Topcon SP-1P User manual

USER MANUAL
SPECULAR MICROSCOPE
SP-1P

1
INTRODUCTION
Thank you for purchasing the TOPCON Specular Microscope SP-1P.
INTENDED USE / INDICATIONS FOR USE
The Topcon Specular Microscope SP-1P is a non-contact ophthalmic microscope, optical
pachymeter, and camera intended for examination of the corneal endothelium and for mea-
surement of the thickness of the cornea.
FEATURES
This instrument features the following:
• The position of the touch panel can be adjusted to accommodate the operator's preferred
position.
• Photography of the corneal endothelium and the measurement of the corneal thickness can
be performed.
• The auto-alignment function ensures quick and easy measurement and photography.
• The cell analysis enables the user to easily get the value of the cell density.
PURPOSE OF THIS MANUAL
This User Manual provides an overview of the basic operation, troubleshooting, checking,
maintenance and cleaning of the TOPCON Specular Microscope SP-1P.
To get the best use of the instrument, read Safety Displays and Safety Cautions.
Keep this Manual at hand for future reference.
• Since this product is a precision instrument, always use and keep it in a normally controlled
living environment, within a temperature range of 10-40°C, humidity levels between 30-90%
and an atmospheric pressure range of 700hPa-1,060hPa.
• The instrument should also be placed away from direct sunlight.
• To ensure smooth operation, install the instrument on a level floor free of vibrations. Also, do
not place anything on the instrument.
• Connect all cables properly before using.
• Use the power at a rated voltage.
• When not in use, switch off the power source and apply the rubber cap and dust cover.
• For accurate Photographing image, take care to keep the Photographing window clean and
free of fingerprints, spots and dust.
[CAUTION] Federal laws restricts this device to the sale by or on the order of a physician.

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Since this product partly uses a program derived from IPA Font, using the product is regarded as
consent to the IPA Font License Agreement v1.0.
For the IPA Font License Agreement v1.0, the following URL.
http://ipafont.ipa.go.jp/ipa_font_license_v1.html
1. No part of this manual may be copied or reprinted, in whole or in part, without prior written permission.
2. The contents of this manual are subject to change without prior notice and without legal obligation.
3. The contents of this manual are correct to the best of our knowledge. Please inform us of any ambiguous or
erroneous descriptions, missing information, etc.
4. Original Instructions
This manual was originally written in English.
©2013 TOPCON CORPORATION
ALL RIGHTS RESERVED

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CONTENTS
INTRODUCTION .....................................................................................................................1
GENERAL SAFETY INFORMATION.......................................................................................6
HOW TO READ THIS MANUAL ..............................................................................................8
GENERAL MAINTENANCE INFORMATION ..........................................................................8
USER MAINTENANCE............................................................................................................8
CLEANING OF PHOTOGRAPHING WINDOW..............................................................8
DISCLAIMERS.........................................................................................................................8
DISPLAYS AND SYMBOLS FOR SAFE USE .........................................................................9
DISPLAYS ......................................................................................................................9
SYMBOLS................................................................................................................................9
POSITIONS OF WARNING AND CAUTION INDICATIONS .................................................10
COMPONENTS
COMPONENT NAMES..........................................................................................................11
COMPOSITION OF PARTS WHICH CONTACT THE HUMAN BODY .................................11
OPERATION METHOD OF CONTROL PANEL....................................................................12
CONTROL PANEL COMPONENTS......................................................................................13
PATIENT SCREEN (DICOM WORK LIST) ..................................................................13
PATIENT SCREEN (ID INPUT)....................................................................................14
HOW TO INPUT A PATIENT ID...................................................................................15
PHOTOGRAPHY SETTING SCREEN .........................................................................17
PHOTOGRAPHING POSITION (SHOWING POSITION OF FFIXATION TARGET)
SELECTING SCREEN .................................................................................................18
CAPUTER SCREEN.....................................................................................................19
PHOTOGRAPHING RESULT SCREEN.......................................................................20
MANUAL EDITING SCREEN .......................................................................................21
THE CHECKING SCREEN IN THE MIDDLE OF PANORAMA PHOTOGRAPHY.......22
RESULT SCREEN FOR PANORAMA PHOTOGRAPHY ............................................22
LIST OF PRINTING ITEMS SCREEN..........................................................................24
PRINTER OUTPUT ...............................................................................................................25
STANDARD ACCESSORIES ................................................................................................27
PREPARATIONS
INSTALLATION .....................................................................................................................28
CONNECTING POWER CABLE ...........................................................................................28
CONNECTING EXTERNAL I/O TERMINALS .......................................................................29
DATA OUTPUT ............................................................................................................29
IMAGEnet .....................................................................................................................30
DATA INPUT ................................................................................................................30
PRINTER PAPER SETTING .................................................................................................31
RECOVERY FROM POWER SAVE STATUS.......................................................................33
ADJUSTING THE CONTROL PANEL POSITION.................................................................33
BASIC OPERATIONS
OPERATION FLOW CHART .................................................................................................34
PREPARATION BEFORE PHOTOGRAPHING (SEQUENCE COURSE) ............................35
TURN THE POWER ON. SET PATIENT ID.................................................................35
SELECT PHOTOGRAPHY POINT AND PATIENT'S EYE...........................................36
PREPARATION OF PATIENT......................................................................................37
PHOTOGRAPHY AND ANALYSIS RESULT DISPLAY ........................................................39
ALIGNMENT AND PHOTOGRAPHY ...........................................................................39
IN MANUAL ALIGNMENT ............................................................................................42

