Tomey AL-4000 User manual

716A9090-10
INSTRUCTION MANUAL
BIO & PACHY METER
AL-4000
Read this manual thoroughly before using the
instrument to ensure proper and safe operation.
Contact Tomey Corporation or our local distributor if
you have any questions or you encounter any
problems during operation.
䕔 Always follow the operation procedures
described in this manual.

䕔
Keep this manual in a readily accessible
place while operating this instrument.

䕔
Contact our local distributor if you lose
this manual.

i-1 䕔
i. Important safety information
ڦ Do not install this instrument in a location where explosives or inflammable
substances are used or stored. Fires or explosion may occur.
ڦ Do not remove the cover of the instrument. You may be directly exposed to
high voltage sections.
ڦ Do not disassemble or modify the instrument. You may be directly exposed to
high voltage sections.
ڦ Disconnect the AC cord from all the connected devices before installing and/or
servicing the instrument. Otherwise, you may get an electric shock.
ڦ Sterilize measurement probes before use.
ڦ Do not use a measurement probe with a damaged contact section.
Measurement error may occur, as well as the corneal or eyelid may be injured.
ڦ Immersion attachment and disposable tip are a disposable part. Do not reuse
these parts. Otherwise, you may contract diseases.
ڦ You are cautioned that changes or modifications not expressly approved by
the party responsible for compliance could void your authority to operate the
equipment.
ڦ Do not place water or chemicals on the instrument. Any water or chemicals
entering the instrument may cause an electric shock or failure.

ڦ
Do not allow water or chemicals to splash on measurement probes except for
the tips. Any water or chemicals entering the probes may cause an electric
shock or failure. 
ڦ
Only use the specified terminal for connection of the instrument. Using
another type of terminal may result in failure of the instrument.
ڦ This instrument is a measuring device specially designed for ophthalmology.
Never use the instrument for other purposes.
ڦ The terminal for connecting the instrument to external devices is not isolated
from the internal circuit. Inappropriate wiring may damage the internal circuit.
Never touch any of these terminals and the patient at the same time. Be sure to
contact Tomey or our local distributor before using the external output
terminal. 
ڦ
When operating this instrument connected to other devices, only use devices
that satisfy IEC60601-1 or equivalent safety requirements, or that conform to
IEC60950 and whose power source is insulated with an insulation transformer,
in order to satisfy the relevant safety requirements for medical equipment.


䕔 i-2
ڦ Never mark or damage the caution labels on the instrument. The
caution labels are provided at two locations as shown below.
ڦ If a label is damaged or becomes illegible, please contact Tomey
Corporation or our local distributor.

i-3 䕔
ڦ This device complies with FCC RF radiation exposure limits set forth
for an uncontrolled environment. The antenna used for this
transmitter must be installed to provide a separation distance of at
least 20 cm from all persons and must not be co-located or operated
in conjunction with any other antenna or transmitter.

䕔 i-4
This page is intentionally blank

ii-1 䕔
ii. How to read this manual
Outline
This manual is structured as follows.
1. PRIOR TO USE
Describes safety precautions and important
information to be understood before installing and
using the instrument.
2. NAMES AND FUNCTIONS
Describes names and functions of each section of
the instrument.
3. OPERATION PROCEDURES
Describes information required for installing and
using the instrument.
4. TECHNICAL INFORMATION
Describes useful technical information about the
instrument.
5. INSPECTION AND MAINTENANCE
Describes procedures for replacing consumable
parts, etc. that the user of the instrument should
normally conduct.
6. TROUBLESHOOTING
Describes how to solve problems.
7. CONSUMABLES AND OPTIONAL EQUIPMENT
Describes consumable parts and optional
equipment.
8. SPECIFICATIONS
Describes the specifications of the instrument.
9. INDEX
Refer to the index when needed.

䕔 ii-2
Symbols used in this manual
Sentences accompanied with the symbols below
indicate the following:
䕔 This is a precaution that, if unheeded, will
result in a hazardous situation where there is
imminent danger of serious injury or death.

䕔 This is a precaution that, if unheeded, could
result in a hazardous situation where there is a
possibility of serious injury or death.

䕔 This is a precaution that, if unheeded, may
result in a situation where there is a possibility
of minor or moderate injury or damage to
property.

