Zeiss S100 User manual

ZEISS
S100 / OPMI pico
Instructions for Use
G-30-1781-en
Version 9.0
2018-11-23

S100 / OPMI pico
Version 9.0
Page 2 G-30-1781-en
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 the topics.
– The contents of each chapter are specified in detail at the beginning of
each chapter.
– A list of abbreviations, key words and technical terms in the annex
facilitates the search for specific terms.
Scope These Instructions for Use apply to the S100 / OPMI pico with the following
identification label:
Trademark OPMI is a trademark or registered trademark 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.
Package Reference
number
S100 / OPMI pico (floor stand) 000000-1403-542
S100 / OPMI pico (wall mount) 000000-1403-544
S100 / OPMI pico (ceiling mount) 000000-1403-572
S100 / OPMI pico (Centro suspension system) 000000-1403-573
S100 / OPMI pico (support unit) 000000-1420-191
S100 / OPMI pico (support unit for secondary lighting) 000000-1095-094
S100 / OPMI pico (Atmos support unit) 000000-1080-349
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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S100 / OPMI pico
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
be prevented.

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Summary of the section
Section: Safety measures 7
Section: Device overview 51
Section: Preparations for use 89
Section: Operation 127
Section: What to do in the event of malfunctions 207
Section: Care and Maintenance 221
Section: Device data 233
Section: Indexes 261
Section: Keyword index 265

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S100 / OPMI pico Safety measures
Safety measures
Key to symbols .................................................................................8
Hazard symbols ..........................................................................................8
Information symbols ...................................................................................8
Target group ....................................................................................9
Field of use .......................................................................................9
Intended use ..............................................................................................9
Normal use .................................................................................................9
Notes for the operator ....................................................................10
Duties of the operator ..............................................................................11
Requirements for operation ............................................................13
Prior to the very first use ...........................................................................13
Before every use .......................................................................................14
During use ................................................................................................15
After every use .........................................................................................16
Risk of burn injuries caused by high illumination intensity .............17
Safety features ...............................................................................19
Symbols and labels on the device ...................................................22
Symbols and labels on the microscope ......................................................22
Symbols and labels on the S100 ...............................................................24
Symbols and labels on the light sources ....................................................40
Symbols and video control units (optional) ................................................48

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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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S100 / OPMI pico Safety measures
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
The S100 / OPMI pico is a surgical microscope designed to illuminate and
magnify the surgical area and to support the visualization of surgical
procedures.
Normal use
The S100 / OPMI pico is a microscope that is operated manually on a sitting
or lying patient.
Provision: The S100 /OPMI pico offers in conjunction with different suspension systems
(e.g. floor stand, wall mount, ceiling mount) and flexible carrier arms, an
ergonomic working position for the treatment environment or surgery.
The system can be securely moved into the working position with the hand
grips without any problems.
Treatment / surgery: The microscope is positioned and roughly focused by the physician or
the surgeon. The most frequently used functions as the setting of focus,

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magnification and light intensity are manually controlled by the physician or
the surgeon during treatment or surgery.
A video player is connected to the system for educational purposes or to
visualize the progress of the treatment / surgery.
After the procedure /
operation
The physician or the surgeon swings the surgical microscope from the
treatment or surgical area into its standby position.
The S100 / OPMI pico can be cleaned and disinfected.
Disposal: For the disposal of electrical and electronic devices, please observe the
relevant national legislation and other regulations applicable in your country.
Notes for the operator
Correct operation of the device is required to ensure safe use,
• so please familiarize yourself thoroughly with these Instructions for
Use before starting up the instrument.
• Please comply with the Instructions for Use of the other system
components as well. You can obtain additional information from
ZEISS Service.
CAUTION Injury to the patient's eye!
• The S100 / OPMI pico must not be used for ophthalmological 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 must not be used for diagnosis purposes. Visualized
images may contain variations in shape, contrast and color.

