Zeiss OPMI Pentero User Manual

OPMI® Pentero®

Software Release 2.20 / 2.21

Instructions for use

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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.

Note:

The hand indicates hints on the use of the system or other tips for the user.

Read the user manual!

OPMI® and Pentero® are registered trademarks of Carl Zeiss Surgical

GmbH.

AutoDrape™, Superlux, FlexiTrax™, MultiVision™ and FLOW™ 800 are trademarks of Carl Zeiss Surgical GmbH.

FLOW 800 SW 2.21

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 infrared 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 (touchscreen)		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		261
(option)
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 servers		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)		393
(option)
		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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OPMI Pentero

Functions at a glance

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 setting: 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,
			154
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

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Functions at a glance

11

13	12		11	10	9	8	7	6	5	4	3	2	1
18	17	16 15	14
19
20
21				25
				26
22				27
				28
				29
				30
23				31
24
					STOP	32			33
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12	Functions at a glance

What to do in an emergency

1	Failure 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).	page 210

3Failure 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 (posi-

tion 2)

page 211

4Some of the magnetic brakes are blocked:

•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 seconds. The computer and touchscreen, however, are disabled.

If the magnetic brakes are still blocked:

•Hold the microscope on its body (not on the handgrips) and position it manually by overcoming the braking ef-

fect.

page 215

5Failure of the touchscreen:

•Do not under any circumstances touch the touchscreen, since this can result in changes to settings and

parameters. Zoom, focus, illumination and brakes can
still be operated.	page 212

6Error 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 touchscreen. page 212

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Functions at a glance

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7Failure 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 handgrips) and position it manually by overcoming the braking ef-

fect.

page 214

		6
		3
		2
		5
8	1
	7
		4
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14	Functions at a glance

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Safety

15

Safety

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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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.

–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 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.

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

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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 information security

The user (or IT officer) must ensure that the national laws and regulations 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 information concerning the personal or material circumstances of an identified or identifiable 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 third 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 until our service representative has repaired it.

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Safety

•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.

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 for 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 patient, image and video data as well as system or user-specific configuration 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 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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Safety

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•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.

•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 the 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 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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Safety

Interference radiation

To ensure permissible operation in conjunction with neuromonitoring 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 are properly connected and screw connections tightened.

–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 instrument.

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, loosen the brakes while holding the microscope tightly at both handgrips. If the system has been correctly balanced, the surgical microscope can be moved almost effortlessly.

Repeat the autobalance procedure, if required.

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Safety

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Connection to data networks

Activities in the data network may interfere with the system. We therefore recommend that you disconnect the system from data networks before surgery.

The network connector must be adequately contact-protected, e.g. made 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 correctness 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 IEC60601- 1 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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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 removed or opened.

•Please pay special attention to labels on the unit (warning triangle with an exclamation mark, warning labels and notes).

•Do not cover any ventilation openings.

For every use of the instrument

•Using the 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 touchsensitive area of the touchscreen.

•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.

•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 illumination 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 Interface Contract and for which the use of the integrated navigation interface with data injection system has been licensed.

Please observe the user manual for the connected system.

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Safety

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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 filters to the visible range 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 intensity 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 different ways:

–If the illuminated area has a large diameter, skin areas are illuminated 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 illumi- nated field to the smallest size needed for the respective proce- dure.

–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 diameter of the illuminated area is reduced.

–A long surgical procedure increases the risk of injury, in particular if a standard procedure takes considerably longer than usual.

–Injuries in the peripheral area can be prevented by covering this area with wet, sterile gauze.

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Safety

–You should also take into account that some areas of the body may be more sensitive than others.

–Certain preparations of the surgical field, local vasoconstrictive medications and incision drapes may also result 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 you to reduce the size of the illuminated field to the area observed during the procedure (page 66).

–You can then set the light intensity to the value required for the procedure using the buttons on the handgrip or foot control panel. Please note that the use of the spot illumination system increases the intensity 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 is usually increased during a procedure, leading to a darker image and thus necessitating an increase in illumination intensity. If zoom-dependent brightness control has been activated, it automatically compensates for this loss in image brightness. (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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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 peripheral area with wet sterile gauze. The area of the incision should be constantly 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 displayed on the touchscreen and in the data 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 the surgeon to reduce the risk of phototoxic 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 system to ensure correct operation in the 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 line 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 operation 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 the initial startup 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 application. This restart runs automatically in the background and restores the full functionality of the system within approx. 2 minutes. All major basic functions of the OPMI Pentero remain fully available 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 fails, a quick-ac- tion changer ensures that the light 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

Heat protection filter

The illumination system is equipped with a heat protection filter.

1

1

1

G-30-1458-en	OPMI® Pentero® Software Release 2.20 / 2.21	Issue 11.1
		Printed on 18. 02. 2009

28

Safety

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.

				ro
				te
		I P	e	n
O	P	M

Laser

Austrittsöffnung

Laser

Aperture

Apertura de Laser

Ouverture

Laser

G-30-1458-en	OPMI® Pentero® Software Release 2.20 / 2.21	Issue 11.1
		Printed on 18. 02. 2009

Safety

29

DRAPE

Hier luftdicht abschließen

Make airtight here

Fermer hermétiquement ici

Cerrar herméticamente aquí

OPMIPentero

				ro
			te
			n
			e
		P
		I
	M
P
O

Options:

Carl Zeiss Surgical GmbH

	SN	10xxxx
	FLOW 800 Pentero
	REF	302581-9250-000

Carl Zeiss Surgical GmbH

	SN	51xxxx
	INFRARED 800 NTSC
	REF	302581-9246-000

Carl Zeiss Surgical GmbH

	SN	51xxxx
	INFRARED 800 PAL
	REF	302581-9245-000

			Carl Zeiss Surgical GmbH
											Laserstrahlung
			SN	50xxxx							nicht in den Strahl
			BLUE 400								blicken
			REF	302581-9050-000							Laser Klasse 2
											nach EN 60 825-1:2002
											Pmax: <1mW λ 635-645nm
											Radiacion Laser
											no mirar en
											el rayo
											Laser de classe 2
											sequm EN 60 825-1:2002
											Pmax: <1mW λ 635-645nm
											Laser radiation
											do not stare
											into beam
											Class 2 laser product
											as per EN 60 825-1:2002
											Pmax: <1mW λ 635-645nm
											Rayonnement Laser
							FABRIQUE EN R. F. A. PAR				ne pas regarder
											dans le faisceau
						Carl Zeiss					Appareil a laser de classe 2
											conforme a EN 60 825-1:2002
											Pmax: <1mW λ 635-645nm
						MANUFACTURED IN GERMANY BY
						Carl Zeiss					Laser radiation
											do not stare into beam
											Power output 1 mW
											wavelength 635-645 nm
											class II laser product

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