Zeiss OPMI Pentero User Manual
OPMI® Pentero
Software Release 2.20 / 2.21
®
Instructions for use
G-30-1458-en
Issue 11.1
Printed on 18. 02. 2009
2
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 system.
FLOW 800 SW 2.21
Note:
The hand indicates hints on the use of the system or other tips for the
user.
Read the user manual!
®
OPMI
GmbH
and Pentero® are registered trademarks of Carl Zeiss Surgical
.
AutoDrape™, Superlux, FlexiTrax™, MultiVision™ and FLOW™ 800
are trademarks of Carl Zeiss Surgical GmbH.
FLOW 800 software release 2.21 is not an update, but a software upgrade
for the IR800 option of OPMI Pentero for the analysis of inf rared video angiography.
Upgrading is only possible for systems with serial number 6631402450
and higher and with software version 2.20.
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Contents
Software Release 2.20 / 2.21 1
– Key to symbols 2
– FLOW 800 SW 2.21 2
Functions at a glance 9
– OPMI Pentero 10
– What to do in an emergency 12
Safety 15
– Protective measures for IT systems and networks 16
– Notes on installation and use 17
– Risk of burn injuries caused by high
illumination intensity 23
– Safety devices of the suspension system 26
– Warning labels and notes 28
Description 33
OPMI Pentero 34
– Intended use 34
– Special properties 36
– Surgical microscope and laser micromanipulator 38
– Injecting video images in the surgical microscope 39
– Injecting navigation information in the surgical microscope *) 40
– Overall system configuration 41
– Configuration options 44
Central user interface (touchscr een) 46
– Main menu 50
Controls and connections 52
– Binocular tubes and eyepieces 60
– Handgrips 64
– Superlux 330 illumination system 66
– Operating principle of the additional illumination 68
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– Autofocus (focusing aid) 69
– Drape vacuum system 70
– Stand base /FlexiTrack™ system 72
– Connector panel 76
Connecting navigation systems 80
Preparations for use 85
– Relocating the unit 86
Assembling the system 88
– Configurations 88
– Mounting the tube and the eyepieces 90
– Attaching documentation / coobservation equipment 92
– Mounting the mouth switch (option) 94
– Adjusting the position of the handgrips 98
– Attaching sterile drapes 100
– Positioning the system at the operating table 102
– Starting the system 104
– Configuring the handgrips 106
Balancing the system 110
– Adjusting the surgical microscope 115
– USER menu / login 116
– Activating IT system rights and data protection 120
– Configuration menu (CONFIG) 124
Operation 163
Checklist 164
Procedure 167
– Working with the surgical microscope 167
– Comfortable control via the mouth switch (pivoting) 168
– Working with the data injection system 170
Patient Files menu (PAT-FILES) 174
– Managing patient data 174
– Viewing patient data 186
– Viewing patient images 188
– Editing images 192
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– Saving 196
– Storing patient data on CD/DVD 198
– Storing patient data on a USB stick 202
What to do in an emergency 208
– Illumination failure - changing the xenon lamp 208
– Failure of the zoom function 210
– Failure of the focusing function 211
– Failure of the magnetic brakes 212
– Touchscreen failure 212
– Failure of the line voltage 212
– Error messages in the data injection system 213
– Failure of all control functions (Emergency mode) 214
– Individual magnetic brakes are blocked
(OPMI can not be moved at all or only to a limited extent) 215
Maintenance/Service 217
– Trouble-shooting 218
– Service Contract (Option) 219
– Starting Remote Service 220
– Changing the lamp module 222
– Recommended cleaning method 224
– Sterile drapes 225
– Ordering data 226
– Spare parts 227
– Accessories 228
– Disposal 230
Technical data 231
– OPMI Pentero 232
– 3 CCD PAL video camera, mono and stereo (version 1) 237
– 3 CCD NTSC video camera, mono and stereo (version 1) 238
– 3 CCD PAL video camera, mono and stereo (version 2) 239
– 3 CCD NTSC video camera, mono and stereo (Version 2) 240
– Ambient requirements 241
– Changes to the system 241
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Digital video recording (option) 243
Digital video recording (option) 244
– Description 244
– Video clips 248
– Editing video clips 250
– Merging video clips 256
INFRARED 800 fluorescence module
(option) 261
Integrated INFRARED 800 (IR 800) fluorescence module 262
– Intended use 262
– Description 266
– Connecting an external monitor (recommended option) 276
