Zeiss OPMI 1 FC Manual de usuario

OPMI®

Surgical

Microscope

]

Instructions

for

use

30-1003-e

]

1997-02-26

Regulations

and

standards

Notes

on installation

and

usage

Phototoxic

Retinal

Damage

Eye

Surgery

Warning

labels

and

notes

General

Safety

devices

OPMIS

Surgical

Microscope

Binocular

tube

and

eyepieces

Installation

Attaching

the

microscope

Installing

the

binocular

tube,

the

eyepieces

and

the

09008

Connections

Re-equipping

the

microscope

Preparations

for

operation

Adjusting

the

balancing

system

Positioning

the

stand

Limitation

downward

movement

Friction

adjustments

Illumination

ㆍ

Adjusting

the

surgical

microscope

What

emergency

Maintenance,

further

information

................

Safe

working

order

Trouble-shooting

table

Exchanging

the

halogen

lamp

Care

the

microscope

Sterilization

.......

Magnifications

Fields

view

Moving

the

S21

Floor

Stand

Spare

parts

........

‘Accessories

Asepsis

Technical

data

に

OPMIS

Surgical

Microscope.

Important

for

safety

page

Satety

precautions

Satety

devices

‘Checklist.

What

emergency

Trouble-shooting

table

...

18301003

OPD!

Suyca!

Morse

1097-0228

Safety

precautions

This

instrument

has

been

developed

and

tested

accordance

with

Carl

Zeiss

safety

standards

and

with

national

and

international

regulations.

high

degree

instrument

safety

thus

ensured.

recommended

these

regulations

that

the

manufacturer

explicitly

informs

the

user

about

the

safety

aspects

operating

the

instrument.

This

chapter

contains

summary

the

most

important

precautions

observed.

Further

safety

notes

are

also

contained

other

parts

this

user's

manual;

they

are

marked

with

warning

triangle

containing

exclamation

mark

shown

here.

Please

pay

special

attention

these

safety

notes.

Safety

only

ensured

when

this

instrument

op-

erated

properly.

Please

read

through

this

manual

carefully

before

turning

the

instrument

on.

Also

read

through

the

user's

manuals

the

other

equipment

used

with

this

instrument,

You

may

ob-

tain

further

information

from

our

service

organiza-

tion

authorized

representatives.

Regulations

and

standards

This

instrument

was

developed

accordance

with

the

following

regulations,

applicable:

ΕΝ

ЕС

CSA

accordance

with

Directive

93/42/EEC,

Sup-

plement

Il,

Article

the

quality

management

system

Carl

Zeiss

has

been

approved

TUV

Rheinland,

which

is a

notified

authority.

The

registration

number

is:

95 102

7601

Nice

19974226

The

instrument

must

connected

‘emergency

backup

line

supply

accordance

with

the

regulations

guidelines

which

apply

your

country.

This

class

medical

instrument

defined

Directive

93/42/EEC.

The

declaration

Conformity

contained

this

manual

only

valid

for

new

instruments

whose

delivery

package

includes

this

user's

manual.

This

declaration

invalid

for

old

in-

struments

which

not

feature

the

CE mark-

ing.

‧

Please

observe

alll

applicable

accident

preven-

tion

regulations.

Notes

installation

and

usage

General

not

operate

the

equipment

contained

the

delivery

package

in:

explosion-risk

areas

—

the

presence

volatile

anesthetics

in-

flammable

solvents

such

alcohol,

benzin

similar

chemicals.

not

station

use

this

instrument

damp

rooms.

not

expose

the

instrument

water

splashes,

dripping

water

sprayed

water.

Immediately

unplug

any

equipment

that

gives

off

smoke,

sparks

strange

noises.

not

use

the

equipment

until

our

service

represen-

tative

has

repaired

it.

not

place

any

fluid-filed

containers

top

the

instrument.

Make

sure

that

fluids

can

seep

into

the

instrument.

