Zeiss Opmi 1 fc User manual

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OPMI®

1

FC

Surgical

Microscope

]

Instructions

for

use

G

30-1003-e

]

1997-02-26

Regulations

and

standards

.

.

Notes

on installation

and

usage

.

Phototoxic

Retinal

Damage

in

Eye

Surgery

Warning

labels

and

notes

General

..

Safety

devices

OPMIS

1

FC

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

E

Limitation

of

downward

movement

Friction

adjustments

Illumination

ㆍ

Adjusting

the

surgical

microscope

What

to

do

in

an

emergency

Maintenance,

further

information

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

24

Safe

working

order

..

24

Trouble-shooting

table

.

24

Exchanging

the

halogen

lamp

25

Care

of

the

microscope

26

Sterilization

.......

26

Magnifications

/

Fields

of

view

27

Moving

the

S21

Floor

Stand

28

Spare

parts

........

30

‘Accessories

30

Asepsis

..

30

Technical

data

に

oo

ev

uu

3

OPMIS

1

FC

Surgical

Microscope.

.

31

Important

for

safety

page

Satety

precautions

4

Satety

devices

10

‘Checklist.

n

21

What

to

do

in

an

emergency

22

Trouble-shooting

table

...

24

18301003

OPD!

FC

Suyca!

Morse

1097-0228

Safety

precautions

This

instrument

has

been

developed

and

tested

in

accordance

with

Carl

Zeiss

safety

standards

and

with

national

and

international

regulations.

A

high

degree

of

instrument

safety

is

thus

ensured.

It

is

recommended

in

these

regulations

that

the

manufacturer

explicitly

informs

the

user

about

the

safety

aspects

of

operating

the

instrument.

This

chapter

contains

a

summary

of

the

most

important

precautions

to

be

observed.

Further

safety

notes

are

also

contained

in

other

parts

of

this

user's

manual;

they

are

marked

with

a

warning

triangle

containing

an

exclamation

mark

as

shown

here.

Please

pay

special

attention

to

these

safety

notes.

Safety

is

only

ensured

when

this

instrument

is

op-

erated

properly.

Please

read

through

this

manual

carefully

before

turning

the

instrument

on.

Also

read

through

the

user's

manuals

of

the

other

equipment

used

with

this

instrument,

You

may

ob-

tain

further

information

from

our

service

organiza-

tion

or

authorized

representatives.

Regulations

and

standards

©

This

instrument

was

developed

in

accordance

with

the

following

regulations,

if

applicable:

-

ΕΝ

-

ЕС

-

UL

-

CSA

In

accordance

with

Directive

93/42/EEC,

Sup-

plement

Il,

Article

3,

the

quality

management

system

of

Carl

Zeiss

has

been

approved

by

TUV

Rheinland,

which

is a

notified

authority.

The

registration

number

is:

95 102

7601

ο

ο

ο

Nice

19974226

©

The

instrument

must

be

connected

to

an

‘emergency

backup

line

supply

in

accordance

with

the

regulations

or

guidelines

which

apply

in

your

country.

©

This

is

a

class

|

medical

instrument

as

defined

by

Directive

93/42/EEC.

*

The

declaration

on

CE

Conformity

contained

in

this

manual

is

only

valid

for

new

instruments

whose

delivery

package

includes

this

user's

manual.

This

declaration

is

invalid

for

old

in-

struments

which

do

not

feature

the

CE mark-

ing.

‧

Please

observe

alll

applicable

accident

preven-

tion

regulations.

Notes

on

installation

and

usage

General

©

Do

not

operate

the

equipment

contained

in

the

delivery

package

in:

-

explosion-risk

areas

—

the

presence

of

volatile

anesthetics

or

in-

flammable

solvents

such

as

alcohol,

benzin

or

similar

chemicals.

©

Do

not

station

or

use

this

instrument

in

damp

rooms.

Do

not

expose

the

instrument

to

water

splashes,

dripping

water

or

sprayed

water.

©

Immediately

unplug

any

equipment

that

gives

off

smoke,

sparks

or

strange

noises.

Do

not

use

the

equipment

until

our

service

represen-

tative

has

repaired

it.

©

Do

not

place

any

fluid-filed

containers

on

top

of

the

instrument.

Make

sure

that

no

fluids

can

seep

into

the

instrument.

ыы

ua

ta

l

l

l

ea

ως

了

|

ως

ha

tal

вы

ыы

μω

Do

not

force

cable

connections.

if

the

male

‘and

female

parts

do

not

readily

connect,

make

‘sure

that

they

are

appropriate

for

one

another.

