Zeiss S7 / OPMI VISU 160 User manual

ZEISS
S7 / OPMI®VISU 160
Instructions for Use
G-30-1528-en
Version 6.0
2016-01-12

About this manual These Instructions for Use are part of the delivery package.
• Carefully read them 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 every subsequent owner or user of the device.
Orientation guides – The section summary at the beginning of these Instructions for Use pro-
vides an overview of the topics.
– You will also find a detailed table of contents at the beginning of each
chapter.
– The index facilitates searching via keywords.
Scope The following Instructions for Use apply to the S7 / OPMI VISU 160 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
Trademarks OPMI®, Invertertube®and MediLive®are registered trademarks of
Carl Zeiss.
Manufacturer
Subject to changes in design and scope of delivery and as a result of ongoing
technical development. Printed in Germany.
Copyright © Carl Zeiss Meditec AG 2015
All rights reserved. Reprints and reproductions, including excerpts, are not
permissible. However, these Instructions for Use may be digitized and
archived for internal use. Access to this data by third parties is not permissible
and must be prevented.
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany
Fax: + 49 (0) 7364 - 20 4823
E-Mail: [email protected]
Internet: www.zeiss.com/med

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Chapter overview
Chapter: Safety Measures 5
Chapter: System Overview 45
Chapter: Preparations for use 107
Chapter: Operation 145
Chapter: What to do in the event of malfunctions 155
Chapter: Care and Maintenance 163
Chapter: System Data 171
Chapter: Index 193

S 7 / O P M I V I S U 1 6 0
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S7 / OPMI VISU 160 Safety Measures
Safety Measures
Key to symbols ..................................................................................7
Hazard symbols ...........................................................................................7
Information symbols....................................................................................7
Target group .....................................................................................8
Field of application ............................................................................8
Intended use ...............................................................................................8
Normal use..................................................................................................8
Liability and warranty........................................................................9
Notes for the operator.....................................................................10
Requirements for operation.............................................................13
Prior to the very first use............................................................................13
Before every use........................................................................................14
During use.................................................................................................15
After every use ..........................................................................................17
Measures to prevent phototoxic injury ............................................18
Exposure time to light................................................................................20
Safety devices of the suspension systems...................................................24
Symbols and labels on the device ....................................................26
Labels on the microscope ..........................................................................26
Labels on S7 floor stand ............................................................................30
Labels on the connection panel .................................................................36
Additional labels on S7 floor stand (instrument tray option).......................37
Labels on S7 ceiling mount ........................................................................38
Additional label on S7 ceiling mount with lifting column ...........................42

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S7 / OPMI VISU 160 Safety Measures
Key to symbols
We would like to inform you about safety aspects which must be observed
when handling this device. This chapter contains a summary of the most im-
portant 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.
Information symbols
The following information symbols are used in these Instructions for Use:
–Listing
Requirements for an action
• Prompt for action
Result of an action
Additional information and hints
WARNING Warning label, which may refer to fatal injuries or severe injuries if pre-
cautions are not followed.
CAUTION Indicating a hazard, which may lead to moderately severe injuries
if risks are not avoided.
NOTE Warning label, which may refer to minor injuries and property damages
if precautions are not followed.

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Target group
These Instructions for Use are intended for physicians, medical and/or tech-
nical staff and nurses who prepare, operate or maintain the system after ap-
propriate training.
It is the duty of the equipment owner/operator to train and brief all the oper-
ating staff.
Service work not described in these Instructions for Use must only be per-
formed by specialists trained by ZEISS.
Field of application
Intended use
S7 / OPMI VISU 160 is a surgical microscope intended for magnifying the sur-
gical area and for supporting visualization in surgical procedures in the field
of ophthalmology.
Normal use
S7 / OPMI VISU 160 has been designed for surgical procedures in the field of
ophthalmology. Through its specific illumination system, the halogen light
source, the clip-on RESIGHT fundus viewing system and its mechanical con-
struction, it is adapted to the ophthalmic needs of the anterior and posterior
segments of the eye.
CAUTION Not for diagnostic purposes!
Do not use the recorded video sequences, video clips (cut sequences) and
single images for diagnostic purposes. The visualized images may include de-
viations in shape, contrast and color.

