Opmi Proergo s7
Opmi Proergo s7
Opmi Proergo s7
S7 / OPMI® PROergo®
About This Manual These Instructions for Use are part of the delivery scope.
• Please read them carefully before using the device.
• Keep them at the site of use of the device.
• Store them for the entire service life of the device.
• Pass them on to any subsequent owner or user of the device.
Help with orientation – At the beginning of these Instructions for Use there is a summary of the
different sections; this provides an overview of all the topics.
– The contents of each chapter are specified in detail at the beginning of
each chapter.
– The index facilitates searching via keywords.
Scope The following Instructions for Use apply to OPMI PROergo with the following
suspension systems and identifications:
– S7 floor stand, reference number: 000000-1087-851
– S7 ceiling mount, rigid, reference number: 000000-1103-022
– S7 ceiling mount with lifting column, reference number: 000000-1226-405
– S7 wall mount with short arm, reference number: 000000-1193-109
– S7 wall mount with long arm, reference number: 000000-1254-579
– S7 Centro suspension system, reference number: 000000-1254-580
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be prevented.
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Safety measures
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Key to symbols
We would like to inform you of the safety aspects that must be observed
when handling this device. This chapter contains a summary of the most
important information concerning matters relevant to instrument safety.
Hazard symbols
The following safety information has been incorporated into the Instructions
for Use. Please note this information and be particularly careful in these cases.
WARNING Indicates a hazard which may lead to fatal injuries or severe injuries if
precautions are not followed.
CAUTION Indicates a hazard which may lead to moderately severe injuries if
precautions are not followed.
NOTE Indicates a hazard which may lead to minor injuries or property damage
if precautions are not followed.
Information symbols
The following information symbols are used in these Instructions for Use:
– Lists
Requirements for an action
• Prompt for action
Result of an action
Additional information and hints
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Target group
These Instructions for Use are intended for physicians, nurses and other
medical and technical staff who prepare, operate or maintain the device after
appropriate training. It is the duty of the device owner/operator to train and
brief all operating personnel.
Additional service activities are not part of these Instructions for Use. They will
be performed by staff specially trained for this purpose by ZEISS.
Field of use
Intended use
Normal use
OPMI PROergo is a microscope designed for dental treatment and for surgical
procedures in the field of dentistry.
Through its selection of illumination systems (halogen, xenon) and its
mechanical construction, it is adapted to the requirements of daily tasks
involved in treatment and surgery applications.
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CAUTION Live video images and recorded video sequences, video clips (cut sequences)
and single images shall not be used for diagnosis purposes. Visualized images
may contain variations in shape, contrast and color.
Loss of warranty!
The manufacturer is not liable for damage caused by unauthorized
modifications to the device. Furthermore, such unauthorized modifications
will render the warranty and any claims under warranty invalid.
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Legal regulations • Check regularly that the legal regulations applicable in your country with
regard to accident prevention and work safety are being complied with.
• This device must not be modified without the manufacturer’s approval. If
the system is modified after consultation with the manufacturer, suitable
inspections and testing must be completed to ensure subsequent safe use.
The manufacturer is not liable for damage caused by an unauthorized
modifications to the device.
• If required by the applicable national laws and regulations, connect the
device to the "special substitute power supply".
Ambient conditions • Do not use the power-operated devices included in the delivery package
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Electrical safety • Always switch off the device before you plug it into or unplug it from the
electricity network, if you are not going to use it for a prolonged period of
time, or if you want to clean its surface.
• Switch off the system at the power switch if you notice any smoke, sparks
or unusual noise. In this case, do not use the device again before it has
been repaired by our Service department.
A potential equalization connector is provided on the instrument's connection
panel (see IEC60601-1). This connector can be used to connect other active
devices to the same ground potential or for redundant connection to the
protective ground.
• Do not use multiple sockets!
• Never open the device! The device contains freely accessible live
components. If you remove the housing, you run the risk of electric shock.
• Do not touch the device if your body is electrostatically charged and the
device is not grounded.
• Please note the information on EMC (electromagnetic compatibility ) in
the chapter "System data" on Page 254.
Transport & Service • The system may only be transported over long distances (e.g. during
relocation, return for repair, etc.) in its original packaging or in special
return packaging. Please contact your dealer or ZEISS Service for this
purpose.
• This instrument is a high-grade technological product. To ensure optimum
performance and safe working order, we recommend having it checked
by our service representative as part of regular scheduled maintenance.
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Optics and light • Never look at the sun through the binocular tube, the objective lens or an
eyepiece.
• Avoid looking directly into the light source, e.g. into the microscope
objective lens or into the light guide, in order to prevent damage to
the eye!
• Start with the lowest brightness setting and gradually increase brightness
up to the necessary and still admissible level.
• 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).
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• If the halogen lamp is used beyond its maximum service life of 50 hours,
sudden failure may occur and interrupt operation. Replace the halogen
lamp in a timely manner (see chapter "Service and maintenance" on
Page 220).
• Keep a replacement lamp (only for halogen light source) ready at hand.
• Never cover any ventilation openings. This may cause the light source of
the device to overheat and fail.
• Never use force when trying to connect any electrical connectors (plugs,
sockets). If a connection cannot be made, check to make sure the plug fits
the socket. If any of the connectors are damaged, have the ZEISS service
team or authorized service representative repair them.
• Position the suspension system in such a way that you can slide or swing
it away from the patient at any time.
• Prior to using the wireless foot control panel (FCP WL), make sure that its
batteries are fully charged. Inadequate power supply to the wireless foot
control panel may cause the device to malfunction.
• Go through the checklist in the chapter "Operation".
• Depending on how the surgical microscope is being used, take
appropriate precautions to ensure that, if necessary, the surgical
procedure or treatment can be completed without the full functionality
of the microscope (e.g. without the lighting).
• If you operate the device in a sterile area, make sure that you use the
corresponding sterile accessories for the device.
The single-use sterile drapes can be used to cover the device.
• When fitting the sterile drape, ensure there is sufficient room for
movement of the microscope carrier and surgical microscope.
• Observe the instructions for use for the sterile drapes and make sure
that the drape is attached in such a way that your field of view is not
obstructed.
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During use
• Never look directly into the light source, e.g. a microscope objective lens
or a light guide, as this might cause phototoxic injury to the eye.