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PRINT-OUT OF PHOTOGRAPHING DATA..........................................................................44
DATA OUTPUT......................................................................................................................44
OPERATION OF AFTER USE...............................................................................................45
OPTIONAL OPERATIONS
FREE STYLE COURSE PHOTOGRAPHY............................................................................46
PANORAMA PHOTOGRAPHY .............................................................................................48
DISPLAYING THE PATIENT ID (PATIENT No.) OR OPERATOR ID ...................................50
FOR DICOM WORK LIST ............................................................................................50
FOR ID INPUT..............................................................................................................50
CELL ANALYSIS IN EDITING MODE ...................................................................................51
OUTPUT TO IMAGEnet SYSTEM.........................................................................................53
INPUT USING USB ...............................................................................................................54
OUTPUT USING LAN............................................................................................................54
SETTING FUNCTIONS ON SETUP SCREEN
OPERATING THE SETUP SCREEN.....................................................................................55
PREPARATONS FOR SETTING .................................................................................55
OUTLINE OF SETUP SCREEN OPERATIONS...........................................................56
RETURNING TO THE MEASUREMENT SCREEN .....................................................58
LIST OF SETUP ITEMS ........................................................................................................59
INITIAL SETTINGS.......................................................................................................59
INTERNAL PRINTER ...................................................................................................60
EXTERNAL PRINTER..................................................................................................61
NETWORK SETTINGS ................................................................................................61
OPERATOR SETTINGS...............................................................................................63
TROUBLESHOOTING
TROUBLE-SHOOTING OPERATIONS .................................................................................64
MESSAGE LIST ...........................................................................................................64
TROUBLE-SHOOTING OPERATIONS........................................................................66
SPECIFICATIONS AND PERFORMANCE
SPECIFICATIONS AND PERFORMANCE ...........................................................................67
GENERAL INFORMATION ON USAGE AND MAINTENANCE
INTENDED PATIENT POPULATION ....................................................................................68
INTENDED USER PROFILE .................................................................................................68
ENVIRONMENTAL CONDITIONS OF USE ..........................................................................68
STORAGE, USAGE PERIOD ................................................................................................68
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE ..................................68
ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATION...................69
ELECTRIC RATING...............................................................................................................69
SAFETY DESIGNATIONS PER IEC 60601-1 STANDARD ..................................................69
DIMENSIONS AND WEIGHT ................................................................................................69
OPERATION PRINCIPLE.....................................................................................................70
CHECKPOINTS FOR MAINTENANCE .................................................................................71
DISPOSAL .............................................................................................................................71
ELECTROMAGNETIC COMPATIBILITY...............................................................................72
REQUIREMENTS FOR THE EXTERNAL DEVICE...............................................................75
PATIENT'S ENVIRONMENT .................................................................................................76
REFERENCE
OPTIONAL ACCESSORIES..................................................................................................77
SHAPE OF PLUG ..................................................................................................................77
MAINTENANCE
MAINTAINING ACCURACY ..................................................................................................78
PHOTOGRAPHING WINDOW.....................................................................................78
BRIGHTNESS ADJUSTMENT OF CONTROL PANEL................................................78