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S7 / OPMI VISU 160 Safety Measures
Use the protective devices offered to reduce radiation exposure in patients
with a high degree of retinal impairment. These devices include the blue bar-
rier filter and the retinal protection device.
Liability and warranty
Warranty and liability depend on the applicable contractual stipulations.
WARNING The device must not be modified without any approval!
This device must not be modified without the manufacturer's approval.
If the device is modified, appropriate examinations and tests must be per-
formed to guarantee the further secure use of the device.
The manufacturer is not liable for damages caused by an unauthorized use
of the device. Furthermore, this will invalidate any rights to make a claim
under the warranty.

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Notes for the operator
The correct use of the device is absolutely vital for safe operation. Therefore,
please thoroughly familiarize yourself with the content of these Instructions
for Use before starting up the system. Please also observe the Instructions for
Use of any additional equipment. You can obtain additional information from
ZEISS Service.
• Only operate the device within the scope of its intended use.
• Only personnel who have undergone training and instruction are allowed
to use this instrument. It is the responsibility of the customer or institution
operating the equipment to train and instruct all staff using the equip-
ment.
• Please keep these Instructions for Use where they are easily accessible at
all times for the persons operating the system.
• Please observe all symbols and labels attached to the device (see Page 26)!
• Only use original accessories or consumables approved by Carl Zeiss.
Legal regulations • Observe the legal regulations for accident prevention and occupational
health and safety applicable in the country concerned.
• This equipment must not be modified without the manufacturer's approv-
al. If the equipment is modified after consulting the manufacturer, appro-
priate examinations and tests must be performed to guarantee the further
secure use of the device.
The manufacturer is not liable for any damage caused by unauthorized use
of the equipment.
• If required by the regulations and directives applicable in the country of
use, connect the system to a special emergency backup power supply.
Ambient requirements • Do not operate the system contained in the delivery package
– in explosion-risk areas,
– if inflammable anesthetics or volatile solvents such as alcohol, benzine
or similar chemicals are present at a distance of less than 25 cm.
• Do not station or use the instrument in damp rooms. Do not expose the
instrument to water splashes, dripping water or sprayed water.
• Do not place any fluid-filled containers on top of the instrument. Make
sure that no fluids can seep into the instrument.

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S7 / OPMI VISU 160 Safety Measures
• Ensure that the installation requirements and the operation of the device
concur with the surgical conditions:
– Minimum vibration
– Clean environment
– Do not use the device under extreme mechanical stresses
Electrical safety • Always switch off the system before disconnecting it from / connecting it
to line power, for cleaning its surface or if it will not be used for a pro-
longed period of time.
• Switch off the unit at the power switch if you notice any smoke, sparks or
unusual noise. Do not use the system until it has been repaired by our serv-
ice team.
• A potential equalization connection can be found on the connection panel
(see IEC 60601-1:2005). This makes it possible to connect other active de-
vices to the same earth potential or it can be used for the redundant con-
nection with the grounding conductor.
• Do not use multiple sockets!
• Never open the device! The device contains freely accessible live compo-
nents. If you remove the housing, you run the risk of electric shock.
• Do not touch the system if your body is electrostatically charged and the
system is not grounded.
• Please note the information on EMC (electromagnetic compatibility) in the
chapter "System Data" on Page 185.
Transport & Service • The device may only be moved over long distances (e.g. relocation, return
for repair etc.) in its original packaging or in special return packaging.
Please contact your dealer or ZEISS Service.
• This system 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.
• 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 neces-
sary safety checks (see section "Care and Maintenance").
• Modifications and repairs of this device or any equipment operated to-
gether with this device may only be performed by ZEISS service staff or
other persons authorized by ZEISS.
Optics and light • Never directly look into the sun with binocular tube, object lens or an eye-
piece.

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• Avoid looking directly into the light source, e.g. into the microscope ob-
jective 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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Requirements for operation
Prior to the very first use
A ZEISS Service representative or an expert authorized by ZEISS 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.
All cables and plugs are in perfect condition.
The voltage set on the system corresponds to the rated line voltage on the
site of installation.
The power cord being used is the one designed for use with this system.
When connecting the device to any network, please ensure the network
is free of dangerous voltages.
More specific information about the floor stand:
The main plug must only be connected to a socket with
a faultless protective ground conductor.
More specific information about the ceiling mount:
The ceiling anchor has been correctly installed by the competent construc-
tion personnel.
This ceiling anchor complies with the specifications contained in our print-
ed "Planning Manual".
The device may only be connected to a power supply network which has
a faultless protective ground conductor.

