AL-100 Instruction Manual

IMPORTANT PRECAUTIONS DO NOT REMOVE THE OUTER COVER of the instrument. If you do, you may be subjected to direct high voltage. The immersion attachment is a disposable part. Do not reuse it. Otherwise, you may contract diseases.

i

CONSULTING OF THIS MANUAL Composition of this operator manual

1.PRIOR TO USE Explains precautions and confirmations prior to installing and operating this instrument. 2.NAMES AND FUNCTIONS OF THE COMPONENTS Explains the names and functions of the components of this instrument 3.OPERATING PROCEDURES Explains significant information necessary for installing and operating this instrument. 4.TECHNICAL REFERENCE Provides the technical information of this instrument 5.MAINTENANCE AND INSPECTION Explains your routine inspection and maintenance and replacing spare parts. 6.TROUBLESHOOTING Explains the spare parts and option parts of this instrument. 7.SPARE PARTS AND OPTIONAL PARTS Explains the spare parts and option parts of this instrument. 8.SPECIFICATIONS Explains the specifications for this instrument.

ii

SYMBOLS USED IN THIS MANUAL The symbols used in this manual represent the following:

This is a precaution that, if unheeded, will result in a hazardous situation where there is an imminent danger of serious injury or death.

This is a precaution that, if unheeded, may cause a hazardous situation where there is the possibility of serious injury or death.

This is a precaution that, if unheeded, may cause minor or moderate injury or property damage.

This is a special precaution that is related, either directly or indirectly, to personal safety or to protection of property.

iii

CONTENTS IMPORTANT PRECAUTIONS ... i CONSULTING OF THIS MANUAL ... ii SYMBOLS USED IN THIS MANUAL ... iii CONTENTS ... iv 1 PRIOR TO USE ... 1-1 1.1

Precautions for use ... 1-1

1.2

Unpacking and receiving inspection ... 1-3

1.3

Symbols used in this manual ... 1-4

1.4

Outline of operation ... 1-5

2 NAMES AND FUNCTIONS OF THE COMPONENTS ... 2-1 2.1

Front and right side of AL-100 and biometry probe ... 2-1

2.2

Back and left side of AL-100 ... 2-3

3 OPERATION PROCEDURES ... 3-1 3.1

Safety precautions ... 3-1

3.2

Preparation before use ... 3-2

3.2.1

Connecting the accessaries ... 3-2 a)

Connecting the biometry probe ... 3-2

b)

Connecting the power cord ... 3-2

c)

Connecting the foot switch ... 3-3

d)

Insertimg the probe holder ... 3-3

3.2.2

3.3

Connecting the option parts ... 3-4 a)

Inserting and removing the memory card ... 3-4

b)

Chin rest installation (AL-1100) ... 3-5

Measurement procedures ... 3-7

3.3.1

Biometry mode setup ... 3-7 a)

Turning the power on and initial adjusting ... 3-7

b)

Start up screen ... 3-8

3.3.2

Front button ... 3-10

3.3.3

Measurement ... 3-11 a)

3.3.4

Data review window / Measurement window ... 3-11 Settings of the measurement conditions ... 3-12

a)

Deleting data measured for both eyes ... 3-12

b)

Setting the eye to be measured ... 3-13

iv

c)

ID / Patient’s name, sex / Physician’s name input ... 3-13

d)

Physician’s list entry ... 3-15

e)

Setting items for measurement ... 3-16

3.3.5

Actual measurement ... 3-23 a)

Checking the performance ... 3-23

b)

Preparation for measurement ... 3-23

c)

Measurement ... 3-24

d)

Retake ... 3-27

e)

Selecting retina waveform ... 3-27

3.3.6

Acceptable waveforms ... 3-28 a)

Contact mode ... 3-28

b)

Immersin mode ... 3-29

3.3.7

EDIT ... 3-30 a)

3.3.8 3.4

Caliper function ... 3-33

IOL calculation ... 3-35

3.4.1

IOL power calculation ... 3-35

3.4.2

Calculation ... 3-36

3.4.3

Calculation functions ... 3-36

3.5

a)

Selecting the IOL formula ... 3-36

b)

Data entry for IOL calculation ... 3-37

c)

Constants (Aconst, SF, ACD) ... 3-39

d)

IOL power entry ... 3-41

e)

P/C Value (Personal Corresponding Value) ... 3-42

f)

Assistant function ... 3-44

Printout ... 3-45

3.5.1

Printout procedure ... 3-45

3.5.2

Sample printout ... 3-47

3.6

a)

Sample biometry printout ... 3-47

b)

Sample IOL power calculation printout following biomtery (SPK/T) ... 3-50

c)

Sample printout using P/C (Personal Corresponding) surgeon factor Value ... 3-53

d)

Sample data communication printout ... 3-54

Data save / load / delete ... 3-55

3.6.1

v

EDIT Screen ... 3-31

Data save ... 3-55 a)

Data saving (EDIT) ... 3-55

b)

Data save on the IOL calculation window ... 3-57

3.6.2

Data loading ... 3-58

3.6.3

Sort ... 3-61

3.6.4

Deleting ... 3-63

3.6.5

Momery card format ... 3-64

3.6.6

Data communication ... 3-65

3.7

a)

