Zeiss OPMI 1 FC User manual

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.

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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.

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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.