Zeiss OPMI Lumera T User manual

ZEISS
S88 / OPMI Lumera T
Instructions for Use
G-30-1682-en
Version 8.0
2018-11-08

S88 / OPMI Lumera T
Version 8.0
Page 2 G-30-1682-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.
– You will also find a detailed table of contents at the beginning of each
section.
– The index facilitates searching via keywords.
Subject to change
without notice
Subject to changes in design and scope of delivery, as well as ongoing
technical development. Printed in Germany.
Scope These Instructions for Use apply to OPMI LUMERA T with the following stand
and identification:
– S88 floor stand, reference number: 305952-9940-000
Device names in
these Instructions for Use
For the purposes of clarity and improved readability, the device name
"S88 / OPMI Lumera T" has been shortened to "OPMI Lumera T" in these
Instructions for Use.
Trademark OPMI, OPMI Lumera, Superlux, Invertertube, HaMode and EDIS are
trademarks or registered trademarks of Carl Zeiss Meditec AG or another
company 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 be prevented.
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

S88 / OPMI Lumera T
Version 8.0
G-30-1682-en Page 3
Summary of the section
Section: Safety measures 5
Section: Device overview 55
Section: Preparations for use 131
Section: Operation 165
Section: What to do in the event of malfunctions 193
Section: Care and Maintenance 211
Section: Device data 225
Section: Keyword index 251

S88 / OPMI Lumera T
Version 8.0
Page 4 G-30-1682-en

Version 8.0
G-30-1682-en Page 5
S88 / OPMI Lumera T Safety measures
Safety measures
Key to symbols .................................................................................7
Hazard symbols ..........................................................................................7
Information symbols ...................................................................................7
Device names in these Instructions for Use .................................................8
Target group ....................................................................................8
Field of use .......................................................................................8
Intended use ..............................................................................................8
Normal use .................................................................................................9
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 ................................................................................................16
After every use .........................................................................................18
Phototoxic injury to the patient's retina ....................................................19
Stand safety equipment ............................................................................24
Symbols and labels on the device ...................................................36
Labels on the microscope .........................................................................36
Labels on S88 floor stand .........................................................................42
Labels on the connector panel of the S88 floor stand ...............................46
Additional label on the S88 floor stand (Instrument tray option) ...............48
Labels on the light sources of the suspension systems ..............................50
Labels on the control panel of the suspension systems .............................52

Safety measures S88 / OPMI Lumera T
Version 8.0
Page 6 G-30-1682-en

Version 8.0
G-30-1682-en Page 7
S88 / OPMI Lumera T Safety measures
Key to symbols
We would like to inform you about safety requirements with which you must
comply when working with this system. 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
9Requirements for an action
• Prompt for action
ÆResult 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.

Safety measures S88 / OPMI Lumera T
Version 8.0
Page 8 G-30-1682-en
Device names in these Instructions for Use
For the purposes of clarity and improved readability, the device name
"S88 / OPMI Lumera T" has been shortened to "OPMI Lumera T" in these
Instructions for Use.
Target group
These instructions for use are intended for physicians, nurses and other
medical staff who prepare, operate or maintain the device after training by
ZEISS personnel. 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 Lumera T is a surgical microscope intended for magnifying the surgical
area and for supporting visualization in surgical procedures in the field of
ophthalmology.

Version 8.0
G-30-1682-en Page 9
S88 / OPMI Lumera T Safety measures
Normal use
OPMI Lumera T was designed for surgical procedures in the field of
ophthalmology. Through its specific SCI (Stereo Coaxial Illumination) system,
various light sources (halogen, Superlux Eye xenon), the clip-on RESIGHT
fundus viewing system and its mechanical construction, it is adapted to the
ophthalmic needs of the anterior and posterior segments of the eye.
Use the protective devices offered to reduce radiation exposure in patients
with a high degree of retinal impairment. These devices include the blue
barrier filter and the retinal protection device.
Liability and warranty
The warranty and liability depend on the contractually specified conditions.
CAUTION Not for diagnostic purposes!
Do not use the recorded video sequences, video clips (cut sequences)
and single images for diagnostic purposes. Visualized images may contain
variations in shape, contrast and color.
NOTE Loss of warranty
Modifications to this device are not permitted. 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.

Safety measures S88 / OPMI Lumera T
Version 8.0
Page 10 G-30-1682-en
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.
•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 available at all times for the operating
personnel.
•Note the symbols and labels attached to the device! (See page 36).
•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 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. Furthermore, such unauthorized modifications
will render the warranty and any claims under warranty invalid.
•If required by the applicable national laws and regulations, connect the
device to the special "equivalent 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 damp rooms. Do not expose the system
to dripping water, running water, gushing water, sprayed water or splashes.