bon EM-2 Specification sheet

Specular Microscope EM-2
Instructions for Use and Maintenance

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GA Endothelmikroskop EM-2 Rev 0.3 220910 E.doc
PO Box 32 26
23581 Lübeck
Stellmacherstraße 14
D-23556 Lübeck
Phone: [phone]
Fax: [phone]
E-Mail: [e-mail]
Internet: www.bon.de
Sparkasse zu Lübeck
(Sort code 230 501 01) Acc.No. 1 014 885
Swift / BIC: NOLADE21SPL
IBAN: DE 2305 0101 0001 0148 85
Commerzbank Lübeck
(Sort code 230 400 22) Acc.No. 0 107 755
Postbank Hamburg
(Sort code 200 100 20) Acc.No. 409 22-204
bon Optic Vertriebsgesellschaft mbH – Managing Director: H. Jochen Kaber – HR Lübeck, HRB 3475 – VAT No. 161662634

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CONTENTS
1. INTRODUCTION ..........................................................................................................................................................4
2. GENERAL SAFETY PRECAUTIONS ........................................................................................................................4
3. BRIEF DESCRIPTION OF THE INSTRUMENT – USES........................................................................................5
3.1. ACCESSORIES.........................................................................................................................................................6
4. OPERATING CONDITIONS .......................................................................................................................................6
5. END-OF-LIFE DISPOSAL ENVIRONMENTAL CONSIDERATION ................................................................... 7
6. LEGEND .........................................................................................................................................................................8
7. INSTALLATION............................................................................................................................................................9
7.1. UNPACKAGE THE INSTRUMENT AND REASSEMBLING THE OPTICAL HEAD (23) ................................9
7.2. CONNECTING THE INSTRUMENT ......................................................................................................................9
7.3. PRECAUTIONS........................................................................................................................................................9
8. INSTRUCTIONS FOR USE........................................................................................................................................11
8.1. LAUNCHING THE SOFTWARE ..........................................................................................................................11
8.2. THE MAIN WINDOW ...........................................................................................................................................11
8.3. TOOLBAR BUTTONS SUMMARY......................................................................................................................12
8.4. SETTINGS ..............................................................................................................................................................12
8.4.1 LANGUAGE 12
8.4.2 GROUPS 13
8.4.3 MISCELLANEOUS 13
8.4.4 DICOM 14
8.5. Patient Management ................................................................................................................................................14
8.5.1 CREATING A NEW PATIENT 14
8.5.2 CREATING A NEW EXAMINATION 14
8.6 CAPTURE ................................................................................................................................................................15
8.6.1 CAPTURE WINDOW COMMANDS 15
8.7 ANONYMOUS CAPTURE .....................................................................................................................................17
8.8 CAPTURING CORNEAS WITH DIFFERENT THICKNESSES...........................................................................18
8.8.1 EXAMPLES 18
8.9 REMOTE CONTROL ..............................................................................................................................................20
8.10 THE REMOTE CONTROL KEY FUNCTIONS ...................................................................................................20
8.11 USING THE REMOTE CONTROL FOR IMAGE CAPTURE.............................................................................21
8.11.1 EXAMPLES 22
8.12 AUTOMATIC CELL COUNT...............................................................................................................................24
8.12.1 TOOLBAR BUTTONS AT THE TOP OF THE SCREEN 25
8.12.2 EDITING SELECTED CELLS 26
8.13 DELETING CELLS ...............................................................................................................................................26
8.14 EDITING IMAGE PARAMETERS.......................................................................................................................27
8.15 PROCESSING........................................................................................................................................................28
8.16 ANALYSIS RESULTS ..........................................................................................................................................29
8.17 COMPARISON ......................................................................................................................................................30
8.18 OVERALL COMPARISON OF ALL THE CORNEAL AREAS (Multifix).........................................................31
8.19 OPENING A PATIENT FILE IN THE ARCHIVE ...............................................................................................32
8.20 ADVANCED SEARCH .........................................................................................................................................32
8.21 PATIENT MENU OPTIONS .................................................................................................................................33
8.22 EXAMINATIONS MENU OPTIONS ...................................................................................................................33
8.23 IMAGES MENU OPTIONS ..................................................................................................................................33
8.24 PRINTING..............................................................................................................................................................34
8.25 DICOM...................................................................................................................................................................35