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Before every use
• When adding accessories and/or components, please ensure the permis-
sible total weight of the device is not exceeded (see label "Maximum load"
or section "Technical Data").
• Before every use, make certain to compensate for any added weight; 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.
• Check the surgical microscope for sufficient freedom of movement. The
device itself or accessories may be damaged if conflicting with each other.
• To prevent accessories from falling down, check before every use that ac-
cessories are securely locked in position and securing screws are firmly
tightened.
• 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.
• Before using a fundus viewing system, make sure that the room for move-
ment is larger than the downward travel path of the microscope.
• Always run cables in a manner that will not impede the user's movements.
• Before every use, check the light source in order to prevent phototoxic in-
jury to the patient's eye.
• Have an OR illuminator or endo-illuminator ready during every procedure.
• Never cover any ventilation openings. This may cause the light source of
the device to overheat and fail.
• In the event of overheating, the lamp switches off automatically. When
the lamp has cooled down, it automatically switches on again. The pa-
tient's eye may be injured by the sudden high light intensity.
Activate the backup lamp immediately after the lamp failure or switch off
the illumination system.
• Do not exert any force when plugging in electrical plug-in connections
(connectors, jacks). If a connector/plug cannot be plugged in easily, check
whether the plug fits the socket. If you discover a plug-in connector is
damaged, have the ZEISS service team or an authorized professional repair
it.
• Position the suspension system in such a way that you can slide or swing
it away from the patient at any time.

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S7 / OPMI VISU 160 Safety Measures
• Prior to using the wireless foot control panel (FCP WL), make sure that its
batteries are fully charged. The system may malfunction if the FCP WL is
not provided an adequate level of power.
• Go through the checklist in the chapter "Operation".
• Depending on the type of application, take appropriate precautions to en-
sure that the surgical procedure or treatment can still be completed even
if the full functionality of this microscope (e.g. illumination) is not availa-
ble.
• If you operate the device in a sterile area, make sure that you use the cor-
responding sterile accessories for the device.
Sterile single-use drapes are available 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.
• Refer to the Instructions for Use for the sterile drape, and attach the drape
to the device in such a fashion that your field of view is not compromised.
More specific information about the ceiling mount:
• Move the lift arm or the lifting column down to its lower end position.
• Do not activate the lifting column or the lift arm during surgery. Do not
use the lifting column or the lift arm for focusing.
More specific information about the floor stand:
• Use the grab handle on the floor stand for moving.
• Pay attention to the height of doorways when passing through.
• Avoid collisions of any kind.
• Be extremely careful when moving over sloped surfaces.
• Do not park the stand on a sloped surface.
• Secure the system in position by pressing at least three of the locking tabs
on the stand base to prevent the stand from rolling away inadvertently.
• Do not exceed the instrument tray's load capacity of 13 kg.
During use
• 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.

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• In order to prevent phototoxic damages to the patient's eye during sur-
gery, use a retina protection filter (blue barrier filter) and/or a retina pro-
tection device that are integrated into the light source.
• Adjust the intensity of the irradiation and the resulting irradiation time by
selecting the appropriate illumination setting in order to prevent photo-
toxic injuries to the patient's eye. You will find the values recommended
by ZEISS in the table "Maximum radiation exposure times" on Page 21.
Any deviation from these values is only permissible when medically justi-
fied.
• In order to prevent phototoxic damages, never look directly into the light
source, e.g. on the microscope or the light guide.
• If the light guide is not connected at both ends, there may be a risk of fire
or burning when the illumination system is activated.
• Never leave a device unattended with the light source still switched on.
• If you have mounted the RESIGHT fundus viewing system on the underside
of the microscope and steeply tilt the microscope, the RESIGHT fundus
viewing system may unintentionally move in and injure the patient.
Remove the RESIGHT fundus viewing system before steeply tilting the mi-
croscope.
• Defective or unidentified accessories may lead to increased leakage cur-
rent on the system and injure the patient. Never connect any defective or
unidentified accessories and never touch the power outlet or video inter-
faces while in contact with the patient.
• If you need to change 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.
• In case of a faulty cable or a malfunction in the motor's electronic system,
the microscope can inadvertently move down on the patient. Turn off the
system at the power switch.
• Malfunctions in the motor's electronic system may cause failure of the
main functions (X-Y movement, focus, zoom, light control) and impair
other functions. Proceed in manual mode.
• In the event that the zoom function can no longer be controlled via the
foot control panel or the control panel, adjust the zoom factor manually
at the microscope.
• In the event that the focusing function can no longer be controlled via the
foot control panel or the control panel, use the suspension arm to focus
the surgical field. This may lead to patient injury or the damaging of at-
tached equipment. Ensure to provide sufficient clearance between equip-
ment and patient (min. 40 mm) when focusing manually. Ensure that any
installed accessories do not come into contact with other objects.

