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 measurement 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.
1
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.
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 disconnect 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.
6
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 immediately.
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.
7
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 instructions.
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 appropriate treatment. The relevant healthcare provider is fully responsible for all diagnosis and treatment decisions
and recommendations.
8
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 damage 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
DISPLAYMEANING
A WARNING is provided to alert the user to potential serious outcomes
WARNING
CAUTION
(death, injury, or serious adverse events) to the patient or the user.
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.
IEC 60417-5032Alternating CurrentCourant alternatif
IEC 60417-5008
IEC 60417-5007
IEC 60878-02-02Type B applied partPartie appliquée du Type B
ISO 7010-W001General warning signSymbole d'avertissement général
ISO 7010-M002
A NOTE is provided when additional general information is applicable.
Off (power: disconnection
from the main power supply)
On (power: connection to
the main power supply)
Refer to instruction manual/
booklet
Éteint (courant: coupure avec le
secteur)
Allumé (courant: raccordement
sur le secteur)
Voir le manuel/la brochure
ISO 7000-2497Date of manufactureDate de fabrication
ISO 7000-2498Serial numberNuméro de série
9
POSITIONS OF WARNING AND CAUTION INDICATIONS
214
3
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.LabelMeaning
WARNING
1
2
3
4
To avoid injury caused by electric shock, do not open the cover.
Ask your dealer for service.
CAUTION
Be careful not to hit the patient's eyes or nose with the instrument during operation.
The patient may be injured.
CAUTION
When operating the chinrest up/down switch, be careful not to pinch the patient's
hand.
The patient may be injured.
Degree of protection against electric shock:
TYPE B APPLIED PART
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.
• The control panel is a touch panel. Do not use any sharp tools; e.g. ball
NOTE
point pen.
• Do not touch two points on a control panel simultaneously.
Tap To select any relevant item.
001081
Touch the control panel softly with a finger.
Drag Under manual alignment.
Continue to press
Used for continuous moving.
(Moving of chinrest and
photographing head)
001081
Continue to touch the screen softly with
a finger.
12
COMPONENTS
Touch and move on screen softly with a
finger.
CONTROL PANEL COMPONENTS
Settings button
List update button
Work list
Scroll bar
Next button
Operator ID
Patient ID input change button
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.
13
COMPONENTS
PATIENT SCREEN (ID INPUT)
Caps Lock button
Ten key changeover button
Next button
Settings button
Operator ID
Query patient button
Patient list button
Patient list button.......................................Displays the Patient screen (DICOM work list).
Caps Lock button........................................The letters on software keyboard changes Capital/small.
Ten key changeover button.........................Layout of software keyboard changes QWERTY/Ten key.
This button displays when the setting in the Setup screen is
ON in "Use DICOM" of "NETWORK SETTINGS". (P.61)
Settings button ........................................Displays the Setup screen.
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)
14
COMPONENTS
HOW TO INPUT A PATIENT ID
Patient ID input change button
Input window
Input button
Input button
Ten key changeover button
Input button
Input window
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.
15
COMPONENTS
5Tap the to return to the capture screen, check that patient ID is updated.
Next button
1081
16
COMPONENTS
PHOTOGRAPHY SETTING SCREEN
OD(R) button
CENTER button
Panorama button
Multi points button
OU(R/L) buttonOS(L) button
Photography point
setting button
Button to select patient's
eye
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.
COMPONENTS
17
PHOTOGRAPHING POSITION (SHOWING POSITION OF FFIXATION TARGET) SELECTING SCREEN
Return button
Selecting position display
Next button
Settings button
RLRL
When Multi point button is selected in photography point, photographing position selecting screen is
shown. Photographing position is determined here.
RLRL
Selecting position display....................................The position to be photographed is selected.
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 displayed.)
• 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.
18
COMPONENTS
CAPUTER SCREEN
01
01
Please touch pupil
on the screen.
Ple ase touch p upil
on the screen.
Please touch pupil
on the screen.
Settings button
Up/down button for chinrest
OD button
OS button
Display
Forward/backward button
for photographing head
ID button
UNDER PHOTOGRAPHING
Device ID number
Photographing position display
(Right)
Photographing position/
number of photography
display (Right)
Photographing position display
(Left)
Operator ID
Patient No./Patient ID
Alignment mark
Return button
Photographing position/
number of photography
display (Left)
Emergency stop button
End button
Pleasetouchpupil
onthescreen.
The image to be observed is displayed operating the instrument to tell the state of setting or the
result of photography.
ID button...............................................Input the patient ID (up to 13 characters) and operator ID (up
OD button/OS button......................Select the right eye or left eye. The main body moves to
Up/down button for chinrest ............Moves the chinrest up/down.
Forward/backward button for photographing head.....Moves the photographing head closer to/
Settings button.......................................Displays the Settings screen.
Photographing position display .............The position selected is colored in orange. The position on
to 13 characters). However, if no patient ID is input, the
patient No. is allocated automatically.
Operator ID is not always shown according to the settings.
(See page 63 regarding on the settings)
selected direction by tapping this button. Selected eye is colored in orange. (OD: Right eye OS: Left eye) R/L display can
be reversed depending on the control panel position.
away from the patient's eye. Forward/backward movement
can be reversed depending on the control panel position.
which photography is complete is shown by white circle.