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9. OPERATING FEATURES .......................................................................................................................................... 37
10 ROUTINE MAINTENANCE ..................................................................................................................................... 38
10.1 REPLACING THE LINE FUSES ..........................................................................................................................38
10.2 REPLACING THE MONITOR FUSE ...................................................................................................................38
10.3 REPLACING THE HALOGEN (28) AND/OR FLASH (27) LAMP ....................................................................38
10.4 PROTECTING THE INSTRUMENT FROM DUST.............................................................................................39
11. TECHNICAL DESCRIPTION..................................................................................................................................40
11.1 CLASSIFICATION ACCORDING TO EN 60601 STANDARD .........................................................................40
11.2 FUNCTION BLOCK DIAGRAM..........................................................................................................................41
11.3 DATA PLATE SYMBOLS ....................................................................................................................................42
12. LIABILITY .................................................................................................................................................................43
13. WARRANTY AND TECHNICAL ASSISTANCE..................................................................................................43
14. CERTIFICATES / STATEMENTS OF COMPLIANCE ....................................................................................... 44
15. REFERENCE STANDARDS .................................................................................................................................... 45

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Monitor Socket Data Plate
Instrument Data Plate
1
1. . I IN NT TR RO OD DU UC CT TI IO ON N
Thank you for having purchased EM-2 by bon Optic
All bon Optic products are manufactured to rigorous safety standards. In
particular, the SP 01 specular microscope is a high-performance instrument. In
order to use it efficiently and in complete safety we recommend reading this
manual carefully before beginning installation and heeding all the safety
warnings provided herein and on the instrument labels. Even technicians who
have already used this type of instrument should verify their knowledge of the
instructions contained in this manual. Keep this manual near the instrument
for handy reference during use
2
2. . G GE EN NE ER RA AL L S SA AF FE ET TY Y P PR RE EC CA AU UT TI IO ON NS S
- Check that your line voltage is the same as that reported on the instrument
data plate. Should the values differ, contact your customer service or the
manufacturer (see INSTALLATION section). Your electrical system must
comply with CEI/IEC standards for electrical systems for medical use. In
case of doubt, contact your installation and maintenance service.
- Never use multiple plugs, adapters, or extension cords to connect the
instrument plug to the line socket.
- When unplugging the instrument from line power supply, even under
emergency conditions, grasp the plug and never the cord; never pull the
cord to disconnect the plug.
- Never touch the power cord with wet hands. Check frequently that the cord
is so placed as not to be stepped on or crushed by weights. Never knot the
cord.
- A damaged power cord can cause fires or electrical shocks. Check
frequently that the instrument power cord is in good condition. If it becomes
necessary to replace the power cord originally supplied with the instrument,
contact your supplier.
- Do not perform any repairs or maintenance work on the instrument or the
electrical system beyond what is explained in this manual.
- Do not use the instrument near water and be careful not to spill liquids on
any part of it. Avoid damp and dusty locations and locations subject to
brusque changes in temperature and humidity.
- Disconnect the instrument from the line power supply before cleaning
and/or disinfecting.
- The instrument neither generates nor receives electromagnetic
interference when used in proximity to other devices; no preventive or
corrective measures need therefore be taken.
- The standard version instrument contains non-medical accessories
(LCD monitor, keyboard, and mouse). The resulting system is tested
in accordance with international standards EN 60601-1 “Medical
Electrical Equipment. PART 1: General Requirements for Safety” and
EN 60601-1-1 “Collateral Standard: Safety Requirements for Medical
Electrical Systems” and is fully compliant with these standards. Note
that the standard version instrument can be connected to other