ыы

ως

了

ως

tal

вы

ыы

μω

not

force

cable

connections.

the

male

‘and

female

parts

not

readily

connect,

make

‘sure

that

they

are

appropriate

for

one

another.

any

the

connectors

are

damaged,

have

our

service

representative

repair

them.

desired,

the

unit

can

incorporated

into

po-

tential

equalization

measures.

Please

contact

our

service

representative.

not

use

cellular

telephone

the

vicinity

the

equipment

because

the radio

interfer-

ence

can

cause

the

equipment

malfunction.

The

effects

radio

interference

medical

equipment

depend

number

various

fac-

tors

and

are

therefore

entirely

unforeseeable.

Modifications

and

repairs

this

instrument

and

instruments

used

with

this

instrument

may

only

performed

our

service

repre-

sentative

other

authorized

persons.

The

manufacturer

not

liable

for

damage

caused

unauthorized

persons

tampering

with

the

instrument;

such

tampering

will

also

forfeit

any

rights

claim

under

warranty.

Use

this

instrument

only

for

the

applications

described.

Only

use

this

instrument

with

the

accessories

contained

the

delivery

package.

Only

use

other

accessory

equipment

when

Carl

Zeiss

the

manufacturer

the

accessory

equipment

has

certified

that

its

usage

will

not

impair

the

safety

the

system.

Only

personnel

who

have

undergone

training

and

instruction

are

allowed

use

this

instru-

ment.

itis

the

responsibilty

the

customer

stitution

operating

the

equipment

train

and

instruct

all

staff

using

the

equipment.

Keep

the

user's

manuals

where

they

are

easily

accessible

all

times

for

the

persons

operat-

ing

the

instrument.

Never

look

the

sun

through

the

binocular

tube, the

objective,

eyepiece.

not

pull

the

light

guide

cable,

the

pow-

cord

or at

other

cable

connections.

(3010096

OPS!

Surg

Merca

1097.02.28

Safe

working

order

This

instrument

high-grade

technological

product.

order

ensure

optimum

perfor-

mance

and

safe

working

order

the

in-

strument,

recommend

that

our

service

re-

presentative

inspect

this

instrument

regu-

lar

basis.

failure

occurs

which

you

cannot

correct

us-

ing

the

trouble

shooting

table,

attach

sign

the

instrument

stating

out

order

and

‘contact our

service

representative.

Requirements

for

operation

Our

service

representative

will

install

the

instru-

ment.

Please

make

sure

that

the

following

require-

ments

for

operation

remain

fulfiled

the future:

All

mechanical

connections

(details

this

us-

er's

manual)

which

are

relevant

safety

are

properly

connected

and

screw

connections

tightened.

= All

cables

and

plugs

are

good

working

condition.

—

The

voltage

the

voltage

selector

the

sus-

pension

system

corresponds

with

the

rated

voltage

the

line

supply

site.

—

The

instrument

plugged

into

power

outlet

which

has

properly

connected

protective

earth

connection.

The power

cord

being

used

one

de-

signed

for

use

with

this

instrument.

Before

use

Make

sure

all

"Requirements

for

operation"

are

fulfilled.

through

the

checklist.

Rerattach

any covers,

panels

caps

which

have been

opened

removed.

Pay

special

attention

warning

symbols

the

instrument

(triangular

warning

signs

with

‘exclamation

marks),

labels

and

any

parts

such

screws

surfaces

painted

red.

not

cover

any

ventilation

grids or

siits.

During

use

The

long

extension

the

stand

base

must

al-

ways

point

the

direction

the

surgical

field.

Avoid

looking

directly

into

the

light

source,

e.g.

into

the

microscope

objective

into

fiber

light

guide.

light

guide

not

installed

one

the

light

guide

receptacies,

there

danger

fire

bum

injuries

when

the

illumination

on.

All

types

radiation

have

damaging

effect

biological

tissue.

This

also

applies

the

light

illuminating

the

surgical

field.

For

this

rea-

son,

reduce

the

brightness

and

the

duration

the

illumination

the

surgical

field

the

mini-

mum

required.

When

operating

the

eye,

always

use

pro-

tection

filter

475

that

the

patient's

retina

not

exposed

unnecessary

(blue)

radiation.