– INFRARED 800 settings before every surgical procedure 278
– Checklist for the IR 800 function test 279
Procedure 280
FLOW 800 (option) 287
Normal use 288
Description 292
– General configuration 292
– Configuring INFRARED 800 296
– Activating FLOW 800 298
– Description of INFRARED 800 300
– Description of FLOW 800 306
Preparations for use 318
– Connecting an external monitor (recommended option) 318
– INFRARED 800 settings before every surgical procedure 320
– Checklist for the IR 800 function test 321
Procedure 322
– SETUP phase 322
– RECORD phase 324
– PLAYBACK phase 326
– FLOW 800 processing phase 328
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BLUE 400 fluorescence module (option) 339
Integrated BLUE 400 (BL 400) fluorescence module 340
– Intended use 340
– Description 344
BL 400 checklist 348
DICOM (option) 351
DICOM 352
– Intended use 352
– Conformance Statement 352
– Configuring the network connection 356
– Further information on the Ethernet connection 362
– Connection test 364
– Configuring the DICOM connection 366
– Adding, editing and deleting a DICOM server 366
– Configuring the DICOM function 368
– Defining the maximum video export size to network serv ers 372
– Error messages during system configuration 376
– Importing patient data sets (from RIS systems) 378
– Importing patient data sets (from PACS system) 380
– Loading patient data 382
– Exporting DICOM data to a PACS 390
HDTV camera system (option)
(option) 393
393
HDTV camera system for OPMI Pentero (option) 394
– Intended use 394
– Configuration 395
– Attaching the HDTV components 396
– Connecting the HDTV camera system 398
– Microscope positions with the HDTV camera system 400
Checklist for HDTV camera system for OPMI Pentero 401
Cleaning the HDTV components 403
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Index 405
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Functions at a glance 9
Functions at a glance
OPMI Pentero 10
What to do in an emergency 12
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10 Functions at a glance
OPMI Pentero
1 Adjusting the microscope page:115, 124ff
2 Programmable button (factory setting: illumination +) page:108, 136
3 Programmable button (factory setting: illumination -) page:108, 136
4 Setting focus +/- (configurable: setting zoom +/-) page:108, 136
5 Setting zoom +/- (configurable: setting focus +/-) page:108, 136
6 Joystick: moving the OPMI in the XY direction page:136, 140
7 Programmable button (factory setting: autofocus) page:108, 142
8 Programmable button (factory sett ing: trigger photo) page:106, 136
9 Unlocking/locking magnetic brakes for selected axes (SB) page:108, 142
10 Unlocking/locking magnetic brakes for all axes (AB) page:106, 142
11 Connecting USB storage media page:200ff
12 Changing the xenon lamp / lamp module page:208, 222
13 CD/DVD drive page:196
14 Connecting an external navigation system page:78, 80ff,
15 Connecting a LAN cable page:78
16 Connecting a modem page:78
17 Connecting a foot rocker switch page:78
18 AUX port for controlling an external device page:78, 234
19 Connecting a foot control panel, foot switch or operating chair page:78
20 Automatic circuit breakers page:78
21 Emergency switch (remove cover) page:200
22 Rated voltage indicator page:76
23 Power outlet page:76
24 Power inlet (115/230V) page:76
25 Video input port (e.g. for connecting an endoscope camera) page:78
26 Video signal output port BNC (VBS) page:76, 276
27 Video DV output port page:76
28 Connecting an external monitor (VGA/RGB) page:76
29 Connecting an external monitor (Y/C) page:76, 276
30 Connecting the system to potential equalization page:76
31 Power switch; powering up the system page:76
32 Locking pedal - press to lock stand in position page:74, 86
33 Setting straight-ahead travel page:74 ,86
154
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Functions at a glance 11
19
812 765432 191013 11
32 33
STOP
18 17 16 15 14
20
21
22
23
24
25
26
27
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29
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12 Functions at a glance
What to do in an emergency
1Failure of illumination - changing the xenon lamp:
• Open flap (1)
• Change the xenon lamp by pulling grip (8) page 208
2 Failure of the zoom function:
• Manually adjust the magnification using zoom knob
(2). If the motorized zoom function becomes active of
its own accord (e.g. travels to the stop), set emergency
switch (7) to the emergency mode (position 2).