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instruments, medical electrical and not; bon Optic cannot test the
compliance of all possible system configurations
- Any additional accessories (printer, scanner, CD reader, etc..)
connected to the analog or digital interfaces must be certified in
accordance with the standards listed below:
For the United States of America:
UL 1950 for ITE devices.
UL 2601-1 for medical electrical devices.
For Europe:
EN 60950 for ITE devices.
EN 60601-1 for medical electrical devices;
- Once all the equipment making up the system has been connected
and assembled, check that the resulting medical electrical system
complies to the requirements set by EN 60601-1-1 “Collateral
Standard: Safety Requirements for Medical Electrical Systems.”
- Should the leakage current values exceed the limits set by standard
EN 60601-1-1, additional safety measures must be adopted as
suggested by the standard itself. In this case, we recommend
powering the entire system through a safety insulating transformer.
3
3. . B BR RI IE EF F D DE ES SC CR RI IP PT TI IO ON N O OF F T TH HE E I IN NS ST TR RU UM ME EN NT T – –
U
US SE ES S
The endothelium is the deep layer of the cornea, in a young subject about 5
micrometers in thickness and possessing about 300,000 hexagonal cells.
The endothelium is important for correct corneal function; for this reason,
analysis of the endothelium is of fundamental importance for diagnosis of the
health of the eye.
The most important characteristic of endothelial cells is their lack of reproductive
capacity; age, surgical treatment, and use of contact lenses are factor
influencing their quantity and form.
As already mentioned, the cells composing the endothelium, which are
hexagonal in children and younger people, do not reproduce and their form and
quantity influence the health of the cornea. At birth, the endothelium contains
about 4000 cells/mm
2
; with time, the number decreases and the structure of the
layer accordingly changes.
The bon Optic specular microscope permits obtaining electronic photographs of
the patient’s endothelium with no instrument contact with the patient. The
acquired endothelium image can then be mathematically processed to display
clinically-useful endothelial parameters relative to the cells, including: cell
number and density, form, surface area, mean area, standard deviation,
coefficient of variation, percentage of cells of different forms, histogram of cell
area distribution, pachimetric datum.
The bon Optic specular microscope permits performing:
•Non-invasive examination of the endothelial tissue.
•Automatic focusing of the endothelial layer of the cornea.
Automatic search for cell borders and broad-based statistical analysis of the
data.
The bon Optic specular microscope is an indispensable aid in diagnosing
corneal health.

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It is extremely useful in pre- and post-transplant examinations, after cataract
surgery, and for analysis of trauma damage to the cornea.
Since the examinations performed with the bon Optic specular microscope are
totally non-invasive with no patient contact,:
•there is no risk of transmission of infectious diseases.
•the examination is absolutely painless and does not require use of any
local anesthetics.
The instrument is composed of:
the SPECULAR MICROSCOPE as such, designed and built by bon Optic, and
the user accessories listed below:
1. 15.1” LCD monitor (50 W max. power requirement);
2. Keyboard;
3. Mouse.
AUXILIARY and ACCESSORY DEVICES:
4. Commercially-available ink jet color printer compliant with
international standard EN 60950.
5. 230V-230V insulating transformer (leakage current limiter)
for use in operating rooms, compliant with international
safety standard EN 60742.
6. Wooden table top and motor-driven telescopic column
workstation, Schumo AG brand, a medical electrical device
compliant with international standard EN 60601-1,
purchased from bon Optic and not modified;
3.1. ACCESSORIES
The instrument is supplied complete with the accessories listed below.
- a protective cover
- one set of socket wrenches
- one package of chin rest papers
- two fuses
- this instruction manual.
4
4. . O OP PE ER RA AT TI IN NG G C CO ON ND DI IT TI IO ON NS S
As long as the specular microscope remains in its original packing it may be
exposed to the environmental conditions listed below, for a maximum of 15
weeks during shipping and warehousing, without suffering damage:
Temperature between -10 °C and +60 °C;
atmospheric pressure between 500 hPa and 1060 hPa;
relative humidity between 10% and 90%.
Ambient conditions for operation are:
Temperature between +15 °C and +30 °C;
atmospheric pressure between 700 hPa and 1060 hPa;
relative humidity between 30% and 75%.
Attention!
•Before examining any patient, clean the forehead rest and the chin rest
with a clean cloth. Before each examination, remove the top strip of paper from
the chin rest pack. If necessary, clean the forehead rest and the chin rest with
a cloth dampened with alcohol.

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5
5. . E EN ND D- -O OF F- -L LI IF FE E D DI IS SP PO OS SA AL L E EN NV VI IR RO ON NM ME EN NT TA AL L
C
CO ON NS SI ID DE ER RA AT TI IO ON N
The symbol in the margin indicates that the end-of-life instrument must not be
disposed of as normal waste. The various materials of which the instrument is
made, as well as the packing materials, must be separated for disposal by type
and in accordance with local laws and waste recycling regulations.
Dispose of the instrument and its packing in accordance with local regulations
governing disposal and recycling of the various different materials of which the
instrument is made.