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DAILY CHECKUPS................................................................................................................78
DAILY MAINTENANCE ................................................................................................78
ORDERING CONSUMABLE ITEMS ............................................................................78
USER MAINTENANCE ITEM .......................................................................................79
MANUFACTURER MAINTENANCE ITEMS ................................................................79
PRINTER PAPER JAM.................................................................................................80
SUPPLYING THE CHINREST TISSUE........................................................................81
MAINTENANCE.....................................................................................................................82
CLEANING THE INSTRUMENT...................................................................................82
CLEANING THE PHOTOGRAPHING WINDOW GLASS ............................................82
CLEANING THE COVER .............................................................................................83
CLEANING THE CONTROL PANEL............................................................................83
CLEANING THE FOREHEAD REST AND CHIN REST...............................................83
SP-1P SOFTWARE LICENSE TERMS ....................................................................................84

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GENERAL SAFETY INFORMATION
WARNINGS
Ensuring the Safety of Patients and Operators
When operating the instrument, do not touch the patient's eye or nose.
Handling the cord on this product or cords associated with accessories sold with this product, will expose you to
lead, a chemical known to the State of California to cause birth detects or other reproductive harm. Wash hands
after handling.
Preventing Electric Shocks and Fires
To avoid fire and electric shock, install the instrument in a dry place free of water and other liquids.
To avoid fire and electric shock, do not put cups or other containers with liquids near the instrument.
To avoid electric shocks, do not insert metal objects into the instrument body through the vent holes or gaps.
To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch " " and discon-
nect the power plug from the outlet if you see smoke coming from the instrument, etc. Don't install the instrument
where it is difficult to disconnect the power plug from the outlet. Ask your dealer for service.

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CAUTIONS
Ensuring the Safety of Patients and Operators
To avoid injury when operating the up/down button for the chinrest, be careful not to catch the patient's fingers.
The light emitted from this instrument involves potential risk; the longer the irradiation time, the more risk of dam-
age to the eye.
When the instrument operates with the maximum light volume, exposure for more than 2 hours will exceed the
safety guideline.
If a symptom of photosensitive epilepsy appears in a patient during photography, please stop photography imme-
diately.
Preventing Electric Shocks and Fires
To avoid injury by electric shock, do not open the cover. For repair, call your service engineer.
Electromagnetic Compatibility (EMC)
This instrument has been tested (with 100/120/230V) and found to comply with IEC60601-1-2:Ed.3.0:2007. This
instrument radiates radio frequency energy within standard and may affect other devices in the vicinity. If you
have discovered that turning on/off the instrument affects other devices, we recommend you change its position,
keep a proper distance from other devices, or plug it into a different outlet. Please consult your authorized dealer
if you have any additional questions.