• Never leave a device unattended when its light source is switched on.
• Defective or unidentified accessories may lead to increased leakage
current on the device 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 replace the lamp shortly after it has failed, the lamp will still be very
hot. Use heat-resistant protective gloves when replacing the lamp to
prevent burns.
• If there is a failure and you cannot get any help from the chapter "What
to do in the event of malfunctions", attach a sign "Out of order" to the
system and contact ZEISS service representative.
• Do not pull at the light guide, power cord or any other connecting cables.
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• Always use the master switch to turn off the device if it is not in use.
• Inadequate, flawed or incorrect cleaning or disinfection that does not
comply with these Instructions for Use can expose the patient or medical
staff to a considerable risk of infection.
• Step on at least three pedals to secure the floor stand in position.
Make sure that the floor stand is stable and cannot roll away.
• Move ceiling mount to its standby position.
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General
The xenon illumination is a light source with high intensity. If used improperly,
excessive illumination intensities may lead to third-degree burns. Keep the
illuminated tissue moist and make sure it is sufficiently rinsed. Carefully
monitor the effect of the illumination on the tissue, particularly under the
following circumstances:
– During longer interventions on skin and tissue using objective lenses with
short focal depth (short working distance),
– During interventions on poorly perfused tissue,
– When the brightness control for the xenon lamp is set to a high
illumination intensity.
Please bear in mind that the values displayed for the light intensity may
not be used as a measuring function. They are intended only as an aid to
orientation.
• Only change the xenon lamp module after switching off the system.
The igniter generates a high voltage when the lamp is on.
• Any type of radiation has a damaging effect on biological tissue. This is
also true for the light illumination the surgical field. You should therefore
reduce brightness, the illuminated field size and the light exposure time to
the absolute minimum required.
If the brightness can no longer be reduced in the case of malfunctions, you
must take this into account in the light exposure time.
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– The size of the luminous field influences the risk of injury in two respects:
– With a large illuminated-field diameter, areas of the skin are
illuminated which are not monitored as strictly by the surgeon and
which are not moistened sufficiently. These areas are particularly
exposed to the risk of injury. Such injuries can be prevented by
adjusting the luminous field size to the smallest size required for that
particular operation.
– If the luminous field is reduced in size, the intensity increases because
the light is more strongly focused. So, if possible, the intensity should
be lowered as soon as the size of the luminous field is reduced.
– A long surgical procedure increases the risk of injury, in particular if
a standard procedure takes considerably longer than usual.
– Injuries in the peripheral area can be prevented by covering this area with
wet, sterile gauze. The risk is increased if dry drapes are used to cover such
areas.
– The interaction of heat and antimicrobial substances in incision foils may
lead to an increase in the patient's reaction to these substances.
– It should also be considered that some areas of the body may be more
sensitive than others.
– Certain preparations of the surgical field, local vasoconstrictive
medications and incision drapes may also result in a higher risk of injury.
Patient-related factors
– The general condition of a patient's health may contribute to the risk of
injury.
– The skin type may also play a major role for the risk of injury.
– Certain medications also affect the sensitivity to light.
Recommendations
Due to the large number of different factors involved and the lack of scientific
publications on this topic, ZEISS cannot provide guidance on acceptable
illumination intensities and exposure durations. However, the surgical
microscope has several features that can help the user to reduce the risk of
burn injuries:
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– Using the buttons on the handgrip or foot control panel, the surgeon can
then set the illumination intensity to the value required for the procedure.
Please note that the intensity increases with decreasing luminous field size
if the Spot function is used. For this reason, the intensity should only be
set only after the size of the luminous field has been changed.
– Never leave a device unattended when its light source is switched on.
– Switch off the light when the microscope is not in use, and make sure that
it is not aimed at unprotected bare skin.
Please note that most burns affected the skin around the incision. The most
important measures to prevent burns are reduction of the size of the
illuminated field using the spot function and the coverage of peripheral areas
with sterile, moist gauze. The area of the incision should be constantly
moistened.
Concluding remarks
ZEISS recommends that the illumination of the surgical field be kept to the
necessary minimum, for the patient's safety and for a good microscopic
image.
Please refer to the relevant warnings and precautions.
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0 No filter
1 GG475 filter: to protect the patient's eyes against unnecessary (blue)
radiation during treatment (retinal injury).
2 KK 40 filter: to increase color temperature
3 No filter
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Lifting column
1 2 Selector switch
for setting the optimum viewing height of the surgical microscope or for
downward movement into the working position.
As long as the selector switch remains in the turned position, the lifting
column moves upward (2) or downward (1), depending on the switch
position. When you release the selector switch, the lifting column stops
immediately.
The switching technology causes a delay of approx. 2 seconds at the upper
and lower end positions of the lifting column. After this time elapses, you can
move the column in the opposite direction again by activating the selector
switch again.
After being in operation for a maximum of one minute, the lifting column
must be turned off for at least nine minutes to prevent the motor from
overheating.
– Before raising or lowering the mount, make sure that there is sufficient
clearance to avoid collision with other objects.
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9 Rating plate
The rating label contains the following information:
– Manufacturer's symbol
– Manufacturer (company name) Carl Zeiss Meditec AG
– Manufacturer's address Goeschwitzer Strasse 51-52
07745 Jena, Germany
– Serial number
– Device name S7 / OPMI PROergo
– Reference number
– Rated Voltage (115V): 100V - 125V
(230V): 220V - 240V
– Connected load (115V): max 850VA
(230V): max 1250VA
– Line frequency range 50Hz - 60Hz
– Maximum total weight (with Max. 190 kg
installed safe workload)
– CSA approval
– CE marking
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12 SIP label
The SIP label contains the following information:
– Manufacturer (company name)
– Manufacturer's contact details,
i.e. phone number, fax number and email address of the local contact
for the national ZEISS sales organization.
XXXX XXXXXX – SIP number
A unique identification number assigned to your device.
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10 SIP label
The SIP label contains the following information:
– Manufacturer (company name)
– Manufacturer's contact details,
i.e. phone number, fax number and email address of the local contact
for the national ZEISS sales organization.
XXXX XXXXXX – SIP number
A unique identification number assigned to your device.
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10 SIP label
The SIP label contains the following information:
– Manufacturer (company name)
– Manufacturer's contact details,
i.e. phone number, fax number and email address of the local contact
for the national ZEISS sales organization.
