Labomed STELLA User manual

To ensure proper use of this instrument as well as to avoid injury while operating instrument,
Understanding this manual completely before use is highly recommended.
User Manual
STELLA
Ophthalmic Microscope
Part No: 6219100-795
Issue 1.0
July,2021

Stella
TABLE OF CONTENTS
1. INTRODUCTION
2. TARGET GROUP
3. FIELD OF USE
4. SAFETY COMPLIANCES AND STANDARDS
5. SAFETY AND LEGAL NOTES
6. KEY NOTES FOR USER
7. SAFE USE OFFUNDUS IMAGING SYSTEM
8. NOTES ON PHOTOTOXIC & RADIATION SAFETY
9. WARNING AND LABELS
10. DESCRIPTION OF PARTS
11. SYSTEM DIAGRAM
12. UNPACKING
13. INSTALLATION
14 . WIRING CODING DIAGRAM
15. CONTROL AND FUNCTIONS
16.USE OF MICROSCOPE
i SETTING UP OF MICROSCOPE
ii SETTING UP OF MAGNIFICATION PERFOCALITY AND PARCENTERATION
iii DEPTH OF FOCUS ADJUSTMENT
iv USE OF RED REFLEX
v USE OF ACCESSORIES
vi USE OF FUNDUS IMAGING SYSTEM
vii RECOMMENDATION OF SAFE USE OF MICROSCOPE
viii EMERGENCY USE OF MICROSCOPE
17. CHANGING THE OBJECTIVE & EYEPIECES
18. REPLACING THE POWER SUPPLY
19.FUSE REPLACEMENT
20. THERMAL CUT OFF
21.TENSION ADJUSTMENT
22. MOVING POSITION
23. CLEANING AND DISINFECTION
24. AMBIENT REQUIREMENT
25. CARE & MAINTENANCE
26. TROUBLESHOOTING TABLE
27. DISPOSALS
28. SPECIFICATION
29. GUIDANCE TABLES
30. DIMENSIONS
31. GLOSSARY
32. WARRANTY
1
2
3
4
5-7
8-10
11
12-13
14-16
17
18
19
20-23
24
25-29
30-32
33
33
33
34
34
35
36
36
37-38
39-40
41
42
43-46
47
48
49

1. INTRODUCTION
Stella
The LABOMED STELLA is an ophthalmic and diagnostic microscope, which is adaptable for different
Surgical needs for consistent visualization during all intra operative phases of ophthalmic surgeries by
providing a magnified view of the surgical field without compromise to performance.
The microscope provides extremely high optical image quality, good depth of focus and wide field of view
for precise surgery. Illumination control, inbuilt tilt, adjustment of the observation head help
to reduce the surgeon’s work fatigue and allow comfortable use over long period.
Salient features of this Microscope are:
• IR & UV safe, high Intensity cold light (50 W LED )using fibre light guide system.
• An advanced motorized magnification changer allows hand free change in magnification.
• Dual Iris Diaphragm for depth management valuable for photography and retina surgery.
• Integrated swing in retina protection mechanism and blue blocking filter for retina safety during
surgery.
• The 0-210° tiltable observation head can easily be positioned with the help of suspension arm.
• Excellent Red reflex.
• The illumination is adjustable to its most suitable brightness using intensity control knob suitably
located at the suspension arm, and is easily approachable to the surgeon.
• When the microscope is not in use, the suspension arm can be folded over the main body to
store it compactly.
• Rigid Star type base rotatable with column together provides greater stability as well as mobility to
the instrument.
• In Built tiltable Mechanism to enable indirect illumination.
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2.TARGET GROUP
This user manual is intended for physicians, nurses and other medical staff who prepare, operate or main-
tain the system after the appropriate training and in accordance with the instructions given in this
manual. It is the duty of the customer or institution operating the system to trainand instruct all staff
using the system.
Installation and service work not described in this manual must only be performed by specialists from
LABOMED.
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3.FIELD OF USE
INTENDED USE
STELLA is a surgical microscope intended for the illumination and magnification of the surgical
area and for the support of visualization During surgical procedures in the field of ophthalmology.
NORMAL USE
In line with the intended use, the system can be used for surgical procedures on both the anterior
segment of the eye (e.g. cataract, cornea, glaucoma) and the posterior segment of the eye
(retina, vitreous).
