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

Version 9.0
G-30-1781-en Page 3
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.

S100 / OPMI pico
Version 9.0
Page 4 G-30-1781-en

S100 / OPMI pico
Version 9.0
G-30-1781-en Page 5
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

S100 / OPMI pico
Version 9.0
Page 6 G-30-1781-en

Version 9.0
G-30-1781-en Page 7
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

Safety measures S100 / OPMI pico
Version 9.0
Page 8 G-30-1781-en
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.

Version 9.0
G-30-1781-en Page 9
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,

Safety measures S100 / OPMI pico
Version 9.0
Page 10 G-30-1781-en
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.