䕔 This is an additional instruction which may
contain a special precaution on company
policy related, either directly or indirectly, to
the safety of personnel or to the protection of
property.

iii-1 䕔
iii. Table of contents
i. Important safety information ................................................................................... i-1
ii. How to read this manual........................................................................................ ii-1
Outline...............................................................................................................................ii-1
Symbols used in this manual............................................................................................ii-2
iii. Table of contents .................................................................................................. iii-1
1. PRIOR TO USE.....................................................................................................1-1
1.1 Precautions for operation........................................................................................ 1-1
1.2 Glossary .................................................................................................................. 1-6
1.3 Checking package contents .................................................................................... 1-8
1.4 Overview ................................................................................................................. 1-9
2. NAMES AND FUNCTIONS ...................................................................................2-1
2.1 Front of the main unit .............................................................................................. 2-1
2.2 Back of the main unit............................................................................................... 2-3
2.3 Sides of the main unit.............................................................................................. 2-4
2.4 Top of the main unit................................................................................................. 2-5
2.5 Bottom of the main unit ........................................................................................... 2-6
2.6 Screen ..................................................................................................................... 2-7
2.6.1 Basic structure and common items ................................................................. 2-7
2.6.2 Axial Length Measurement (Biometry) ............................................................ 2-9
2.6.3 Corneal thickness measurement ................................................................... 2-15
2.6.4 Diagnosis in mode A ...................................................................................... 2-17
2.7 Auto power off function ......................................................................................... 2-20
3. OPERATION PROCEDURES ...............................................................................3-1
3.1 Safety precautions .................................................................................................. 3-1
3.1.1 Precautions for installing the instrument.......................................................... 3-2
3.1.2 Precautions for connecting the power ............................................................. 3-3
3.2 Preparation before use............................................................................................ 3-4
3.2.1 Connections ..................................................................................................... 3-4
3.2.2 Wireless connection with UD-8000 and IOL calculation unit......................... 3-12
3.2.3 Turning the power on and adjustment after turning the power on................. 3-16
3.2.4 Switching modes............................................................................................ 3-18
3.2.5 Setting measurement conditions ................................................................... 3-19
3.2.6 Entering the patient data................................................................................ 3-19

䕔 iii-2
3.2.7 Clear all measurement data (preparation for measuring a new patient)....... 3-22
3.2.8 Selecting the eye to be measured................................................................. 3-23
3.3 Axial length measurement function....................................................................... 3-24
3.3.1 Connecting the biometry probe ..................................................................... 3-24
3.3.2 Setting axial length calculation method and converted acoustic velocity for eye
to be measured.............................................................................................. 3-24
3.3.3 Contact/immersion mode settings ................................................................. 3-29
3.3.4 Operation check............................................................................................. 3-29
3.3.5 Preparation for measurement ........................................................................ 3-29
3.3.6 Precautions for measurement ....................................................................... 3-30
3.3.7 Measurement ................................................................................................. 3-40
3.3.8 Checking waveforms after measurement...................................................... 3-45
3.4 IOL power calculation............................................................................................ 3-53
3.4.1 Calculation ..................................................................................................... 3-53
3.4.2 Setting calculation conditions ........................................................................ 3-53
3.4.3 Entering calculation parameters .................................................................... 3-53
3.4.4 Setting calculation formula............................................................................. 3-59
3.4.5 Saving measurement data............................................................................. 3-60
3.5 Pachymetry function.............................................................................................. 3-61
3.5.1 Connecting the pachymetry probe................................................................. 3-61
3.5.2 Setting the data type to be displayed ............................................................ 3-61
3.5.3 Setting how to display the converted acoustic velocity and bias value......... 3-61
3.5.4 Setting the measurement mode/range and data display............................... 3-63
3.5.5 Operation check............................................................................................. 3-65
3.5.6 Preparation for measurement........................................................................ 3-65
3.5.7 Measurement ................................................................................................. 3-66
3.5.8 Checking the measurement data................................................................... 3-73
3.5.9 Saving the measurement data....................................................................... 3-76
3.6 A-scan diagnosis................................................................................................... 3-77
3.6.1 Connecting the probe .................................................................................... 3-77
3.6.2 Switching to the A-scan diagnosis................................................................. 3-77
3.6.3 Gain setting.................................................................................................... 3-79
3.6.4 Setting analysis method................................................................................. 3-80
3.6.5 Measurement ................................................................................................. 3-81
3.6.6 Various functions in FREEZE mode .............................................................. 3-82
3.6.7 Various functions in real time mode............................................................... 3-85
3.6.8 Analysis function............................................................................................ 3-86