The system-integrated illumination provides an optimum red reflex and delivers a sharply defined,
high-contrast image of the patient's eye. The foot control panel ensure maximum operating
comfort for the surgeon who can configure all settings required to meet his/her specific needs. The
integrated tilting mechanism , retina protection device and depth management system expand the
surgeon's scope of work. After completion of the surgical procedure, the system should be cleaned
and reset to original function to ensure an optimum starting position for the next surgery.
The system can be supplemented by various accessories and can be prepared for sterile use by attaching
resterilizable caps, hand grips and drapes.
The system is intended for use in offices, hospitals or other human medicine institutions. For disposal,
please observe the instructions in this manual as well as the applicable legal regulations in your country.
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4. SAFETY COMPLIANCES AND STANDARDS
SAFETY
The instrument described in this manual has been developed and tested in accordance with
national and international regulations. A high degree on Instrument safety is thus ensured.
Additional safety notes are also contained in other parts of this user’s manual; marked with a warning
triangle containing an exclamation mark as shown here . Please pay special attention to these
safety notes.
Safety is only ensures when this instrument is operated properly. Please read this manual
carefully before turning the instrument on. Also read thorough the user’s manuals on the other
equipment used with this instrument.
DIRECTIVES AND STANDARDS
• MDR 2017/745 Annex IX and Rule 13
• Directives 93/42/EEC, Articles II, Section 5, Annex VII.
• IEC 60601-1-3.1 edition (2012)
• IEC 60601-1-2-4th edition (2014)
• EN 55011:2016
. ISO 14971-2019
. ISO 13485:2015
. ISO 10936-1
. ISO 10936-2
. ISO 15004-1
. ISO 15004-2
. ANSI Z80.36-2016
CLASSIFICATIONS
• For Europe, per MDR 2017/745, the unit is a Class I instrument, per rule 13, Annex IX.
• For the United States, the FDA classification is Class I.
• Please observe all applicable accident prevention regulations
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FOR SAFE WORKING ORDER
• Only trained personnel are allowed to use this instrument. Training to the operator is the
responsibility of the customer or institution.
• Always keep this user manual at a place easily accessible at all times for the persons
operating this device.
• The internal circuitry of the instrument contains electrostatic sensitive devices (ESD) that may be
sensitive to static charges produced by the human body. Do not remove the covers without
taking proper ESD precautions.
• Do not use solvents or strong cleaning solutions on any part of this instrument to avoid damage to
the unit. see the care and maintenance section for detailed cleaning instructions.
• Portable and mobile RF communications equipment can affect medical electrical equipment.
• This instrument is not to be used near high-frequency emitting surgical equipment.
• Do not operate the equipment in:
- Areas having explosion or inflammability, risk the presence of inflammable anesthetics or
Volatile solvents such as alcohol, benzene or similar chemicals.
- Do not install, store or use the instrument in damp rooms, It is important and cautionary
To protect the instrument from being exposed to humidity, wet conditions, water splashes or
water sprays.
- Do not use the instrument if you notice any electrical arcing, sparks, abnormal noises,
smokes or fumes. Unplug it immediately and contact authorized LABOMED.
Ensure that the power point is properly grounded
If Voltage Fluctuation are more than 10% of rated voltage. Always ensure to use a Constant
Voltage stabilizer with this Instrument.
• Do not force cable connections. If the male and female parts do not readily connect.
Make sure that they are appropriate for one another. If any of the connectors are damaged,
have our service representative to repair them.
• Should you wish to use other accessories with this equipment, make sure that labomed has
certified its use.
• Do not pull at the light source cable, at the power cord or at other cable connections.
• Note the symbols and labels attached to the device!
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5. SAFETY AND LEGAL NOTES
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LEGAL REGULATIONS
• Observe the legal regulations for accident prevention and occupational health and safety
applicable in the country concerned.
• Modifications and repairs of this device or any equipment operated together with this device
may only be performed by Labomed or other persons authorized by Labomed.
• This system must not be modified without Labomed approval. If modified, suitable inspections
and testing must be completed to ensure that it can still be used safely.
• The manufacturer is not liable for damage caused by unauthorized persons tampering with
the system. Furthermore, this will forfeit any rights to claim under warranty.