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HOW TO READ THIS MANUAL
• Read the instructions on pages 1 to 10 before using the machine.
• Regarding connection to various devices, see "CONNECTING EXTERNAL I/O TERMINALS" on
page 29.
• If you would like an overview of the system, begin by reading "BASIC OPERATIONS"(page 34).
• For setting various functions, see "SETTING FUNCTIONS ON SETUP SCREEN" on page 55.
GENERAL MAINTENANCE INFORMATION
USER MAINTENANCE
To maintain the safety and performance of the equipment, never attempt to repair or perform maintenance.
These tasks should be performed by an authorized service representative.
Maintenance tasks that can be performed by the user are as follows; for details, follow the manual’s instruc-
tions.
CLEANING OF PHOTOGRAPHING WINDOW
For details, See "CLEANING THE PHOTOGRAPHING WINDOW GLASS" on page 82.
DISCLAIMERS
• TOPCON is not responsible for damage due to fire, earthquakes, actions or inactions of third persons or other
accidents, or damage due to negligence and misuse by the user and any use under unusual conditions.
• TOPCON is not responsible for damage derived from inability to properly use this equipment, such as loss of
business profits and suspension of business.
• TOPCON is not responsible for damage caused by operations other than those described in this User Manual.
• The device does not provide a diagnosis of any condition or lack thereof or any recommendations for appropri-
ate treatment. The relevant healthcare provider is fully responsible for all diagnosis and treatment decisions
and recommendations.

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DISPLAYS AND SYMBOLS FOR SAFE USE
In order to encourage the safe use of the instrument and to avoid danger to the operator and others as well as dam-
age to properties, warnings are described in the User Manual and marked on the instrument body.
We suggest you thoroughly understand the meaning of the following displays/icons and Safety Cautions, as well as
read the Manual, and strictly observe the instructions.
DISPLAYS
SYMBOLS
DISPLAY MEANING
WARNING A WARNING is provided to alert the user to potential serious outcomes
(death, injury, or serious adverse events) to the patient or the user.
CAUTION
A CAUTION is provided to alert the user to use special care necessary
for the safe and effective use of the device. They may include actions to
be taken to avoid effects on patients or users that may not be potentially
life threatening or result in serious injury, but about which the user
should be aware. Cautions are also provided to alert the user to
adverse effects on this device of use or misuse and the care necessary
to avoid such effects.
NOTES A NOTE is provided when additional general information is applicable.
Symbol IEC/ISO Publication Description Description (French)
IEC 60417-5032 Alternating Current Courant alternatif
IEC 60417-5008 Off (power: disconnection
from the main power supply)
Éteint (courant: coupure avec le
secteur)
IEC 60417-5007 On (power: connection to
the main power supply)
Allumé (courant: raccordement
sur le secteur)
IEC 60878-02-02 Type B applied part Partie appliquée du Type B
ISO 7010-W001 General warning sign Symbole d'avertissement général
ISO 7010-M002 Refer to instruction manual/
booklet Voir le manuel/la brochure
ISO 7000-2497 Date of manufacture Date de fabrication
ISO 7000-2498 Serial number Numéro de série

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POSITIONS OF WARNING AND CAUTION INDICATIONS
To secure safety, this equipment provides warnings.
Correctly use the equipment following these warning instructions. If any of the following marking labels are missing,
please contact your dealer or TOPCON at the address stated on the back cover.
No. Label Meaning
1
WARNING
To avoid injury caused by electric shock, do not open the cover.
Ask your dealer for service.
2
CAUTION
Be careful not to hit the patient's eyes or nose with the instrument during operation.
The patient may be injured.
3
CAUTION
When operating the chinrest up/down switch, be careful not to pinch the patient's
hand.
The patient may be injured.
4Degree of protection against electric shock:
TYPE B APPLIED PART
2 1 4
3

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COMPONENTS
COMPONENTS
COMPONENT NAMES
COMPOSITION OF PARTS WHICH CONTACT THE HUMAN BODY
Forehead rest : Silicone rubber
Chinrest : Acrylonitrile butadiene styrene resin
Control panel
Photographing head
External I/O terminal cover
Main body Section
Power unit Section
Printer cover open switch
Printer cover
Forehead rest
Eye height mark
Chinrest tissue pin
Chinrest
Chinrest Section
Power inlet
*1
*1
*1: Contacting part (class B)
POWER switch
Photographing
window

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COMPONENTS
OPERATION METHOD OF CONTROL PANEL
The control panel is designed as a touch panel for performing various operations and settings.
It displays images and shows information, including set conditions and photographing results.
NOTE
• The control panel is a touch panel. Do not use any sharp tools; e.g. ball
point pen.
• Do not touch two points on a control panel simultaneously.
Tap To select any relevant item. Continue to press
Used for continuous moving.
(Moving of chinrest and
photographing head)
Touch the control panel softly with a fin-
ger.
Continue to touch the screen softly with
a finger.
Drag Under manual alignment.
Touch and move on screen softly with a
finger.
001081
001081
001081