iii-3 䕔
3.7 Utilities ................................................................................................................... 3-90
3.7.1 Buttons and icons on the screen ................................................................... 3-91
3.7.2 Operations for each setting............................................................................ 3-95
4. TECHNICAL INFORMATION ................................................................................4-1
4.1 IOL power calculation formula................................................................................. 4-1
4.1.1 SRK-II formula ................................................................................................. 4-1
4.1.2 SRK/T formula ................................................................................................. 4-2
4.1.3 HOLLADAY formula ......................................................................................... 4-4
4.1.4 Hoffer Q formula .............................................................................................. 4-6
4.1.5 HAIGIS standard formula................................................................................. 4-7
4.2 How to calculate axial length using the axial length measurement function .......... 4-9
4.2.1 Phakic eye ....................................................................................................... 4-9
4.2.2 Dense cataract eye .......................................................................................... 4-9
4.2.3 Aphakic eye ..................................................................................................... 4-9
4.2.4 IOL eye........................................................................................................... 4-10
4.3 Amplifier characteristics of the A-scan diagnosis ................................................. 4-11
4.4 Checking the software version.............................................................................. 4-11
4.5 Ultrasound wave output ........................................................................................ 4-12
4.5.1 MI (mechanical index).................................................................................... 4-12
4.5.2 TIS (thermal index of soft tissue)................................................................... 4-12
5. INSPECTION AND MAINTENANCE .....................................................................5-1
5.1 Warranty .................................................................................................................. 5-1
5.2 Durable years .......................................................................................................... 5-2
5.3 Inspection ................................................................................................................ 5-2
5.4 Routine maintenance .............................................................................................. 5-2
5.4.1 Maintenance of measurement probes............................................................. 5-3
5.4.2 Cleaning and Disinfection of measurement probes (for Europe).................... 5-6
5.4.3 Maintenance of main unit................................................................................. 5-8
5.5 Replacing consumables .......................................................................................... 5-9
5.6 Storing ..................................................................................................................... 5-9
5.7 Disposal................................................................................................................. 5-10
6. TROUBLESHOOTING ..........................................................................................6-1
7. SPARE PARTS AND OPTIONAL PARTS ..............................................................7-1
7.1 Spare parts .............................................................................................................. 7-1
7.2 Optional parts .......................................................................................................... 7-1

䕔 iii-4
8. SPECIFICATIONS.................................................................................................8-1
8.1 Specifications .......................................................................................................... 8-1
8.1.1 Biometry/IOL power calculations ..................................................................... 8-1
8.1.2 Function of pachymetry ................................................................................... 8-2
8.1.3 A-scan Diagnosis............................................................................................. 8-3
8.1.4 Main unit........................................................................................................... 8-3
8.1.5 AC adapter....................................................................................................... 8-3
8.1.6 Battery.............................................................................................................. 8-3
8.2 Energy and other consumption ............................................................................... 8-4
8.2.1 Influences of ultrasound energy on the human body ...................................... 8-4
8.2.2 Ultrasound energy............................................................................................ 8-5
8.3 Noise ..................................................................................................................... 8-10
8.4 Environment conditions......................................................................................... 8-10
8.5 Classification ofME Equipment ............................................................................. 8-11
8.6 Declaration of Conformity to EMC ........................................................................ 8-12
9. INDEX ...................................................................................................................9-1

