Zeiss OPMI® Sensera User Manual

OPMI® Sensera

on S7 Suspension Systems

Instructions for use

G-30-1434-en

Issue 10.0

Printed on 30. 01. 2009

Key to symbols

Different symbols used in this manual draw your attention to safety as­pects and useful tips. These 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 instruments or other tips for the
user.

OPMI

®

is a registered trademark of Carl Zeiss.

Contents

– Key to symbols 2

Functions at a glance 7

– OPMI Sensera surgical microscope 8
– Illumination systems 10
– S7 floor stand 11
– S7 ceiling mount with rigid column 12
– S7 ceiling mount with lifting column 13

Safety 15

– Notes on installation and use 17
– Safety devices of the suspension system 22
– Warning labels and notes 26

Description 31

Sensera surgical microscope on S7 suspension systems 34
– Intended use 34
– Description of the system 34
– System components 36
OPMI Sensera surgical microscope 38
– Design 38
– Controls, displays, connections 40
– Tiltable binocular tube and eyepieces 46
S7 floor stand 50
– Design 50
– Controls, displays, connections 52
– Suspension arm 52
– Carrier arm, stand column, stand base 54
– Connector panel of S7 floor stand 56
– Instrument tray (option) 58
S7 ceiling mount 60

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– Design 60
– Controls, displays, connections 62
– Carrier and suspension arms 62
– Connector panel of S7 ceiling mount 64
S7 ceiling mount with lifting column 66
– Design 66
– Controls, displays, connections 68
– Ceiling flange with lifting column 68
– Carrier and suspension arms 70
– Connector panel of S7 ceiling mount with lifting column 72
Illumination system 74
– Halogen illumination system 76
– Xenon illumination system 78
Control panel and menu overview 82
– Structure of the menus 84
Foot control panel (option) 104
– Intended use 104
–Design 104
– Foot control panel with 14 functions 106
– Foot control panel with 8 functions 107

Preparations for use 109

Attaching the equipment 112
– Mounting the tube and eyepieces 112
Connections 114
– Connecting the strain relief device 114
– Connecting the suspension system - S7 floor stand 116
– Connecting the suspension system - S7 ceiling mount with

rigid column 118
– Connecting the suspension system - S7 ceiling mount with

lifting column 120
– Connecting video monitor and MediLive ImageBox (option) 122
Adjusting the system - S7 floor stand 124
– Balancing the suspension arm 124
– Setting the limit of downward travel of the suspension arm 124

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Adjusting the system - S7 ceiling mount with rigid column 126
– Balancing the suspension arm 126
– Setting the limit of downward travel of the suspension arm 126
Adjusting the system - S7 ceiling mount with lifting column 128
– Setting an ergonomic working height 128
– Balancing the suspension arm (ceiling mount with lifting column) 130
– Setting the limit of downward travel of the suspension arm 130
Balancing the surgical microscope 132
Surgical microscope with a laser micromanipulator 136
Adjusting the surgical microscope 138
Configuring the camera settings (config) 139
Configuring Image Capture 144
Relocating the S7 floor stand 152

Operation 155

Checklist for S7 floor stand 156
Checklist for S7 ceiling mount with rigid column 160
Checklist for S7 ceiling mount with lifting column 164
Procedure 168
– Working with the SpeedFokus autofocus option 169
– Display and deletion of images (USB option) 170
What to do in an emergency 172
– Failure of the focusing function 172
– Failure of the zoom function 174
– Failure of the halogen lamp 176
– Lamp failure of the xenon illumination 178
– Failure of the SpeedFokus autofocus option 182

Maintenance / Further information 183

– Trouble-shooting 184
– Replacing the halogen lamp 190
– Changing the xenon lamp module 194
– Magnifications / Fields of view 198
– Care of the unit 200
– Cleaning optical surfaces 200

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– Auxiliaries from Zeiss 201
– Cleaning mechanical surfaces 201
– Sterilization 201
– Disinfecting the control keys 203
– Ordering data 204
– Spare parts 207
– Accessories 209
– Disposal 210

Technical data 211

– Technical data 212
– Integrated 1 CCD PAL video camera (option) 219
– Integrated 1 CCD NTSC video camera (option) 219
– Ambient requirements 220
– Changes to the system 220

Index 221

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Functions at a glance 7

Functions at a glance

OPMI Sensera surgical microscope 8
Illumination systems 10
S7 floor stand 11
S7 ceiling mount with rigid column 12
S7 ceiling mount with lifting column 13

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8 Functions at a glance

OPMI Sensera surgical microscope

1 Adjusting the eyecup and the prescription Pages 36/87
2 Adjusting the interpupillary distance Page 34
3 Manually adjusting the friction of the front-to-back tilt Page 84
4 Motorized adjustment of tilt axis B