3 Failure of the focusing function:
• Manually adjust the working distance using focusing
knob (3). If the motorized focusing function becomes
active of its own accord (e.g. travels to the stop), set
the emergency switch to the emergency mode (position 2)
4 Some of the magnetic brakes are blocked:
page 210
page 211
• Switch off power switch (4). As soon as the blue
screen appears (approx. 10 sec), switch the system
back on.
The OPMI functions (zoom, focus, light and magnetic
brakes) are available again after approx. 15 seco nds.
The computer and touchscreen, however, are disabled.
If the magnetic brakes are still blocked:
• Hol d the microscope on its body (not on the handgrips )
and position it manually by over coming the br aking effect.
5 Failure of the touchscreen:
• Do not under any circumstances touch the touchscreen, since this can result in changes to settings and
parameters. Zoom, focus, i llumin ati on a nd brakes can
still be operated.
6 Error messages in the data injection system:
• System errors are displayed in the microscope's integrated data injection system. You can delete these
messages by acknowledgement using the joystick of
the right handgrip (pushbutton) or the t ouchscreen.
page 215
page 212
page 212
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Functions at a glance 13
5
1
4
7
2
3
8
6
7 Failure of control functions:
• Set emergency switch (7) to the emergency mode (position 2). Zoom and focus must then be operated manually (2, 3).
• Hold the microscope on its body (not on the handgri ps)
and position it manually by overcoming the braking effect.
page 214
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14 Functions at a glance
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Safety
Safety 15
Protective measures for IT systems and networks 16
Notes on installation and use 17
Risk of burn injuries caused by high
illumination intensity 23
Safety devices of the suspension system 26
Warning labels and notes 28
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16 Safety
The device described in this manual has been desi gned and teste d 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 Zert ifi zierung von Manag ementsy stemen GmbH, a
notified body, under registration number 250758 MP23.
– In compliance with Directive 93/42 /EEC, the basic configuration of
this system is a class I device.
Equipped with the Integrated Fluorescence Module option, it is a
class IIa device.
– For USA: FDA classification: Class I.
We would like to provide you with information about safe ty aspects which
must be observed when handling this device. This chapter contains a
summary of the most important information concerning matters relevant
to instrumen t sa f e ty .
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 sy stem is absolutel y vital for s afe operation. Ple ase
make yourself totally familiar wi th the contents of this manual prior to star tup of the instrument. Please also observe the user manuals of any additional equipment. Further information i s available from our service department or from authorized representatives.
• Please observe all applicable accident prev ention regulations.
• 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.
Protective measures for IT systems and networks
The user (or IT officer) is responsible for ensuring that no viruses are
transferred to the OPMI Pentero system via the network connection.
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Safety 17
It is the user's responsibility to ensure that the media used for data communication (CD, DVD, USB stick) are free from viruses.
Responsibilities for data protection and inf ormation security
The user (or IT officer) must ensu re that the national laws and regulat ions
relating to data protection are complied with.
The operators of IT systems and IT networks are responsible for the definition of the safety standards required, i.e. for the creation of the necessary technical and organizational framework.
Definition of terms
Personal data means any inform ation concerning the per sonal or material
circumstances of an identified or i dentifiable individual. All data directly attributable to a person ( employee, customer, supplier), e.g. marital status,
type of employment, religion, income, etc., must be protected.
Data processing means the storage (entry, recording or preservation),
transfer (transmission to t hird parties outside the organization), modification (alteration of the substance, including anonymization and aliasing),
erasure (deletion) and blocking (labeling so as to restrict further
processing or use) of data.
Use means any utilization of data (e.g. in-house transmission).
Recipient means any person or body receiving data. Third party means
any person or body other than the controller (legal entity). The transmission of data to third parties is deemed to constitute data transfer.
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 unt il our ser vice rep rese ntative has repaired it.
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18 Safety
• Do not place any fluid-filled c ontainer s on t op of the ins trume nt. 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 servi ce 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.
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.
The company Carl Zeiss shall not be liable fo r any defective CD/DVD and
any resultant loss of images.
• If you have burnt important images on a CD/DVD, we recommend you
to create a backup of this CD/DVD using a PC.
Caution:
The company Carl Zeiss accepts no liability for any loss of pati ent, image
and video data as well as system or user-specific configurat ion data. If required, arrange for patient, image and video data as well as all system
settings to be backed up by your IT administrator on a regular basis.
In the event of repairs by Carl Zeiss service staff, the recovery of patient,
image, video and configuration data is no longer
possible.
