Zeiss Opmi lumera 700 Manual de usuario

Carl Zeiss

OPMI LUMERA®700

User manual

G-30-1673-en

Version 7.3

2012-05-02

OPMI LUMERA® 700

Version 7.3

Page 2 G-30-1673-en

About this manual The instruction for use is part of the delivery package.

• Carefully read it before using the device.

• Keep it at the site of use of the device.

• Store it for the entire service life of the device.

• Pass it on to every subsequent owner or user of the device.

Orientation aids – The chapter overview at the beginning of these instructions for use pro-

vides a summary of all subjects.

– 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 facili-

tates the search for specific terms.

Scope of application The present operating manual applies to the OPMI LUMERA 700 with soft-

ware release 2.0 and the following identification:

– Reference number 6634 (floor stand)

– Reference number 6726 (ceiling mount)

Trademarks –OPMI

®, LUMERA®, Invertertube®E, CALLISTO eye®, HaMode®,

Superlux®, RESIGHT®, VISULUX®, VisionGuard®and MediLive®Trio,

ZALIGN

® and K TRACK® are registered trademarks of Carl Zeiss.

–SCI

™(Stereo Coaxial Illumination) and MEDIALINK™100 are trademarks

of Carl Zeiss.

Manufacturer

Subject to changes in design and scope of delivery and as a result of ongoing

technical development. Printed in Germany.

permissible. However, this manual may be digitized and archived for internal

use. Access to this data by third parties is not permissible and must be pre-

vented.

Carl Zeiss Meditec AG

Goeschwitzer Strasse 51-52

07745 Jena

Germany

Fax: + 49 (0) 7364 - 20 4823

E-Mail: [email protected]

Internet: www.meditec.zeiss.com

OPMI LUMERA® 700

Version 7.3

G-30-1673-en Page 3

Chapter Overview

Chapter: Safety Measures 5

Chapter: System Overview 47

Chapter: Preparations for use 107

Chapter: Operation 161

Chapter: What to do in the event of malfunctions 239

Chapter: Care and Maintenance 255

Chapter: System Data 271

Chapter: Annex / Options 305

Chapter: Indexes 407

OPMI LUMERA® 700

Version 7.3

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OPMI LUMERA® 700 Safety Measures

Safety Measures

Key to symbols ..................................................................................7

Hazard symbols ...........................................................................................7

Information symbols....................................................................................7

Target group .....................................................................................8

Field of application ............................................................................8

Intended use ...............................................................................................8

Normal use..................................................................................................8

Notes for the operator.....................................................................10

Requirements for operation.............................................................13

Prior to the very first use............................................................................13

Before every use........................................................................................13

During use.................................................................................................15

After every use ..........................................................................................16

Liability and warranty......................................................................17

Measures to prevent phototoxic injury ............................................18

Illumination characteristics (spectral composition)......................................18

Illumination intensity .................................................................................18

Angle of illumination .................................................................................19

Focus of the light source ...........................................................................19

Exposure time to light................................................................................20

Safety devices..................................................................................24

Symbols and labels on the device ....................................................30

Microscope labels......................................................................................30

Safety Measures OPMI LUMERA® 700

Version 7.3

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Labels on the suspension system............................................................... 32

Labels on the lamp housing ...................................................................... 42

Device connector signs ............................................................................. 44

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G-30-1673-en Page 7

OPMI LUMERA® 700 Safety Measures

Key to symbols

We would like to inform you about safety aspects which must be observed

when handling this device. This chapter contains a summary of the most im-

portant 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:

–Listing

Requirements for an action

• Prompt for action

Result of an action

Additional information and hints

WARNING Warning label, which may refer to fatal injuries or severe injuries if pre-

cautions are not followed.

CAUTION Indicating a hazard, which may lead to moderately severe injuries

if risks are not avoided.

NOTE Warning label, which may refer to minor injuries and property damages

if precautions are not followed.

