illuminate by turning ON ( | ) the power even if the power cord is
connected properly, fuses may be blown. In this case, replace the fuses with new ones according
to the procedure below:
1
Turn OFF the power switch and disconnect the power cord from the inlet of the device.
2
Pull out the fuse holder next to the power inlet.
Pull out the fuse holder while pushing the lever in
the arrow direction.
Fuse holder
Lever
3
Replace blown fuses with new ones.
Always use two specified fuses together.
[250V T1.6A (∅ 5 x 20 mm): 100V region]
[250V T0.8A (∅ 5 x 20 mm): 230V region]
Fuse
Fuse holder
4
Attach the fuse holder.
5
Connect the power cord to both inlets.
6
Turn ON ( | ) the power, and confirm that the pilot lamp illuminates.
If fuses blow again soon, contact NIDEK or your authorized distributor.
130
MAINTENANCE: Cleaning
5.5
Cleaning
5.5.1
Cleaning cover
When the cover or panel of the device becomes contaminated, wipe them with a soft cloth. For
severe stains, wipe with a soft cloth soaked in a neutral detergent and wrung out. After that, wipe
with a dry and soft cloth.
CAUTION
• Never use an organic solvent such as paint thinner.
The surfaces of the device may be ruined.
• Never use a sponge or cloth soaked in water.
The water may leak into the device and malufnciton may result.
5.5.2
Cleaning printer
After repeated usage, the paper slot of the auto cutter of the printer is soiled with powdery paper.
If powdery paper is settled, a malfunction of the auto cutter may result; clean it.
1
5
Open the printer cover and take out the printer paper.
See “5.3 Replacing Printer Paper” (Page 128).
2
Apply the nozzle of a vacuum cleaner to the paper slot for the printer paper to suck powdery paper.
Never blow off powdery paper the with a blower. If powdery paper settles on the internal working structure, malufnciton may result.
Automatic paper cutter
3
Set the printer paper roll as it was.
131
MAINTENANCE: Cleaning
5.5.3
Cleaning touch screen
Soak a soft cloth in water or ethanol, and lightly wipe the dirty parts.
CAUTION
• Do not wipe the touch screen with a cloth soaked in ethanol.
If ethanol seeps into the internal structure of the touch screen through the gap between the
screen and the body, the touch panel may malfunction.
• Do not use any solution other than ethanol to clean the touch screen.
132
MAINTENANCE: Maintenance of Ultrasound Probe
5.6
Maintenance of Ultrasound Probe
5.6.1
Cleaning ultrasound probe
Parts to be cleaned
Tip of the A-scan probe
Tip of the B-scan probe
Tip of the Pachymetry probe (only the tip for detachable tip type)
Time to perform cleaning
Before disinfection and sterilization
1
If foreign object is attached to the tip of the probe, wipe of the tip with a soft cloth soaked
in water or disinfectant alcohol.
CAUTION
• Do not clean the ultrasound probe with water of 45°C or hotter.
5
The ultrasound probe may become damaged.
• Perform cleaning before the body fluid or chemical solution on the probe become dry.
The body fluid and chemical solution may become difficult to remove.
133
MAINTENANCE: Maintenance of Ultrasound Probe
5.6.2
Disinfecting ultrasound probe
Parts to be cleaned
Tip of the A-scan probe
Tip of the B-scan probe
Tip of the Pachymetry probe (only the tip for detachable tip type)
Time to perform disinfection
Before and after use of the device
1
Clean the tip of the probe.
See “5.6.1 Cleaning ultrasound probe” (Page 133).
2
Soak the tip (less than 20 mm) of the probe in disinfectant solution.
See the instruction of the disinfectant for the duration to soak the tip.
ex.) chlorhexidine gluconate solution
Disinfectant alcohol
Within 20 mm
ex.) A-scan probe
CAUTION
3
4
134
• See the instruction of the disinfectant for its use.
Wipe the disinfectant solution on the tip of the probe with a sterilized absorbent cotton
soaked in ethanol for disinfection.
Leave the probe sit until the tip of it becomes dry.
MAINTENANCE: Maintenance of Ultrasound Probe
5.6.3
Sterilizing ultrasound probe
Parts to be cleaned
Tip of the A-scan probe
Tip of the B-scan probe
Tip of the Pachymetry probe (only the tip for detachable tip type)
Time to perform sterilization
After using the probe for an infected patient
1
Clean the tip of the probe.
See “5.6.1 Cleaning ultrasound probe” (Page 133).
2
Soak the tip (less than 20 mm) of the probe in the glutaraldehyde solution.
See the instruction of the glutaraldehyde solution for the duration to soak the tip.
ex.) Cidex plus 28
5
Within 20 mm
ex.: A-scan probe
CAUTION • See the instruction of the glutaraldehyde solution for its use.
3
Wash the tip of the probe soaked in the sterilization solution with a large amount of sterile water or water.