K

any

of

the

connectors

are

damaged,

have

our

service

representative

repair

them.

If

desired,

the

unit

can

be

incorporated

into

po-

tential

equalization

measures.

Please

contact

our

service

representative.

Do

not

use

a

cellular

telephone

in

the

vicinity

of

the

equipment

because

the radio

interfer-

ence

can

cause

the

equipment

to

malfunction.

The

effects

of

radio

interference

on

medical

equipment

depend

on

a

number

of

various

fac-

tors

and

are

therefore

entirely

unforeseeable.

Modifications

and

repairs

on

this

instrument

and

on

instruments

used

with

this

instrument

may

only

be

performed

by

our

service

repre-

sentative

or

by

other

authorized

persons.

The

manufacturer

is

not

liable

for

damage

caused

by

unauthorized

persons

tampering

with

the

instrument;

such

tampering

will

also

forfeit

any

rights

to

claim

under

warranty.

Use

this

instrument

only

for

the

applications

described.

Only

use

this

instrument

with

the

accessories

contained

in

the

delivery

package.

Only

use

other

accessory

equipment

when

Carl

Zeiss

or

the

manufacturer

of

the

accessory

equipment

has

certified

that

its

usage

will

not

impair

the

safety

of

the

system.

Only

personnel

who

have

undergone

training

and

instruction

are

allowed

to

use

this

instru-

ment.

itis

the

responsibilty

of

the

customer

or

stitution

operating

the

equipment

to

train

and

instruct

all

staff

using

the

equipment.

Keep

the

user's

manuals

where

they

are

easily

accessible

at

all

times

for

the

persons

operat-

ing

the

instrument.

Never

look

at

the

sun

through

the

binocular

tube, the

objective,

or

an

eyepiece.

Do

not

pull

at

the

light

guide

cable,

at

the

pow-

er

cord

or at

other

cable

connections.

(3010096

OPS!

FO

Surg

Merca

1097.02.28

Safe

working

order

*

This

instrument

is

a

high-grade

technological

product.

In

order

to

ensure

optimum

perfor-

mance

and

safe

working

order

of

the

in-

strument,

we

recommend

that

our

service

re-

presentative

inspect

this

instrument

on

a

regu-

lar

basis.

If

a

failure

occurs

which

you

cannot

correct

us-

ing

the

trouble

shooting

table,

attach

a

sign

to

the

instrument

stating

it

is

out

of

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

in

the future:

=

All

mechanical

connections

(details

in

this

us-

er's

manual)

which

are

relevant

to

safety

are

properly

connected

and

screw

connections

tightened.

= All

cables

and

plugs

are

in

good

working

condition.

—

The

voltage

at

the

voltage

selector

on

the

sus-

pension

system

corresponds

with

the

rated

voltage

of

the

line

supply

on

site.

—

The

instrument

is

plugged

into

a

power

outlet

which

has

a

properly

connected

protective

earth

connection.

-

The power

cord

being

used

is

te

one

de-

signed

for

use

with

this

instrument.

|

Before

use

©

Make

sure

all

"Requirements

for

operation"

are

fulfilled.

©

Go

through

the

checklist.

©

Rerattach

or

close

any covers,

panels

or

caps

which

have been

opened

or

removed.

©

Pay

special

attention

to

warning

symbols

on

the

instrument

(triangular

warning

signs

with

‘exclamation

marks),

labels

and

any

parts

such

as

screws

or

surfaces

painted

red.

©

Do

not

cover

any

ventilation

grids or

siits.

During

use

+

The

long

extension

of

the

stand

base

must

al-

ways

point

in

the

direction

of

the

surgical

field.

©

|

Avoid

looking

directly

into

the

light

source,

e.g.

into

the

microscope

objective

or

into

a

fiber

light

guide.

©

if

a

light

guide

is

not

installed

in

one

of

the

light

guide

receptacies,

there

is

a

danger

of

fire

or

bum

injuries

when

the

illumination

is

on.

+

All

types

of

radiation

have

a

damaging

effect

on

biological

tissue.

This

also

applies

to

the

light

illuminating

the

surgical

field.

For

this

rea-

son,

reduce

the

brightness

and

the

duration

of

the

illumination

of

the

surgical

field

to

the

mini-

mum

required.

©

When

operating

on

the

eye,

always

use

pro-

tection

filter

GG

475

so

that

the

patient's

retina

is

not

exposed

to

unnecessary

(blue)

radiation.

(930400540

OMI

FC

Supa!

