Zeiss OPMI Vario Retrolux User manual

OPMI Vario®

Retrolux® System

Instructions for use

G-30-1721-en

Issue 1.0

Printed on 12. 03. 2008

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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.

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

GmbH.

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Contents

–	Key to symbols	2
Functions at a glance		7
–	OPMI® VARIO	8
–	S88 floor stand	10
Safety		13
– Notes on installation and use		15
– Phototoxic retinal injury in eye surgery		21
– Safety devices of the suspension systems		26
– Warning labels and notes		32
Description		37
OPMI Vario Retrolux System		38
–	Intended use	38
– Components of the OPMI Vario Retrolux System		38
Components of the surgical microscope		40
–	Controls, displays, connections	42
– Binocular tubes and eyepieces		50
–	Retrolux illumination module	54
Components of the S88 floor stand		56
– Description of the modules		57
–	Design	58
– Display field with control keys		60
– Lamp housing with xenon light source		62
–	Suspension arm	68
– Stand base with column		70
–	Connector panel	72
–	Instrument tray (option)	74
–	Video monitor (option)	76
Foot control panel (option)		84

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–	Intended use	84
–	Design	84
– Foot control panel with 14 functions		86
– Foot control panel with 8 functions		87
Preparations		89
Attaching the equipment		90
– Mounting the surgical microscope		90
–	Attaching accessories	92
– Mounting the tube and eyepieces		94
– Mounting the Retrolux illumination module		96
– Bringing the Retrolux illumination module into its standby position
100
– Attaching the fundus imaging system to the illumination module		102
Connections		104
– Connecting the surgical microscope		104
– Mounting the light guide		104
– Aligning the X-Y coupling		108
– Strain relief device on S88 floor stand		110
– Connecting the S88 floor stand		112
Adjusting the supension system		114
– Adjusting the balance setting of the suspension arm		114
– Adjusting the limit of downward movement		116
Balancing the surgical microscope		118
Settings on the control and display panel		120
– Adjusting the suspension system		120
Adjusting the surgical microscope		121
Surgical microscope with a laser micromanipulator		123
Relocating the system		126
Operation		129
Checklist		130
Positioning the S88 floor stand		134
Using the display and key field		136
–	General functions	136

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–OPMI Vario on the suspension system, user interface

with SpeedFokus option		140
Procedure		160
What to do in an emergency		162
– Failure of a xenon lamp		162
– Failure of lamp control		164
– Failure of the zoom function		165
– Failure of the focusing function		166
– Failure of magnetic brakes		167
Maintenance / Further information		169
–	Trouble-shooting	170
– Changing the xenon lamp module		178
– Adjusting the monitor arm		180
– Magnifications / Fields of view		182
– Care of the unit		184
–	Sterilization	185
– Disinfecting the control keys		186
–	Ordering data	188
–	Spare parts	190
–	Accessories	191
–	Disposal	193
Technical data		195
– Technical data of OPMI VARIO		197
– Technical data of S88 floor stand		198
–	Ambient requirements	205
–	CE conformity	205
– Changes to the system		205
Index		207

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Functions at a glance

7

Functions at a glance

OPMI® VARIO	8
S88 floor stand	10

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OPMI® VARIO

Functions at a glance

1	Adjusting the eyecup and the prescription	page 52
2	Adjusting the interpupillary distance	page 50
3	Adjusting the friction of vertical adjustment	page 42
4	Recentering the X-Y coupling	page 48
5	Adjusting the friction of the OPMI® axis of rotation	page 48
6	Manual zoom setting	page 44
7	Manual focusing	page 44
8	Manual setting of the illuminated field diameter	page 44
9	Connecting the light guide	page 104
10	Balance setting of the microscope's	page 42
	front-to-back tilt
11	Balance setting of the microscope's	page 42
	lateral tilt
12	Motorized focusing	page 46
13	Motorized zoom setting	page 46
14	Display of the magnification factor of	page 42
	the zoom system
15	Releasing the magnetic brakes	page 46
16	Programmable release buttons	page 46
17	Switching off the electrical drive of the	page 44
	focusing system
18	Connecting the mouth switch	page 42