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6
6. .
L
LE EG GE EN ND D
1. Chin rest height adjustment
knob.
2. LCD monitor.
3. Paper-holder pins on chin
rest.
4. Instrument computer ON
pushbutton.
5. Chin rest.
6. Optical unit.
7. Mouse.
8. Keyboard.
9. Instrument head assembly
screws.
10. Forehead rest.
11. Power socket with fuse holder
compartment and voltage
changer.
12. Main switch.
13. Data plate.
14. USB socket (printer
connector).
15. Monitor fuse 0.5A T.
16. Monitor connector socket.
17. Mouse connector socket.
18. Keyboard connector socket.
19. Monitor outlet socket data
plate.
20. Monitor power socket (max.
output 50W).
21. Optical unit lock screws (see
pag. 25).
22. Lamp door screws.
23. Optical head unit.
24. Optical head power
connector.
25. Firewire signal connector.
26. Lamp maintenance door (see
pag. 25).
27. Flash lamp (see pag. 25).
28. 12V 30W halogen projector
lamp (see pag. 25).
29. Antivibration plate.
30. Videocamera driver cable

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7
7. . I IN NS ST TA AL LL LA AT TI IO ON N
The instrument as supplied is packed for best withstanding standard
shipping and warehousing conditions. Should you notice defects
attributable to shipping when unpacking the instrument, contact your
installation service.
7.1. UNPACKAGE THE INSTRUMENT AND
REASSEMBLING THE OPTICAL HEAD (23)
For reasons of mechanical safety, the instrument is shipped with the
optical head disassembled and separately packed. Unpack the
instrument and proceed as described below to reassemble.
1) Loosen screws (9) and remove the optical head casing.
2) Take off the antivibration plate (29);
3) Connect the power cable (24) and the signal cable (25) to the
optical head.
4) Insert the optical head in the instrument and lock in place by
tightening the lock screws (21).
5) Reassemble the optical head casing and lock in place by
tightening screws (9).
Place the instrument on a stable surface close to the monitor and
keyboard to create an ergonomically-sound and comfortable
workstation layout.
No software installation is required since the necessary software is
pre-installed on the built-in instrument PC.
7.2. CONNECTING THE INSTRUMENT
Connect the instrument to the::
-monitor, using the VGA video cable (16) and the power cord
(20). Warning ! Maximum admissible monitor power is 50
W.
-keyboard (socket 18).
-mouse (socket 17).
-power supply. Before connecting, check the setting of the
voltage changer on the power socket (11), which must be set to
the voltage at which the instrument will be used. If necessary,
extract the relative cells and rotate until the correct voltage
value appears in the window.
-printer (if used), using the parallel port or USB socket (14)
(recommended).
7.3. PRECAUTIONS
Respect the precautions explained below for correct use of the
instrument.
 In order to guarantee that the instrument always operates
correctly, perform maintenance as described in this manual.
Before using the instrument, check that the fixation point and
the instrument flash system operate correctly.
 Take special care when examining children and subjects with

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occluded corneas. It may be impossible to acquire images of
the epithelium of the corneas of these subjects.
 Always check that the patient’s chin is correctly positioned on
the chin rest and his forehead is firmly placed against the
forehead rest.
 There are endothelia which could be acquired with a certain
difficulties, and can give ambiguous result. These can be:
irregular corneas, recently-treated patients (3-4 days), patients
suffering from keratoconus.
 Check that the patient’s eye is not obstructed by the lid or
lashes, and that there are no teardrops on the eye surface, lids,
or lashes. If necessary, help the patient open his eyelids fully or
dry his eyes before beginning examination.
 Acquisition is not possible if the patient is wearing contact
lenses or intra-ocular lenses.
The result analysis must be done by a medicine doctor specialist.