4
Wipe the water on the tip of the probe with a sterilized absorbent cotton.
5
Leave the probe sit until the tip of it becomes dry.
6
Put the protective cap on the probe and store it in the special case.
135
MAINTENANCE: List of Replacement Parts
5.7
List of Replacement Parts
Part name
Part number
Printer paper
80620-00001
Fuse
80402-02040 (100V)
80402-02038 (230V)
* After replacement of consumables, restock them.
136
Note
Width 58 mm, 25 m
250V T1.6A (∅ 5 x 20 mm): 100V regions
250V T0.8A (∅ 5 x 20 mm): 230Vregions
6.
6.1
SPECIFICATIONS AND CONFIGURATION
Classifications
Protection method against electric shock Class I
The US-4000 is classified as a Class I device.
A Class I system provides protection against electric shock and does not rely on basic insulation only, but which includes additional safety grounding of accessible conductive parts in
the fixed wiring 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 B applied part
The US-4000 is classified as a device with a Type B applied part.
A device with a Type-B applied part contains an internal electrical power source providing an
adequate degree of protection against electric shock in regards to:
- allowable leakage currents
- reliability of the protective ground connection (if present).
Degree of protection against ingress of water: IPX1
The US-4000 is classified as an ordinary device.
An IPX1 is an ordinary unit without protection against an ingress of water. Do not expose
water to the device.
Degree of safety application in the presence of flammable anesthetics and/or flammable cleaning agents
The US-4000 should be used in an environment where no flammable anesthetics and/or
flammable cleaning agents are present.
Methods of disinfection recommended by manufacturer
The US-4000 is a device that includes parts that need sterilization or disinfection.
Mode of operation
The US-4000 is classified as a continuous operating device.
Classification by transference
The US-4000 is classified as a transportable device.
137
6
SPECIFICATIONS AND CONFIGURATION: Specifications
6.2
Specifications
6.2.1
•
A-scan biometry/IOL power calculation
Probe
Solid probe
Frequency: 10MHz (± 20%)
Internal fixation lamp: LED (Red), Illumination
•
Display
Measurement method: Ultrasonic pulse reflective method A-scan biometry
Measurement value: Axial length, anterior chamber depth, lens thickness, vitreous body thickness,
and A-scan waveform (measurement values of 10 times, the average value, and the starndard
deviation)
Measurement range: 12.00 to 40.00mm
Minimum display unit: 0.01mm
Accuracy: ± 0.1 mm
•
Measurement function: Manual, Auto, Speed
Gate: Cornea, Lens-F (anterior), Lens-B (posterior), retina
Sonic velocity to calculate distance:
Average axial length: 1550m/s (Phakic eye), 1548m/s (Eye with mature cataract: DENSE CAT ON)
1532m/s (Aphakic eye)
Setting range: 1000 to 2000m/s
Anterior chamber, vitreous body: 1532m/s
Setting range: 1000 to 2000m/s (Anterior chamber)
Setting range: 500 to 2000m/s (Vitreous body)
Lens: 1641m/s, 1629m/s (Eye with mature cataract: DENSE CAT ON)
Setting range: 1000 to 2000m/s
IOL: 2060m/s (Acrylic)
2760m/s (PMMA)
1049m/s (Silicone)
Setting range: 500 to 3000m/s
•
IOL power calculation IOL formula: Binkhorst, Holladay, SRK, SRK II, SRK/T, Hoffer Q
Calculated IOL power: IOL refractive power for ametropia (IOL)
Postoperative refractive error (ERROR)
IOL data registration: Manufacturer, model, A-Constant, SF value, ACD value (A maximum of 16
types of IOL data can be registered.)
IOL power calculation range: A-Constant 100 to 130
ACD value: 1.60 to 9.99
SF value: 0.00 to 9.99
Axial length: 12.00 to 40.00 mm
Keratometry: 5.00 to 19.99 mm (curvature radius)
20.00 to 60.00D (refraction)
Postoperative target refraction: -10.00 to +10.00D
Calculated IOL power: -99.99 to +99.99D
Comparison display: Three types of IOL power calculation results are displayed for a single IOL
power calculation formula. The calculation results of estimated
postoperative refractive power for the IOL power is displayed.
IOL power calculation comparison: Three types of IOL power calculation results are displayed for
multiple calculation method selected by the physician.
138
SPECIFICATIONS AND CONFIGURATION: Specifications
6.2.2
•
B-scan imaging
Probe
Permanent oil filled & compact probe
Frequency: 10 MHz (± 15%)
Scanning type: Mechanical sector scanning
Scanning angle: 60°
Scanning speed: 10 Hz
Scanning range: 35 mm or 50 mm from the edge of the probe (± 10%) (equivalent sonic velocity 1550 m\s)
Gray scale (color scale): 256 levels (Color scale can be displayed.)
Display mode: B-scan, CV (B+BIO)
The BIO mode waveform of the line specified with the cross-vector is displayed
along with the B-scan cross-sectional image.