PC communication ... 3-65

b)

Sending data ... 3-67

c)

Receiving data ... 3-69

Utilities ... 3-71

3.7.1

Contents of utilities ... 3-71

3.7.2

Biometry /IOL power calculation utilities ... 3-72

3.8

a)

Time and date ... 3-72

b)

Sound setup ... 3-73

c)

Print mode setup ... 3-74

d)

Fix light ON/OFF ... 3-75

e)

Extended Export setting (Extended Export) ... 3-76

Memory card (option) ... 3-77

3.8.1

Memory card specifications ... 3-77

3.8.2

Memory card battery ... 3-78 a)

“No Battery!” ... 3-78

b)

“Low Battery!” ... 3-78

c)

Battery life ... 3-78

3.8.3

Reading the memory card on Windows PC ... 3-79

3.8.4

Taking out the memory card from PC ... 3-82

3.9

Shut down ... 3-84

4 TECHNICAL REFERENCE ... 4-1 4.1

IOL calculation formulae ... 4-1

4.1.1

SRK II ... 4-1

4.1.2

SRK/T ... 4-3

4.1.3

Holladay ... 4-4

4.1.4

Haigis standard / Haigis optimized ... 4-6

4.1.5

Showa (Modified SRK formula for Japanese) ... 4-8

4.1.6

Hoffer Q ... 4-9

4.1.7

Shammas-PL ... 4-10

4.2

Axial length calculation with biometry ... 4-12

4.2.1

Normal ... 4-12

4.2.2

Dense cataract ... 4-12

4.2.3

Aphakic ... 4-12

4.2.4

Pseudophakic (1-3) ... 4-12

4.3

Version information ... 4-13

vi

4.4

Acoustic output ... 4-14

4.4.1

MI (MECHANICAL INDEX) ... 4-14

4.4.2

TIS (SOFT TISSUE THERMAL INDEX) ... 4-14

5 INSPECTION AND MAINTENANCE ... 5-1 5.1

Warranty ... 5-1

5.2

Fuses ... 5-2

5.3

Routine maintenance ... 5-3

5.3.1

Maintenance of the probe ... 5-3

5.3.2

Cleaning and Disinfection of measurement probes (for Europe) ... 5-4

5.3.3

Maintenance of the main unit ... 5-6

5.4

Printer paper ... 5-7

5.5

Storage ... 5-8

5.6

Packing materials ... 5-9

6 TROUBLESHOOTING ... 6-1 7 SPARE PARTS AND OPTION PARTS ... 7-1 7.1

Option parts ... 7-1

7.2

Spare parts ... 7-2

8 SPECIFICATIONS ... 8-1 8.1

Specifications ... 8-1

8.1.1

Biometry /IOL calculation ... 8-1

8.1.2

Main unit ... 8-2

8.1.3

Power supply ... 8-2

8.2

Energy and other consumptions ... 8-3

8.2.1

Influences of ultrasound energy to human body ... 8-3

8.2.2

Ultrasound energy ... 8-3

8.3

Noise ... 8-6

8.4

Environment conditions ... 8-6

8.5

Declaration of conformity to EMC ... 8-7

vii

1 PRIOR TO USE 1.1

Precautions for use Make sure that this Instrument must be installed in a place without any intensive electromagnetic wave or the wave generating devices. An intensive electromagnetic field causes noises to interrupt the Instrument from functioning proper diagnosis and measurement. Nothing must be put on this unit. Read this Operator manual carefully before using the instrument in order to operate it properly and safely. Do not use any procedures that are not specified in the manual.

Only well-trained personnel should operate this instrument. When installing this instrument, observe the following: - Do not install the instrument in a place where it might be exposed to moisture or chemicals. - Do not install the instrument in a place where it is subject to adverse condition, such as direct sunlight, high temparature, excessive humidity, dust, sulfur or salt. - Ascertain that any adverse factors such as excessive slope, vibration and impact will not endanger the instrument (including during transportation). - Do not install the instrument in or near the storage area of chemical substances or where any gas may be generated. - Follow frequency, voltage and allowable current (or allowable power consumption) specifications. - Be cautious of electrical power condition such as discharge, polarity, etc. - Connect the grounding properly, which may otherwise cause an electric shock.

1-1

Before using this instrument, observe the following: - Ascertain that all cables and cords are properly connected. - Carefully inspect the probe tip before using. - Ascertain that the power source is properly grounded. - When using this instrument with other unit, be careful not to cause any inaccurate diagnosis or danger. - Check if there is no crack or rash on the probe tip before it is applied to the patient. While using this instrument, observe the following: - Always make sure that the patient is comfortable. - Always make sure that both instrument and patient are under normal condition. - If any complication or abnormality is encountered, either with the patient or instrument, ensure the safety of the patient by discontinuing testing. - Make sure that patient has no contact with the instrument (other than the probe) during testing. After using this instrument, observe the following: - Make sure that the unit is the same condition as initial, before turnning off the unit. (See 3.9 Shut Down, page 3-80) - When disconnecting the power cord, hold the plug, not the cord, and do not use excessive force. - Be sure to clean the probe and other accessaries after each use. - If you do not plan to use the instrument for a considerable period of time, refer to Section 5.5 for storage instructions. - Be sure to clean the instrument to prepare for next use. In case of a malfunction, do not attempt to repair the instrument yourself. Place a sign on the instrument indicating that it is malfunctioning and contact your Tomey representative. Do not technically modify this instrument. Please be informed that the instrument should be inspected regularly. When using the instrument, which has not been used for a certain period of time, make sure that the instrument works normally and safely, before using.