(microscope tilts downward) Page 84

5 Motorized adjustment of tilt axis B

(microscope tilts upward) Page 84
6 Manually adjusting the friction of lateral tilt axis A Page 82
7 Manually adjusting the balance of lateral tilt axis A Page 82
8 Manually adjusting the friction of the microscope's

axis of rotation
9 Locking the handgrip in a convenient position Page 32
10 Manually adjusting zoom (emergency mode) Pages 30/98
11 Manual focusing Pages 30/96
12 Adjusting the spot illumination Page 30
13 Triggering motorized microscope functions Page 32
14 External focus (option) Page 30

Page 82

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Functions at a glance 9

12 3

45 67

10 11 129

8

13

A

B

14

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10 Functions at a glance

124 8753 96

Illumination systems

Halogen illumination system

1 Closed flap: main lamp is on - Open flap: backup lamp

is on
2 Selecting a filter page 76
3 Opening the lamp module page 76
4 Manual activation of the backup lamp page 76

Xenon illumination system
5 Selecting a filter page 78
6 Resetting the counter page 80
7 Manual activation of the backup lamp page 78
8 Opening the lamp module page 78
9 Red segment is lit - backup lamp is in use page 78

page 76

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S7 floor stand

12

13

18
17

16

15

14

11

10

9

S

7

Functions at a glance 11

9 Lamp housing with halogen or xenon illumination Page 40
10 Control panel Page 54
11 Maneuvering handle with hooks on which to hang the

Page 88

foot control panel
12 Connector panel Page 46
13 Casters with locking tabs (4 x) Page 44
14 Adjusting the friction of the carrier arm's swivel

Page 44

movement
15 Adjusting the friction of the suspension arm's

Page 44

swivel movement
16 Balancing the suspension arm Page 80
17 Adjusting the limit of downward travel Page 80
18 Adjusting the friction of upward/downward movement Page 42

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12 Functions at a glance

9

10

11

12

13 14 15

16 17

S7 ceiling mount with rigid column

9 Control panel Page 50
10 Power switch Page 50
11 Connector panel Page 44
12 Lamp housing with halogen or xenon illumination Page 46
13 Balancing the suspension arm Page 78
14 Adjusting the limit of downward travel Page 78
15 Adjusting the friction of upward/downward movement Page 42
16 Adjusting the friction of the suspension arm's

swivel movement

17 Adjusting the friction of the carrier arm's swivel

movement

Page 42

Page 42

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Functions at a glance 13

16

9

12

18

17

10

11

13 14 15

S7 ceiling mount with lifting column

9 Control panel page 82
10 Power switch page 82
11 Connector panel page 72
12 Lamp housing with halogen or xenon illumination page 74
13 Balancing the suspension arm page 130
14 Adjusting the limit of downward travel page 130
15 Adjusting the friction of upward/downward movement page 62
16 Lifting/lowering the lifting column page 68
17 Adjusting the friction of the carrier arm's swivel

movement

18 Adjusting the friction of the suspension arm's

swivel movement

page 62

page 62

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14 Functions at a glance

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Safety

Safety 15

Notes on installation and use 17
Safety devices of the suspension system 22
Warning labels and notes 26

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16 Safety

The device described in this manual has been designed and tested in ac­cordance with Carl Zeiss safety standards as well as German and inter­national standards. This guarantees a high degree of instrument safety.

The system described in this user manual has been designed in compli­ance with the requirements of:

–EN –IEC –UL –CSA

In accordance with Directive 93/42/EEC for medical devices, the com­plete quality management system of the company Carl Zeiss Surgical
GmbH, 73446 Oberkochen, Germany, has been certified by DQS Deut­sche Gesellschaft zur Zertifizierung von Managementsystemen GmbH, a
notified body, under registration number 250758 MP23.

– As per Directive 93/42/EEC, the unit is a Class I instrument.

– For USA: FDA classification Class I.

We would like to provide you with information about safety aspects which
must be observed when handling this device. This chapter contains a
summary of the most important information concerning matters relevant
to instrument safety.

Important safety information has been incorporated in this manual and is
marked with a warning triangle accordingly. Please give this information
your special attention.

The correct use of the system is absolutely vital for safe operation. Please
make yourself totally familiar with the contents of this manual prior to start­up of the instrument. Please also observe the user manuals of any addi­tional equipment. Further information is available from our service depart­ment or from authorized representatives.

• Please observe all applicable accident prevention regulations.

• The instrument must be connected to a special emergency backup
line supply in accordance with the regulations or directives which ap­ply in your country.

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Safety 17

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 represent­ative 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 incorpora­ted 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 ef­fects 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 for­feit any rights to claim under warranty.

• Over longer distances (e.g. removal, return for repair, etc), the instru­ment may only be transported in the original packaging or in special
return packaging. Please contact your dealer or the Carl Zeiss service
team.

• Use this instrument only for the applications described.

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18 Safety

• 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.

• Only personnel who have undergone training and instruction are al­lowed 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 opti­mum performance and safe working order of the instrument, its safety
must be checked once every 12 months. We recommend having this
check performed by our service representative as part of regular main­tenance 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 con­tact our service representative.

Warning!

Do not use the video images for diagnostic purposes, as the video cam­eras and the monitor have not been calibrated. The visualized images
may therefore include deviations in shape, contrast and color.

