Zeiss S100/OPMI pico Manual de usuario

ZEISS

S100 / OPMI®pico

Instructions for Use

G-30-1781-en

Version 7.0

2015-09-09

S100 / OPMI pico

Version 7.0

Page 2 G-30-1781-en

About this manual These Instructions for Use are part of the delivery package.

• Carefully read them 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 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.

Area of application These Instructions for Use apply to the S100 / OPMI®pico with the following

identification:

Trademarks OPMI® is a registered trademark of Carl Zeiss.

Configuration REF. no.

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 non-Zeiss illumination)

000000-1095-094

S100 / OPMI®pico (Atmos support unit) 000000-1080-349

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G-30-1781-en Page 3

S100 / OPMI pico

Manufacturer

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

technical development. Printed in Germany.

permissible. 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

E-Mail: [email protected]

Internet: www.zeiss.com/med

S100 / OPMI pico

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S100 / OPMI pico

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G-30-1781-en Page 5

Chapter overview

Chapter: Safety Measures 7

Chapter: System Overview 51

Chapter: Preparations for use 89

Chapter: Operation 127

Chapter: What to do in the event of malfunctions 209

Chapter: Care and Maintenance 221

Chapter: System Data 233

Chapter: Indexes 261

S100 / OPMI pico

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Version 7.0

G-30-1781-en Page 7

S100 / OPMI pico Safety Measures

Safety Measures

Hazard symbols ...........................................................................................8

Information symbols....................................................................................8

Target group .....................................................................................9

Field of application ............................................................................9

Intended use ...............................................................................................9

Normal use..................................................................................................9

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

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

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

Before every use........................................................................................14

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

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

Liability and warranty ................................................................................16

Possible burn injuries due to a high illumination intensity...............17

Safety devices..................................................................................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

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.

Safety Measures S100 / OPMI pico

Version 7.0

Page 8 G-30-1781-en

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.

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G-30-1781-en Page 9

S100 / OPMI pico Safety Measures

Target group

These Instructions for Use are intended for physicians, nurses and other med-

ical and technical staff who prepare, operate or maintain the device after ap-

propriate training. It is the duty of the equipment owner/operator to train and

brief all the operating staff.

Extended service tasks are not part of these Instructions for Use. They will be

performed by staff specially trained for this purpose by ZEISS.

Field of application

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 proce-

dures.

Normal use

The S100 / OPMI pico is a microscope that is operated manually on a sitting

or lying patient.

Provision: The S100 / OPMI offers in conjunction with different suspension systems (e.g.

floor stand, wall mount, ceiling mount) and flexible carrier arms, an ergo-

nomic 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.

Safety Measures S100 / OPMI pico

Version 7.0

Page 10 G-30-1781-en

Treatment/surgery: The microscope is positioned and roughly focused by the physician or the sur-

geon. The most frequently used functions as the setting of focus, magnifica-

tion and light intensity are manually controlled by the physician or the sur-

geon during treatment or surgery.

A video player is connected to the system for educational purposes or to vis-

ualize the progress of the treatment/surgery.

After the treatment / surgery The physician or the surgeon swings the surgical microscope from the treat-

ment 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 rele-

vant national legislation and other regulations applicable in your country.

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 also observe the instructions for

use of any additional equipment. You can obtain additional information from

ZEISS Service.

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

• Only personnel who have undergone appropriate training and instruction

are allowed to use this device. It is the responsibility of the customer or

the company operating the device to train and instruct all operating per-

sonnel.

• Please keep these Instructions for Use where they are easily accessible at

all times for the persons operating the system.

CAUTION Injury to the patient's eye!

• The S100 / OPMI pico must not be used for ophthalmic 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 im-

ages may contain variations in shape, contrast and color.

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