TRANSPORT AND SERVICE
• The device shall only be transported over long distances (e.g. move, re- turning for repair
etc.) within its original packaging or in a special safe return packaging. For details, please contact
your authorized dealer or the Labomed.
• To ensure optimum performance and safe working order, it is recommended having it
checked as part of regular scheduled maintenance.
• In order to prevent any impairment of the device's safety due to age, wear, etc., the user
must ensure that the device is subjected to the necessary safety checks per section "Care
and Maintenance".
• Never attempt to forcefully connect any electrical connectors (plugs, sockets). If connection
is not readily possible, check whether the plug fits the socket. If any of the connectors are
damaged, approach Labomed or authorized service representative to repair them.
• If a failure occurs which you cannot correct with the aid of the chapter "troubleshooting
”, contact the Labomed.
• To cross over steps and edges, two persons are needed to jointly hold and lift the device:
Risk of tripping.
• Avoid collisions of any kind.
• Be extremely careful when moving over slopes.
• Do not park the stand on slopes.
OPTICS AND LIGHT
• Never directly look with binocular tube, object lens or an eyepiece into the sun.
• Never directly look into the light source, e.g. a microscope object lens to avoid phototoxic damages to
the eyes.
Stella
SAFETY AND LEGAL NOTES (continued)
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• Start with the lowest brightness and slowly increase it to the required but not more than the
allowed brightness.
• With increasing age of the light source, the actual illumination intensity delivered at the
respective setting decreases (this is a normal property of the system).
• The device is equipped with temperature monitoring for the LED light source. If the
temperature is too high, the light source switches off automatically. When the LED has
cooled down, the light source automatically switches on again. Therefore, constantly monitor
the system when the light source is switched on in order to prevent any phototoxic injury to
the patient's eye.
ACCESSORIES
• Any additional equipment connected to this medical electrical device must demonstrably
comply with the applicable standards and directives .In addition; all configurations must meet
the normative requirements per IEC 60601-1:2006.
• Please note that local legislation takes priority over the above-mentioned normative
requirements. If you have any questions, please contact LABOMED.
• Never attempt to forcefully connect any electrical connectors (plugs, sockets). If connection
is not readily possible, check whether the plug fits the socket. If any of the connectors are
damaged, contact Labomed.
• When mounting accessory equipment, please make sure that the admissible total weight of
the surgical microscope is not exceeded. (Refer label "Maximum load”)
• When mounting Non-Labomed equipment, make sure that sufficient free space is available
for focus positioning.
WARRANTY AND LIABILITY
• Warranty and liability depend on the applicable contractual stipulations.
LOSS OF WARRANTY
• The manufacturer is not liable for damage caused by unauthorized persons tampering with
the system. Furthermore, this will forfeit any rights to claim under warranty.
Stella
SAFETY AND LEGAL NOTES (continued)
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PRIOR TO THE VERY FIRST USE
• Every operator is advised to be thoroughly familiarized with the content of this user manual
before starting up the device to ensure correct use of this device.
• Labomed trained installation person or trained authorized representative of Labomed dealer
will install the system. Please make sure that the following requirements continue to be met
for further operation:
• The connecting components have been properly connected. The screw connections have
been firmly tightened.
• The device is connected with the power cord supplied. The power cord being used is the
one designed for use with this system.
• When using drapes for the surgical microscope, make sure to remove the protective cover
from the drape window below the objective lens.
• The main plug shall only be connected to a socket with a faultless protective ground conductor.
BEFORE EVERY USE
• Always use the device within the scope of its intended use.
• When adding accessories and/or components please ensure the permissible total weight of
the device is not exceeded (Refer label "Maximum load”)
• Adjust gas cylinder torque to compensate for any added weight if any; this will enable the
surgical microscope to maintain its balance in all positions of the working range.
• Before every use, limit the stroke of the suspension arm to prevent any contact with the
patient if the surgical microscope is lowered accidentally.
• Position the instrument in such a way that you can move it away from the patient at any time.
• When connecting accessories, make sure that sufficient free space is provided and that the
surgical microscope does not touch the patient.
• Before using a fundus viewing system, make sure that the room for movement is larger than
the downward travel path of the microscope.
