Zeiss OPMI Lumera T Bedienungsanleitung

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.

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

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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

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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

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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

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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.

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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

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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.

•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.

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