1-2

1.2

Unpacking and receiving inspection When unpacking the instrument, make sure that all of the components are present and that none of them are visibly damaged. If any items are missing or damaged, contact your Tomey representative. Be sure to keep the box and the packing material for use if the instrument is moved to another location.

AL-100 Main Unit ...1 Biometry probe (A-scan probe) ...1 Probe holder ...1 Test piece for axial length measurement ...1 Immersion attachment (20pcs / box) . ...1 Attachment for Chin rest (Aplanation Tonometer) ...1 Power cord ...1 Foot Switch ...1 Biometry Test Piece ...1 Printer paper roll ...1 Dust cover ...1 Fuses ...2 Instruction Manual(This book) ...1

1-3

1.3

Symbols used in this manual The symbols used in this manual represent the following:

[

1-4

:Contrast Volume

]

[MEMORY CARD]

:PC card slot

[

]

:Main Switch ON

[

]

:Main Switch OFF

[

]

:Communication Cable Terminal

[

]

:Maintenace port and Switch (Manufacturer’s use)

[

]

:Fuses

[BIO PROBE]

:Biometry probe connector

[FIX LIGHT]

:Fixation Light connector with AL-1100 (Chin rest)

[FOOT SWITCH]

:Foot Switch Connector

1.4

Outline of operation The AL-100 is an ultrasound instrument designed for measuring the axial length of the eye for medical ophthalmic use.

Acoustic output is switched off after measurement.

Ultrasound energy is emitted from the probe tip. The probe acts as both the transmitter and receiver of ultrasound energy. This instrument has auto-measurement and tone-monitoring function which makes the operator easy to operate. IOL power calculation can be performed immediately after measuring the axial length. Six atandard IOL formulae are provided. The instrument can store axial length and implanted IOL data and each customer can calculate personal A constants with these values.

1-5

This page is intentionally blank.

1-6

2 NAMES AND FUNCTIONS OF THE COMPONENTS 2.1

Front and right side of AL-100 and biometry probe

MEA

SUR E IOL EDIT

2-1

(1) Display (touch panel) Measurement data and other information are displayed on the screen. The instrument is operated by touching the keys.

(2) Probe holder When the probe is not in use, place them in the holder.

(3) Terminal of Biometry Probe The Biometry probe is connected here.

(4) Power indicator Lit when power is on.

(5) MEASURE Button Switch display to Measurement mode

(6) IOL Button Switch display to IOL Calculation Mode

(7) EDIT Button Switch display to EDIT Mode

(8) PC card slot Memory card (Optional) should be inserted to store acquired data.

(9) Built-in Printer Prints measured data and calculated results.

(10) Biometry probe Use for axial length measurement.

2-2

2.2

Back and left side of AL-100

2-3

(1) Communication Cable Terminal The communication cable is connected here.

(2) Power supply terminal The power cord is connected here.

(3) Fuse holders Fuses are in use in these holders.

(4) Power switch Press the “ I ” side of the switch to turn on the power. Press the “ O ” side to turn it off.

(5) Contrast adjuster Controls the contrast of the screen

(6) Power cord with 3-prong plug Connection of this cord to a 3-prong power receptacle provides power to the AL-2000.

(7) Meintenance Switch Switch for Manufacturer’s use only. Do not change its position.

(8) Footswitch Terminal The footswitch is connected here.

(9) Power supply terminal for chin rest fixation light The power plug for the fixation light for the chin rest.

2-4

3 OPERATION PROCEDURES 3.1

Safety precautions

ALWAYS cleans the probe tip before taking a measurement on a human eye. NEVER use the probe if there is any visible damage to its tip. Such use may cause an incorrect maeasurement and/or damage to the cornea.

This instrument is designed exclusively for ophthalmic use. DO NOT use the instrument for any purpose other than ophthalmic diagnosis and measurement. DO NOT use any cables or memory cards other than those specified in this manual. Such use may result in damage to the instrument.

The protection cap should be used for the probe and put it on a probe holder when you do not use a probe.

3-1

3.2

Prepartion before use

3.2.1

Connecting the accessaries a) Connecting the biometry probe

Connector should be plugged into the terminal with a proper direction. Plug the biometry probe connector (1) into the terminal (2) labeled BIO on the front side of the instrument. When it is properly insetrted, you will hear it click.

b) Connecting the power cord

Power cord should be plugged into the terminal with a proper direction. Plug the power cord connector (1) into the terminal (2) on the back of the AL-100. All of 3-Pin in the plug must be connected.

3-2