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Functions at a glance

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1		2				3			4								5

6

7

8

9

10

11

12

13

14

15 16 17 18

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S88 floor stand

Functions at a glance

	Xenon illumination system
1	Selecting a filter	page 64
2	Manual activation of backup lamp	page 62
3	Resetting the counter	page 64
4	Opening the lamp module	page 64
5	Red segment is lit - backup lamp is in use	page 62
6	Control panel	page 66
7	Lamp housing of xenon illumination system	page 62
8	Unlocking the magnetic brakes of the suspension page 68
	system
9	Limiting the suspension arm's downward movement	page 116
10	Removing/mounting the coupling for the	page 68
	surgical microscope
11	Balance setting	page 68
12	Locking the stand in position	page 70
13	Locking the suspension arm in its horizontal position	page 68
14	Connecting the foot control panel or hand switch,	page 72
	connecting the remote control connector
15	Rated voltage display	page 72
16	Connector panel	page 72
17	Turning on the suspension system	page 72

1		2		3		4		5

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Functions at a glance

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6		7		8		9					10			11

12

9

13 14

15, 16, 17

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12	Functions at a glance

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Safety

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Safety

Notes on installation and use	15
Phototoxic retinal injury in eye surgery	21
Safety devices of the suspension systems	26
Warning labels and notes	32

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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.

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

–For USA: FDA classification Class I.

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

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

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

•Please observe all applicable accident prevention regulations.

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

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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.

•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: The instrument can be incorporated into potential equalization measures. For this purpose, contact our service department.

•Do not use a mobile phone in the vicinity of the equipment because the radio interference can cause the equipment to malfunction. The effects of radio interference on medical equipment depend on a number of various factors and are therefore entirely unforeseeable.

•Modifications and repairs on these instruments or instruments used with them may only be performed by our service representative or by other authorized persons.

•The manufacturer will not accept any liability for damage caused by unauthorized persons tampering with the instrument; this will also forfeit any rights to claim under warranty.

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

•Use this instrument only for the applications described.

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Safety

•Only use the instrument with the accessories supplied. Should you wish to use other accessory equipment, make sure that Carl Zeiss or the equipment manufacturer has certified that its use will not impair the safety of instrument.

•Only personnel who have undergone training and instruction are allowed to use this instrument. It is the responsibility of the customer or institution operating the equipment to train and instruct all staff using the equipment.

•Keep the user's manuals where they are easily accessible at all times for the persons operating the instrument.

•Never look at the sun through the binocular tube, the objective lens or an eyepiece.

•Do not pull at the light guide cable, at the power cord or at other cable connections.

•This instrument is a high-grade technological product. To ensure optimum performance and safe working order of the instrument, its safety must be checked once every 12 months. We recommend having this check performed by our service representative as part of regular maintenance work.

If a failure occurs which you cannot correct using the trouble-shooting table, attach a sign to the instrument stating it is out of order and contact our service representative.

•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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Connection of a laser micromanipulator

The link-up of a laser micromanipulator with the OPMI results in a medical system for which the system manufacturer must meet the necessary requirements (approval, qualification, laser protection, etc.). Please note the user manuals provided by the laser micromanipulator manufacturer and laser manufacturer. Further information is available from our service department or from authorized representatives.

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Safety

Connection of navigation systems (option)

The Carl Zeiss components "Surgical microscope on suspension system" can be integrated into an external navigation system. An optional navigation interface is available.

•The manufacturer of the external navigation system (system supplier) is responsible for the following:

–Confirmation that his navigation systems have been tested and certified for operation with the respective Carl Zeiss surgical microscope on a suspension system in accordance with the requirements specified in the Carl Zeiss interface description "Navigation Interface for Carl Zeiss Surgical Microscopes".

