Zeiss OPMI 1FR XY User manual

OPMI®1FR XY
Surgical Microscope
on S7 Floor Stand
Instructions for use
G-30-1416-en
Issue 4.0
Printed on 14. 11. 2007

2
G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Key to symbols
Different symbols used in this user's manual draw your attention to safety
aspects and useful tips. The symbols are explained in the following.
Warning!
The warning triangle indicates potential sources of danger which may
constitute a risk of injury for the user or a health hazard.
Caution:
The square indicates situations which may lead to malfunction, defects,
collision or damage of the instrument.
Note:
The hand indicates hints on the use of the instrument or other tips for the
user.
OPMI®is a registered trademark of Carl Zeiss.
OPMI®

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Contents
– Key to symbols 2
Functions at a glance 7
– OPMI 1 FR XY surgical microscope 8
– S7 floor stand 9
Safety 11
– Directives and standards 12
– Notes on installation and use 13
– Phototoxic retinal injury in eye surgery 15
– Safety devices of the suspension system 19
– Warning labels and notes 20
Description 23
OPMI 1FR XY surgical microscope on S7 floor stand 24
– Intended use 24
– Design 24
OPMI 1FR XY surgical microscope 26
– Intended use 26
– Description of the modules 26
– Controls, displays, connections 30
– Binocular tubes and eyepieces 34
S7 floor stand 39
– Intended use 39
– Description of the modules 39
– Controls and connections 42
Foot control panel 52
– Intended use 52
– Design 52
Preparations for use 55
Attaching the equipment 56

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
– Mounting the tube, the eyepieces and the objective lens 56
Connections 60
– Connecting the light guide 60
– Connecting the strain relief device 62
– Connecting the suspension system 64
Adjusting the system 66
– Balance setting of the suspension arm 66
– Setting the limit of downward travel of the suspension arm 66
– Setting the tilt angle 68
– Adjusting the surgical microscope 69
– Adjusting the stand 70
Relocating the unit 72
Operation 75
Checklist 76
– Positioning the stand 78
Procedure 80
What to do in an emergency 82
– Failure of the halogen lamp 82
– Failure of X-Y coupling 84
– Failure of focusing function 84
Maintenance / Further information 85
– Trouble-shooting 86
– Changing the halogen lamp 90
– Magnifications / Fields of view 92
– Care of the unit 93
– Sterilization 94
– Disinfecting the control keys 95
– Ordering data 96
– Spare parts 97
– Accessories 98
– Disposal 99

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Technical data 101
– Technical data 102
– Ambient requirements 105
Index 107

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Functions at a glance 7
Functions at a glance
OPMI 1 FR XY surgical microscope 8
S7 floor stand 9

8Functions at a glance
G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
OPMI 1 FR XY surgical microscope
1 Recentering the X-Y coupling page 26
2 Setting the interpupillary distance page 34
3 Setting your prescription page 36
4 Adjusting the eyecups page 36
5 Setting the friction of the microscope's tilt motion page 30
6 Swinging the retinal protection device into/out of the beam
path page 32
7 Connecting the light guide page 32
8 Changing the magnification page 32
1
2
34567 8
4
3
2

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Functions at a glance 9
S7 floor stand
Halogen illumination system
1 Lamp housing with halogen lamp page 44
2 Closed flap: main lamp is on, open flap: backup lamp is on page 44
3 Manual selection of backup lamp page 82
4 Selecting a filter page 44
5 Opening the lamp module page 44
Stand
6 Control panel page 48
7 Maneuvering handle with hooks on which to hang the foot
control panel page 46
8 Connector panel page 50
9 Casters with brake tabs (4 x) page 78
10 Adjusting the friction of the carrier arm swivel movement page 46
11 Adj. the friction of the suspension arm swivel movement page 46
12 Balance setting page 66
13 Setting the limit of downward travel page 66
14 Adjusting the friction of upward/downward movement page 42
15 Adjusting the friction of the microscope's rotation page 42
8
6
9
15
14
13
12
11
10
7
4
5
3
2
1

10 Functions at a glance
G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Safety 11
Safety
Directives and standards 12
Notes on installation and use 13
Phototoxic retinal injury in eye surgery 15
Safety devices of the suspension system 19
Warning labels and notes 20

12 Safety
G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
The instrument described in this manual has been developed and tested
in accordance with Carl Zeiss safety standards and with national and in-
ternational regulations. A high degree of instrument safety is thus en-
sured.
We would like to inform you on the safety aspects involved in 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 exclama-
tion mark as shown here. Please pay special attention to these safety
notes.
Safety is only ensured when this instrument is operated 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 in-
strument. You may obtain further information from our service organiza-
tion or authorized representatives.
Directives and standards
The instrument described in this manual has been designed in compli-
ance with the following standards:
–EN
–IEC
–UL
–CSA
In accordance with Directive 93/42/EEC, Annex II, Article 3, the quality-
management system ofCarl Zeisshas been approved by TÜVRheinland,
which is a notified body. The registration number is: 95 102 7601.
• The instrument must be connected to a special emergency backup
line supply in accordance with the regulations or directives which ap-
ply in your country.
• This is a class I instrument as defined by Directive 93/42 /EEC.
• Please observe all applicable accident prevention regulations.