• 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 tamp ering wi th the i nstrument ; this will also f orfeit 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 con tact your dealer or the Carl Ze iss service
team.
• Use this instrument only for the applicati ons described.
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Safety 19
• 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 easi ly acce ssible at all ti mes
for the persons operating the instrument .
• Never look at the sun through the binocula r tube, the obje ctive lens or
an eyepiece.
• Please do not pull at the power cable or any other connecting cables.
• This system is a high-grade technological product. To ensure optimum performance and safe working order, we recommend having th e
system checked by our service representative on a regular basis.
If a failure occurs which you cannot correct with the help of this user
manual, attach a sign to the system stating that 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 communic ation devices
in the vicinity of the system, as t his may le ad t o an impai rment of i ts f unction.
The system complies with the limits for a Class A devic e 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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20 Safety
Interference radiation
To ensure permissible operation in conjuncti on with neuromonitor ing systems, an optional upgrade kit is available which significantly reduces the
system's permissible interference radiation for these sensitive measurements (see Accessories, neuromonitoring upgrade kit, page 229)
Requirements for operation
Note:
– Please also take note of the latest Release Notes about the installed
software version. These are part of the delivery package when the
system is supplied. After a software update, you will always receive
the latest version.
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 ar e properly connected and s crew connections tight-
ened.
– All cables and plugs are in good working condition.
– 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.
Warning!
For safety reasons, the system must only be used when correctly balanced. Despite the autobalance function, it may happen in exceptional
cases that the surgical microscope is not correctly balanced.
With an incorrectly balanced system, brake release may lead to uncontrolled movements of the suspension system. For this reason, the balancing procedure and the subsequent test must not be performed above
the patient and only at a safe distance from other persons and instruments.
To check correct balancing of the system, l oosen the brakes while holding
the microscope tightly at b oth handgri ps. If t he system has b een correctl y
balanced, the surgical microscope can be moved almost eff o rtlessly.
Repeat the autobalance procedure, if required.
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Safety 21
R
1
.
5
m
R
5
9
"
Connection to data networks
Activities in the data network may interfer e with the system. We theref ore
recommend that you disconnect the system from data networks before
surgery.
The network connector must be adequatel y contact -prot ected , e.g. mad e
of plastic material.
The cable and connector of the network connection must at least comply
with Cat-5e EIA/TIA-568A-5, i.e. the more recent Class D values from
ISO/IEC 11801:2002 or EN 50173-I:2002.
Warning!
Data transmitted by the system into the data network or data available in
the data network risk to be corrupted or transmitted incompletely. Therefore, no liability can be accepted for the corr ectness of the data.
The operator of the data network is responsible for compliance with the
legal requirements regarding data security and for the protection of personal rights.
Connection of equipment from other manufacturers
If you operate this system within the patient area* in conjunction with devices from other manufacturers which do not comply with the IEC606011 standard, you must ensure that either the third-party devices are powered via an isolating transformer, or that each of them is connected with
the central ground system via an additional ground terminal (potential
equalization).
The leakage current may increase if the system is connected with other
devices. The resulting new system must comply with the EN 60601-1-1
standard (Safety Requirements for Medical-Electrical Systems).
*Fig.: Patient area
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22 Safety
Before every use and after re-equipping the instrument
• Make sure that all ”Requirements for operation” are fulfilled.
• Go through the checklist (see chapter "Operation“ or the index).
• Re-attach or close any covers, panels or caps which have been re-
moved or opened.
• Please pay special attention to labels on the uni t (warning triangle with
an exclamation mark, warning labels and notes) .
• Do not cover any ventilation openings.
For every use of the instrument
• Using the locking pedal on the base, secure the stand in position.
Make sure that the stand is stable and cannot roll away.
• Make sure that nothing obstructs the touch-sensitive area of the
touchscreen. Prevent objects from exerting pressure on the touch-
sensitive area of the touchscreen.
• Any kind of radiation has a detrimental effect on biol ogical tissue. This
also applies to the light illuminat ing the surgical f ield. Please therefor e
reduce the brightness and duration of illumi nation on the surg ical fiel d
to the absolute minimum required.
•Never
use xenon illumination for ophthalmic procedures.
• Make sure that no xenon light enters the patient's eyes.
• The illumination intensity required depends on the type of application
involved. Make sure that no tissue damage is caused by excessive il-
lumination intensity.
