Carl Zeiss
OPMI VISU 160 on S8, S81, S88 Suspension Systems Instructions for use Issue 1.0 June 2004
Instructions for Use
242 Pages
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Page 1
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Instructions for use G-30-1529-en Issue 1.0 Printed on 14. 06. 2004
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®
OPMI® is a registered trademark of Carl Zeiss.
Contents –
G-30-1529-en
Key to symbols
2
Functions at a glance
7
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VISU 160 surgical microscope
8
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Illumination systems
9
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S88 floor stand
10
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S8 ceiling mount
12
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S81 ceiling mount
14
Safety
17
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Directives and standards
18
–
Notes on installation and use
19
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When using a fundus imaging system (e.g. BIOM 3)
23
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Phototoxic retinal injury in eye surgery
23
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Safety devices of the suspension systems
28
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Warning labels and notes
36
Description
41
VISU 160 surgical microscope
44
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Intended use
44
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Description of the modules
44
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Illumination system
49
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Controls, displays, connections
52
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Binocular tubes and eyepieces
58
Illumination systems - halogen and xenon
62
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Halogen illumination system
62
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Xenon illumination system
66
S88 floor stand
70
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Intended use
70
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Description of the modules
71
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Design
72
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
G-30-1529-en
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Stand base with column
76
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Connection panel
78
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Suspension arm
80
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Display field with control keys
82
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Instrument tray (option)
84
S8 ceiling mount
86
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Intended use
86
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Description of the modules
87
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Design
88
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Handle
92
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Power switch with connector (option)
94
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Suspension arm
96
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Display field with control keys
98
S81 ceiling mount
100
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Intended use
100
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Description of the modules
101
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Design
102
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Power switch, connector and socket (option)
106
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Suspension arm
108
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Display field with control keys
110
VISU 160 surgical microscope on S88 floor stand
112
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Intended use
112
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Design
112
VISU 160 surgical microscope on S8 ceiling mount
114
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Intended use
114
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Design
114
VISU 160 surgical microscope on S81 ceiling mount
116
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Intended use
116
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Design
116
Foot control panel (option)
118
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Intended use
118
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Design
118
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
G-30-1529-en
Preparations
121
Attaching the equipment
122
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Mounting the surgical microscope
122
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Mounting the tube, the eyepieces and the objective lens
126
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Changing the microscope accessories
128
Connections
130
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Connecting the surgical microscope
130
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Connecting the S light guide
130
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Strain relief device on S88 floor stand
132
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Connecting the S88 floor stand
134
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Relocating the system
136
Adjusting the system - S88 floor stand
138
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Adjusting the balance setting of the suspension arm
138
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Adjusting the limit of downward movement
140
Adjusting the system - S8 ceiling mount
142
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Adjusting the balance setting of the suspension arm
142
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Adjusting the limit of downward movement
144
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Positioning the S8 ceiling mount
146
Adjusting the system - S81 ceiling mount
148
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Adjusting the balance setting of the suspension arm
148
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Adjusting the limit of downward movement
150
Adjusting the system - General
152
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Adjusting the supension system
152
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Adjusting the tilt angle
153
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Adjusting the microscope tilt to angles greater than 15°
154
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Adjusting the surgical microscope
155
Operation
157
Checklist
158
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162
When using a fundus imaging system (e.g. BIOM 3)
Positioning the S88 floor stand
164
Using the display and key field
166
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General functions
166
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Operating the OPMI on the suspension system
170
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
Procedure
182
What to do in an emergency
184
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Failure of the halogen lamp
184
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Failure of a xenon lamp
186
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Failure of lamp control
188
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Failure of focusing system
188
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Failure of magnetic brakes
190
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Failure of the X-Y coupling
190
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Failure of the zoom function
191
Maintenance / Further information
193
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Trouble-shooting
194
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Changing the halogen lamp
202
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Changing the xenon lamp module
206
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Magnifications / Fields of view
