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