Zeiss OPMI PROergo S7 User manual

ZEISS
S7 / OPMI®PROergo®
Instructions for Use
G-30-1435-en
Version 11.0
2018-11-30

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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
Trademarks OPMI und PROergo is a trademark/are trademarks or registered trademark(s)
of Carl Zeiss Meditec AG or other companies of the ZEISS Group in Germany
and/or other countries.
Manufacturer's details
Subject to changes in design and scope of delivery, as well as ongoing
technical development. Printed in Germany.
Copyright © Carl Zeiss Meditec AG 2018
All rights reserved. Reprints and reproductions, in whole or in part, are
prohibited. 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
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany
Fax: + 49 (0) 7364 - 20 4823
Email: [email protected]
Internet: www.zeiss.com/med

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be prevented.

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Summary of the section
Section: Safety measures 7
Section: Device overview 57
Section: Preparations for use 139
Section: Operation 179
Section: What to do in the event of malfunctions 197
Section: Care and maintenance 213
Section: Device data 227
Section: Keyword index 259

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Safety measures
Key to symbols .................................................................................9
Hazard symbols ..........................................................................................9
Information symbols ...................................................................................9
Target group ..................................................................................10
Field of use .....................................................................................10
Intended use ............................................................................................10
Normal use ...............................................................................................10
Reasonably foreseeable misuse .................................................................11
Liability and warranty .....................................................................11
Notes for the operator ....................................................................12
Requirements for operation ............................................................15
Prior to the very first use ...........................................................................15
Before every use .......................................................................................16
During use ................................................................................................18
After every use .........................................................................................19
Risk of burn injuries caused by high illumination intensity .........................20
Stand safety equipment ............................................................................23
Symbols and labels on the device ...................................................28
Labels on the microscope .........................................................................28
Labels on the connection panel ................................................................31
Labels on S7 floor stand ...........................................................................32
Additional labels on S7 floor stand (instrument tray option) ......................38
Labels on S7 ceiling mount .......................................................................40
Additional label on S7 ceiling mount with lifting column ..........................44

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Labels on S7 wall mount and on S7 Centro suspension system ................ 46
Additional labels on S7 wall mount .......................................................... 51
Labels on the light sources of the suspension systems .............................. 52
Labels on the wall power outlet (optional) ............................................... 55

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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.
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
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.

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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
OPMI PROergo is a surgical microscope intended for the illumination and
magnification of the treatment and surgical area and for the support of
visualization in treatment and surgical procedures.
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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Reasonably foreseeable misuse
Liability and warranty
The warranty and liability depend on the contractually specified conditions.
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.
CAUTION Injury to the patient's eye!
• The S7 / OPMI PROergo must not be used for ophthalmic procedures!
• Make sure that no light enters the patient's eyes.
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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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 comply with the Instructions for
Use of the other system components as well. You can obtain additional
information from ZEISS Service.
•Only operate the device within the scope of its intended use.
•This device must be used by properly instructed and trained personnel
only. It is the duty of the customer or institution operating the equipment
to train and instruct all staff using the equipment.
•Keep the Instructions for Use accessible to the operating personnel at all
times.
•Note the symbols and labels attached to the device! (See Page 28.)
•Only use original accessories or consumables approved by ZEISS.
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
WARNING The device must not be modified without any approval!
Do not modify the device without approval from the manufacturer. 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.

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– in areas where there is a risk of explosion,
– or at a distance of less than 25 cm from flammable anesthetics or
volatile solvents such as alcohol, benzine or similar substances.
•Do not use or store the device in a damp place. Do not expose the system
to dripping water, running water, sprayed water or splashes.
•Ensure that fluids cannot enter the device.
•Ensure that the installation conditions and the use of the device meet
surgical requirements:
–Lowvibration
– Clean environment
– Avoidance of extreme mechanical stress
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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•In order to prevent any impairment of the device’s safety due to age,
wear, etc., the user must ensure that the device is subjected to the
necessary safety checks (see section "Care and maintenance").
•Modifications and repairs of this device or any equipment operated
together with this device may only be performed by ZEISS SERVICE or
other specialists authorized by Carl Zeiss.
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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Requirements for operation
Prior to the very first use
The system is installed by ZEISS Service or by a specialist designated by ZEISS.
Make sure that the following requirements continue to be met for subsequent
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 device is connected with the power cord supplied.
When connecting the device to a network, make sure that the network
does not carry a hazardous voltage.
Specific information about the floor stand:
The power cord may only be plugged into a power outlet that
is properly grounded.
More specific information about the ceiling mount:
The ceiling anchor has been correctly installed by the competent
construction personnel.
This ceiling anchor complies with the specifications contained in our
printed "Planning Manual".
The device may only be connected to a power outlet that
is properly grounded.

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Before every use
•When mounting accessory equipment, please make sure that the
admissible total weight of the surgical microscope is not exceeded.
(see "maximum load" label or the 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 make sure that accessories do not fall down, check before each use
that they are firmly seated and the securing screws are firmly tightened.
•When connecting accessories, make sure that there is sufficient clearance
and that the surgical microscope does not touch the patient.
•Before every use, check the user settings in the software to avoid
unexpected behavior of the system.
•Always route cables so that they do not hinder the user.
•Never connect any unknown or defective devices to the electrical
interfaces (e.g. for data, video or foot control panel).
• Connect components only to properly grounded outlets.
• When setting up your system, make sure to comply with the requirements
of IEC 60601-1, chapter 16 (in some countries IEC 60601-1-1 may still be
valid).
•Reattach any covers or caps that have been removed. Close any existing
openings with the corresponding caps.
Before starting the system, remove the protective cover used for
transportation from the objective lens.
•If the xenon lamp is used beyond its maximum service life of 500 hours,
asudden failure may occur. Change to the backup lamp (see Page 204)
or replace the lamp module in a timely manner (see Page 222). Reset the
service hour counter of the xenon illumination.

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S7 / OPMI PROergo Safety measures
•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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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.
Specific information about the floor stand:
•Use the grab handle on the floor stand for moving.
• Mind the maximum vertical clearance when passing through doorways.
• Avoid any jolting.
• Risk of toppling – only move the device over steps or raised edges if two
people are available to hold and lift it!
• Be extremely careful when moving over slopes.Be extremely careful when
moving over slopes.
• Do not park the device on sloped surfaces.Do not park the device on
sloped surfaces.
•Secure the device in position by pressing down the immobilizers on the
stand base to prevent the stand from rolling away by itself.
•Do not exceed the instrument tray’s load capacity of 13 kg.
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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•Constantly monitor the system during use.
•Risk of crushing - mind your fingers!
Fingers may be crushed in the areas marked with the "Risk of crushing"
sign.
Do not touch these areas while the device is being moved.
After every use
•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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Risk of burn injuries caused by high illumination intensity
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.
Various factors influence the risk of burn injuries:
System-related factors
– The wavelength range is limited by filters to the visible range between
400 nm and 700 nm in order to reduce the risk of burn injuries.
– The illumination intensity decreases with increasing number of operating
hours of the light source. In case of a lamp exchange, illumination
increases to the originally high value.
Surgery-related factors
– The selected intensity of the light source is a major factor for the risk of
injury. It should always be set to the minimum required for the surgical
procedure to be performed.