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COMPONENTS
CONTROL PANEL COMPONENTS
PATIENT SCREEN (DICOM WORK LIST)
Patient ID input change button.............A patient screen is switched to ID input.
Work list ...........................The work list which is gained by DICOM MWM (Modality
Work list Management) server is shown.
List update button.................................Select this list to select a patient.
Operator ID........................................When Fixed operator ID is off, the button is tapped and
patient screen appears waiting operator ID input.
Settings button .......................................Displays the Setup screen.
Scroll bar ................................................When there are many work lists, the following hidden list is
displayed.
Next button .............................................Patient selecting is complete and moves to photography set-
ting screen is set.
Settings button
List update button
Work list
Scroll bar
Next button
Operator ID
Patient ID input change button

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COMPONENTS
PATIENT SCREEN (ID INPUT)
Patient list button.......................................Displays the Patient screen (DICOM work list).
This button displays when the setting in the Setup screen is
ON in "Use DICOM" of "NETWORK SETTINGS". (P.61)
Caps Lock button........................................The letters on software keyboard changes Capital/small.
Settings button ........................................Displays the Setup screen.
Ten key changeover button.........................Layout of software keyboard changes QWERTY/Ten key.
Next button ............................................Patient selecting is complete and photography setting screen
is set.
Query patient button..............................Query the inputted patient in the DICOM work list. This button
displays when the setting in the Setup screen is ON in "Use
DICOM" of "NETWORK SETTINGS". (P.61)
Caps Lock button
Ten key changeover button
Next button
Settings button
Operator ID
Query patient button
Patient list button

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COMPONENTS
HOW TO INPUT A PATIENT ID
1Tap the on the control panel.
Patient ID input screen is selected.
2Tap the input window of patient ID to change the frame color to orange.
3Enter the Patient ID tapping the .
4If you need to input numeral by ten-key, ten-key input screen appears by tapping the
.
Input in same manner above 2-3.
Patient ID input change button
Input window
Input button
Input button
Ten key changeover button
Input button
Input window

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COMPONENTS
5Tap the to return to the capture screen, check that patient ID is updated.
Next button
1081

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COMPONENTS
PHOTOGRAPHY SETTING SCREEN
CENTER button ..............................Centering photography is set.
Panorama button.............................Panorama photography that is to photograph 3 points around
the center is set.
Multi points button...........................Multi points photography that is to photograph specified cir-
cumference position is set.
OD(R) button...................................Photographs right eye only in the selected photography
point. If selection is complete, moves to capture screen.
OU(R/L) button................................Photographs two eyes (R/L) in the selected photography
point. If selection is complete, moves to capture screen.
OS(L) button....................................Photographs left eye only in the selected photography point.
If selection is complete, moves to capture screen.
• When Multi points button is selected, selecting one of OD(R) button, OU(R/L) button or
OS(L) button moves to photographing position selecting screen.
OD(R) button
CENTER button
Panorama button
Multi points button
OU(R/L) button OS(L) button
Photography point
setting button
Button to select patient's
eye

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COMPONENTS
PHOTOGRAPHING POSITION (SHOWING POSITION OF FFIXATION TARGET) SELECTING SCREEN
When Multi point button is selected in photography point, photographing position selecting screen is
shown. Photographing position is determined here.
Selecting position display....................................The position to be photographed is selected.
Settings button ......................................Displays Setup screen.
Return button ........................................What has been entered is abandoned returns to patient
screen.
Next button ............................................The position selected is determined, moves to capture
screen. (If no position is selected, the next button is not dis-
played.)
• Operation on photographing position selecting screen.
Tap the button for the position to be photographed. Selected position is colored in orange.
• The fixation target is lighted on diagonal location for selecting the desired position.
R L R L
Return button
Selecting position display
Next button
Settings button
R L R L