XXXX XXXXXX – SIP number
A unique identification number assigned to your device.
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2 Remote connector
Identifies a connector to which devices with a maximum breaking
capacity of 24V/0.5A may be connected.
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Device overview
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Properties
Suspension systems
The S7 floor stand is a suspension system for ZEISS surgical microscopes.
It comprises a suspension arm, a carrier arm, a stand column and a stand
base.
There is a handle mounted on the stand column. It is used to move the stand
and to suspend the foot control panel. The stand column is equipped on both
sides with cable supports for winding up cables before the unit is moved to
another location.
The stand base is extremely easy to move on its four casters. It has been
designed in such a way that high stability is ensured even with unfavorable
loading of the stand. The locking tabs permit you to reliably secure the floor
stand in position at the site of use.
Because the stand moves so smoothly, it is easy to underestimate how heavy
it is. Therefore, move the stand slowly and carefully!
The S7 ceiling mount with rigid column is a suspension system for ZEISS
surgical microscopes. It comprises a suspension arm, a carrier arm, a ceiling
column and a ceiling flange.
The S7 ceiling mount with lifting column is a suspension system for ZEISS
surgical microscopes. It comprises a suspension arm, a carrier arm, a ceiling
flange and a lifting column. This motorized lifting column permits the viewing
height to be perfectly matched to the surgeon's requirements.
The S7 wall mount and S7 Centro suspension system are carrier systems
for ZEISS surgical microscopes. The wall mount comprises a suspension arm,
carrier arm and wall anchor plate. The Centro suspension system comprises
a suspension arm and carrier arm.
The carrier arm of all suspension systems contains the control unit with all
electrical supply systems required for the control of a motorized surgical
microscope. You can control the motorized functions using the handgrips,
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or via a foot control panel (option). A light guide (fiber optic illumination)
directs the light from the lamp housing in the suspension system to the
surgical microscope.
The suspension arm of all types of suspension system permits almost effortless
positioning of the surgical microscope. The spring force of the suspension arm
can be adjusted within a range from 6 to 14 kg. permitting reliable balancing
of the microscope even with accessory equipment attached. The downward
movement of the suspension arm can be limited using an adjustable
positioning aid.
A control panel allows the adjustment of user-defined settings such as the
zoom, focus, brightness and video settings, and the programming of the
configurable handgrip buttons.
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System components
1 S7 ceiling mount
2 S7 ceiling mount with lifting column
3 S7 wall mount
4 Floor stand S7
5 S7 central stand
6 OPMI PROergo surgical microscope
with 180° tiltable tube and magnetic eyepieces.
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Straight tube
1 2 3 4 5 6 7
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Floor stand S7
Set-up
1 Suspension arm
2 Lamp housing (either xenon or halogen illumination)
3 Support arm
4 Control panel
5 Connector panel
6 Handle
7 Cable supports (2x, on the right and left of the stand column)
8 Stand column
9 Stand base
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Suspension arm
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The S7 floor stand can be equipped or retrofitted with an instrument tray (1).
In the case of retrofitting, our Service staff or an authorized person will install
the instrument tray on your suspension system.
The instrument tray (1) can carry a maximum of 13 kg. It is designed to
securely carry items such as a video recorder. Further accessories can be
installed on the instrument tray using the strap provided.
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S7 ceiling mount
Set-up
1 Ceiling flange
2 Stand column
3 Control panel
4 Connector panel
5 Lamp housing (either xenon or halogen illumination)
6 Suspension arm
7 Support arm
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Set-up
1 Ceiling flange
2 Lifting column
3 Control panel
4 Connector panel
5 Lamp housing (either xenon or halogen illumination)
6 Suspension arm
7 Support arm
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1 Lifting column
2 Selector switch
for setting the optimum viewing height of the surgical microscope or for
3 4 downward movement into the working position.
As long as you hold the selector switch in the turned position, the lifting
column moves downward (3) or upward (4), depending on the switch
position. When you release the selector switch, the lifting column stops
immediately.
The switching technology causes a delay of approx. 2 seconds at the
upper and lower end positions of the lifting column. After this time
elapses, you can move the column in the opposite direction again by
activating the selector switch again.
The lifting column is used to move the microscope into position for
surgery prior to the surgical procedure.
Do not constantly move the lifting column up and down, because this will
trigger the thermal cut-out, which automatically deactivates the drive
motor. If this occurs, the lifting column cannot be moved until the motor
has cooled down.
Note: After being in operation for a maximum period of one minute, the
lifting column must be turned off for at least nine minutes to prevent the
motor from overheating.
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The functions of the S7 Centro suspension system are identical to those of the
S7 wall mount.
Set-up
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1 Remote connection
For controlling external devices (e.g. MEDIALINK 100) with a maximum
switching capacity of 24 V / 0.5 A.
2 connection strip for switching element (option)
Connection option for a foot control panel
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Illumination system
Two different types of illumination are available for the suspension system.
1 Halogen illumination
The halogen light source is equipped with an illumination system for
fiber illumination. The lamp housing contains a backup lamp which
automatically swings into position when the first lamp fails.
2 XENON illumination
The xenon light source is equipped with an illumination system for fiber
illumination. The xenon lamp generates light whose spectrum resembles
that of natural daylight. Regardless of the brightness setting, the color
temperature of the light always remains the same. Normal daylight film
without any additional conversion filters can therefore be used for
photographic documentation. The lamp module contains two xenon
lamps. The second lamp is used as a backup lamp which must be manually
swung into the illumination beam path when the first lamp fails. You have
to pull out the lamp module all the way before being able to swing in the
backup lamp.
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The illumination system has been designed for fiber illumination. The lamp
housing contains a backup lamp which automatically swings into position
when the first lamp fails.
1 Lamp module
2 Ventilation grid
NOTE Overheating of the lamp module!
If ventilation grids are covered e.g. by drapes, this may lead to overheating
of the ventilation modules and deactivation of the lamp.
• Never cover the ventilation grids.
• Lamps switched off due to overheating will be automatically switched on
again when they have cooled down.
3 Flap
The flap is used as the mechanical indicator for the operating status of the
halogen lamps.
– When the flap is closed, the main lamp is operative.