Meceeepe

19070228

After

use

Be

sure

to

turn

off

the

instrument

when

not

in

use.

Always

use

the

main power

switch

to

tum

it

off.

Re-equipping

the

microscope

Put the

suspension

arm

in

the top

position

be-

fore

changing

the

microscope

equipment

(mi-

croscope,

tube,

etc.).

When

finished,

the

bal-

ance

setting

of

the

suspension

system

must

be

re-adjusted.

The

weight

of

the

surgical

microscope

and

all

of

its

accessories

must

not

exceed

the

maxi-

mum

load

specified

for

the

suspension

system

being used.

Please

refer

to

the

user's

manual

of

your

suspension

system

for

the

maximum

load

allowed.

The

maximum

load

of

the

S21

Floor

Stand,

shown

in

figure

1, is

11

kg.

a

oe

A

O

a

ee

a

고

Phototoxic

Retinal

Damage

in

Eye

Sur-

gery

General

Several

papers

have

been

published

dealing

with

the

problems

of

phototoxicity during

eye

surgery.

A

comprehensive

review

of

these

publications

re-

veals

five

aspects

of

particular

concern:

—

Illumination

characteristics

(spectral

composi-

tion)

—

Intensity

of

illumination

=

Angle

of

illumination

=

Focus

of

the

light

source

=

Exposure

time

to

the

light

In

the

following,

comments

on

these

aspects

are

given

and

a

description

how

Carl

Zeiss,

as

a

man-

ufacturer,

makes

allowance

for

them

in

its

instru-

ments.

Illumination

characteristics

(spectral

composi-

tion)

Studies

on

exposure

of

the

eye

to

light

of

varying

spectral

composition

date

back

to

the

early

1950's.

These

studies

suggest

that

the

potential

hazard

of

phototoxic

damage

to

the

patient's

retina

can

be

reduced

by

blocking

out

the

blue

and

ultraviolet

light

below

a

wavelength

of

475

nm.

Carl

Zeiss

provides

a

GG

475

eye

protection

filter

for

surgical

microscopes

recommended

for

use

in

ophthalmic

surgery.

This

reduces

not

only

the

light

exposure

of

the

patient's

eye,

but

also

that

of

the

‘surgeon's.

(62010030

OPM?

FC

Sil

Morscapa

1997-0226,

|

It

should

be

noted

here

that

the

use

of

filters

will

of

necessity

cause

a

change

in

the

color

of

ilumina-

tion.

The

physician

may

need

to

become

familiar

with

the

resulting

changes

in

the

appearance

of

anatomical

structures.

Intensity

of

illumination

The

majority

of

researchers

suggest

that

the

sur-

geon

should

use

the

lowest

light

intensity

neces-

sary

to

guarantee

good

viewing

during

surgery.

Carl

Zeiss

has

addressed

this

concern

by

provid-

ing

a

device

for

continuously

varying

the

bright-

ness

of

the

light

source.

The

physician

is

thus

able

to

perfectly

adapt

the

light

intensity

at

the

patients

eye

to

the

conditions

existing

in

each

case. Zeiss

strongly

discourages

the

use

of

xenon

or

other

high-intensity

light

sources

in

ophthalmology.

Angle

of

illumination

A

number

of

publications

suggest

that

the

micro-

scope

should

be

tilted

to

reduce

the

exposure

of

the

macula

to

direct

illumination.

Carl

Zeiss

ophthalmic

surgical

microscopes

are

therefore

equipped

with

the

following:

=

Tilting

mechanism

for

microscope

body

=

Oblique

illumination

with

intensity

control

Focus

of

the

light

source

‘Studies

show

that

damages

are

likely

to

occur

if

the

filament

of

the

light

source

is

imaged

on

the

patient's

retina.

The

resulting

macular

edema

will

duplicate

the

pattern

of

the

illuminating

filament.

The

peak

intensity

of

the

filament

image

is

much

higher

than

the

peek

intensity

of

an

even

and

ex-

tended source

like

a

fiber

guide.

Carl

Zeiss

therefore

recommends

the

use

of

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

to

the

light

According

to

some

publications,

the

phakic

or

aphakic

eye

should

not

be

exposed

to

the

light

source

longer

than

a

few

minutes.

In all

surgical

cases,

the

retinal

exposure

time

depends

to

a

great

extent

on

the

surgical

technique,

the

effi-

ciency

of

the

surgeon

and

possible

case

complica-

tions.