1-1 䕔 
1. PRIOR TO USE
ڦ Read this manual thoroughly before using this
instrument to ensure proper and safe operation.
ڦ Always follow the operation procedures
described in this manual.
ڦ Do not place any other objects on this
instrument.
ڦ Check that there are no devices that generate
strong magnetic field near the instrument. A
strong magnetic field may cause noise and
affect measurement.
1.1 Precautions for operation
䕔 When measuring the axial length, fully examine the measured data for
waveforms and variations. If the measurement result is doubtful,
perform measurement again or another inspection to review the
inspection result. If incorrect measurement data is used to select
intraocular lenses, further surgery might be required.
䕔 When using the IOL calculation result to select intraocular lenses,
thoroughly determine the selection by also examining cataract
surgery methods and other inspections.
䕔 When measuring corneal thickness, the measurement accuracy may
exceed ±5 μm depending on the conditions of measurement or
patient's corneal. Carefully consider the history of corneal diseases
and surgeries, and review the inspection result by performing
measurement again or another inspection if the measurement result is
doubtful.
䕔 Only allow qualified operators to use the instrument.
䕔 Artifacts may occur in the ultrasonic measurements.
If measurement values are questionable, determine the values by
overall judgment (using the wave forms or results from other
equipment).

䕔 1-2
䕔 Precautions when installing the instrument and accessories
-Install the instrument in a location free of water or chemicals. Any water
or chemicals entering the instrument or devices may cause an electric
shock or failure.
-Do not install the instrument in a location where chemicals are stored
or gases may occur. Any chemicals or vapor entering the devices may
result in fire.
-Check that the frequency, voltage, and allowable current (or power
consumption) of the power source are appropriate. Otherwise, fire or
electric shock may occur.
-Do not place any heavy object on the AC cord or squash the power
cord. Fire or electric shock may occur.
-Fully insert the power plug into the outlet. Faulty contact, allowing any
metal to contact the exposed terminal of the plug, or dust accumulated
on the exposed terminal of the plug may result in fire or electric shock.
-Do not connect a device with data transmission specifications that are
not compatible. Fire or electric shock may occur. Contact Tomey
Corporation or our local distributor before using the instrument while
connected to another device.
-Install the instrument in a location not subject to direct sunlight, high
temperature and humidity, or air containing dust, salt, and/or sulfur.
Otherwise, failure or malfunction may occur.
-Install the instrument in a leveled stable location free of vibration or
mechanical impact. Otherwise, measurement cannot be conducted
correctly. Also, the instrument may topple over or fall down, resulting in
fire or a serious accident.
-Install the instrument in a location with ample clearance from other
devices to allow smooth inspection.
-Check that the frequency, voltage, and allowable current (or power
consumption) of the power source are appropriate.
-Check the power source (discharge condition, polarity, etc.).

1-3 䕔 
-A magnet is built into the instrument. Do not place any electronic device,
magnetic card, and other objects that may be affected by magnetism
near the instrument. These may become unusable.

䕔
Precautions before operation
-Check the electrical contact of switches, polarity, dial setting, and
meters, and that the instrument is working correctly.
-Check that all cables are connected correctly.
-Do not allow water or chemicals to splash on measurement probes,
except for the tips. Any water or chemicals entering the probes may
cause an electric shock or failure.
-Check the sections that the patient will directly touch.
-Check that the date set in the instrument conforms to the actual
operation date and time.
䕔 Precautions during operation 
-Do not place any container with liquid in it on the instrument. Any liquid
entering the instrument may cause electric shock or failure.
-Be sure to touch the “New”button on the main unit to delete the
measurement data for the previous patient before measuring a new
patient. If new measurement is started without deleting the previous
data, the measurement data for the previous patient may be included.
-Do not allow the patient to touch the terminals for connecting the
instrument to external devices.
-Do not press on the instrument from the top. Doing so may cause
failure of the instrument.
-Do not allow water or chemicals to splash on probes, except for the tips.
Any water or chemicals entering the probes may cause an electric
shock or failure.
-Be extremely careful not to take too much time or too many
measurements, as this can stress the patient.

䕔 1-4
-Constantly observe that both the instrument and patient are free of
problems.
-If a problem with the instrument or the patient occurs, take appropriate
action, such as stopping the device, to ensure the patient’s safety.
-Do not allow the patient to touch the instrument.
-If any smoke, offensive odor, or abnormal sound occurs, turn off the
instrument immediately, disconnect the power plug from the outlet, and
contact our local distributor or Tomey Corporation.
䕔 Precautions after operation 
-Do not place any container with liquid in it on the instrument. Any liquid
entering the instrument may cause electric shock or failure.
-Do not use organic solvents such as thinner, benzene, or acetone to
clean the instrument. Fire or electric shock may occur. (These solvents
may also corrode the resin or coating on the cover of the instrument.)
䠅
-Follow the specified procedures to return the operation switch, dial, etc.
to their original positions and turn the instrument off.
-Hold the plug when disconnecting the power plug from the outlet to
avoid placing excessive force on the cord. Pulling the cord may
damage the inner core wires, resulting in electric shock or fire.
-When disconnecting cords, do not apply too much force to them, for
example, do not hold and pull the cord.
-Refer to “5.6 Storing”for instructions on the storage of the instrument.
-Clean the instrument at the end of operation in preparation for the next
use.
-Clean and neatly arrange the accessories and cables.