– When the flap is open, the main lamp has failed. The backup lamp
is on.
4 Manual switching to the backup lamp
If the automatic activation function fails, press this button to switch on the
backup lamp.
5 Opening the lamp module
When you press this button, the slide-in lamp module is partially ejected.
Pull out the lamp module all the way to change the lamp.
6 Filter selector
The filter selector knob has four positions:
0 No filter
1 GG475 filter: to protect the patient's eyes against unnecessary (blue)
radiation during surgery (retinal injury).
2 KK 40 filter: to increase color temperature
3 No filter
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When inserting a new lamp module, make sure that the knob (2) is set to "1".
If the first lamp fails, switch to the second lamp in logical sequence.
3 Indicator: backup lamp is in use
When the segment in knob (2) lights up, the backup lamp is in use.
4 Filter selector
The filter selector knob has two positions:
0 No filter
1 Filter moved into position
(there is no integrated filter in the standard configuration)
5 Counter
The counter records the service hours of the xenon light source.
• Change the xenon lamps after a maximum operating time of 500 hours to
avoid any rupture of the xenon lamps. Then reset the counter to "0" by
pressing the "Reset" button (6).
6 Reset button
The reset button resets the service hour counter to "0".
7 Opening the lamp module
When you press this button, the slide-in lamp module is partially ejected.
• To change the lamp, pull out the lamp module as far as it will go. Turn the
knob (2) through 180° until it snaps in place. This moves the backup lamp
into the illumination beam path.
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The control panel consists of a graphic display (1) with control keys (3).
All functions can be interactively controlled via menus. The display shows
the selected functions and settings. Using control buttons (3) you can move
through the menus and activate a selection field. The field activated is then
highlighted by a dark background. Press Enter button (4) to confirm your
selection or entry.
For entering, briefly press any of control buttons (3). In some settings,
the control buttons have a repeat function, i.e. constant pressing of a button
causes the command to be repeated.
The menus are clearly laid out and user-friendly. The name of the menu is
given in bar (2) at the bottom. At the right-hand end of the bar, a small
pictogram is shown for quick orientation. At the left-hand end of the bar,
the activation field (OK) is located. If the background of this field is dark,
press the "Enter" button to confirm your entry.
The following diagram depicts how the menus are linked.
Power switch (5)
For switching the system on and off. When the system has been switched on,
the green lamp in the switch is lit.
The power switch contains an automatic circuit breaker. If a short circuit
occurs, the automatic circuit breaker will respond and switch the system off.
2
4
3
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Version ......
USER 1
USER 2 NONE
USER 3 NONE
Off Off
4.9 x 300 mm 20 %
Standard
Close
12.5 x
Off
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User menu
The User menu comprises one standard profile and three other user profiles.
USER 1
When a user profile is selected, the system imports the settings stored under
USER 2
this profile, e.g. focusing speed, zoom link setting, zoom speed and handgrip
USER 3
settings. The stored start values ("Start at") for the magnification factor,
the focus position and the brightness are automatically set. The three user
profiles are used to adjust these settings for different users.
When the system is started up for the first time, the Standard User is
displayed; at every subsequent start-up, the user active last is displayed.
– The Standard User profile allows the adjustment of settings, but these
settings cannot be saved (fixed factory settings).
– In the Standard User profile, all "Start at" fields are deactivated. No bar is
displayed; it is not possible to adjust any settings.
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Functions of buttons:
– When the input keyboard has been activated with the Edit button (1),
the input function is active.
2
– Select the individual characters using the arrow keys and confirm the
characters by pressing the "Enter" button.
You must activate the OK button (2) using the arrow buttons and then
press the Enter button to save the name entered under the selected user.
After selecting a user or an application, press the "Enter" button to return to
the "Surgery" menu.
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Surgery menu
The Surgery menu is constantly displayed during operation. The menu
4.9 x 300 mm 20 % includes the icons (from left to right) for the following menus: Zoom, Focus,
Illumination. Below: User, Options, Video and Balance. The displays below the
Standard zoom, focus, illumination and user icons show the current settings for total
magnification, working distance, brightness level and selected User.
Zoom menu
You can adjust the settings for the following functions in the Zoom menu:
50 % 1.4
Speed:
The zoom speed from minimum to maximum speed from 5% to 100% in
increments of 5%.
Start at:
the zoom start value. Enter the magnification factor at which the zoom system
should start when the system is switched on or is switched to a different user.
The magnification factor can be set and saved within a range between
γ = 0.4 x and γ = 2.4 x in increments of 0.1.
γ is only the magnification factor of the zoom system. The total magnification
provided by the system is also determined by the eyepieces and the working
distance used.
• Activate the function desired (Speed or Start at) and move the indicator
bar using one of the arrow buttons ( , ), until the reading required is
displayed in the field at the top.
• Press the Enter button to save the value set and to return to the Surgery
menu. If you do not press any key, the display will automatically jump back
to the Surgery menu after approx. 30 seconds.
In the Standard User profile, all "Start at" fields are deactivated. No bar is
displayed; it is not possible to adjust any settings.
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Focus menu
You can adjust the settings for the following functions in the Focus menu:
Zoom Link:
On 50 % 300 mm
The Zoom Link function lets you couple the focusing speed to the current
On
magnification. This means that the focusing speed is automatically reduced
when a high magnification is used. Whether the Zoom Link function has been
activated or deactivated is stored in the respective user profile.
Speed:
Focus
The focusing speed from minimum to maximum speed from 5% to 100% in
increments of 5%.
OnOn
Start at:
focus start value. Adjust the working distance at which the focusing system
should start when you call your user profile. The setting can be adjusted and
saved within a range of 200 to 415 mm in increments of 1 mm.
The value shown in the graphic display is not a measuring function. It is only
intended as an aid for orientation and may not be used as a measurement
value.
• Activate the function desired and move the indicator bar using one of the
arrow buttons ( , ) until the reading required is displayed in the field
at the top.
• Press the Enter button to save the value set and to return to the Surgery
menu. If you do not press any button, the display will automatically
jump back to the Surgery menu after approx. 30 seconds and save the
values set.
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Illumination menu
You can adjust the settings for the following functions in the Illumination
menu:
Zoom link
On 50 % 50 % Intensity:
On the illumination intensity from minimum to maximum brightness from
5% to 100% in increments of 5%. This setting can be adjusted for the xenon
illumination and the halogen illumination.