Saving B-scan image: CV mode image can be saved - a maximum of 12 still images (internal
volatile memory)
Saving still images to USB flash drive
Saving about 20 seconds of moving image (cleared when the
measurement is resumed)
Multiple B-scan images display: A maximum of four saved images can be displayed in a screen.
Magnifying B-scan image: CV mode image (measurement depth 35 or 50 mm) can be magnified (x
2.5, x 5)
•
Display
•
Measurement function Two sets of calipers (precision of measuring the distance between two points: ± 10%)
Area measurement (precision of area measurement:
± 10%)
•
Gain
For near-field sensitivity (TGC): 0 to -20dB
For total sensitivity (GAIN): 0 to 90dB
•
Scale
1 mm scales under the B-scan image (5 mm intervals are marked with a medium line, and 10 mm
intervals are marked with a long line)
•
Resolution
Distance resolution: 1 mm
Lateral resolution: 1 mm
6.2.3
Pachymetry
•
Probe
Solid probe
Frequency: 10 MHz (± 10%)
•
Display
Measurement type: Ultrasonic pulse reflective method
Measurement value: A maximum of 25 points of corneal thickness values can be saved.
Measurement range: 200 to 1300 µm
Minimum display unit: 1 µm
Accuracy: ± 5 µm
Sonic velocity to calculate distance: 1640m/s
6.2.4
6
Other functions
•
Observation/Display type: 8.4-inch color LCD
•
Printer
•
Interface connector
Thermal line printer with automatic paper cutter
Paper width 57.5 mm
RS-232C: 1 port (used to connect the KM manufactured by NIDEK)
USB: 1 port (1.1)
VIDEO output: (NTSC)
LAN: 1 port
139
SPECIFICATIONS AND CONFIGURATION: Specifications
6.2.5
Dimensions and weight
•
Dimensions
300 (W) x 285 (D) x 330 (H) mm
•
Weight
8.5kg
•
Power supply
AC 100 to 120, 230V
•
Power consumption 70VA
6.2.6
Environemntal conditions (during use)
•
Temperature
+10 to +35°C
•
Humidity
30 to 75%
•
Atmospharic pressure 800 to 1060 hPa
6.2.7
± 10% 50/60Hz
Environmental conditions (during storage and shipping)
•
Temperature
- 10 to +55°C
•
Humidity
10 to 95% (Non-condensing)
6.2.8
Composition of parts that come into contact with human body
•
Biomentry probe - Polystyrene
•
B-scan probe - Polymethylpentene
•
Pachymetry probe - Polystyrene
6.2.9
Others
•
Installation category: II (OVERVOLTAGE CATEGORIES)
•
Pollution degree: 2 (IEC60664)
•
Unit per package
140
1 unit
SPECIFICATIONS AND CONFIGURATION: Configuration
6.3
6.3.1
6.3.2
Configuration
Standard accessories
• Stylus
•1 unit
• B-scan probe
•1 unit
• A-scan probe
•1 unit
• Foot switch
•1 unit
• Test piece (for Biometry measurement)
•1 unit
• Printer paper
•3 rolls
• Power cord
•1 unit
• Ultrasonic gel
•1 unit
• Dust cover
•1 unit
• Spare fuse
•2 units
• Probe rest
•3 units
• Operator's manual
•1 volume
6
Optional accessories
• Video printer
•1 unit
• Video printer paper
•6 rolls
• Pachymetry 45° probe *
•1 unit
• Pachymetry probe (straight type)
•1 unit
• Pachymetry probe (45° detachable type)
•1 unit
• Test piece (for Pachymetry measurement) *
•1 unit
• Probe stand
•1 unit
* Provided as standard accessories depending on the configuration.
141
SPECIFICATIONS AND CONFIGURATION: Configuration
142
7.
7.1
IOL FORMULA
Outline of IOL Formula
The following six types of IOL formulas are preprogrammed into the US-4000, and there may be a difference in the last digit to an extent because of the number of effective digits for the inside calculation.
(1) SRK (SANDERS-RETZLAFF-KRAFF), SRK II, and SRK/T formula
These programs are based on the formula of Dr. Sanders, Dr. Retzlaff and Dr. Kraff. SRK
formula is the most famous one among the regression formulas. SRK II is the corrected
SRK formula, and SRK/T is a theoretical formula.
(2) Binkhorst formula
This program is based on the formula of Dr. Binkhorst in order to calculate the refractive
power of IOLs. This is the most famous formula among the theoretical formulas.
(3) Hoffer-Q formula
This program is based on the formula of Dr. Hoffer. This theoretical formula adopts the predictable anterior chamber depth.
(4) Holladay formula
This program is based on the formula of Dr. Holladay. It calculates reversely the SF value
from the stable postoperative refractive power to make an adjustment based on a physician’s surgical tendencies for each IOL.