–Meeting all requirements (approval, qualifications, etc.) for the medical system created through coupling via the navigation interface.

–Provision of all accompanying documents required.

–Ensuring that the navigation system is only connected by personnel who have undergone appropriate training and instruction.

–Contacting the local Carl Zeiss representative for any inquiries that may arise.

–Implementation of a procedure that guarantees the calibration of the surgical microscope which is absolutely vital for the use of the Carl Zeiss components "Surgical microscope on suspension system" in combination with a connected navigation system.

This allows the calibrated surgical microscope combined with the navigation system to be used like an optical pointer with a variable length (corresponds to the working distance).

–Conducting complete functional testing, alignment and calibration (landmark test) of the navigation system after every subsequent installation or exchange of navigation system components

–Incorporation of a regularly changing icon in the data injection display of surgical microscopes equipped with a data injection system, i.e. the "heartbeat" of the navigation system must be constantly visible for the user to permit data transmission errors to be immediately detected.

•To check the accuracy of the overall system, perform the test specified by the navigation system manufacturer, e.g. the landmark test, also using the surgical microscope. This allows you to ensure that the stereotactic data has been correctly generated and transmitted to the navigation system without errors.

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•Do not use any rotatable tube dovetail mounts when operating the surgical microscope with a connected navigation system. If mounts of this type have been attached to the microscope, they must be carefully locked in their central positions (tighten the knurled screw for rotation).

Requirements on the antenna design (non-Zeiss antennas)

•The antenna manufacturer must confirm that his antenna has been tested and certified for operation with the respective Carl Zeiss surgical microscope on a suspension system in accordance with the requirements specified in the Carl Zeiss interface description "Navigation Interface for Carl Zeiss Surgical Microscopes".

•The following requirements, in particular, apply to the antenna:

–The surgical microscope with accessories and the antenna must not exceed the admissible total weight (see label or the chapter "Technical data").

–The antenna must not project over the bottom edge of the microscope body in the direction of the surgical field.

–The antenna must neither obstruct the movement and adjustability of the accessories which can be used on the surgical microscope (usually a stereo coobservation tube, a camera adapter, a face-to- face tube for spinal surgery, a laser micromanipulator) nor collide with these accessories.

–The antenna configuration must be implemented in such a way that the localizer camera can always "see" the diodes or trackballs when the surgical microscope and its accessories are in their usual positions.

–When the system's internal antenna wiring is used, the EN60601- 1-2 standard (electromagnetic compatibility) must be complied with.

–The output power of the LEDs or infrared LEDs (IRED) must always comply with the IEC 60825 laser safety standard, even in the event of cable defects.

–The failure of one or several LEDs of the antenna may impair navigation or lead to navigation failure. Take the necessary precautions.

Requirements for operation

•Our service representative or an expert authorized by us will install the system. Please ensure that the following requirements are met for further operation:

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Safety

–All connecting components (details in the user's manual) which are relevant to system safety have been properly connected, and the screw connections have been firmly tightened.

–All cables and plugs are in perfect condition.

–The voltage set on the instrument corresponds to the rated line voltage on the site of installation.

–The power cord has been 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 system.

Before every use and after re-equipping the instrument

•Make sure that all ”Requirements for operation” are fulfilled.

•Go through the checklist.

•Re-attach or close any covers, panels or caps which have been removed or opened.

•Pay special attention to warning symbols on the instrument (triangular warning signs with exclamation marks), labels and any parts such as screws or surfaces painted red.

•Do not cover any ventilation openings.

For every use of the instrument

General

•Never operate the system unattended.

•Avoid looking directly into the light source, e.g. into the microscope objective lens or a light guide.

•When the illumination is on, the light guide must be connected at both ends. Otherwise there is a risk of fire or burn injuries.