Start at:
the brightness start value. Use one of the arrow buttons ( , ) to adjust the
illumination intensity in percent. The xenon or halogen lamp will then go on
at this brightness level after activation.
Illumination
The "Start at" field will be active only if "Zoom Link" is in the "Off" position.
On If Zoom Link is On, the "Start at" field will not be active. No bar is displayed;
On
it is not possible to adjust any settings.
Zoom Link:
the automatic light readjustment. When this function is active (ON),
the illumination is adjusted in such a way that the user is provided with
a subjectively constant brightness level in the eyepiece, regardless of the
zoom factor set. Whether the Zoom Link function has been activated or
deactivated is stored in the respective user profile.
• Press the Enter button to save the value set and to return to the "Surgery"
menu. If you do not press any button, the display will automatically jump
back to the Surgery menu after approx. 30 seconds and save the values
set.
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Assignment of functions:
Use the ( , ) arrow buttons to select the required function from the table.
Use the ( , ) arrow buttons to select the button required (C or D).
After you have pressed the "Enter" button, a check mark ( ) indicates
that the selected function has been assigned to the selected button.
When you press the "Enter" button again, your selection is saved and you
return to the "Surgery" menu.
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(1), the magnetic brakes are unlocked and you can position the balanced
surgical microscope. When you let go of release button (1), the magnetic
brakes are locked and the surgical microscope is fixed in position again.
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The default setting for Standard User is the large ROI. You can change the size
of the ROI, but the change cannot be saved for the Standard User.
For specific users, the ROI size can be set and saved for each user as required.
Submenu "AF - ROI Position"
This submenu permits you to define the ROI position within the microscope's
field of view.
When you start your system, the ROI is always positioned at the center of the
field of view. The ROI is visualized as a square in the graphic display. Use the
arrow buttons to shift the ROI.
Press the OK button to return to the Autofocus menu. If you do not press any
of the buttons, the display will automatically jump back to the Surgery menu
after approx. 20 seconds.
Menu item "Brake Automatic, on/off"
This function permits you to activate or deactivate the automatic start of the
focusing process.
For repositioning the OPMI PROergo, you have to unlock its magnetic brakes.
Press the release button for the magnetic brakes on one of the handgrips. The
magnetic brakes of the microscope are unlocked for as long as you press one
of these release buttons.
If you have selected "Brake Automatic, on", focusing by the SpeedFokus
(autofocus) option will start automatically as soon as the magnetic brakes
have been locked, i.e. as soon as you let go of the release buttons.
If you have selected "Brake Automatic, off", focusing by the SpeedFokus
(autofocus) option will not start automatically when the magnetic brakes
are locked, i.e. when you let go of the release buttons. You can trigger the
focusing process using the handgrips or the foot control panel. This is only
possible if the Autofocus option has been selected in the handgrip menu
or foot control menu (for foot control panels with 8 or 14 functions).
You can stop focusing by the SpeedFokus (autofocus) option by pressing one
of the release buttons on the handgrips or on the foot control panel (with 8
or 14 functions) during the focusing process.
Menu item "Camera Position"
If you are using an external video camera, the orientation of the video camera
must be known to the video autofocus.
This function is only available in systems equipped with an external video
camera.
The video image must have the same orientation as the image in the main
eyepieces of the surgical microscope.
In addition, the video autofocus needs the information whether the video
camera is connected on the left or right, i.e. whether the beam splitter
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projects into the main beam path from the left or right, to enable the video
focus to perform corrections in the right direction during the focusing
process.
Submenu "Advanced Settings"
– This submenu is only available in systems equipped with an external video
camera.
– This submenu contains camera-specific settings. These settings only need
to be changed when a different video camera is installed.
– The SpeedFokus (autofocus) option does not function properly if
parameters have not been correctly set.
The "Advanced Settings" submenu contains the following camera-specific
settings:
– Video Focal Length
– Camera Chip Size (size of the CCD array)
Video Focal Length and Camera Chip Size (size of the CCD array):
These settings must conform to the technical specifications of the video
camera used.
If you are using the "1Chip HD Camera" option on a surgical microscope
featuring SpeedFokus, you have to configure the following software settings
on the surgical microscope to ensure correct visualization of the image
format:
• set the focal length of the video optics to f = 50 mm and the size of the
CCD array to 1/3".
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Balance menu
The Balance menu has been designed as a user prompt and consists of six
images explaining the balancing procedure. You can scroll through the
Balance menu using the arrow buttons ( , ). The OK button has no
function.
Press the enter button or the arrow buttons ( , ) several times to return
to the "Surgery" menu.
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Laser menu
Since this surgical microscope model does not allow the attachment of
a laser, the Laser menu is not used.
You should therefore check that the default setting "NO NE" - No Laser is
displayed in all menus (1) to ensure problem-free operation.
1 The User Selection menu permits you to access the laser selection menu
via the respective Edit button using the arrow button ( ). After you have
User 1 NoNONE
Laser activated Laser menu button (1), a pull-down menu is automatically opened
User 2 No Laser
TwinER in the display.
User 3 No Laser
TwinER
Note: The pull-down menu will be automatically opened if you approach from
the left with the arrow button ( ). If you select the field using the ( , )
arrow buttons, the pull-down menu can be opened by pressing the ENTER
key.
Use the arrow keys ( , ) to switch to None- No Laser.
By activating the setting "None" and pressing the Enter button, you can
transfer the selection to the Laser menu (1).
If you do not press any key, the display will automatically jump back to the
Surgery menu after approx. 30 seconds.
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You can delete the error message by pressing the "Enter" button. Internally,
the system keeps a record of the malfunctions occurred.
If you cannot eliminate the malfunction, you may perhaps be able to continue
working by switching off the suspension system or separating the plug-in
connection to the surgical microscope (see "Failure of main functions",
Page 199).
Acoustic signals
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14-function foot control panel, wired (FCP) and wireless (FCP WL)
A retrofit kit for the 14 function foot control panel is available as an option.
The prerequisite for this is that your device is equipped with the foot control
panel connector socket.
Please observe the G-30-1707 Instructions for Use which are contained in the
delivery scope for the 14 function foot control panel.