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S100 / OPMI pico Safety measures
Duties of the operator
• Only operate the device within the scope of its intended use.
• The device may be operated only by properly instructed and trained
persons. It is the responsibility 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.
• For planning the S100 ceiling support or S100 wall support, follow the
Planning Manual (publication M-30-1385).
• Note the symbols and labels attached to the device (see Page 22)!
• Use only original accessories 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 device is modified, appropriate examinations and tests must
be performed to guarantee the further secure use of the device.
The manufacturer is not liable for damage caused by unauthorized use
of the device. Furthermore, such unauthorized modifications will render
the warranty and any claims under warranty invalid.
• Modifications and repairs on this device or any equipment operated
together with this device may only be performed by ZEISS SERVICE.
• If required by the regulations and directives applicable in the country of
use, connect the system to a special emergency backup power supply.
Ambient conditions • Do not use the power-operated devices included in the delivery package
– 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.

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• Make sure that the installation conditions and the use of the device meet
surgical requirements: See "Ambient conditions" on Page 259
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.
•Donot
use multiplug strips or extension cords!
• Position the device so that you can disconnect it from the power supply at
any time.
• 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 pull on the light guide, power cord or any other connecting cables.
• Do not touch the device if your body is electrostatically charged and the
device is not grounded.
• A potential equalization connector is provided on the instrument's
connection panel (see IEC60601-1). This connector is optional for halogen
and xenon lighting. This connector can be used to connect other active
devices to the same ground potential or for redundant connection to the
protective ground.
• Please note the information on EMC (electromagnetic compatibility) in the
chapter "System data" on Page 247.
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.
• 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").
Accessories and additional
equipment
Any additional equipment you connect to medical electrical devices
must demonstrably comply with the applicable standards and directives

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S100 / OPMI pico Safety measures
(e.g. IEC 60950 for data processing equipment).
In addition,, all configurations must comply with the standards for medical
systems (see IEC 60601-1, section 16; in some countries IEC 60601-1-1 may
still be valid). Anyone connecting additional equipment to medical electrical
devices is a system configurer and as such responsible for compliance of the
system with the normative requirements for 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 ZEISS Service.
Optics and light • Never look into a light source or the sun with the binocular tube,
the objective lens or an eyepiece.
• Never look directly into the light source, e.g. the microscope objective lens
or light guide, as this may cause phototoxic injury to the eye.
• Adjust the brightness on the suspension system. Start with the lowest
brightness and then slowly increase the brightness until the necessary
level is reached but do not exceed the permissible level.
• With increasing age of the light source, the actual illumination intensity
delivered at the setting in question decreases (this is a normal property of
the system).
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:

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The connecting components have been properly connected. The screw
connections have been firmly tightened.
All cables and plugs are in perfect condition, i.e. without signs of wear,
kinks or other damage.
Determine the supply voltage at the place of installation and set the
voltage of the device accordingly.
The device is connected with the power cord supplied.
Check whether the device fuse used is the correct one as specified on the
fuse label.
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").
• When connecting accessories make sure that sufficient free space is
provided and that the surgical microscope does not touch the patient.
• Before every use, perform the balancing procedure to enable the surgical
microscope to maintain its balance in all positions of the working range.
• Check the surgical microscope for sufficient freedom of movement. The
device itself or accessories may be damaged if conflicting with each other.
WARNING The device must not be modified without any approval!
Do not modify the device without approval from the manufacturer.
If the device is modified, suitable inspections and testing must be carried out
to ensure that it can still be used safely.
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.
WARNING Danger! Electrical voltage!
• To avoid the risk of electrical shock, this device may only be connected
to a power supply network which is provided with a protective ground
conductor.

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S100 / OPMI pico Safety measures
• 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.
• Always route cables so that they do not hinder the user.
• If you operate the device in a sterile area, make sure that you use the
corresponding sterile accessories for the device.
• Make sure that the operating staff is briefed about the sterile operation of
the system.
• Never cover any ventilation openings, as the light source of the system
switches off in the event of overheating.
• Never use force when trying to connect any electrical connectors (plugs,
sockets). If the connection cannot be made easily, check whether the plug
fits the socket. If you detect any damage to the plug-in connection,
arrange for the damage to be repaired by ZEISS Service.
• Please refer to the functional test in chapter "Operation" (Page 129).
More specific information about the floor stand:
• Press the locking tabs on the stand base to secure the stand in position.
Make sure that the stand is stable and cannot roll away.
During use
• Reduce the brightness and duration of light exposure of the surgical area
to the absolute minimum level required to avoid burn injuries.
• Never look directly into the light source, e.g. the microscope objective lens
or light guide, as this may cause phototoxic injury to the eye.
• Never leave a device unattended when its light source is switched on.
• Defective or unapproved accessories may lead to increased leakage
current on the device. Do not connect any defective or unapproved
accessories to the device.
• Never touch the video interfaces or other signal interfaces while you are
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.

