Carl Zeiss
OPMI VISU Microscopes
OPMI VISU 140 Surgical Microscope on S7 Suspension Systems Instructions for use Issue 4.2 Nov 2011
Instructions for Use
170 Pages
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Page 1
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems
Instructions for use G-30-1527-en Issue 4.2 Printed on 29. 11. 2011
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 provides hints on the use of the instrument or other tips for the user.
OPMI® is a registered trademark of Carl Zeiss.
Contents
G-30-1527-en
– Key to symbols
2
Functions at a glance
7
– VISU 140 surgical microscope
8
– Illumination system
9
– S7 floor stand
10
– S7 ceiling mount with rigid column
11
– S7 ceiling mount with lifting column
12
Safety
13
– Notes on installation and use
15
– Phototoxic retinal injury in eye surgery
18
– Safety devices of the suspension systems
22
– Warning labels and notes
24
Description
29
VISU 140 surgical microscope
32
– Intended use
32
– Description of the modules
32
– Illumination system
37
– Controls, displays, connections
38
– Binocular tubes and eyepieces
42
Illumination system
46
S7 floor stand
48
– Intended use
48
– Description of the modules
49
– Design
50
– Controls and connections
52
– Connector panel
58
– Instrument tray (option)
60
S7 ceiling mount with rigid column
63
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
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– Intended use
63
– Description of the modules
63
– Design
64
– Controls, displays, connections
66
– Carrier and suspension arms
66
– Connector panel
68
S7 ceiling mount with lifting column
73
– Intended use
73
– Description of the modules
73
– Design
74
– Controls, displays, connections
76
– Ceiling flange with lifting column
76
– Carrier and suspension arms
78
– Connector panel
80
VISU 140 surgical microscope on S7 floor stand
84
– Intended use
84
– Design
84
VISU 140 surgical microscope on S7 ceiling mount with rigid column
86
– Intended use
86
– Design
86
VISU 140 surgical microscope on S7 ceiling mount with lifting column
88
– Intended use
88
– Design
88
Foot control panel (option)
90
– Intended use
90
– Design
90
Preparations
93
Attaching the equipment
96
– Mounting the tube, the eyepieces and the objective lens
96
– Changing the microscope accessories
98
Connections
100
– Connecting the light guide
100
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
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Connections
102
– Connecting the strain relief device
102
– Connecting the suspension system - S7 floor stand
104
– Connecting the suspension system - S7 ceiling mount with rigid column
106
– Connecting the suspension system - S7 ceiling mount with lifting column
108
Adjusting the system - S7 floor stand
110
– Balance setting of the suspension arm
110
– Setting the limit of downward travel of the suspension arm
110
Adjusting the system - S7 ceiling mount with rigid column
112
– Balance setting of the suspension arm
112
– Setting the limit of downward travel of the suspension arm
112
Adjusting the system - S7 ceiling mount with lifting column
114
– Setting an ergonomic working height
114
– Balance setting of the suspension arm
116
– Setting the limit of downward travel of the suspension arm
116
Adjusting the system - General
118
– Adjusting the supension system
118
– Adjusting the tilt angle
120
– Adjusting the microscope tilt to angles greater than 15°
121
– Adjusting the surgical microscope
122
– Optimizing the red reflex
123
Relocating the S7 floor stand
124
Operation
127
Checklist
128
Positioning the S7 floor stand
130
Procedure
132
What to do in an emergency
134
– Failure of the halogen lamp
134
– Failure of the zoom function
136
– Failure of the X-Y coupling
137
– Failure of the focusing function
137
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
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Maintenance / Further information
139
– Trouble-shooting
140
– Changing the halogen lamp
144
– Magnifications / Fields of view
146
– Care of the unit
147
– Auxiliaries from Zeiss
148
– Sterilization
148
– Disinfection
149
– Ordering data
150
– Spare parts
152
– Accessories
153
– Disposal
154
Technical data
155
– Technical data
156
– Ambient requirements
162
– Changes to the system
162
Index
163
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
Functions at a glance
7
Functions at a glance
G-30-1527-en
VISU 140 surgical microscope
8
Illumination system
9
S7 floor stand
10
S7 ceiling mount with rigid column
11
S7 ceiling mount with lifting column
12
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
8
Functions at a glance
VISU 140 surgical microscope 1
Resetting the X-Y coupling and focus to their initial positions 2 Tilting the surgical microscope 3 Adjusting the eyecups 4 Setting your prescription 5 Display of the magnification factor of the zoom system 6 Handgrip 7 Handgrip release button 8 Adjusting the interpupillary distance 9 Arrows indicating the focusing range 10 Manual zoom adjustment 11 Connecting the light guide
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OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems
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Issue 4.2 Printed on 29. 11. 2011
9
Functions at a glance
Illumination system Halogen illumination system 1 2 3 4
Closed flap: main lamp is on Open flap: backup lamp is on Selecting a filter Opening the lamp module Manual activation of backup lamp
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page 46 page 46 page 46 page 46
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OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
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Functions at a glance
S7 floor stand 1 2
Control panel page 56 Maneuvering handle with hooks on which to hang the page 38 foot control panel 3 Connector panel page 58 4 Steerable casters with brake tabs (4 x) page 54 5 Adjusting the friction of the carrier arm's swivel movement page 54 6 Adjusting the friction of the suspension arm's page 54 swivel movement 7 Balance setting page 66 8 Adjusting the limit of downward travel page 110 9 Adjusting the friction of upward/downward movement page 52 10 Adjusting the friction of the microscope's rotation page 52
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OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems
Issue 4.2 Printed on 29. 11. 2011
11
Functions at a glance
S7 ceiling mount with rigid column 1 2 3 4 5 6 7 8 9
Control panel Power switch Connector panel Lamp housing with halogen lamp Balancing the suspension arm Adjusting the limit of downward travel Adjusting the friction of upward/downward movement Adjusting the friction of the suspension arm's swivel movement Adjusting the friction of the carrier arm's swivel movement
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page 56 page 56 page 58 page 66 page 66 page 110 page 52 page 54 page 54
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OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
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Functions at a glance
S7 ceiling mount with lifting column 1 2 3 4 5 6 7 8 9 10
Control panel page 56 Power switch page 56 Connector panel page 58 Lamp housing with halogen lamp page 52 Balancing the suspension arm page 66 Adjusting the limit of downward travel page 110 Adjusting the friction of upward/downward movement page 52 Lifting /lowering the lifting column page 76 Adjusting the friction of the carrier arm's swivel movement page 52 Adjusting the friction of the suspension arm's page 52 swivel movement
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OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems
Issue 4.2 Printed on 29. 11. 2011
Safety
13
Notes on installation and use
15
Phototoxic retinal injury in eye surgery
18
Safety devices of the suspension systems
22
Warning labels and notes
24
Safety
G-30-1527-en
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
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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 Meditec AG, 07745 Jena, Germany, has been certified by DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen GmbH, a notified body, under registration number 263168 MP23CMDR. – 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.