Connection and operation of navigation systems
Only systems from authorized manufacturers may be connected and
used on the navigation interface of OPMI Pentero (see page 80). Authorized manufacturers are companies or institutions with which Carl Zeiss
Surgical has concluded an Open Interf ace Contract and for which the use
of the integrated navigat ion i nte rface wi th data i nje ction system has been
licensed.
Please observe the user manual for the connected system.
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Safety 23
Risk of burn injuries caused by high
illumination intensity
General
The OPMI Pentero is equipped with a powerful xenon illumination system.
Excessive illumination intensities may lead to third-degree burns, if used
improperly.
The risk of burns is influenced by several different factors:
System-related factors:
– The wavelength range is limited by fi lters to t he visible ran ge between
400 nm and 700 nm (between 400 nm and 780 nm in the IR 800 mode
only). These filters remain stable over a very long period of time and
cannot be exchanged by the user.
– With increasing age of the light source, the actual illumination intensi ty
delivered at the respective setting decreases. When the light source
is finally replaced, the illumination intensity increases again to the
high, original value.
Surgery-related factors:
– The selected intensity of the light source is a major factor for the risk
of injury. It should always be set to the minimum required for the surgical procedure to be performed.
– The size of the illuminated field influences the risk of injury in two dif-
ferent ways:
– If the illuminated area has a large diameter, skin areas are illumi-
nated that are not closely monitored by the surgeon and are not
sufficiently irrigated. These areas are particularly prone to injury.
Injuries can be prevented by adjusting the diameter of the illuminated field to the smallest size needed for the respective procedure.
– Reducing the illuminated field increases the intensity because the
light becomes more focused. The light intensity should therefore
be reduced, if possible, as soon as the diamet er of the illuminate d
area is reduced.
– A long surgical procedure increas es the risk of injury, in particu lar if a
standard procedure takes considerably longer t han usual.
– Injuries in the peripheral area can be prevented by covering this area
with wet, sterile gauze.
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24 Safety
– You should also take int o account that some ar eas of the body may be
more sensitive than others.
– Certain preparations of the surgical field, local vasoconstrictive medi-
cations and incision drapes may also resu lt in a higher risk of injury.
Patient-related factors:
– The general condition of a patient's health may contribute to the risk
of injury.
– The skin type may also play a major role in this respect.
– Certain medications affect the sensitivity to light.
Recommendations
Due to the large number of different factors involved and the lack of scientific publications on this topic, Carl Zeiss cannot provide guidance on
acceptable intensities and exposure durations. However, the OPMI
Pentero has several features that can help the user to reduce the risk of
burns:
– The start value of the light intensity can be set to a low value (page
134).
– The spot function permits y ou to reduce the size of t he illuminated field
to the area observed during the procedure (page 66).
– You can then set the light int ensity to the val ue required for the p roce-
dure using the buttons on the handgrip or foot control panel. Please
note that the use of t he spot i llumination system incr eases th e intensi-
ty as the size of the illuminated field decreases. Therefore adjust the
light intensity after changing the diameter of the illuminated field.
– If the system features Automatic Light Field Limitation, this function
has been activated at the factory and should not be deactivated.
In systems without automatic light field limitation, the Light Intensity
Control function has been activated at the factory and should not be
deactivated.
– The magnification level i s us ually in crea sed duri ng a proc edure, lead-
ing to a darker image and thus necessitating an increase in illumina-
tion intensity. If zoom-dependent brightness control has been
activated, it automatically compensates for this loss in image bright-
ness. (page 134)
– Switch off the light when the microscope is not used, and make sure
that it is not pointed at unprotected bare skin.
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Safety 25
Please note that most burns affected the skin around the incision. The
most important measures to prevent burns are the reduction of the area
illuminated by spot illumination and covering the peri pheral area with wet
sterile gauze. The area of the incision should be constan tl y irrigated.
Final remark
Carl Zeiss recommends:
– Reduce the illumination of the surgical field to the extent required for
the patient's safety and for clear microscopic visualization.
The illumination intensity is preconfigured (factory settings) in such a
way that a warning is di splayed on t he touchs creen and in the dat a injection system when the threshold value of 25% is exceeded, informing the user of possible tissue damage
when the light intensity is too
high.
– Please note the warning and safety notes in the "Light“ configuration
menu (page 134).
– Reduce the exposure time to a minimum.
These measures should help t he s urgeon to r educe the r isk of phototo xic
injury of the patient.
After every use of the instrument
• Switch off the system at the power switch after every use.