• To prevent accessories from falling down, check before every use that accessories are
securely locked in position and securing screws are firmly tightened.
• Check that the movement of the surgical microscope is unobstructed to avoid any collisions
and damage to cables.
• When mounting non-Labomed equipment, make sure that sufficient free space is available
for focus positioning.
6.KEY NOTES FOR USER
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• Have an OR illuminator or Endo-illuminator ready during every procedure.
• Before every use, check the filter settings in order to prevent phototoxic injury to the patient's eye.
• Depending on the type of application, take appropriate precautions to ensure that the
surgical procedure or treatment can still be completed even if the full functionality of this
microscope (e.g. illumination) is not available.
• If you operate the device in a sterile area, make sure that you use the corresponding sterile accesso-
ries for the device.
• Make sure that the operating staff is briefed about sterile use of the system.
• Ensure that heat sink openings are free from dirt and are not covered.
• Make sure that all symbols and labels on the instrument are legible and understood by
operators.
• Secure the system in position by pressing all of the locking tabs on the castors to prevent the
stand from rolling away inadvertently.
• When mounting accessories (e.g. fundus viewing systems) on the system, make sure that
sufficient free space is available for focus positioning and that the surgical microscope
cannot touch the patient.
DURING USE
• Only use the system after it has been properly balanced.
• Never operate the system unattended.
• Excessive radiation exposure times may lead to retinal injury in the patient's eye. Never
leave a system unattended when the light source has been activated.
• Never directly look into the light source, e.g. a microscope object lens or a light guide to
avoid phototoxic damages to the eyes.
• Never leave a device unattended with the light source still switched on.
• In order to prevent phototoxic damages to the patient's eye, reduce the brightness and the
light exposure of the surgical area to an amount that is absolutely necessary for the surgery.
• Phototoxic effect of light beams. When operating on the eye, always use the retina protection
filter (blue barrier filter) installed in the light source to ensure that the patient’s eye is not
exposed to unnecessary (blue) radiation.
• Adjust the illumination intensity by using the potentiometer.
KEY NOTES FOR USER (continued)
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• Defective or unidentified accessories may lead to increased leakage current on the system
and injure the patient. Never connect any defective or unidentified accessories and never
touch the power outlet or video interfaces while in contact with the patient.
• If you have mounted the fundus viewing system on the underside of the microscope and
steeply tilt the microscope, the fundus viewing system may unintentionally move in and injure
the patient. Remove the fundus viewing system before steeply tilting the microscope.
• Malfunctions in the motor's electronic system may cause the main functions to fail (XY
movement, focus, zoom) and affect other functions. Use manual mode.
• In the event that the focusing function can no longer be controlled via the foot control panel,
use the suspension arm to focus the surgical field. This may lead to patient injury or
damaging attached equipment. Ensure to provide sufficient clearance between equipment
and patient (min. 50 mm) when focusing manually. Ensure that any accessories installed do
not come into contact with other objects.
• In the event that the X-Y movement of the surgical microscope can no longer be controlled
via the foot control panel, position the device manually via the suspension arm. Again, you
should ensure to provide sufficient clearance between equipment and patient (min. 50 mm).
• If a failure occurs which you cannot correct with the aid of the section “troubleshooting”,
contact Labomed.
• Do not pull at the power cord or the foot control panel cable.
• Always switch off the system
- Before disconnecting it from / connecting it to line power
- If it will not be used for a prolonged period of time
- Or for cleaning purposes.
AFTER EVERY USE
• Always use the master switch to turn off the device if it is not in use.
• Insufficient, incorrect or wrong cleaning or disinfection contrary to the directions in this user
manual may expose the patient or medical staff to a considerable risk of infection. For more
information, please refer section "Care and maintenance".
• lock all four castors to secure the floor stand in position. Make sure that the floor stand is
stable and cannot roll away.
•Insufficient, incorrect or wrong cleaning or disinfection not complying with this user manual can
expose the patient or medical staff to a considerable risk of infection.
KEY NOTES FOR USER (continued)
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When using a fundus imaging system (e.g. Merlin from Volk company) which is usually installed between
the surgical microscope and the patient, make sure that the patient is neither put at risk
nor injured by the motorized focusing system or the movement of the stand arm.
Only use accessories expressly certified by the labomed for combination with the surgical microscope
described in this manual.