7
7.1.1
SRK Formula
(1) IOL refractive power for ametropia (IOL)
IOL = A - 2.5 × AL - 0.9 × K - DR × (0.0875 × A - 8.55)
(2) Postoperative refractive error (ERROR)
ERROR = (A - 2.5 × AL - 0.9 × K - LP)/(0.0875 × A - 8.55)
K: Corneal refractive power [D]
AL: Axial length [mm]
A: A-constant
DR: Desired postoperative refractive power of a corrective lens [D]
(+value: hyperopia, -value: myopia)
LP: Refractive power of the IOL to be implanted [D]
143
IOL FORMULA: Outline of IOL Formula
7.1.2
SRK II Formula
(1) IOL refractive power for ametropia (IOL)
IOL = A’ - 2.5 × AL - 0.9 × K - DR × CR
(2) Postoperative refractive error (ERROR)
ERROR = (A’ - 2.5 × AL - 0.9 × K × LP)/CR
(3) Personal A-constant
AINDIV = SEQ × RF + LP + 2.5 × AL + 0.9 × K - C
AL: Axial length [mm]
K : Corneal refractive power [D]
A : A-constant
DR: Desired postoperative refractive power of a corrective lens [D]
(+value: hyperopia, -value: myopia)
LP: IOL refractive power to be implanted [D]
A’: Correction value of A-constant A’ = A + C
C : AL < 20.0 mm, C = 3
20.0 mm ≤ AL < 21.0 mm, C = 2
21.0 mm ≤ AL < 22.0 mm, C = 1
22.0 mm ≤ AL < 24.5 mm, C = 0
24.5 mm ≤ AL ,
C = -0.5
CR: Constant for calculation
P ≤ 14.0, CR = 1.00
P > 14.0, CR = 1.25
* P = A’ - 2.5 × AL - 0.9 × K
SEQ: SEQ = SPH + (CYL/2) [D]
SPH: Actual postoperative spherical refractive power [D]
CYL: Actual postoperative cylindrical refractive power [D]
RF: LP > 16 RF = 1.25
LP ≤ 16 RF = 1.00
144
IOL FORMULA: Outline of IOL Formula
<Cautions in use>
In the SRK-II formula, the A-constant is corrected when the axial length is outside the range of 22 to
24.5mm, which is said to be the most reliable range in the SRK formulas. Also the calculated constants for IOL refractive power for ametropia and postoperative refractive power are changed at the
IOL refractive power (P) for emmetropia of 14D. Thus the conditions are added and the SRK-II formula becomes a non-linear calculation formula. Therefore, when calculation is made with values
close to those conditions, the result will vary about 0.5 to 1D.
ex.)K = 45D, DR = -2D, A = 116.5
SRK, SRK II, SRK/T
When the AL = 21.99mm
IOL = 24.31D, 24.53D, 23.87D
When the AL = 22.00mm - IOL = 24.29D, 23.50D, 23.84D
Difference
0.02D,
1.03D,
0.03D
As explained above, the calculated results of the SRK II formula varies considerably
depending on the axial length and IOL refractive power for ametropia. Care should be taken
when performing IOL calculation with values close to the conditions described above.
7
145
IOL FORMULA: Outline of IOL Formula
7.1.3
SRK/T Formula
(1) IOL refractive power for ametropia (IOL)
IOL =
1000 × na × (na × R - ncm1 × LO - 0.001 × DR
(LO - AD’) × (na × R - ncm1 × AD’ - 0.001 × DR
× (V × (na × R - ncm1 × LO) + LO × R)
× (V × (na × R - ncm1 × AD’) + AD’ × R)
(2) Postoperative refractive error (ERROR)
ERROR=
1000 × na × (na × R - ncm1 × LO) + LP × (LO - AD’)
na × (V × (na × R - ncm1 × LO) + LO × R) - 0.001 × LP
× (na × R - ncm1 × AD’)
× (LO - AD’) × (V × (na × R - ncm1 × AD’) + AD’ × R)
R
: Corneal radius [mm] R = 337.5/K
LO : AL + RT [mm]
RT : Retinal thickness [mm] RT = 0.65696 - 0.02029 × AL
AL : Axial length [mm]
AD' : Estimated postoperative anterior chamber depth for the patient [mm]
AD’ = H + OF, OF = AD -3.336
AD : Predictable postoperative anterior chamber depth [mm]
AD = 0.62467 × A - 68.747
A
: A-constant
H
: Height of corneal dome [mm] H = R – R × R – ( ( Cw × Cw ) ⁄ 4 )
However, in the case of (R × R - ((Cw × Cw)/4)) < 0, H = R
Cw : Computed corneal width [mm] Cw = -5.41 + 0.58412 × LC + 0.098 × K
LC : Corrected axial length [mm]
When the AL ≤ 24.2, LC = AL
When the AL > 24.2, LC = -3.446 + 1.716 × AL - 0.0237 × AL2
DR : Desired postoperative refractive power of a corrective lens [D]
LP : Refractive power of the IOL to be implanted [D]
V
: Vertex distance
na : Refractive index of aqueous and vitreous (= 1.336)
nc : Refractive index of the cornea (= 1.333)
ncml : nc - 1 (= 0.333)
146
IOL FORMULA: Outline of IOL Formula
7.1.4
Binkhorst Formula
(1) IOL refractive power for ametropia (IOL)
IOL =
1000 × N2 × (N2 × R - (N1 - 1) × AL’ - 0.001 × DR
(AL’ - AD) × (N2 × R - (N1 - 1) × AD - 0.001 × DR
× (VD × (N2 × R - (N1 - 1) × AL’) + AL’ × R))
× (VD × (N2 × R - (N1 - 1) × AD) + AD × R))
(2) Postoperative refractive error (ERROR)
ERROR=
1000 × N2 × (N2 × R - (N1 - 1) × AL’) - LP × (AL’ - AD)
N2 × (VD × (N2 × R - (N1 - 1) × AL’) + AL’ × R) - 0.001
× (N2 × R - (N1 - 1) × AD)
× LP × (AL’ - AD) × (VD × (N2 × R - (N1- 1) × AD) + AD × R)
+
1
RD
AL’ = AL + B - T × (1 - N2/N3)
N1 : Corneal refractive index (= 4/3 (= 1.333...))