1-5 䕔 
䕔 If any failure occurs in the instrument, immediately stop operation,
identify the failure in the instrument, and contact our local distributor
for repairs.

-Do not modify the instrument. Doing so may cause electric shock or
failure of the instrument. There is a high-voltage section in the
instrument. Touching this section will result in death or serious injuries.
-Use the AC cord provided with the instrument or one specified by
Tomey to ensure safety. Also, do not use the accessories provided with
the instrument for other equipment.
-Conduct regular inspections of the instrument and components.
When the instrument is not used for 1 month or longer, check that the
instrument is operating correctly and safely before starting operation.
Refer to “5.3 Inspection”in this manual for the relevant procedures.

䕔 1-6
1.2 Glossary
[ACD] : Anterior chamber depth
[Acrylic] : Acrylic lens
[Aphakic㼉: Aphakic eye
[AVG] : Average value
[Axial㼉: Axial length measurement (biometry)
[A-Diag] : A-scan diagnosis
[BD address] : Bluetooth® Device Address 
Number set to each device to identify the connection
[Bluetooth ®] : Registered mark of Bluetooth SIG, Inc.
[Calibration] : Calibration of the pachymetry probe
[CCT] : Corneal center thickness
[Contact㼉: Method of taking measurements by directly applying
the contact section of the biometry probe to the center
of the corneal
[D] : Diopter The unit of refractive power representing the
level of myopia, hyperopia, or astigmatism. Reciprocal
of the focal length measured in meters.
[FREEZE] : Status where ultrasound waves are not transmitted
[Immersion㼉: Method of taking measurements by applying corneal
protective agent between the corneal and contact
section of the biometry probe, or attaching a special
tool to the eye and using water between the corneal
and contact section.
[IOL] : Intraocular lens
[K1] : Radius of corneal curvature of minor meridian [mm]
[K2] : Radius of corneal curvature of major meridian [mm]
[Obj.] : Section to be measured
[Pachy㼉: Corneal thickness measurement
[Pre] : Before refractive power correction surgery
[Phakic㼉: Phakic eye
[PMMA] : PMMA lens
[Post] : After refractive power correction surgery
[Ref.] : Reference section
[Silicone] : Silicone lens
[US] : Ultrasound biometry

1-7 䕔 
[Auto power off function] : The power turns off automatically when no operation is
conducted for a specified time.
[Caliper] : Manually moves the measurement point.
[Gain] : Adjusts amplification and amplitude of waveforms.
[Gate] : Specifies the range of waveforms to be detected.
[Measurement point] : Indicates the point where corneal thickness is
measured by diameters and angles.
[Touch panel] : Allows you to make various settings, etc. by directly
touching the monitor.
[Bias value] : Value obtained by converting actual measurements
using a specified percentage or correction value

䕔 1-8
1.3 Checking package contents
Open the package and check that the required
quantity of the following items is included and they are
not damaged. If any item is missing or damaged,
contact our local distributor as soon as possible.
䕔 Keep the box and packing materials for use
when moving or transporting the instrument.

Main unit BIO & PACHY METER AL-4000...................1
Biometry probe (with protective cap and the case)......1
Footswitch.....................................................................1
AC adapter ...................................................................1
AC cord.........................................................................1
Biometry Test piece ......................................................1
Immersion attachment (20pcs/box)..............................1
USB cable.....................................................................1
Sleeve for eye axis probe.............................................1
Probe holder .................................................................1
Touch pen .....................................................................1
Carrying bag .................................................................1
Dust cover ....................................................................1
Instruction manual (this manual) ..................................1
Installation manual for TB-1000 ...................................1
Installation CD for TB-1000 ..........................................1