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System kit Any additional equipment you connect to medical electrical devices must
demonstrably comply with the applicable standards and directives (e.g.
IEC 60950-1 for data processing equipment). In addition, all configurations
must meet the requirements set out in the standards for medical electrical
systems (see IEC 60601-1, chapter 16).
Anyone connecting additional equipment to medical electrical devices is
a system configurer and, as such, is responsible for compliance of the system
with the standard requirements for medical electrical systems.
Please note that local legislation takes priority over the requirements of the
above-mentioned standards. If you have any questions, contact your local
dealer or Carl Zeiss Service.
R017 Your devices may not be modified without the manufacturer’s approval.
If the system is modified after consultation with the manufacturer, suitable
inspections and testing must be completed to ensure subsequent safe use.
The manufacturer is not liable for damages caused by an unauthorized use
of the device. Furthermore, such unauthorized modifications will render the
warranty and any claims under warranty invalid.
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Connections, establishing
You can secure the power plug and the multipoint connector of the switching
component against inadvertent loosening by installing the two cables in strain
relief device (1).
After you have mounted strain relief device (1), the cable must have the
following length:
– 320 mm from the strain relief device up to and including power
connector (9).
– 320 mm from the strain relief device up to connector (10) of the foot
control panel.
• Form a loop with the cable (3).
• Open flap (4).
• Feed the cable through the opening (5).
• Close the flap (6).
• Tighten the cable until it encloses the flap (7).
• Check the cable length.
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5 6 7 8
320 mm
10
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• Connect the plug of the foot control panel to the connection strip (2) of
the stand if you wish to use a foot control panel.
• Connect the stand using the power cord provided (4).
• If required, use the potential equalization pin (1) to connect the stand to
the equipotential bonding strip in the OR.
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The image quality obtained with Y/C connections and cables shorter than
10 m is always better than that obtained with BNC connections of the same
length. If cable lengths exceed 10 m, the image quality provided by a Y/C
connection will decrease markedly; in these cases, only BNC connections
should be used.
If possible, you should position the individual units in such a way that you can
use Y/C connections. The Y/C connection provides the best image quality,
in particular for images recorded with MEDIALINK 100.
If this is not possible, position the individual units in such a way that you can
at least use the Y/C cable for the video input port of the MEDIALINK 100.
Set-up
1 Standard video monitor
2 Standard video recorder, video printer, video projector
3 MEDIALINK 100
4 CCU connector panel (on back of the system) for the 1Chip HD camera
5 Connector panel of the suspension system
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Video monitor 1
VIDEO IN
Video recorder 2
MEDIALINK 100 3
Y/C
SD - Y/C Remote
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Normally the 1Chip HD camera is located on the right side as viewed from the
main eyepieces. The iris diaphragm for video lenses on the 1Chip HD camera
allows you to re-equip your surgical microscope quickly. The 1Chip HD camera
can be attached to and removed from the beam splitter, and therefore the
output ports of the beam splitter (left/right sides) can also be changed.
After changing sides, you will have to adjust the position of the image.
For further details please refer to the Instructions for Use of the "1Chip HD
camera" (G-30-1946), in the chapters "Using the CCU to configure the 1Chip
HD camera / Configuring the picture settings". These Instructions for Use are
included automatically in systems with the "1Chip HD camera" option.
1 2 3
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Camera cable
DC 12V - 15V
from the permanently installed
suspension in suspension system
system
CCU
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• Lower the surgical microscope until it can be focused on the surgical field
(according to the focal length of the lens). At the same time, ensure that
there is a sufficiently safe distance between the microscope and the
surgical field.
• Firmly retighten locking lever (2) for the upward/downward movement.
• Lower the surgical microscope to its lowest position again, and check the
distance between the microscope and the surgical field.
– The limit of downward travel is only effective in the lower part of the
suspension arm's vertical movement range (starting from the arm's
horizontal position).
– If you wish to use the suspension arm's full range of vertical movement,
lower the suspension arm as far as it will go and then firmly retighten
locking lever (2).
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• Lower the surgical microscope until it can be focused on the surgical field
(according to the focal length of the lens). At the same time, ensure that
there is a sufficiently safe distance between the microscope and the
surgical field.
• Firmly retighten locking lever (2) for the upward/downward movement.
• Lower the surgical microscope to its lowest position again, and check the
distance between the microscope and the surgical field.
– The limit of downward travel is only effective in the lower part of the
suspension arm's vertical movement range (starting from the arm's
horizontal position).
– If you wish to use the suspension arm's full range of vertical movement,
lower the suspension arm as far as it will go and then firmly retighten
locking lever (2).
1 2 3
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Bring the surgical microscope into a position convenient for you before each
surgical procedure, and set the optimum ergonomic working height of the
suspension system via the lifting column (without patient!).
As long as you keep selector switch (2) in the turned position, lifting column
(1) moves upward or downward, depending on the switch position. When
you release the selector switch, the lifting column stops immediately.
After being in operation for a maximum of one minute, the lifting column
must be turned off for at least nine minutes to prevent the motor from
overheating.
• Before raising or lowering the stand or mount, make sure that there is
sufficient clearance so as to avoid any collision with other objects.
The lifting column is used to move the microscope into position for surgery
prior to the surgical procedure.
Do not constantly move the lifting column up and down, because this will
trigger the thermal cut-out, which automatically deactivates the drive motor.
If this occurs, the lifting column cannot be moved until the motor has cooled
down.
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• Lower the surgical microscope to its lowest position again, and check the
distance between the microscope and the surgical field.
– The limit of downward travel is only effective in the lower part of the
suspension arm's vertical movement range (starting from the arm's
horizontal position).
– If you wish to use the suspension arm's full range of vertical movement,
lower the suspension arm as far as it will go and then firmly retighten
locking lever (2).
1 2 3
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Notes on adjustment
– To permit fast setup of the microscope, it is advisable to store the pupillary
distances and prescriptions of the different users so that they can be easily
preset during system preparation.
– Do not wear any bifocal or progressive lenses for the adjustment
procedure and subsequent work with the microscope.
Lenses of this kind make correct diopter setting impossible and result in
unsatisfactory imaging.
– Optimum image clarity in the eyepieces and at the optical port for
documentation equipment (photo, video) can only be achieved through
careful focusing and precisely adjusting the binocular tube.