N2 : Refractive index of aqueous and vitreous (= 1.336)
N3 : IOL refractive index (= 1.49)
B : Distance from the vitreoretinal interface to the visual cell layer (= 0.25mm)
T : Thickness of the IOL to be implanted (= 0.5mm)
7
RD : Refractive distance (= 6m)
R : Corneal radius [mm] R = 337.5/K
AD : Predictable postoperative anterior chamber depth [mm]
AL : Axial length [mm]
LP : IOL refractive power to be implanted [D]
DR : Desired postoperative refractive power of a corrective lens [D]
(+value: hyperopia, -value: myopia)
VD : Vertex distance
147
IOL FORMULA: Outline of IOL Formula
7.1.5
Hoffer Q Formula
1) IOL refractive power for ametropia (IOL)
Rx
R = -------------------------------1 – 0.012Rx
1336
1.336
IOL = ------------------------------- – -------------------------------------------L – C – 0.05 1.336 C + 0.05
--------------- – ---------------------K+R
1000
(2) Postoperative refractive error (ERROR)
R
ERROR = ----------------------------1 + 0.012R
1.336
R = ----------------------------------------------------------------------- – K
1.336
C + 0.05
----------------------------------------- + ---------------------1336
1000
------------------------------- – P
L – C – 0.05
However,
C = AD + 0.3•(L - 23.5) + (tan K)2 + 0.1M•(23.5 - L)2•tan{0.1•(G - L)2} - 0.99166
When the L ≤ 23, M = +1, G = 28
When the L > 23, M = -1, G = 23.5
When the C > 6.5, C = 6.5
When the C < 2.5, C = 2.5
(3) Personal ACD (PACD)
2 4 × 1336 × ( N – L )
L + N – ( L – N ) + -----------------------------------------------P
PACD = ------------------------------------------------------------------------------------------------------ – 0.05
2
However,
1336
N = -------------K+R
Rx
R = -------------------------------1 – 0.012Rx
IOL : IOL refractive power [D]
L
: Axial length [mm]
C
: Predictable anterior chamber depth [mm]
K
: Average corneal refractive power ((K1 + K2)/2 [D])
Rx
: Desired postoperative refractive power [D] (VD = 12 mm)
P
: IOL refractive power to be implanted [D]
ERROR : Refractive power after implanting IOL [D]
AD
: Anterior chamber depth [mm:]
Anterior chamber depth after implanting an IOL or PACD
PACD : Personal ACD [mm]
148
IOL FORMULA: Outline of IOL Formula
7.1.6
Holladay Formula
(1) IOL refractive power for ametropia (IOL)
IOL =
1000 × N2 × (N2 × R - (N1 - 1) × Alm - 0.001 × DR
(Alm - AD - SF) × (N2 × R - (N1 - 1) × (AD + SF) - 0.001 × DR
× (VD × (N2 × R - (N1 - 1) × Alm) + Alm × R))
× (VD × (N2 × R - (N1 - 1) × (AD + SF)) + (AD + SF) × R))
(2) Postoperative refractive error (ERROR)
ERROR=
1000 × N2 × (N2 × R - (N1 - 1) × Alm) - LP × (Alm - AD - SF)
N2 × (VD × (N2 × R - (N1 - 1) × Alm) + Alm × R) - 0.001
× (N2 × R - (N1 - 1) × (AD + SF))
× LP × (Alm - AD - SF) × (VD × (N2 × R - (N1 - 1) × (AD + SF)) + {(AD + SF) × R)
(3) Surgeon factor
( – BQ – BQ × BQ – 4 × AQ × CQ )
SF = --------------------------------------------------------------------------------------------- – AD
2 × AQ
Alm = AL + RT
AQ = (N1 - 1) - (0.001 × ER × ((VD × (N1 - 1)) - R))
BQ = ER × 0.001 × ((Alm × VD × (N1 - 1)) - (R × (Alm - (VD × N2))))
- (((N1 - 1) × Alm) + (N2 × R))
CQ = (Alm × N2 × R) - (0.001 × ER × Alm × VD × R × N2) - (1000 × N2 ×
7
((N2 × R) - ((N1 - 1) × Alm) - (0.001 × ER × ((VD × ((N2 × R) ((N1 - 1) × Alm))) + {(Alm × R)))))/LP
AD = 0.56 + Rag
– Rag × Rag – Ag × ( Ag ) ⁄ 4
AG = 12.5 × AL/23.45
I f AG > 13.5, then AG = 13.5
N1 : Corneal refractive index (= 4/3 (= 1.333...))