• Observe the labels showing the symbol "Risk of crushing“!

Notes on EMC (Electromagnetic Compatibility)

The device complies with the EMC requirements of IEC 60601-1-2. For
operating the device, observe the EMC precautions specified below.

Only use spare parts approved by Carl Zeiss for this device.

Do not use any portable or mobile HF communication equipment in the
vicinity of the device, as it cannot be ruled out that the function of the de­vice will be impaired.

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Safety 19

Requirements for operation

• For ceiling mounts only: Our service staff or a qualified person ap­pointed by us will install the system on ceiling anchors which have
been properly mounted by the construction engineers responsible.
These ceiling anchors must comply with the specifications contained
in our planning manual.

Our service representative or a specialist authorized by us will install the
instrument. Please make sure that the following requirements for opera­tion remain fulfilled in the future:

– All mechanical connections (details in the user'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 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 re­moved or opened.

• 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 openings.

For every use of the instrument

General

• Never operate the system unattended.

• Avoid looking directly into the light source, e.g. into the microscope ob­jective 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.

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20 Safety

• Make sure that the instrument has been switched off before you
change the xenon lamp module. When switched on, the ignition sys­tem generates high voltage.

• The xenon illumination system is a high-intensity light source which ­if used improperly - can cause thermal injury to skin or tissue. Keep
the exposed tissue moist and provide sufficient irrigation. Carefully
monitor the effects of the illumination on the tissue, in particular in the
following cases:

– during prolonged procedures on skin and tissue using objective

– during procedures on tissue with a low blood supply,

– with high brightness settings of the xenon lamp.

• Since the xenon lamp provides high light intensity and generates light
with a spectrum similar to daylight, it must not be used for ophthalmic
applications.

lenses with a short focal length (short working distance),

• 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.

S7 floor stand

• Using the brake tabs on the base, secure the stand in position. Make
sure that the stand is stable and cannot roll away.

S7 ceiling mount with lifting column

• The lifting column is used to move the microscope into position for sur-

gery prior to the surgical procedure.

Do not constantly move the lifting column up and down, since a ther­mal cut-out will then automatically switch off the drive motor. If this oc­curs, the lifting column cannot be moved again until the motor has
cooled down.

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 be turned off when the instrument
is not in use.

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Safety 21

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22 Safety

12

Safety devices of the suspension system

Lifting column

Selector switch
for setting the optimum viewing height of the surgical microscope or for
downward movement into the working position.
As long as you keep the selector switch in the turned position, the lifting
column moves upward (2) or downward (1), depending on the switch po­sition. When you release the selector switch, the lifting column stops im­mediately.
The switching technology causes a delay of approx. 2 seconds at the
upper and lower end positions of the lifting column. After this time, you
can move the column in the opposite direction again by activating the se­lector switch.

– Before raising or lowering the suspension system, make sure that

there is sufficient clearance from other objects so that any collision is
avoided.

Warning!

– Do not

– Do not

– Make sure that the patient is not

adjustment of the lifting column.

activate the lifting column during surgery!

use the lifting column for focusing.

put at risk or injured by the motorized

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Safety 23

1

2

Halogen illumination system

1 Manual 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.

2 GG 475 retina protection filter

The filter selector knob has four positions:

0 no filter
1 GG 475 filter: to protect the patient's eye during treatment

against unnecessary (blue) radiation (retinal injury).
2 KK 40 filter: to increase color temperature
3 no filter

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24 Safety

Xenon illumination system

Warning!

The xenon lamp has a limited service life of 500 h.

If used beyond its maximum service life, the xenon lamp may explode.

Change the xenon lamp in good time.

Warning!

Lamp rupture (audible as a loud bang) may lead to jamming of the lamp
module and/or failure of the electronics modules.

• Before opening the lamp housing, make sure that the system is moved
to a position where neither the patient nor the user is put at risk by fall­ing items.

• Do not continue using the system if the lamp module is jammed or the
illumination is no longer operational due to defective electronics mod­ules. Inform our service department.

1 Switching to the backup lamp

The lamp module contains two xenon lamps. The second lamp is used
as a backup lamp which has to be swung into the illumination beam
path when the first lamp fails.
If the xenon lamp fails, open the lamp module as follows:
Press button (3). The lamp module is slightly ejected. Pull out the lamp
module as far as it will go. Turn knob (1) through 180° until it snaps in.
This moves the backup lamp into the illumination beam path. Push the
lamp module all the way back into the lamp housing.

2 Indicator: backup lamp is in use

When the red segment in knob (1) lights up, the backup lamp is in use.

Note:
If the first lamp has failed and the backup lamp is in use, make sure to
have a backup lamp module ready at hand as a precaution.

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Safety 25

3

1

2

2

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26 Safety

000000-0000-000

OPMI® Sensera

1

2

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.

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Safety 27

14

- Balance +

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28 Safety

S7 floor stand with instrument tray option

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Safety 29

- Balance +

14

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30 Safety

14

- Balance +

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