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8
8. . I IN NS ST TR RU UC CT TI IO ON NS S F FO OR R U US SE E
8.1. LAUNCHING THE SOFTWARE
All the software required for using the BON OPTIC specular microscope is pre-installed on the instrument’s
built-in computer. This PC does not support installation of other types of software. In order not to jeopardize
the instrument performance level and/or correct operation, do not install software for other uses on this PC.
Press button (4) to switch on the instrument. After the operating system has booted, double-click the
“ANKAA” desktop icon to launch the software.
Fig. 1 – Main wIndow
8.2. THE MAIN WINDOW
When the software is launched, the screen will
display the main window shown in figure 1.
Fig. 2 – Patient list
The top of the window contains some
commands which will be described below.
On the left is the LIST PATIENTS, which is
accessed by pressing the button.
With the button is emptied textbooks
patients.

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8.3. TOOLBAR BUTTONS SUMMARY
BUTTON KEYBOARD
SHORTCUT
ICON FUNCTION
Settings -
Opens the general settings and database settings
panel.
New Patient - Allows the user to create a new patient.
New Exam
- Allows the user to create a new examination.
Capture Space bar Accesses the CAPTURE screen.
Info -
Displays general information on software and
database versions.
Esc - Closes the program.
Open patient list
- Open the patient list
Empty patient list
-
Empty the patient list
Extended
examination
- Open window for extended examination
Fig. 3 – Main Window Commands
8.4. SETTINGS
Fig. 4 – Settings
To access system settings, empty the patients
list, if open, and then click .
In this section, the user may change:
- the language used by the software
- the pathology groups to be attributed to
the single examinations
- the database configurations
- the DICOM configurations.
8.4.1 LANGUAGE
The first screen allows the user to select the
language used by the software (Fig. 4).

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Fig. 5 - Groups
Fig. 6 - Miscellaneous
8.4.2 GROUPS
Select the GROUPS menu to manage the
pathology groups to be assigned to each
examination, distinguishing between right eye
and left eye (OD/OS) (Fig. 5).
Click the button to create a new group.
Click the button to edit a pre-existing
group.
The button allows the user to delete a
group.
This function is applicable only if the group
selected has not been matched with any
examination currently in the database.
8.4.3 MISCELLANEOUS
The MISCELLANEOUS menu is
composed of 4 sections:
Database
Click the button to select the
reference database file path,
phoenix.mdb.
Use the button to locate the file
path of the root.cso file, which indicates
the folder containing the images.
Patient Management
Select the (External)Patient ID issuer box
to automatically assign a new ID code
every time a patient is created.
It is also possible to obtain the code from
an external database, using the PMS
mode.
If the Patient ID box is deselected, it will be
possible to insert the ID code each time a
new patient is created.
Reminder
Selecting the four options in this section
enables display of alarm and confirmation
messages.
Performance
This section allows the user to select the
number of examinations displayed at any

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one time in the patients list. In the Figure 6
example: 100 examinations.
Fig. 7 – DICOM
8.4.4 DICOM
If the Suppress DICOM warnings
box is selected, the menus and alarm
messages referred to DICOM management
will not be displayed.
Deselecting this box allows the user to
manage the PACS and PMS configurations
needed for DICOM data transfer.
For explanations about DICOM, see the
relative section below.
Fig. 8 – Create new patient
8.5. Patient Management
8.5.1 CREATING A NEW PATIENT
To create a new patient, click the
icon (see Fig. 1).
The new patient personal data entry
window will open
(Fig. 8).
Type in the last name, first name, and date
of birth; indicate gender.
In the right-hand window, enter the
identification code if the Patient ID box has
been deselected (Figure 6).
Click OK after all the required personal
data has been entered.
8.5.2 CREATING A NEW
EXAMINATION
After a new patient is created, an
examination will be created automatically
and the capture screen will open.
To create an examination for a patient
already in the archive, select the patient
and click the button.
A new examination will be created and the
capture screen will open.