Adjusting the • Position the microscope vertically above a flat object, e.g. a piece of paper
pupillary distance with writing on.
• Bring the eyepieces on the binocular tube to eye distance, so that the two
eyepiece images (the object and the periphery of the field of view) merge
to produce a single image.
Adjusting the eyepieces The following procedure must be performed separately for each eyepiece in
the order described.
• Set to the smallest magnification on the microscope.
• Set the diopter adjustment ring at the eyepiece to zero position.
• Look through the eyepiece and move the microscope to focus the image.
• Set the microscope to the highest magnification and correct the fine
focusing until the image is defined sharply.
• Now set to the smallest magnification once again without changing the
working distance.
• Set the diopter adjustment ring at the eyepiece to its maximum value (plus
direction).
• Look through the eyepiece and slowly turn the diopter adjustment ring to
the minus direction until the image is sharply defined.
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Adjusting the eyecups • Adjust the eyecups so that you can survey the entire field of view.
– Viewing with eyeglasses: screw in the eyecups.
– Viewing without eyeglasses: remove the eyecups.
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The device can be equipped with resterilizable products for sterile use.
The asepsis sets available from ZEISS contain caps and handgrips which can
be sterilized in autoclaves. For more detailed information about sterilization,
please refer to the enclosed "Preparation of resterilizable products" manual
for each Asepsis Set.
You can also use disposable sterile drapes to cover the system. When draping
the system, make sure there is enough slack in the drapes to allow for
movement of the microscope carrier and surgical microscope.
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4 • Hold the device by the grab handle (1) and carefully push it into its new
position. Ensure the device is standing on even ground.
• Press at least three of the locking tabs (4) and make sure that the stand is
no longer able to move away by itself.
Because the stand moves so smoothly, it is easy to underestimate how heavy
it is. Therefore, move the stand slowly and carefully!
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Operation
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Check that the xenon illumination is on and the green indicator lamp is lit.
If the first lamp has failed and the backup lamp is in use (segment in the
switching knob lights up), make sure to have a backup lamp module ready
to hand as a precaution.
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Balancing
The suspension arm is properly balanced. If the suspension arm is properly
balanced, the surgical microscope should remain immobile in all positions
of the working range and should not swivel up or down.
Stroke limit
Check that the minimum working distance (height) from the surgical field
has been adjusted.
Stand base
At least two of the immobilizers have been pressed down to prevent the
stand from rolling away by itself.
Accessories
Proper functioning of all other equipment (surgical microscope,
coobservation equipment, video system, etc.) has been checked using the
relevant user's manuals.
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Check that the xenon illumination is on and the green indicator lamp is lit.
If the first lamp has failed and the backup lamp is in use (segment in the
switching knob lights up), make sure to have a backup lamp module ready
to hand as a precaution.
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Operation S7 / OPMI PROergo
Balancing
The suspension arm is properly balanced. If the suspension arm is properly
balanced, the surgical microscope should remain immobile in all positions
within the working range and should not swivel up or down.
Stroke limit
The minimum working distance (height) from the surgical field has been
adjusted.
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Check that the xenon illumination is on and the green indicator lamp is lit.
If the first lamp has failed and the backup lamp is in use (segment in the
switching knob lights up), make sure to have a backup lamp module ready
to hand as a precaution.
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Operating procedure
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CAUTION Live video images and recorded video sequences, video clips (cut sequences)
and single images shall not be used for diagnosis purposes. Visualized images
may contain variations in shape, contrast and color.
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SD-video monitor
S-Video SpeedFokus
on S-video
(optional)
connector
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In the event of magnetic brake failure (magnetic brakes are closed), you can
manually position the microscope by overriding the locking effect of the
brakes.
Failure of the SpeedFokus (autofocus) option while the rest of the OPMI
PROergo system is working correctly on the S7 system:
You can continue using your OPMI PROergo / S7 system, but you can no
longer benefit from the SpeedFokus autofocus option until it has been
repaired by the service staff.
• Continue surgery using the motorized focusing system of the OPMI
PROergo.
• Focus the image manually on the OPMI PROergo.
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1
2
3
4
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• Turn knob (1) through 180° until it snaps in. This swings the second xenon
lamp (backup lamp) into the beam path.
• Push the lamp module all the way back into the lamp housing.
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• Reset the operating hours counter to "0". Use a pointed object and press
it into the recess of reset button (1).
• Switch the suspension system back on again at the power switch.
If the first lamp has failed and the backup lamp is in use (segment in the knob
is lit), make sure to have a backup lamp module ready to hand as
a precaution.
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S7 suspension system
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Focusing cannot Different function assigned • Call up the Handgrip Page 124
be activated to handgrip button Settings menu and
(A, B, C or D). assign the Autofocus
function to one of the
buttons.
Different function assigned • Call up the Foot Control Page 124
to foot control panel menu and assign the
button (C or D). Autofocus function to
one of the buttons.
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Cleaning
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Sterilization
Asepsis sets
The asepsis sets available from ZEISS contain rubber caps and hand grips
that can be sterilized in autoclaves. For more detailed information about
sterilization, please refer to the enclosed "Preparation of resterilizable
products" manual for each Asepsis Set.
• Loosely attach the sterile drapes so that there is sufficient space for the
microscope supporting stand and the surgical microscope to move.
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Disinfection
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Device maintenance
Maintenance intervals
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Safety check
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– Check the function of the xenon lamp and backup xenon lamp.
– Pack the old lamp module (5) in the transport packaging of the new
lamp module. Fill in the enclosed return card and send the old lamp
module to the nearest ZEISS service representative.
– Only use original the transport case (2), as it also provides explosion
protection should the xenon lamps be faulty.
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Spare parts
Asepsis sets
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Disposal
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Device data
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Device data S7 / OPMI PROergo
Technical data
Surgical microscope
Component Properties
Magnification Motorized zoom system, zoom ratio 1:6,
magnification factor γ = 0.4x - 2.4x.