G-30-1458-en OPMI® Pentero® Software Release 2.20 / 2.21 Issue 11.1
Printed on 18. 02. 2009
26 Safety
Safety devices of the suspension system
Mechanical end stops
protect cables and the light guide against bending and stretching.
Transport locks (1)
for locking the axes in position during transportation.
Safety switch
The brakes will be locked if a spring or cable breaks. You can nevertheless finish surgery, as you can still move the surgical microscope by applying slight force.
Uninterruptible power supply (UPS)
A UPS is integrated in the syst em to ensure correc t operation in t he event
of short power failure. It powers the electronic system and the touchscreen, but not the light source.
Messages:
– Line power failure: in the event of li ne power failure, the system is
supplied for a short time. If no power is available for a prolonged
period, the system is shut down.
– Line power is back: the user is informed when line power is back
(Power OK), and all subsystems are re-initialized. This process
may take a few seconds.
Note:
In general, the system is ready for oper ation after power-up. A continuous
beep indicates extreme discharging of the USP. In this case, the system
should not be powered up for at least five minutes. After this time, you can
power up the system again for charging the UPS. For t he ini tial start up or
after long rest periods, we recommend the following: leave the poweredup system connected to line power for approx. 12 hours in order to fully
charge the UPS.
The system automatically tries to remedy problems in the control software. After several unsuccessful attempts, the system executes a PC
reset to restart the applicat ion. This restart ru ns automatically in the background and restores the full functionality of the system within approx. 2
minutes. All major basi c f unctions of the OPMI Pent ero remain fu ll y avai lable to the user during this time (operation of focus, zoom, light, brakes,
motorized XY movement)
.
Backup illumination
The lamp module contains two identical lamps. If lamp 1 fail s, a quick-action changer ensures that the li ght guide is supplied by lamp 2. The lamp
change does not impair the surgeon in his work.
G-30-1458-en OPMI® Pentero® Software Release 2.20 / 2.21 Issue 11.1
Printed on 18. 02. 2009
Safety 27
1
1
1
Heat protection filter
The illumination system is equipped with a heat protection filter.
G-30-1458-en OPMI® Pentero® Software Release 2.20 / 2.21 Issue 11.1
Printed on 18. 02. 2009
28 Safety
Laser
Austrittsöffnung
Laser
Aperture
Apertura
de Laser
Ouverture
Laser
O
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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.
G-30-1458-en OPMI® Pentero® Software Release 2.20 / 2.21 Issue 11.1
Printed on 18. 02. 2009
Safety 29
MANUFACTURED IN GERMANY BY
Carl Zeiss
Laserstrahlung
nicht in den Strahl
blicken
Laser Klasse 2
Pmax: <1mW
λ
635-645nm
nach EN 60 825-1:2002
Radiacion Laser
no mirar en
el rayo
Laser de classe 2
Pmax: <1mW λ 635-645nm
sequm EN 60 825-1:2002
Laser radiation
do not stare
into beam
Class 2 laser product
Pmax: <1mW
λ
635-645nm
as per EN 60 825-1:2002
Rayonnement Laser
ne pas regarder
dans le faisceau
Appareil a laser de classe 2
Pmax: <1mW
λ
635-645nm
conforme a EN 60 825-1:2002
Laser radiation
do not stare into beam
Power output 1 m W
wavelength 635-645 nm
class II laser product
FABRIQUE EN R. F. A. PAR
Carl Zeiss
O
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DRAPE
Hier luftdicht abschließen
Make airtight here
Fermer hermétiquement ici
Cerrar herméticamente aquí
O
P
M
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P
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n
t
e
r
o
FLOW 800 Pentero
Carl Zeiss Surgical GmbH
302581-9250-000
SN 10xxxx
REF
Options:
INFRARED 800 NTSC
Carl Zeiss Surgical GmbH
302581-9246-000
SN 51xxxx
REF
INFRARED 800 PAL
Carl Zeiss Surgical GmbH
302581-9245-000
SN 51xxxx
REF
BLUE 400
Carl Zeiss Surgical GmbH
302581-9050-000
SN 50xxxx
REF
G-30-1458-en OPMI® Pentero® Software Release 2.20 / 2.21 Issue 11.1
Printed on 18. 02. 2009
30 Safety
Labels: transport locks and risk of crushing
G-30-1458-en OPMI® Pentero® Software Release 2.20 / 2.21 Issue 11.1
Printed on 18. 02. 2009
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