N2 : Refractive index of aqueous and lens (= 1.336)
RT : Retinal thickness (= 0.200 mm)
R : Corneal radius [mm]R = 337.5/K
AD : Predictable postoperative anterior chamber depth [mm]
AL : Axial length [mm]
LP : Refractive power of the IOL to be implanted [D]
DR : Desired postoperative refractive power of a corrective lens [D]
(+value: hyperopia, -value: myopia)
149
IOL FORMULA: Outline of IOL Formula
VD : Vertex distance
SF : Surgeon factor
ER : Actual postoperative refractive power [D]
Rag : R ≥ 7 mm, Rag = R
R < 7 mm, Rag = 7 mm
<Feature of Holladay formula>
The correction value of each surgeon (SF value: surgeon factor) for each IOL is reversely
calculated from the patient’s actual refractive power in the stable postoperative period, and
the result can be used for the calculation of IOL refractive power.
The SF value can be used to correct deviations from the IOL data that result from physicians’ surgical habits. Eventually, an IOL formula that is suited for each physician can be
obtained.
When using a new IOL, the SF value can be obtained with the following equations and registered as a new set of IOL data (see “{ Inputting IOL data (page 64)) to be used for IOL
power calculation:
SF = (A × 0.5663) - 65.60
SF: SF value (Surgeon factor)
A : A-constant
ex.) When the A-constant = 116.7
SF = (116.7 × 0.5663) – 65.60 = 0.48721
Use SF value, 0.49
When a reversely calculated postoperative SF value becomes stable after many surgical
experiences, register the reversely calculated SF value as the IOL data again and use it for
IOL power calculation. (For details, see “{ Inputting IOL data (page 64).)
150
8.
8.1
EMC & Acoustic output
EMC (ELECTROMAGNETIC COMPATIBILITY)
The US-4000 complies with these standard as tabled below. Follow the guidance on the tables for use
of the device in the electromagnetic environment.
EMC (IEC 60601-1-2:2001)
Guidance and manufacturer's declaration - electromagnetic emissions
The US-4000 is intended for use in the electromagnetic environment specified below. The customer or the user of the
US-4000 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The US-4000 uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
The US-4000 is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Complies
8
151
EMC & Acoustic output
Guidance and manufacturer's declaration - electromagnetic immunity
The US-4000 is intended for use in the electromagnetic environment specified below. The customer or the user of the
US-4000 should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment - guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floor should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV
for power supply lines
±1 kV
for input/output lines
±2 kV
for power supply lines
±1 kV
for input/output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV
differential mode
±2 kV
common mode
±1 kV
differential mode
±2 kV
common mode
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage, dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT
<5% UT
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the US-4000 requires continued operation
during power mains interruptions, it is
recommended that the US-4000 be powered
from an uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
(>95% dip in UT)
(> 95% dip in UT)
for 0.5 cycle
40% UT
for 0.5 cycle
40% UT
(60% dip in UT)
(60% dip in UT)
for 5 cycles
70% UT
for 5 cycles
70% UT
(30% dip in UT)
(30% dip in UT)
for 25 cycles
< 5% UT
for 25 cycles
< 5% UT
(> 95% dip in UT)
(> 95% dip in UT)
for 5 sec
for 5 sec
3 A/m
3 A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
152
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
EMC & Acoustic output
Guidance and manufacturer's declaration - electromagnetic immunity
The US-4000 is intended for use in the electromagnetic environment specified below. The customer or the user of the
US-4000 should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Comliance level
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the US-4000, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d=1.2x √ P
d=1.2x √ P 80 MHz to 800 MHz
Conduted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