End button ............................................Move the chinrest and photographing head to the last posi-
tion.
Photographing position/number of photography display.....Displays contemporary Photographing
position selected and number of photographing.
Emergency stop button .....................Appears only when automatic operation is carried out. The
operation stops immediately.
COMPONENTS
19
PHOTOGRAPHING RESULT SCREEN
Corneal endothelium image
(basis image)
Analyzing image
Print/Output reservation mark
Corneal thickness
Cell density
Coefficient of variation
Frequency of hexagon cells
Anterior image
Date of photographing
Square-shaped distribution
graph
Area distribution graph
Number of cell analyzed
Minimum cell area
Maximum cell area
Average cell area
Standard deviation of cell
area
Function button
Photographing position tab
OD button/OS button
Photographing point display
Rephotographing button
Print/output reservation button
Overlay button
Print/output button
Manual editing button
Next button
FUNCTION BUTTON
20
COMPONENTS
Rephotographing button ....................Photographing the same position.(The screen changes for
Photographing.)
Print/output reservation button .................This is shown only when more than 2 times photographed on
the same position.
Data contemporarily displayed is set to print/output.
Print/output button.........................Printing/output carried out according to the settings.
Next button........................................If there are more than 2 positions to photograph, next button
is displayed instead of Print/output button until photography
for the last position is complete. Tapping next button return to
capture screen to photograph the next position.
Overlay button........................................Classifies the image to analyze in color according to the
number of cell's angle or cell area.
Manual editing button.............................Moves to the screen for manual editing.
MANUAL EDITING SCREEN
Scroll bar
Thumb nail display
Excluding button
Return button
Zoom button
Screen for editing the result of automatic cell analysis.
Thumb nail display ..............................................When the image is enlarged the enlarged area is shown. The
area is flamed in green.
Scroll bar.............................................................Uses to show the hidden list by dragging up and down.
Excluding button ......................................Exclude the cell specified form analysis while remains
boundary line of cell.
Zoom button ............................................Enlargement/reduction of image is done.
When enlarged, you can move the area to be displayed by
dragging corneal endothelium image.
Return button......................................What is edited is canceled returning to the screen for analyz-
ing result image.
21
COMPONENTS
THE CHECKING SCREEN IN THE MIDDLE OF PANORAMA PHOTOGRAPHY
Rephotographing button
Next button
Photographing result
Left sideRight side
Center
Photographing point display
OD button/OS button
This screen appears when panorama photography is carried out, where 3 images are combined and
photographing result of each position is checked.
RESULT SCREEN FOR PANORAMA PHOTOGRAPHY
Result screen after photographing 3 images in Panorama photography.
Button layout is same as that of normal photography result screen.
22
COMPONENTS
SETUP SCREEN
23
COMPONENTS
LIST OF PRINTING ITEMS SCREEN
Patient ID
TOPCON_TAROU
When more than 2 positions is photographed list of printing items is shown during print/output is carried.
After print/output is complete, the screen returns to patient screen automatically waiting next patient.
If the reliability is low, the character is displayed in yellow.
24
COMPONENTS
PRINTER OUTPUT
Barcode
Patient No.
Patient No.
(Patient ID when patient ID is input)
Device ID number
Operator ID
Cell density
Name entry column
Device ID number
Patient's eye
Measurement date
Photographing position
Number of cell analyzed
Minimum cell area
Maximum cell area
Average cell area
Standard deviation of cell area
Corneal endothelium image
Frequency of hexagon cells
Coefficient of variation
Corneal thickness
Input message
TOPCON logo mark
Low reliability mark
PRINTOUT OF SINGLE EYE PHOTOGRAPHED
OID:0123456
NAME
-SP01 0017-
2012_12_18
NO: 001081
OS(L)*
TOKO HOSPITAL
AM 11:00:53
POSCenter
CD
556
1490
CCT
CV
HEX
179
N
MIN
MAX583
AVG303
SD95
TOPCON
31
49
107
cells
/mm
%
%
cells
01
2
• As for the patient No., the result of the printing will differ depending on whether the patient
ID is inputted or not inputted.
Input :Patient ID is printed.
Not input :Patient No. (starts from 0001, automatically added +1 upon completion of
• If the reliability is low, low reliability mark(*) is outputted.
measurement) is printed.
25
COMPONENTS
PRINTOUT OF PANORAMA PHOTOGRAPHED
Barcode
Patient No.
Patient No.
(Patient ID when patient ID is input)
Device ID number
Operator ID
Cell density
Name entry column
Patient's eye
Measurement date
Number of cell analyzed
Minimum cell area
Maximum cell area
Average cell area
Standard deviation of cell area
Corneal endothelium image
Frequency of hexagon cells
Coefficient of variation
Corneal thickness
Input message
TOPCON logo mark
Device ID number
-SP01 0017-
OID:0123456
NAME
2012_12_18AM 11:00:53
NO: 001081
OD(R)
01
CCT
HEX
TOKO HOSPITAL
556
1490
CD
CV
31
49
179
N
MIN107
MAX583
AVG303
SD95
cells
/mm
%
cells
2
TOPCON
26
COMPONENTS
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