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Safety 13
Notes on installation and use
Safe working order
• Do not operate the equipment contained in the delivery package in
– explosion-risk areas,
– the presence of inflammable anesthetics or volatile solvents such
as alcohol, benzine or similar chemicals.
• Do not station or use the 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 instrument until our service represent-
ative has repaired it.
• Do not place any fluid-filled containers on top of the instrument. Make
sure that no fluids can seep into the instrument.
• Do not force cable connections. If the male and female parts do not
readily connect, make sure that they are appropriate for one another.
If any of the connectors are damaged, have our service representative
repair them.
• Potential equalization: If requested, the instrument can be incorpora-
ted into potential equalization measures.
• Do not use a mobile phone in the vicinity of the equipment because
the radio interference can cause the equipment to malfunction.The ef-
fects of radio interference on medical equipment depend on a number
of various factors and are therefore entirely unforeseeable.
• Modifications and repairs on these instruments or instruments used
with them may only be performed by our service representative or by
other authorized persons.
• The manufacturer will not accept any liability for damage caused by
unauthorized persons tampering with the instrument; this will also for-
feit any rights to claim under warranty.
• Use this instrument only for the applications described.
• Only use the instrument with the accessories supplied. Should you
wish to use other accessory equipment, make sure that Carl Zeiss or
the equipment manufacturer has certified that its use will not impair
the safety of instrument.

14 Safety
G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
• Only personnel who have undergone training and instruction are al-
lowed to use this instrument. It is the responsibility of the customer or
institution 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 operating the instrument.
• Never look at the sun through the binocular tube, the objective lens or
an eyepiece.
• Do not pull at the light guide cable, at the power cord or at other cable
connections.
• This instrument is a high-grade technological product. To ensure opti-
mum performance and safe working order of the instrument, its safety
must be checked once every 12 months. We recommend having this
check performed by ourservicerepresentative as partof regularmain-
tenance work.
If a failure occurs which you cannot correct using the trouble-shooting
table, attach a sign to the instrument stating it is out of order and con-
tact our service representative.
Requirements for operation
Our service representative or a specialist authorized by us will install the
instrument. Please make sure that the following requirements for opera-
tion remain fulfilled in the future:
– All mechanical connections (details in the user's manual) which are
relevantto safetyare properly connected and screw connectionstight-
ened.
– All cables and plugs are in good working condition.
– The voltage setting on the instrument conforms to the rated voltage of
the line supply on site.
– The instrument is plugged into a power outlet which has a properly
connected protective ground contact.
– The power cord being used is the one designed for use with this in-
strument.
Before every use and after re-equipping the instrument
• Make sure that all ”Requirements for operation” are fulfilled.
• Go through the checklist.
• Re-attach or close any covers, panels or caps which have been re-
moved or opened.

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Safety 15
• Please pay special attention to labels on the unit (warning triangle with
an exclamation mark, warning labels and notes).
• Do not cover any ventilation openings.
For every use of the instrument
• Using the brake tabs on the base, secure the stand in position. Make
sure that the stand is stable and cannot roll away.
• Avoidlooking directly intothelight source,e.g.intothe microscope ob-
jective lens or a light guide.
• When the illumination is on, the light guide must be connected at both
ends. Otherwise there is a risk of fire or burn injuries.
• Any kind of radiation has a detrimental effect on biological tissue.This
also applies to the light illuminating the surgical field. Please therefore
reduce the brightness and duration of illumination on the surgical field
to the absolute minimum required.
• When operating on the eye, always use a GG 475 protection filter to
ensure that the patient's retina is not exposed to unnecessary (blue)
radiation (retinal injury).
After every use of the instrument
• Always use the main power switch of the instrument to turn it off.
• The main power switch must always beturned off when the instrument
is not in use.
Phototoxic retinal injury in eye surgery
General
Several papers have been published dealing with the problems of photo-
toxicity during eye surgery. A comprehensive review of these publications
reveals five aspects of particular concern:
– Illumination characteristics (spectral composition)
– Intensity of illumination
– Angle of illumination
– Focus of the light source
– Exposure time to light