(V1=3)
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
(E1=3)
d=2.3x √ P 800 MHz to 2.5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in
each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. 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 US-4000 is used exceeds the applicable RF
compliance level above, the US-4000 should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the US-4000.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
153
8
EMC & Acoustic output
Recommended separation distances between portable and mobile RF communications equipment and the
US-4000
The US-4000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the US-4000 can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the US-4000 as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=1.2 √ P
80 MHz to 800 MHz
d=1.2 √ P
800 MHz to 2.5 GHz
d=2.3 √ P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
154
EMC & Acoustic output
8
155
EMC & Acoustic output
8.2
8.2.1
Acoustic output reporting table(IEC 60601-2-37:2005)
A-scan probe
TIS
Index Label
MI
Maximum index value
(MPa)
pra
P
Aaprt ≤ 1 cm2
Aaprt > 1 cm2
#
7.17E-3
-
#
0.150
(cm)
-
zbp
(cm)
-
zb
(cm)
(a)
#
#
-
(MHz)
#
10.0
-
#
#
X(cm)
#
0.45
-
#
#
Y(cm)
#
0.45
-
#
#
td (µsec)
prr
(b)
2.1
(cm)
Dim of Aaprt
TIC
-
z at max. Ipi, (cm)
fawf
Non-scan
-
(mW)
zs
deq (zb)
Other
information
Non-scan
0.448
(mW)
Min. of [P(zs), Ita,(zs)]
Associated
acoustic
parameters
0.142
Scan
TIB
(Hz)
pr at max. Ipi (MPa)
10.0
0.0833
2000
0.927
deq at max. Ipi (cm)
Ipa, at max. MI (W/cm3)
#
9.01
Operating
control
conditions
NOTE 1: Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode.
NOTE 2: nformation need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial
or neonatal cephalic uses.
NOTE 3: Information on MI and TI need not be provided if the equipment meets both exemption clauses given in 51.2 aa)
and 51.2 dd).
(a)
Intended use does not include cephalic so TIC is not computed.
(b)
Intended use is Ophthalmic and does not involve bone so TIB is not computed.
#
No data reported
156
EMC & Acoustic output
8.2.2
B-scan probe
TIS
Index Label
MI
Maximum index value
(MPa)
pra
P
Aaprt ≤ 1 cm2
Aaprt > 1 cm2
0.0114
-
-
0.268
-
(cm)
-
zbp
(cm)
-
zb
(cm)
(a)
-
#
-
(MHz)
8.91
8.91
-
-
-
#
X(cm)
0.450
-
-
-
#
Y(cm)
0.450
-
-
-
#
td (µsec)
0.156
prr
8000
(Hz)
pr at max. Ipi (MPa)
0.882
deq at max. Ipi (cm)
Ipa, at max. MI (W/cm3)
Operating
control
conditions
-
1.70
(cm)
Dim of Aaprt
TIC
-
z at max. Ipi, (cm)
fawf
Non-scan
-
(mW)
zs
deq (zb)
Other
information
Non-scan
0.522
(mW)
Min. of [P(zs), Ita,(zs)]
Associated
acoustic
parameters
0.175
Scan
TIB
9.74
Scan angle:60 degreees
Scan rate:20Hz
Scan Lines:400
NOTE 1: Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode.
NOTE 2: nformation need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial
or neonatal cephalic uses.
NOTE 3: Information on MI and TI need not be provided if the equipment meets both exemption clauses given in 51.2 aa)
and 51.2 dd).
(a)
Intended use does not include cephalic so TIC is not computed
#
No data reported
157
8
EMC & Acoustic output
8.2.3
45° angled probe with detachable tip
TIS
Index Label
MI
Maximum index value
(MPa)
pra
P
Aaprt ≤ 1 cm2
Aaprt > 1 cm2
#
8.62E-4
-
#
0.0173
(cm)
-
zbp
(cm)
-
zb
(cm)
(b)
(a)
#
#
0.2
(cm)
#
(MHz)
Dim of Aaprt
TIC
#
z at max. Ipi, (cm)
fawf
Non-scan
-
(mW)
zs
deq (zb)
Other
information
Non-scan
0.486
(mW)
Min. of [P(zs), Ita,(zs)]
Associated
acoustic
parameters
0.150
Scan
TIB
10.5
#
10.5
-
#
#
X(cm)
#
0.15
-
#
#
Y(cm)
#
0.15
-
#
#
td (µsec)
0.103
prr
3950
(Hz)
pr at max. Ipi (MPa)
0.522
deq at max. Ipi (cm)
Ipa, at max. MI (W/cm3)
#
6.11
Operating
control
conditions
NOTE 1: Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode.
NOTE 2: nformation need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial
or neonatal cephalic uses.
NOTE 3: Information on MI and TI need not be provided if the equipment meets both exemption clauses given in 51.2 aa)
and 51.2 dd).
(a)
Intended use does not include cephalic so TIC is not computed.
(b)
Intended use is Ophthalmic and does not involve bone so TIB is not computed.