Caution!
• With the fundus imaging system swung out of position, always position the microscope body in such
a way that reffering figure 1 index arrow (A) of the microscope arm is in the middle of two triangles marked
as (B).
• Select a medium magnification (e.g. 1.0).
• Lower the surgical microscope towards the surgical field until you see
the patient's cornea sharply
defined.
• Turn the screw for limiting the downward movement clockwise
as far as it will go.
• It is vital that you read the user’s manual on the fundus imaging system
(e.g. Merlin from the company Volk).
.
7.SAFE USE OF FUNDUS IMAGING SYSTEM(E.G.MARLIN)
Fig 1
A
B
A
B
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General
Several papers have been published dealing with the problems of phototoxicity during eye surgery. A
comprehensive review of these publications reveals following five aspects of particular concern:
– Illumination characteristics (spectral composition)
– Intensity of illumination
– Angle of illumination
– Focus of the light source
– Exposure time to light
All these aspects are explained in following with a brief description, how LABOMED, as a
manufacturer, makes allowance for them in Stella Microscope:
ILLUMINATION CHARACTERISTICS (SPECTRAL COMPOSITION)
• Studies on the exposure of the eye to light of varying spectral composition date back to the early
1950s. These studies suggest that the potential hazard of phototoxic injury to the patient's retina
can be reduced by blocking out the blue and ultraviolet light below a wavelength of 475 nm.
• For protection of the retina, LABOMED use UV and IR safe LED for illumination of eye in Stella
ophthalmic microscope and offers the swing-in blue block filter as standard feature of this
surgical microscope. This reduces not only the exposure of the patient's eye to light, but also
that of the surgeon's
• An important point to note here, however, is that the use of filters will inevitably change the
perceived color of the light. The surgeon may therefore initially have to get used to the changed
appearance of the anatomical structures.
INTENSITY OF ILLUMINATION
The majority of researchers suggest that the surgeon should use the lowest light intensity necessary
to guarantee good viewing during surgery.
Labomed has addressed this concern by providing a device for continuously varying the brightness
of the light source. This permits the surgeonto optimally adapt the light intensity at the patient's eye to
the conditions existing in each case.
ANGLE OF ILLUMINATION
A number of publications suggest that the microscope should be tilted to reduce the exposure of the
macula to direct illumination.
Labomed Stella surgical microscope therefore equipped with feature of tilting mechanism for the main
microscope to enable indirect illumination.
FOCUS OF THE LIGHT SOURCE
Studies show that injuries are likely to occur if the filament of the light source is imaged on the
patient's retina. The peak intensity of a direct filament is considerably higher than the peak intensity of
an even and extended light guide such as a fiber guide. This is the reason labomed use fiber optic
illumination in stella surgical microscope.
Stella
8.NOTES ON PHOTOTOXIC & RADIATION SAFETY
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EXPOSURE TIME TO LIGHT
According to some publications, the phakic or aphakic eye should not be exposed to the light source
longer than a few minutes. In every operation the exposure of the retina to light is dependent on the
type and duration of surgery and on any complications which occur. It is therefore recommended in
ophthalmic surgery to keep the light intensity as low as possible, or to use a device which prevents the
light from entering through the patient's pupil. Also, the surrounding light sources should not cause
additional strain to the patient's eye.
Labomed has taken care to this problem in the form of a swinging retinal protection device for insertion
into the beam path of the surgical microscope. This device ensures total eclipsing of the pupil, prevent-
ing light from entering into the patient's eye. It can be swung out when a red reflex is required.
IN CONCLUSION
Labomed recommends:
– Use of the blue blocking eye protection filter.
– Reduction of the illumination of the surgical area to the extent required for the patient's safety and for
microscopic visualization.
– Tilting of the microscope body as required.
– Insertion of the retinal protection device.
– Maximum reduction of the exposure of the patient's eye to light from surrounding light sources.
These measures should help the surgeon to reduce the likelihood of phototoxic retinal injury.
RADIATION EXPOSURE SEFTY
Looking into a light source through a tube, an objectve lens or an eyepieces may cause eye injury.
Neverlook into a light source or the sun with a tube,an objective lens or an eyepiece
When selecting the brightness level for the patient's eye, always take care to keep the strain on the
patient's eye to a minimum.