(930400540

OMI

Supa!

Meceeepe

19070228

After

use

sure

turn

off

the

instrument

when

not

use.

Always

use

the

main power

switch

tum

off.

Re-equipping

the

microscope

Put the

suspension

arm

the top

position

be-

fore

changing

the

microscope

equipment

(mi-

croscope,

tube,

etc.).

When

finished,

the

bal-

ance

setting

the

suspension

system

must

re-adjusted.

The

weight

the

surgical

microscope

and

all

its

accessories

must

not

exceed

the

maxi-

mum

load

specified

for

the

suspension

system

being used.

Please

refer

the

user's

manual

your

suspension

system

for

the

maximum

load

allowed.

The

maximum

load

the

S21

Floor

Stand,

shown

figure

1, is

kg.

고

Phototoxic

Retinal

Damage

Eye

Sur-

gery

General

Several

papers

have

been

published

dealing

with

the

problems

phototoxicity during

eye

surgery.

comprehensive

review

these

publications

re-

veals

five

aspects

particular

concern:

—

Illumination

characteristics

(spectral

composi-

tion)

—

Intensity

illumination

Angle

illumination

Focus

the

light

source

Exposure

time

the

light

the

following,

comments

these

aspects

are

given

and

description

how

Carl

Zeiss,

man-

ufacturer,

makes

allowance

for

them

its

instru-

ments.

Illumination

characteristics

(spectral

composi-

tion)

Studies

exposure

the

eye

light

varying

spectral

composition

date

back

the

early

1950's.

These

studies

suggest

that

the

potential

hazard

phototoxic

damage

the

patient's

retina

can

reduced

blocking

out

the

blue

and

ultraviolet

light

below

wavelength

475

nm.

Carl

Zeiss

provides

475

eye

protection

filter

for

surgical

microscopes

recommended

for

use

ophthalmic

surgery.

This

reduces

not

only

the

light

exposure

the

patient's

eye,

but

also

that

the

‘surgeon's.

(62010030

OPM?

Sil

Morscapa

1997-0226,

should

noted

here

that

the

use

filters

will

necessity

cause

change

the

color

ilumina-

tion.

The

physician

may

need

become

familiar

with

the

resulting

changes

the

appearance

anatomical

structures.

Intensity

illumination

The

majority

researchers

suggest

that

the

sur-

geon

should

use

the

lowest

light

intensity

neces-

sary

guarantee

good

viewing

during

surgery.

Carl

Zeiss

has

addressed

this

concern

provid-

ing

device

for

continuously

varying

the

bright-

ness

the

light

source.

The

physician

thus

able

perfectly

adapt

the

light

intensity

the

patients

eye

the

conditions

existing

each

case. Zeiss

strongly

discourages

the

use

xenon

other

high-intensity

light

sources

ophthalmology.

Angle

illumination

number

publications

suggest

that

the

micro-

scope

should

tilted

reduce

the

exposure

the

macula

direct

illumination.

Carl

Zeiss

ophthalmic

surgical

microscopes

are

therefore

equipped

with

the

following:

Tilting

mechanism

for

microscope

body

Oblique

illumination

with

intensity

control

Focus

the

light

source

‘Studies

show

that

damages

are

likely

occur

the

filament

the

light

source

imaged

the

patient's

retina.

The

resulting

macular

edema

will

duplicate

the

pattern

the

illuminating

filament.

The

peak

intensity

the

filament

image

much

higher

than

the

peek

intensity

even

and

ex-

tended source

fiber

guide.

Carl

Zeiss

therefore

recommends

the

use

fiber

optic

illumination

for

axial,

coaxial

and oblique

illu-

mination.

This

provides

the

surgical

area

and

the

retina

with

even

and

diffuse

light.

Exposure

time

the

light

According

some

publications,

the

phakic

aphakic

eye

should

not

exposed

the

light

source

longer

than

few

minutes.