It

is

therefore

recommended

in

ophthalmic

surgery

to

keep

the

light

intensity

as

low as

possi-

ble, or

to

use

a

device

which

prevents

light

from

entering

through

the

patient's

pupil.

Also,

the

sur-

rounding

light

sources

should

not

cause

additional

strain

to

the

eye.

Carl

Zeiss

has

provided

an

answer

to

this

problem

in

the

form

of

a

swing-in

retinal

protection

devi

for

insertion

into

the

beam

path

of

the

surgical

croscope.

This

device

ensures

total

eclipsing

of

the

pupil,

preventing

light

from

entering

through

it.

It

can

be

swung

out

when

a

red

reflex

is

required.

.09070090

opwe

FO

Surge

Moose

1997-0225,

In

conclusion

Carl

Zeiss

recommends:

—

Use

of

the

GG

475 eye

protection

filter

=

Reduction

of

the

illumination

of

the

surgical

ar-

ea

to

the

extent

required

for

the

patient’s

safe-

ty

and

for

microscopic

visualization

=

Tilting

of

the

microscope

body

as

required

—

Insertion

of

the

retinal

protection

device

—

Reduction

of

the

patient's

eye

to

light

expo-

sure from

surrounding

light

sources

These

measures

should

help

the

surgeon

to

re-

duce

the

likelihood

of

phototoxic

retinal

damage.

Warning

labels

and

notes

(figure

1)

Caution:

Observe

all

warning

labels

and

notes!

If

any

label

is

missing

on

your

instrument

or

has

become

illegible,

please

contact

us

or

our

autho-

rized

representative.

We

will

supply

the

missing

la-

bels.

Transportposition:

Moving

position:

Position

de

transport:

Posición

de

transporte:

max.

Belastung

max.

load

11

kg

see

instructions

General

The

OPMIS

1

FC

is

a

manually-operated,

multi-

purpose

surgical

microscope

designed

for

use

in

all

disciplines

as

a

=

surgical

microscope

=

examination

microscope

=

training

and

dissecting

microscope.

The

OPMI

1

FC

is

equipped

with

a

5-stage

mag-

nification

changer

which

is

operated

manually.

Fine-focussing

is

done

at

the

focus

knob

located

‘on

the

microscope

body.

The

focus

drive

has

range

of

50

mm.

To

change

the

viewing

angle,

you

can

tilt

the

mi-

croscope

in

stepless

motion.

The

friction

of

the

tit

motion

and

the

focussing

motion

can

be

adjusted

to

the

weight

of

the

microscope

equipment.

The

suspension

system

is

equipped

with

a

100

W

halogen

lamp.

The

light

is

conducted

to

the

micro-

scope

via

a

fiber

light

guide.

This

system

provides

for

coaxial

ilumination

of

the

field

of

view.

The

OPMIS

1FC

can

be

equipped

with

a

wide

range

of

accessories:

8“

or 0“

assistant's

microscope

-

|

various

coobservation

systems

-

photographic

and video

equipment

‘These

accessories

can

be

mounted

quickly

and

easily.

For

adjustment

of

the

depth

of

field,

we

recom-

mend

using

the

double

iris

diaphragm,

order

no.

3033

54.

0000.

ο

ο

ο...

This

user's

manual

describes

the

OPMI®

1

FC

to-

gether

with

other

units

and

accessories

(e.g.

the

821

Floor

Stand).

The

system

described

herein

re-

Presents

a

common

instrument

configuration

which

may

differ

from

your

system.

The

description

gen-

erally

applies

for

other

similar

configurations

2s

well.

Some

of

the

accessories

and

features

men-

tioned

may not

be

in

your

configuration:

The

scope

of

the

delivery

package

is

specified

in

the

delivery

papers.

Safety

devices

(figure

2)

1

Retinal

protection

fiter

GG

475

When

operating

on

the

eye,

always

use

pro-

tection

filter

GG

475

so

that

the

patient's

retina

is

not

exposed

to

unnecessary

(blue)

radiation.

Thermal

circuit

break

The

thermal

circuit

breaker

switches

off

the

halogen

lamp

in

the

lamp

module

when

it

over-

heats.

If

this

happens,

you

must

correct

the

cause

of

the

overheating.

For

example, drapes

might

be

covering

the

ventilation

slits.

Press

the

thermal

circuit

breaker

back

in

after

the

halogen lamps have

cooled

down.

Adjustment

screw

for

limitation

of

downward

м

The

safety

slider

is

used

to

limit

the

minimum

vertical

working

distance

to

the

field

of

sur-

gery.

This

setting

must

be

adjusted

before

sur-

gery.