If the red reflex is not necessary, move the retinal protection device into the beam path. Only use the
retro-illumination contrast stop, if the surgical procedure requires a red reflex.
When operating on the eye, always use a retina protection filter to ensure that the patient's eye is not
exposed to unnecessary (blue) radiation (retinal injury).
Stella
NOTES ON PHOTOTOXIC & RADIATION SAFETY(continued)
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REF
9. WARNING AND LABELS
Caution
Observe all warnings labels and notes!
If any label is missing on your instrument or has become illegible,
please contact us or one of our authorized representatives.
We will supply the missing labels.
Instrument label plate
The instrument label plate indicates the following:
• Name of the unit
• Cat. No.
• Rated voltage and current consumption
• Rated frequency range
• Serial number
• Safety compliance
• Brand name
XYZ Coupling centering position/button
Brightness Control
After the illumination has been switched on, you can continuously adjust
the brightness of the fiber illumination by turning the appropriate knob.
Red & Green LED
LED light shown here at front of swivel arm, always glow “GREEN” during
working position of the instrument. This LED will glow “RED” when
suspension arm is parked at uppermost position, i.e. instrument is not in
working position. This is an indication to the user that he has to bring the
arm down to use it again to LED became green again. Please note that
at parking position, illumination LED will be off to save LED life but at the
same time fans will be in operating condition to keep the unit cool & safe.
Balance setting
Turn the screw to adjust the balance setting of the suspension arm.
Maximum load
When the surgical microscope are mounted on the suspension systems
the overall weight of the microscope including accessories and coupling
must not exceed a maximum value of 12kg. Please consult the user
manual for the suspension system about the admissible maximum load.
Accompanying Documents must be consulted
Catalog Number
Compliance to Medical Device Regulation MDR 2017/745
T
O
R
Q
U
E
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LABOMED
LABO AMERICA, INC.
920, Auburn Court
Fremont CA 94538 USA
www.laboamerica.com
Y
Part # ..................
R
IP X6
WARNING AND LABELS (continued)
Protective Earth
This Way Up-Indicates correct upright position of the transport
package.
Keep Dry- Transport package shall be kept away from rain.
The CE mark (an acronym for the French “Conformity Europeenne”)
Certifies that a product has met European Union Health, safety and
Environment requirements which ensure consumer safety
Manufacture Name
Fragile- Content of the transport package are fragile and therefore
shall be handled with care
IPX label for foot control switch
Microscope Magnichanger Tilt
Arm Lock
Suspetion Arm Limit Stop knob
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WARNING AND LABELS (continued)
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10. DESCRIPTION OF PARTS
Stella
3
2
11
516
10
7
1
6
9
4
812
13
14
21
15
25
17
18
19
20
1. Wheel with brake
2. Star Base
3. Monitor Mounting
4. Moving Handle
5. Locking Knob Column
6. Mesh Holder Fibre Cable
7. Locking Knob Suspension Arm
8. Lower limit stopper
9. Locking Knob Up and Down Arm
10. Locking Knob X-Y Coupling
11. Potentiometer
12. XYZ Assembly
13. Home Button XYZ
14. Microscope Carrier
15. Tilting Knob
16. Ergo Head
17. Eye Pieces
18. Lever Filter Change
19. Handle
20. Foot Switch
21. Safety Screw
22. Suspension Arm
23. Swivel Arm
24. Column Assembly
25. Z-Axis Assembly
22
23
24
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11. SYSTEM DIAGRAM
Stella
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BAYONET MOUNT
NIKON
CAMERA MOUNT DSLR
CANON/NIKON
VESA MOUNT
DOUBLE IRIS
DBS DSLR ADAPTER ASSISTOSCOPE
SBS SURGICAL
CMOS CAMERA
TILTBLE ERGO
HEAD (0-210°)
EYE PIECE 10X EYE PIECE 12.5X
CELL PHONE ADAPTER
FOOT SWITCH
BAYONET MOUNT
CANON
BAYONET MOUNT
CANON CMOS M10
CMO-200 CMO-175
CCD ATTACHMENT
CAMERA MOUNT
SONY
BAYONET MOUNT
LLECLASREVINU
TNUOMENOHP
SONY
)012-0(DAEHOGREELBATLIT
0