16 Safety
G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
In the following, comments on these aspects are given and a description
of how Carl Zeiss, as a manufacturer, makes allowance for them in its in-
struments.
Illumination characteristics (spectral composition)
Studies on exposure of the eye to light of varying spectral composition
date back to the early 1950s. These studies suggest that the potential
hazard of phototoxic injury 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 retina protection filter for surgical micro-
scopes 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.
It should be noted in this context that the use of filters inevitably leads to
a change in the color of the light. The surgeon may therefore have to get
used to the changed appearance of anatomical structures.
Intensity of illumination
The majority of researchers suggest that the surgeon should use the
lowest light intensity necessary to guarantee good viewing during sur-
gery.
Carl Zeiss has addressed this concern by providing a device for continu-
ously varying the brightness of the light source. This permits the surgeon
to optimally adapt the light intensity at the patient's eye to the conditions
existing in each case. CarlZeiss strongly discourages the use ofxenon or
other high-intensity light sources in ophthalmology.
Angle of illumination
A number of publications suggest that the microscope 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 the microscope body
– Oblique illumination with brightness control
Focus of the light source
Studies show that injuries are likely to occur if the filament of the light
source is imaged on the patient's retina. The peak intensity of a filament
is considerably higher than the peak intensity of an even and extended
light source such as a fiber guide.

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Safety 17
This is the reason why fiber optic illumination is used in surgical micro-
scopes from Carl Zeiss.
Exposure time to light
According to some publications, the phakic or aphakic eye should not be
exposed to the light source longer than a few minutes. In every operation
the exposure of the retina to light is dependent on the type and duration
of surgery and on any complications which occur. It is therefore recom-
mended in ophthalmic surgery to keep the light intensity as low as pos-
sible, orto use a device which prevents the lightfrom enteringthrough the
patient's pupil. Also, the surrounding light sources should not cause addi-
tional strain to the patient's eye.
Carl Zeiss has provided an answer to this problem in the form of a swing-
in retinal protection device for insertion into the beam path of the surgical
microscope. This device ensures total eclipsing of the pupil, preventing
light from entering into the patient's eye. It can be swung out when a red
reflex is required.
Intensity scale
The intensity scale of our suspension system is calibrated in units of the
”Spectrally weighted radiance for the photochemical hazard of the phakic
eye (LB)”
LBis the spectral radiance integrated over the spectralrange from 380 nm
to 700 nm and weighted using B(λ):
where B(λ) is the spectral weighting function for the photochemical ha-
zard of the retina in the phakic eye.
The quantity LB= 500 mW/cm² sr is the reference value and is defined as
1.0 on the intensity scale of the suspension system as recommended in
the ISO 10936-2 draft on surgical microscopes used in ophthalmic appli-
cations. At this reference value, photoretinitis might be expected to occur
as a result of the microscope illumination after a retinal exposure time to-
taling 10 minutes. This applies to the exposure of a specific point on the
retina with an uninterrupted illumination beam. In cataract surgery, instru-
ments such as the phacoemulsification handpiece, the use of fluids in the
eye, manipulation in and movements of the eye ensure that the illumina-
tion beam path is interrupted. These are factors which considerably
increase the period after which photoretinitis might be expected to occur.
700
LB= ∑L(λ) B(λ) Δλ
380

18 Safety
G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
In conclusion
Carl Zeiss recommends:
– Use of the GG 475 eye protection filter.
– Reduction of the illumination of the surgical area to the extent required
for the patient's safety and for microscopic visualization.
– Tilting of the microscope body as required.
– Insertion of the retinal protection device.
– Maximum reduction of the exposure of the patient's eye to light from
surrounding light sources.
These measures should help the surgeon to reduce the likelihood of pho-
totoxic retinal injury.

G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Safety 19
Safety devices of the suspension system
Halogen illumination system
1Manual switching to the backup lamp
The lamp housing contains a backup lamp which is automatically
swung into the illumination beam path when the first lamp fails. If this
automatic function fails, you can switch on the backup lamp by
pressing this button.
2GG 475 retina protection filter
When operating on the eye, always use a GG 475 protection filter to
ensure that the patient's retina is not exposed to unnecessary (blue)
radiation (risk of retinal injury). The filter knob has four positions:
0 no filter
1 475 GG filter : to protect the patient's eye against unnecessary
(blue) radiation (retinal injury).
2 KK 40 filter: to increase color temperature
3 no filter
1
2

20 Safety
G-30-1416-en OPMI® 1FR XY Surgical Microscope on S7 Floor Stand Issue 4.0
Printed on 14. 11. 2007
Warning labels and notes
Caution:
Observe all warning labels and notes!
If any label is missing on your instrument or has become illegible, please
contact us or one of our authorized representatives. We will supply the
missing labels.
OPMI 1 FR