#
No data reported
158
EMC & Acoustic output
8.2.4
45° angled Probe
TIS
Index Label
MI
Maximum index value
(MPa)
pra
P
Aaprt
≤ 1 cm2
#
1.30E-3
#
0.0264
Aaprt > 1 cm2
-
(cm)
-
zbp
(cm)
-
zb
(cm)
(b)
(a)
#
#
0.32
(cm)
#
(MHz)
Dim of Aaprt
TIC
#
z at max. Ipi, (cm)
fawf
Non-scan
-
(mW)
zs
deq (zb)
Other
information
Non-scan
0.567
(mW)
Min. of [P(zs), Ita,(zs)]
Associated
acoustic
parameters
0.177
Scan
TIB
10.4
#
10.4
-
#
#
X(cm)
#
0.150
-
#
#
Y(cm)
#
0.150
-
#
#
td (µsec)
0.110
prr
3950
(Hz)
pr at max. Ipi (MPa)
0.638
deq at max. Ipi (cm)
Ipa, at max. MI (W/cm3)
#
8.90
Operating
control
conditions
NOTE 1: Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode.
NOTE 2: nformation need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial
or neonatal cephalic uses.
NOTE 3: Information on MI and TI need not be provided if the equipment meets both exemption clauses given in 51.2 aa)
and 51.2 dd).
(a)
Intended use does not include cephalic so TIC is not computed.
(b)
Intended use is Ophthalmic and does not involve bone so TIB is not computed.
#
No data reported
159
8
EMC & Acoustic output
8.2.5
Pachymetry probe
TIS
Index Label
MI
Maximum index value
(MPa)
pra
P
Aaprt ≤ 1 cm2
Aaprt > 1 cm2
#
9.53E-4
-
#
0.0198
(cm)
-
zbp
(cm)
-
zb
(cm)
(b)
(a)
#
#
0.2
(cm)
#
(MHz)
Dim of Aaprt
TIC
#
z at max. Ipi, (cm)
fawf
Non-scan
-
(mW)
zs
deq (zb)
Other
information
Non-scan
0.551
(mW)
Min. of [P(zs), Ita,(zs)]
Associated
acoustic
parameters
0.174
Scan
TIB
10.1
#
10.5
-
#
#
X(cm)
#
0.15
-
#
#
Y(cm)
#
0.15
-
#
#
td (µsec)
0.108
prr
3950
(Hz)
pr at max. Ipi (MPa)
0.591
deq at max. Ipi (cm)
Ipa, at max. MI (W/cm3)
#
8.03
Operating
control
conditions
NOTE 1: Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode.
NOTE 2: nformation need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial
or neonatal cephalic uses.
NOTE 3: Information on MI and TI need not be provided if the equipment meets both exemption clauses given in 51.2 aa)
and 51.2 dd).
(a)
Intended use does not include cephalic so TIC is not computed.
(b)
Intended use is Ophthalmic and does not involve bone so TIB is not computed.
#
No data reported
160
EMC & Acoustic output
8.2.6
GLOBAL ACOUSTIC OUTPUT LIMITS
MI
Probe
[Unitless]
A-Scan
ISPTA.3
ISPPA.3
[mW/cm2]
(mW/cm2)
0.161
2.35
15.14
B-scan
0.208
0.55
15.6
45° angled
with detachable tip
0.174
3.36
7.79
45° angled
0.203
5.19
12.43
Pachymetry
0.194
3.79
9.46
8
161
EMC & Acoustic output
162
Glossary
9.
Glossary
A-scan
The A-(amplitude) and B-(brightness) scans are basic methods of representing the echoes reflected
from portions of the eye interior. The ultrasonic waves are highly directive and reflected by boundaries
between materials with different acoustical impedance. The distances of the materials can be calculated from the time taken until the reflected ultrasonic waves are received. The A-scan image is a
graph of the distances of materials in the horizontal axis and the amplitude of reflected echoes in the
vertical axis.
B-scan
Whereas the A-scan shows the distances of materials with the amplitude of echoes, the B-scan shows
the amplitude of echoes in the form of brightness of spots. Only one-dimensional image can be
obtained with an ultrasonic beam. However, a two-dimensional image can be created with multiple
ultrasonic beams. In most cases, the word "ultrasonography" indicates the B-scan.
Gain
The gain is obtained by comparing the signal values input to and output from the amplifier of the electrical circuit. The unit is dB.
O.D. (Oculus Dexter)
Right eye
O.S. (Oculus Sinister)
Left eye
TGC (Time Gain Control)
Pulses from deep portions of the eye interior, that takes time between the emission and reception,
travel long distances and decrease their amplitudes. They needs to be amplified to make the brightness of the spots they represent uniform with that of spots that represents the pulses reflected from
shallow portions of the eye.
TGC adjusts the amplitude of pulses according to their distances (time before they are received). This
device attenuates the echoes at the anterior segment of the eye so that the brightness of the spots in
the B-scan.
USB flash drive
An auxiliary storage to which data is transmitted through the USB port.
9
163
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