208
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Care of the unit
209
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Sterilization
210
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Disinfecting the control keys
211
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Auxiliaries from Zeiss
212
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Ordering data
213
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Spare parts
215
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Accessories
217
Technical data
219
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Technical data
220
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Ambient requirements
234
Index
G-30-1529-en
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
235
Issue 1.0 Printed on 14. 06. 2004
7
Functions at a glance
Functions at a glance
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VISU 160 surgical microscope
8
Illumination systems
9
S88 floor stand
10
S8 ceiling mount
12
S81 ceiling mount
14
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
8
Functions at a glance
VISU 160 surgical microscope 1 2 3 4 5 6 7 8 9 10 11 12 13
Resetting the X-Y coupling and focus to their initial posi- page 44 tions Tilting the surgical microscope page 153 Adjusting the eyecups page 60 Setting your prescription page 60 Handgrip page 54 Display of the magnification factor of the zoom system page 54 DeepView button page 56 Selecting light stops page 56 Setting the 6° illumination page 56 Arrows indicating the focusing range page 52 Adjusting the interpupillary distance page 58 Manual zoom adjustment page 191 Connecting the light guide page 130
7
8 9
1 2
3 4
5 6 5
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10
11
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
12
13
Issue 1.0 Printed on 14. 06. 2004
9
Functions at a glance
Illumination systems
2 3 4
Halogen illumination system Closed flap: main lamp is on - open flap: backup lamp is on Selecting a filter Opening the lamp module Manual selection of backup lamp
page 62 page 62 page 62
5 6 7 8
Xenon illumination system Selecting a filter Manual selection of backup lamp Opening the lamp module Red segment is lit - backup lamp is in use
page 66 page 66 page 66 page 66
1
1
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5 6
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
7
page 62
8
Issue 1.0 Printed on 14. 06. 2004
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Functions at a glance
S88 floor stand 1 2
Control panel page 166 Lamp housing for halogen illumination (xenon illumi- page 74 nation) 3 Releasing the magnetic brakes of the suspension page 80 system 4 Limiting the suspension arm's downward movement page 80 5 Removing/mounting the coupling for the surgical mi- page 122 croscope 6 Balance setting page 138 7 Locking the stand in position page 76 8 Locking the suspension arm in its horizontal position page 80 9 Connecting a foot control panel or hand switch, connecting the remote control connector. page 134 10 Rated voltage display page 78 11 Connector panel page 78 12 Switching on the suspension system page 78
G-30-1529-en
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
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Functions at a glance
1
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7
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3
4
4
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8 9 10, 11, 12
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
12
Functions at a glance
S8 ceiling mount 1 2 3 4 5 6
Locking the suspension arm in its horizontal position page 80 Releasing the magnetic brakes of the suspension system page 80 Balance setting page 138 Lamp housing with halogen or xenon illumination page 74 Control panel (rotatable through 180°) page 82 Connecting a foot control panel or hand switch, connecting the remote control connector page 94 7 Switching on the suspension system page 78 8 Releasing - moving - locking the lift arm page 92 9 Removing/mounting the coupling for the surgical micro- page 122 scope 10 Setting the limit of downward travel page 80
G-30-1529-en
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
13
Functions at a glance
2
1
7
G-30-1529-en
3
8
4
2
5
9
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OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
14
Functions at a glance
S81 ceiling mount 1 2 3 4 5 6 7 8 9 10
Locking the suspension arm in its horizontal position page 80 Releasing the magnetic brakes of the suspension system page 80 Balance setting page 138 Lamp housing with halogen or xenon illumination page 62 Control panel (rotatable through 180°) page 82 Option: Hand control panel socket for ceiling track mount page 106 Plugging in the remote control connector page 106 Connecting the foot control panel or hand switch page 106 Switching on the suspension system page 106 Removing/mounting the coupling for the surgical micro- page 122 scope 11 Setting the limit of downward travel page 80
G-30-1529-en
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
15
Functions at a glance
1
2
3
4
9
G-30-1529-en
2
5
10
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
6
7
8
11
Issue 1.0 Printed on 14. 06. 2004
16
Functions at a glance
G-30-1529-en
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
Safety
17
Directives and standards
18
Notes on installation and use
19
When using a fundus imaging system (e.g. BIOM 3)
23
Phototoxic retinal injury in eye surgery
23
Safety devices of the suspension systems
28
Warning labels and notes
36
Safety
G-30-1529-en
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
18
Safety
The instrument described in this manual 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. 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 exclamation 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 instrument. You may obtain further information from our service organization or authorized representatives.
Directives and standards The system described in the user manual has been designed in compliance with: – EN – IEC – UL – CSA In accordance with Directive 93/42/EEC, Annex II, Article 3, the complete quality management system of the company Carl Zeiss has been certified by the DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen mbH, a notified body, under registration number 250881 MP21.
G-30-1529-en
•
The instrument must be connected to a special emergency backup line supply in accordance with the regulations or directives which apply in your country.
–
As per Directive 93/42/EEC, the unit is a Class I instrument.
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For USA: FDA classification Class I.
•
Please observe all applicable accident prevention regulations.
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
19
Safety
Notes on installation and use Safe working order •
G-30-1529-en
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.
•
Switch off the unit at the power switch if you notice any smoke, sparks or unusual noise. Do not use the unit until it has been repaired by our service team.
•
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.
•
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.
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004
20
Safety
•
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.
Requirements for operation
G-30-1529-en
•
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 an expert authorized by us will install the system. Please ensure that the following requirements are met for further operation:
–
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.
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The voltage setting on the instrument conforms to the rated voltage of the line supply on site.
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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 instrument.
OPMI® VISU 160 on S8, S81, S88 Suspension Systems
Issue 1.0 Printed on 14. 06. 2004