In all

surgical

cases,

the

retinal

exposure

time

depends

great

extent

the

surgical

technique,

the

effi-

ciency

the

surgeon

and

possible

case

complica-

tions.

therefore

recommended

ophthalmic

surgery

keep

the

light

intensity

low as

possi-

ble, or

use

device

which

prevents

light

from

entering

through

the

patient's

pupil.

Also,

the

sur-

rounding

light

sources

should

not

cause

additional

strain

the

eye.

Carl

Zeiss

has

provided

answer

this

problem

the

form

swing-in

retinal

protection

devi

for

insertion

into

the

beam

path

the

surgical

croscope.

This

device

ensures

total

eclipsing

the

pupil,

preventing

light

from

entering

through

it.

can

swung

out

when

red

reflex

required.

.09070090

opwe

Surge

Moose

1997-0225,

conclusion

Carl

Zeiss

recommends:

—

Use

the

475 eye

protection

filter

Reduction

the

illumination

the

surgical

ar-

the

extent

required

for

the

patient’s

safe-

and

for

microscopic

visualization

Tilting

the

microscope

body

required

—

Insertion

the

retinal

protection

device

—

Reduction

the

patient's

eye

light

expo-

sure from

surrounding

light

sources

These

measures

should

help

the

surgeon

re-

duce

the

likelihood

phototoxic

retinal

damage.

Warning

labels

and

notes

(figure

Caution:

Observe

all

warning

labels

and

notes!

any

label

missing

your

instrument

has

become

illegible,

please

contact

our

autho-

rized

representative.

will

supply

the

missing

la-

bels.

Transportposition:

Moving

position:

Position

transport:

Posición

transporte:

max.

Belastung

max.

load

see

instructions

General

The

OPMIS

manually-operated,

multi-

purpose

surgical

microscope

designed

for

use

all

disciplines

surgical

microscope

examination

microscope

training

and

dissecting

microscope.

The

OPMI

equipped

with

5-stage

mag-

nification

changer

which

operated

manually.

Fine-focussing

done

the

focus

knob

located

‘on

the

microscope

body.

The

focus

drive

has

range

mm.

change

the

viewing

angle,

you

can

tilt

the

mi-

croscope

stepless

motion.

The

friction

the

tit

motion

and

the

focussing

motion

can

adjusted

the

weight

the

microscope

equipment.

The

suspension

system

equipped

with

100

halogen

lamp.

The

light

conducted

the

micro-

scope

via

fiber

light

guide.

This

system

provides

for

coaxial

ilumination

the

field

view.

The

OPMIS

1FC

can

equipped

with

wide

range

accessories:

8“

or 0“

assistant's

microscope

various

coobservation

systems

photographic

and video

equipment

‘These

accessories

can

mounted

quickly

and

easily.

For

adjustment

the

depth

field,

recom-

mend

using

the

double

iris

diaphragm,

order

no.

3033

54.

0000.

ο...

This

user's

manual

describes

the

OPMI®

to-

gether

with

other

units

and

accessories

(e.g.

the

821

Floor

Stand).

The

system

described

herein

re-

Presents

common

instrument

configuration

which

may

differ

from

your

system.

The

description

gen-

erally

applies

for

other

similar

configurations

well.

Some

the

accessories

and

features

men-

tioned

may not

your

configuration:

The

scope

the

delivery

package

specified

the

delivery

papers.

Safety

devices

(figure

Retinal

protection

fiter

475

When

operating

the

eye,

always

use

pro-

tection

filter

475

that

the

patient's

retina

not

exposed

unnecessary

(blue)

radiation.

Thermal

circuit

break

The

thermal

circuit

breaker

switches

off

the

halogen

lamp

the

lamp

module

when

over-

heats.

this

happens,

you

must

correct

the

cause

the

overheating.

For

example, drapes

might

covering

the

ventilation

slits.

Press

the

thermal

circuit

breaker

back

after

the

halogen lamps have

cooled

down.

Adjustment

screw

for

limitation

downward

The

safety

slider

used

limit

the

minimum

vertical

working

distance

the

field

sur-

gery.

This

setting

must

adjusted

before

sur-

gery.

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