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S7 / OPMI VISU 160 Safety Measures
• In the event that the X-Y movement of the surgical microscope can no
longer be controlled via the foot control panel or the control panel, posi-
tion the device manually via the suspension arm. Again, you should ensure
to provide sufficient clearance between equipment and patient (min. 40
mm).
• In the event that the light intensity can no longer be controlled via the foot
control panel or the control panel, regulate the illumination manually at
the suspension system.
• If a failure occurs which you cannot correct with the aid of the chapter
"What to do in the event of malfunctions attach a sign to the system stat-
ing it is out of order and inform ZEISS Service.
• Do not pull at the light guide, power cord or any other connecting cables.
• Never operate the system unattended.
• Risk of crushing fingers!
Fingers may be crushed in the areas marked with the "Risk of crushing fin-
gers" label.
Do not touch these areas while the machine is being moved.
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 not complying
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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Measures to prevent phototoxic injury
Several papers1)-5) dealing with the problem of phototoxicity in ophthalmic
surgery have been published. A comprehensive review of these publications
reveals five aspects of particular concern:
– Illumination characteristics (spectral composition)
– Illumination intensity
– Angle of illumination
– Focus of the light source
– Exposure time to light
In the following, comments on these aspects are given and a description of
how ZEISS, as a manufacturer, makes allowance for them in its systems.
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.
ZEISS offers the blue barrier filter (retina protection filter) for surgical micro-
scopes recommended for use in ophthalmic surgery. 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 inevi-
tably change the perceived color of the light. For this reason, the surgeon may
initially have to get used to the changed appearance of the anatomical struc-
tures.
Illumination intensity
The majority of researchers suggest that the surgeon should use the lowest
light intensity required at the patient's eye to guarantee good viewing during
surgery.
ZEISS has addressed this aspect by providing its systems with a device for con-
tinuously varying the brightness of the light source. This permits the surgeon
to optimally adapt the light intensity at the patient's eye to the conditions ex-
isting in each case.

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Angle of illumination
A number of publications1)-4) suggest that the microscope should be tilted to
reduce the exposure of the macula to direct illumination.
The surgical microscope features a 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 filament is consider-
ably higher than that of an even and extended light source such as a light
guide.
This is the reason why ZEISS uses fiber optic illumination in its surgical micro-
scope systems.

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Exposure time to light
Duration of exposure to light
According to some publications, the phakic and aphakic eye should not be ex-
posed to the light source longer than a few minutes. In all surgical cases, the
retinal exposure time to light depends on the type and duration of the proce-
dure and possible case complications. It is therefore recommended in oph-
thalmic 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. It is also
recommended to make sure that the patient's eye is not additionally exposed
to the light of surrounding light sources. This problem has been solved by
ZEISS by the use of a retinal protection device that can be swung into the mi-
croscope's illumination beam path and a blue barrier filter (retina protection
filter).
The microscope light source - like any bright light source - may present a
hazard to the patient's eye both in the form of immediately visible thermal
damage to the retina as well as phototoxic chemical reactions which may lead
to photoretinitis. The factors which play an important role in determining the
phototoxic risk are:
– Lamp brightness.
– Spectral distribution of the light (UV and blue are more dangerous than
longer wavelengths).
– Duration of direct exposure.
– Pupil size.
– Clarity of ocular media (infants and young children, for example, may be
at a higher risk).
– Phakic status of the eye (aphakic and pseudo-aphakic eyes without UV
and blue filtering IOLs are at a higher risk).
– Previous exposure to bright light such as retinal photography, especially
within the last 24 hrs.
During cataract procedures, factors such as lenticular material, instruments
such as the phaco handpiece, and movement of the eye provide interruption
of the exposure and would be expected to significantly lengthen the time be-
fore photoretinitis might be expected to occur.
A prospective study 7) of the effects of microscope illumination during surgery
did not reveal any phototoxic retinal injuries for procedure times of up to 30
minutes if the calculated maximum recommended exposure time was 150
seconds. However, it was also found that at the same brightness setting, pho-
totoxic retinal injury could be expected after approximately 100 min.