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• If the xenon lamp is used beyond its maximum service life of 500 hours
(see chapter "Maintenance intervals" on Page 222), sudden failure may
occur and interrupt operation. Change to the backup lamp or replace the
lamp module in a timely manner.
• 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 224).
• Do not pull on the power cord or any other connecting cables.
• 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.
• Constantly monitor the system during use.
• Always switch off the system every time before:
- connecting it to / disconnecting it from line power
- if it will not be used for a prolonged period of time
- or if you want to clean its surface.
• If the light guide is not connected at both ends, there may be a risk of fire
or burning when the light source is activated.
• 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.
• Insufficient, incorrect or wrong cleaning or disinfection contrary to the
instructions of the Instructions for Use may expose the patient or medical
staff to a considerable risk of infection. For more information, please see
"Maintenance of the device" in the chapter "Care and maintenance".

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Risk of burn injuries caused by high illumination intensity
General
This device is optionally equipped with a powerful xenon light source.
Various factors can contribute to the risk of burn injuries:
Device-related factors:
– With increasing service life of the lamp, the actual light intensity delivered
at the respective setting decreases. 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.
– 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 gauze must be moistened at regular intervals to prevent the area from
drying out or heating up.
– Certain preparations of the surgical field, the administration of
vasoconstrictive medications and surgical incision drapes may also result
in a higher risk of injury (surgical drapes may heat up to varying degrees
depending on their color and moisture content).
– It should also be considered that some areas of the body may be more
sensitive than others.
CAUTION Risk of burns caused by high light intensity!
In case of a misuse of the light source, a too high illumination intensity may
cause tertiary burns.
• Please read and note the following points.

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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.
– The interaction of heat and antimicrobial substances in incision foils may
lead to an increased reaction of the patient to these substances.
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, this system has
several features that can help the user to reduce the risk of burns.
– The start value of the illumination intensity can be set to a low value.
– The risk of burns can be reduced by constantly by irrigating the illuminated
surgical field and by keeping it moist.
– If used, surgical drapes should also be remoistened at regular intervals in
order to prevent heat from accumulating underneath the surgical drape.
– 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 in most published cases of burns the skin around the incision
was affected. The most important measure for avoiding burns is to cover the
peripheral area with wet, sterile 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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Safety features
Halogen light source
1Flap
The flap is used as mechanic indicator of the operating status of the
halogen light source.
– 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.
2Switching to the backup lamp
The lamp housing contains a backup lamp. If the first lamp fails, you can
switch on the backup lamp by pressing this button.
• Replace the defective lamp at the first opportunity (see Page 224).
Fig. 1: Safety device for the
halogen light source
2
1

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xenon light source
– UV / IR heat protection filter
The filter protects against UV and IR radiation.
– Temperature monitoring
A sensor constantly monitors the lamp temperature.
1Switching to the backup lamp
The xenon light source has a lamp module containing two xenon lamps.
The second lamp is used as backup lamp. Manually swivel in the backup
lamp into position (Page 217), if the maximum service ;life of 500hours
is reached (see chapter "Maintenance intervals" on Page 222). When the
red segment (2) in the knob (1) lights up, the backup lamp is in use.
Keep the lamp module ready if you work with the backup lamp.
If the backup lamp is operated, replace the lamp module in a timely
manner (see Page 224) before it is used beyond its maximum service life
of 500 hours (see chapter "Maintenance intervals on Page 222).
Fig. 2: Safety system xenon
light source
CAUTION Limited service life of the xenon lamp!
If used longer than the indicated service life of 500 hours the xenon lamp
may fail or burst.
Dropping fragments may contaminate the sterile area. Risk of infection.
• Change the lamp module on time.
1
3
2