Safety Measures OPMI LUMERA® 700

Version 7.3

Page 8 G-30-1673-en

Target group

These instructions for use are intended for physicians, nurses and other med-

ical staff who prepare, operate or maintain the system after the appropriate

training and in accordance with the instructions given in these instructions for

use. It is the duty of the customer or institution operating the system to train

and instruct all staff using the system.

Installation and service work not described in these instructions for use must

only be performed by specialists from Carl Zeiss.

Field of application

Intended use

OPMI LUMERA 700 is a surgical microscope intended for the illumination and

magnification of the surgical area and for the support of visualization in sur-

gical procedures in the field of ophthalmology.

Normal use

In line with the intended use of the system, you can use it for surgical proce-

dures on both the anterior segment of the eye (e.g. cataract, cornea, glau-

coma) and the posterior segment of the eye (retina, vitreous).

The system-integrated SCI illumination provides an optimum red reflex and

delivers a sharply defined, high-contrast image of the patient's eye. The freely

programmable foot control panel or, alternatively, the handgrips ensure max-

imum operating comfort for the surgeon who can configure all settings re-

quired to meet his/her specific needs. In addition, the OR staff can configure

the microscope, the integrated SD 3CCD/HD 3CCD camera or change the SD/

HD video and image acquisition system using the adjustable 5.7" control

panel. The fast focus allows rapid movement over a defined travel range and

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OPMI LUMERA® 700 Safety Measures

enables the surgeon to move the focus very easily over long distances (e.g. for

folding lenses) and back to its initial position. Assistant functions such as the

keratoscope, the data injection system or the integrated slit illuminator ex-

pand the surgeon's scope of work. After completion of the surgical proce-

dure, the system can be reset to the selected, freely programmable starting

values via the standby position or reset function to ensure an optimum

starting position for the next surgery.

The system is available as a mobile and as a ceiling-mounted surgical micro-

scope. It can be supplemented by various accessories and can be prepared for

sterile use by attaching resterilizable caps, handgrips and sterile drapes. For

attachment and alignment of a 22" TFT monitor, CALLISTO eye or an oper-

ating light, the ceiling.mounted surgical microscope can be fitted with an ad-

ditional carrier arm system.

The system is intended for use in offices, hospitals or other human medicine

institutions. For disposal, please observe these instructions of use as well as

the applicable legal regulations in your country.

Safety Measures OPMI LUMERA® 700

Version 7.3

Page 10 G-30-1673-en

Notes for the operator

• Prior to using the device for the first time, please read the instructions for

use thoroughly. Also ensure to read the instructions of accessory tools.

• Only personnel who have undergone training and instruction are allowed

to use this instrument. It is the responsibility of the customer or institution

operating the equipment to train and instruct all staff using the equip-

ment.

• Only operate the device within the scope of its intended use.

• Please keep these instructions for use where there are easily accessible at

all times for the persons operating the system.

• Only personnel who have been appropriately briefed are allowed to con-

trol the surgical microscope via CALLISTO eye (option). Any change in the

focus and zoom setting via CALLISTO eye may lead to unwanted move-

ment at the surgical microscope during application (e.g. in the OP mode).

• Please observe all symbols and labels attached to the device! (see page 30)

• Observe the legal regulations for accident prevention and occupational

health and safety applicable in the country concerned.

• This system must not be modified without the manufacturer's approval. If

the system is modified, suitable inspections and testing must be complet-

ed to ensure that it can still be used safely.

The manufacturer is not liable for damage caused by unauthorized per-

sons tampering with the system. Furthermore, this will forfeit any rights

to claim under warranty.

• Modifications and repairs of this device or any equipment operated to-

gether with this device may only be performed by Carl Zeiss service staff

or other persons authorized by Carl Zeiss.

• Connect the system to a special emergency backup power supply in ac-

cordance with the regulations and directives applicable in the country of

use.

• Ensure that the installation requirements and the operation of the device

concur with the surgical conditions:

– minimum vibration

– clean environment

– do not use the device under extreme mechanical stresses

• Do not use any power-operated device that is part of the delivery scope

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