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

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

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–during prolonged procedures on skin and tissue using objective lenses with a short focal length (short working distance),

–during procedures on tissue with a low blood supply,

–with high brightness settings of the xenon lamp.

Warning!

Due to the high luminance of the xenon lamp and its light spectrum, which resembles that of natural daylight, its use in ophthalmic applications is only permissible in combination with the Retrolux illumination module.

•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.

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

After every use of the instrument

•Always use the main power switch of the instrument to turn it off.

•The main power switch must always be turned off when the instrument is not in use.

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

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.

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Safety

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.

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

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

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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. This problem has been solved by Carl Zeiss by the use of a retinal protection device that can be swung into the illumination beam path of the Retrolux illumination module.

Brightness control

The brightness control scale of our systems has a linear structure with values ranging from 1 to 10. The stipulations of standard ISO/DDIS 15004-2:2006(E) result in maximum radiation exposure times for the different illumination configurations as specified in the table "Maximum radiation exposure times".

The microscope light source - like any bright light source - may present a hazard to the patient's eye both in the form of immediately visible thermal damage to the retina as well phototoxic chemical reactions which may lead to photoretinitis. The factors which play an important role in determining the phototoxic risk are:

–Lamp brightness.

–Spectral distribution of the light (UV and blue are more dangerous that longer wavelengths).

–Duration of direct exposure.

–Pupil size.

–Clarity of ocular media (infants and young children, for example, may be at a higher risk).

–Phakic status of the eye (aphakic and pseudo-aphakic eyes without UV and blue filtering IOLs are at a higher risk).

–Previous exposure to bright light such as retinal photography, especially within the last 24 hrs.

The following table is intended to provide the surgeon with a guideline in determining the potential hazard. The data has been calculated for a worst-case scenario of direct, uninterrupted exposure of an aphakic eye with an 8 mm dilated pupil. The calculations are based on the recommended occupational health daily exposure limits as defined in 6). A safety factor of 10 has been used in determining these limits.

During cataract procedures, factors such as lenticular material, instruments such as the phaco handpiece, and movement of the eye provide interruption of the exposure and would be expected to significantly lengthen the time before photoretinits might be expected to occur.

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Safety

A prospective study 7) of the effects of microscope illumination during surgery did not reveal any phototoxic retinal injuries for procedure times of up to 30 minutes if the calculated maximum recommended exposure time was 150 seconds. However, it was also found that at the same brightness setting, phototoxic retinal injury could be expected after approximately 100 min.

Carl Zeiss recommends the following measures in order to minimize phototoxic risk:

•Always use the lowest possible brightness setting.

•When working on the exterior eye, use the retinal protection device to prevent light from entering the pupil, especially when the pupil is dilated.

•Turn off the microscope illumination system or cover the patient's eye during pauses in surgery.

The following table shows the maximum radiation exposure to the xenon illumination.

Maximum radiation exposure times
		Max. exposure time
Illumination display scale
2,5		3.4 minutes
5,0		1.5 minutes
7,5		1.0 minutes
10		0.8 minutes

Warning!

This exposure time must not be exceeded, as serious eye injury could otherwise be caused by the xenon illumination.

Note:

A UV blocking filter is contained as a standard feature in the Retrolux illumination module on the microscope side.

This helps the surgeon to reduce the risk of phototoxic retinal injury in the patient.

List of references

1) H. Stiller, and B. Rassow, "Light hazards to the patient's retina from ophthalmic instruments," Applied Optics-OT 30, 2187-2196 (1991).

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2)American Conference of Governmental Industrial Hygienists, "Documentation of the Threshold Limit Values for physical agents. 7th Edition," (American Conference of Governmental Industrial Hygienists, Cincinnati, 2001).

3)S. G. Khwarg, F. A. Linstone, S. A. Daniels, S. J. Isenberg, T. A. Hanscom, M. Geoghegan, and B. R. Straatsma, "Incidence, risk factors, and morphology in operating microscope light retinopathy," Am. J. Ophthalmol. 103, 255-263 (1987).