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8.6 CAPTURE
8.6.1 CAPTURE WINDOW COMMANDS
BUTTON
KEYBOARD
SHORTCUT
ICON FUNCTION
TK
-
Allows the user to select the correction to be applied for
different corneal thicknesses.
Sensitivity
-
Allows the user to select the video camera sensitivity
threshold (High, Normal, Low) for working with opaque,
normal, and highly reflective corneas, respectively.
FMC - Allows the user to enable the correct capture procedure for
corneas with very large curvature radiuses.
Capture Space Bar Enabled when the patient is correctly positioned. Allows the
user to capture the image.
Home Position
-
Returns the optical head to the “rest” position.
Esc Esc
Exits the capture window.
Follow the procedure outlined below to acquire an image. Position the patient’s chin on the chin rest. The
chin rest automatically detects correct placement for right eye (OD) or left eye (OS) capture.
Left eye capture
Position the patient’s head on the RIGHT SIDE of the chin
rest; check that the patient’s forehead rests correctly on the
forehead rest. If the patient is correctly positioned the
reflection of the cornea will fall within the green square.
The capture mode is automatic.
Fig. 9 – Incorrect patient positioning
Right eye capture
Position the patient’s head on the LEFT SIDE
of the chin rest; check that the patient’s
forehead rests correctly on the forehead rest. If
the patient is correctly positioned the reflection
of the cornea will fall within the green square.
Select the patient and click the icon to
create a new examination and access the
capture screen. If the patient has not been
closed, capture may continue using the same
examination. In this case the “new exam” icon
will be replaced by the icon.
A green square delimiting the instrument
scanning quadrant, with a center cross-hair,
will appear.
In the LIVE mode, the instrument positions
itself to capture the endothelium in the central
corneal area. To capture the endothelium in a
peripheral area, click the icon of the desired
area:

Page 16 of 45
Fig.10 – Correct patient positioning
Now position the patient’s head on the right
side of the chin rest to capture the left eye or,
vice-versa, on the left side to capture the right
eye.
Check that the patient’s chin is solidly
positioned on the chin rest and the forehead on
the forehead rest.
If the patient is not correctly positioned, the
reflection will fall outside of the green square
and the icon will be disabled Fig. 9. Move
the patient’s head, if necessary changing chin
rest elevation, until the reflection of the eye
falls within the scanning quadrant as shown in
Fig. 10.
Ensure that the patient always looks directly at
the fixation point inside the instrument and
does not close the eye during the examination.
The reflection of the eye in the scanning
quadrant must be in focus. Use the and 
keyboard arrows to optimize focus.
To start the examination, click the capture
button or press the SPACE BAR. The
instrument will automatically capture the image
of the endothelium and, at the end of this
operation, display it in the gallery. The preview
will be visible in the foreground with the ruler at
the top.
(Fig. 11)

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Fig. 11 – Gallery image
To view the preview of another image, simply
select it.
Double-click the gallery image to proceed with
processing.
8.7 ANONYMOUS CAPTURE
This new capture mode permits capturing and
processing an image without attributing it to any
patient.
To access this mode, empty the patients list
and click the toolbar button.
Following capture, the instrument automatically
accesses the processing screen. Fig.12
Fig. 12 – Anonymous capture
It is always possible to create a new patient to
which to assign the image After processing has
been completed and any operations of interest
have been carried out. Simply click the
button to open the “create new patient”
screen. After the data has been saved, the
patient will be visible in the gallery.

Page 18 of 45
Fig. 13 – Corrections menu
8.8 CAPTURING CORNEAS
WITH DIFFERENT
THICKNESSES
A new cursor has been added to regulate the
quality of capture of corneas with differing
thicknesses. This cursor contains various
values from -5 to +5 with a default 0 position at
the center. In general, if the patient is correctly
positioned and the cornea is normal, the cursor
may be left in the 0 position.
The effect produced by thicker-than-normal
corneas is to yield images that are not perfectly
in focus on the left-hand side. In this case,
move the cursor to the positive values to obtain
images in better focus.
The effect produced by thinner-than-normal
corneas is to yield images that are not perfectly
in focus on the right-hand side. In this case,
move the cursor to the negative values to
improve capture.
8.8.1 EXAMPLES
Fig. 14 – Focused image
To aid in understanding the correct correction
value to be used, an indicative scale is
displayed over the preview image.
In order for the pachymetric datum supplied by
the instrument to be reliable, the image must
be perfectly focused and the left edge of the
captured image must correspond to the “0”
value on the scale at the top of the screen
(Figure 14).

Page 19 of 45
Fig. 15 – Positive correction
If the left edge of the image corresponds to a
positive value, repeat capture after setting the
cursor to the corresponding scale value. In the
example (Figure 15), repeat the capture with
the thickness value set to “+2.”
Fig. 16 – Negative correction
If the left edge of the image corresponds to a
negative value, repeat capture after setting the
cursor to the corresponding scale value. In the
example (Figure 16), repeat the capture with
the thickness value set to “-1.”