Total magnification 2.5x – 14.9x at a working distance of 200 mm
(10x eyepiece) 1.5x – 8.9x at a working distance of 415 mm
Total magnification 3.1x – 18.6x at a working distance of 200 mm
(12.5x eyepiece) 1.8x – 11.1x at a working distance of 415 mm
Field of view 14 – 83 mm at a working distance of 200 mm
(10x eyepiece) 23 – 140 mm at a working distance of 415 mm
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Component Properties
Fields of view 12–71 mm at a working distance of 200 mm
(12.5x eyepiece) 20–119 mm at a working distance of 415 mm
Focus Continuous motorized focusing via Varioskop
focusing range 200 - 415 mm
Note: The values shown on the display are different
from the real values. They are rounded values and
serve for information only.
Focal lengths f At a working distance of 200 mm: f = 278 mm
At a working distance of 300 mm: f = 366 mm
At a working distance of 415 mm: f = 466 mm
Light field diameter At a working distance of 200 mm:
min. 11 mm – max. 85 mm
At a working distance of 415 mm:
min. 19 mm – max. 142 mm
Tubes / Eyepieces 180° tiltable binocular tube, f = 170 mm.
10x or 12.5x widefield eyepieces with magnetic
coupling.
Weight Approx. 9.2 kg (without tube and eyepieces)
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Stands/mounts
Component Properties
Power supply Only connect the floor stand to wall outlets which
are provided with a properly connected protective
ground conductor.
Rated Voltage (115 V): 100–125 V
(230 V): 220–240 V
Power consumption Floor stand:
(115 V): max. 850 VA
Remote connection socket (230 V): max.1250 VA
View of connector side Ceiling mount with rigid column or lifting column:
(115 V): max. 450 VA
2 (230 V): max. 450 VA
Rated Frequency 50–60 Hz
3 1 Fuses Automatic circuit breaker
Electrical – Power outlet (floor stand only)
outputs (115 V): max. 400 VA
1 (230 V): max. 800 VA
2 – Surgical microscope
– Remote socket for an external signal with max.
3
24 V / 0.5 A (floor stand only)
The device is designed for continuous operation.
Fiber-optic
illumination 2 halogen reflector lamps 12 V 100 W in quick-
change module for light guide, with GG 475 and KK
40 filters
Fully automated switching between lamps.
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Floor stand S7
Mechanics
Component Properties
Support arm Length: 450 mm
Swivel angle: 360°
Suspension arm Length: 865 mm
Swivel angle: 305°
Lifting range: -320 mm / +400 mm
coupling Swivel angle: 350°
Stand height 1730 mm
Base dimensions 640 x 640 mm
Max. weight load on 14 kg (complete microscope equipment,
suspension arm including accessories)
Weight Approx. 177 kg (including microscope)
Maximum total weight 190 kg (with installed safe workload)
305°
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S7 ceiling mount
Mechanics
Component Properties
Support arm Length: 450 mm
Swivel angle: 296°
Suspension arm Length: 865 mm
Swivel angle: 296°
Lifting range: -320 mm / +400 mm
coupling Swivel angle: 350°
Admissible 14 kg (complete microscope equipment,
max. load on including accessories)
suspension arm
Weight (including Approx. 80 kg
microscope)
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S7 wall mount
Mechanics
Component Properties
Support arm Length: 450 mm
Swivel angle: 190°
Suspension arm Length: 865 mm Length: 1065 mm
Swivel angle: 360° Swivel angle: 360°
Lifting range: +400 mm Lifting range: +540 mm
-320 m -390 mm
coupling Swivel angle: 350°
Admissible 14 kg (complete microscope equipment,
max. load on including accessories)
suspension arm
Weight (including Approx. 68 kg Approx. 69 kg
microscope)
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S7 central stand
Mechanics
Component Properties
Support arm Length: 450 mm
Swivel angle: 190°
Suspension arm Length: 1065 mm
Swivel angle: 360°
Lifting range: +540 mm
-390 mm
coupling Swivel angle: 350°
Max. weight load 14 kg (complete microscope equipment,
on suspension arm including accessories)
Weight (including Approx. 53 kg
microscope)
540
390
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Ordering data
Only operate the device using the accessories recommended by ZEISS and
included in the delivery package. To find the contact person responsible for
orders in your country, visit:
www.zeiss.com/med
For authorized ZEISS partners, the contractual product configurations,
accessories and spare parts apply.
Please contact your authorized ZEISS partner for more information.
The given catalog number refers to the basic component. Further components
for the respective function are evident from the descriptive text. For this
reason, you should also cite the descriptive text in any orders.
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Cleaning agents
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Video accessories
For external video accessories for this surgical microscope, please refer to the
separate product overview G-30-1888.
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Compliance
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Environmental conditions
For operation
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Electromagnetic interference
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System enhancements
CAUTION As per IEC 60601-1-1 and IEC 60601-1, Section 16.2, this system's power
outlet is a multiple electrical outlet intended for use with an ME system.
Connecting electrical devices not approved by ZEISS can lead to a reduced
level of safety on the ME system.
• When configuring your ME system (using the power output socket),
make sure to comply with the requirements of IEC 60601-1, Section 16,
as well as the following measures:
– Do not place multiple electrical outlets on the floor.
– Do not connect any additional multiple electrical outlets.
– Only connect compatible components to the system.
– Do not exceed the max permissible electrical load of multiple
electrical outlets.
– Use multiple electrical outlets only for components of the system.
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Keyword index
Numerics
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Photo .....................................................................................................124
Pinhole diaphragm, medium-sized ............................................................68
Pinhole diaphragm, small ..........................................................................68
Potential equalization pin .....................................................82, 90, 98, 104
Power output socket ................................................................................82
Power switch ..........................................................................................116
Preparations for use ...............................................................................139
Prior to the very first use ...........................................................................15
Protective ground conductor ....................................................................15
Rated voltage display window ..............................82, 90, 98, 104, 106, 158
Rating label ................................................................34, 42, 43, 48, 49, 50
Red-free ...................................................................................................68
Regulatory information ...........................................................................250
Remote connection ......................................................82, 90, 98, 104, 106
Requirements for operation ......................................................................16
Risk of burn injuries caused by high illumination intensity .........................20
Risk of collision and crushing ....................................................................84
ROI (region of interest, measuring field) ..................................................127
ROI, display of ........................................................................................127
ROI, position of ..............................................................................127, 128
ROI, shifting of .......................................................................................128
ROI, size of .............................................................................................127
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Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52 Fax: + 49 (0)7364 - 20 4823
07745 Jena Email: [email protected]
Germany Internet: www.zeiss.com/med