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•
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.
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems
Issue 4.2 Printed on 29. 11. 2011
Safety
15
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.
G-30-1527-en
•
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.
•
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.
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
16
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 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.
•
Observe the labels showing the symbol "Risk of crushing“!
Notes on EMC (electromagnetic compatibility) The system meets the EMC requirements of IEC 60601-1-2. During use of the system, the precautionary measures concerning EMC listed below must be observed. Only use accessories that have been approved by Carl Zeiss for this system. Do not use any portable or mobile high frequency communication devices in the vicinity of the system, as this may lead to an impairment of its function. The system complies with the limits for a Class A device concerning radio frequency emission. However, the possibility of interference to high frequency receiving devices (e.g. TV sets or radios) being used in the surroundings cannot be ruled out. If interference of this type occurs, please inform your Carl Zeiss Service.
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OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems
Issue 4.2 Printed on 29. 11. 2011
Safety
17
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 instrument. 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.
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Avoid looking directly into the light source, e.g. into the microscope objective lens or a light guide.
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When the illumination is on, the light guide must be connected at both ends. Otherwise there is a risk of fire or burn injuries.
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
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Safety
•
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 the blue barrier filter (retina protection filter) to ensure that the patient's eye is not exposed to unnecessary (blue) radiation (risk of retinal injury).
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 surgery 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 system •
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.
Phototoxic retinal injury in eye surgery General Several papers1)-5) dealing with the problem of phototoxicity in ophthalmic surgery have been published. A comprehensive review of these publications reveals five aspects of particular concern: – Illumination characteristics (spectral composition) – Illumination intensity – Angle of illumination – Focus of the light source – Exposure time to light
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OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems
Issue 4.2 Printed on 29. 11. 2011
Safety
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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 systems. Illumination characteristics (spectral composition) Studies on the 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 offers the blue barrier filter (retina protection filter) for surgical microscopes recommended for use in ophthalmic surgery. This reduces not only the exposure of the patient's eye to light, but also that of the surgeon's. An important point to note here, however, is that the use of filters will inevitably change the perceived color of the light. For this reason, the physician may initially have to get used to the changed appearance of the anatomical structures. Illumination intensity The majority of researchers suggest that the surgeon should use the lowest light intensity required at the patient's eye to guarantee good viewing during surgery. Carl Zeiss has addressed this aspect by providing its systems with a device for continuously 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. Angle of illumination A number of publications1)-4) 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
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OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems Issue 4.2 Printed on 29. 11. 2011
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Safety
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 that of an even and extended light source such as a light guide. This is the reason why Carl Zeiss uses fiber optic illumination in its surgical microscope systems. Exposure time to light According to some publications, the phakic and aphakic eye should not be exposed to the light source longer than a few minutes. In all surgical cases, the retinal exposure time depends on the type and duration of the procedure and possible case complications. It is therefore recommended in ophthalmic surgery to keep the light intensity as low as possible, or to use a device which prevents the light from entering through the patient's pupil. It is alsorecommended to make sure that the patient's eye is not additionally exposed to the light of surrounding light sources. Intensity scale The intensity scale of our suspension system is calibrated in units of the ”spectrally weighted radiance for the photochemical hazard to the phakic eye (LB)”5). LB is the spectral radiance L(λ) integrated over the spectral range from 380 nm to 700 nm and weighted using B(λ): 700 LB = ∑L(λ) B(λ) Δλ 380 where B(λ) is the spectral weighting function for the photochemical hazard 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 system5) . At this reference value, photoretinitis might be expected to occur as a result of the microscope illumination after a retinal exposure time totaling 10 minutes. This applies to the exposure of a specific point on the retina with an uninterrupted illumination beam. In cataract surgery, instruments such as the phacoemulsification handpiece, the use of fluids in the eye, manipulation in and movements of the eye ensure that the illumination beam path is interrupted. These are factors which considerably increase the period after which photoretinitis might be expected to occur.
G-30-1527-en
OPMI® VISU 140 Surgical Microscope on S7 Suspension Systems
Issue 4.2 Printed on 29. 11. 2011