4)G. Kleinmann, P. Hoffman, E. Schechtman, and A. Pollack, "Micro- scope-induced retinal phototoxicity in cataract surgery of short duration," Ophthalmology 109, 334-338 (2002).

5)ISO/FDIS 15004-2:2006(E) Optical instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection

6)David Sliney, Danielle Aron-Rosa, Francois DeLori, Franz Fankhauser, Robert Landry, Martin Mainster, John Marshall, Bernard Rassow, Bruce Stuck, Stephen Trokel, Teresa Motz West, and Michael Wolffe, Adjustment of guidelines for exposure of the eye to optical radiation from ocular instruments: statement from a task group of the International Commission on Non-Ionizing Radiation Protection (ICNIRP) APPLIED OPTICS Vol. 44, No. 11, p 2162 (10 April 2005)

7)Byrnes, G.A., Antoszyk, A.N., Mazur, D.O., Kao, T.C., Miller, S.A., Photic maculopathy after extracapsular cataract surgery. A prospective study, 1992/05/01 Ophthalmology, VL - 99, IS - 5, SP - 731, EP - 737, PB - Elsevier

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Safety

Safety devices of the suspension systems

1Release bar

Allows non-sterile persons to release the magnetic brakes of the suspension system.

2Adjustment screw for limiting the downward travel

Use this screw to set the minimum vertical distance (working distance) from the surgical field. Check this setting before each surgical procedure.

3Locking knob

for locking the suspension arm in its horizontal position.

Before removing or attaching a unit (microscope, tube, etc.), move the suspension arm into a horizontal position. Pull out the locking knob and turn it clockwise or counterclockwise through 180°, while slightly moving the suspension arm up and down until the lock engages. When locked, the suspension arm can no longer suddenly spring upward when insufficient weight is attached. After attaching a unit, perform the balancing procedure.

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1			2

3			1

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Safety

Xenon illumination system

Warning!

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

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

•Replace the xenon lamp in good time.

•Reset the service hour counter to "0" after replacing the lamp.

1Switching to the backup bulb

The lamp module contains two xenon bulbs. The second bulb is used as a backup bulb which must be swung into the illumination beam path if the first bulb fails.

•If the xenon bulb fails, open the lamp module as follows: Press button (7). The lamp module is slightly ejected.

•Pull out the lamp module as far as it will go.

•Turn knob (1) 180° until it snaps in place. This moves the backup bulb into the illumination beam path.

•Push the lamp module all the way back into the lamp housing.

•Reset service hour counter (6) to "0". Use a pointed object and press it into the recess of reset button (5).

2Indicator: backup bulb is in use

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

Note:

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

3Yellow indicator lamp

Lights when the bulb has failed, or if the lamp module is defective. After activation and ignition of the backup bulb, the yellow indicator lamp turns off again.

4Manual function

When the manual function has been activated, all electrical control systems are disabled. The bulb brightness is automatically adjusted to a fixed setting.

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1

2

5

6

7

2

3

4

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Safety

Manual function

1Manual key

The Manual key permits you to switch to manual operation. The motorized control functions of the surgical microscope are deactivated. The lamp brightness is automatically adjusted to a fixed setting, the value being shown in the first display section.

When the manual mode is activated, the yellow LED is lit and the word "MANUAL" blinks in the third display section.

The surgical microscope can no longer be operated via the foot control panel, the handgrips or the display and key field.

In the manual mode, you can only switch the illumination on and off on the foot control panel and release the magnetic brakes by pressing the appropriate key on the surgical microscope.

The manual mode is retained even if you turn the power switch of the instrument off and on again.

Press the Manual key once again to reactivate electronic control; the display in the display and key field then returns to the basic mode.

G-30-1721-en	OPMI® VARIO Retrolux System	Issue 1.0
		Printed on 12. 03. 2008