Zeiss OPMI Lumera T User Manual

OPMI Lumera® T

with Integrated

Assistant's Microscope

Instructions for use

G-30-1682-en

Issue 4.0

Printed on 02. 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.

OPMI®, Lumera®, Superlux®, Invertertube® and HaMode® are registered trademarks of Carl Zeiss Surgical GmbH.

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Contents

–	Key to symbols	2
Functions at a glance		7
– OPMI Lumera T with integrated assistant's microscope		8
– OPMI Lumera T (option)		9
–	Light sources	10
–	S88 floor stand	12
–	S8 ceiling mount	14
–	S81 ceiling mount	16
Safety		19
– Notes on installation and use		21
– When using a wide-angle observation system (e.g. BIOM 3)		25
– Phototoxic retinal injury in eye surgery		25
– Safety devices of the suspension systems		32
– Warning labels and notes		44
Description		51
Lumera T surgical microscope		54
–	Intended use	54
–	Description of components	54
–	Illumination system	60
–	Controls, displays, connections	64
– Binocular tubes and eyepieces		72
Light sources		78
– Halogen light source (option)		80
– Superlux Eye light source		84
– Superlux Eye with integrated halogen light source (option)		92
Identical components of the suspension systems		98
–	Suspension arm	98
– Display field with control keys		100

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

S88 floor stand		102
–	Intended use	102
–	Description of components	103
–	Design	104
– Stand base with column		106
–	Connection panel	108
–	Instrument tray (option)	110
–	Video monitor (option)	112
S8 ceiling mount		120
–	Intended use	120
–	Description of components	121
–	Design	122
– Power switch with connector (option)		124
S81 ceiling mount		126
–	Intended use	126
–	Description of components	127
–	Design	128
– Power switch, connector and socket (option)		130
OPMI Lumera T with integrated assistant's microscope
on S88 floor stand		132
–	Intended use	132
–	Design	132
OPMI Lumera T with integrated assistant's microscope
on S8 ceiling mount		134
–	Intended use	134
–	Design	134
OPMI Lumera T with integrated assistant's microscope
on S81 ceiling mount		136
–	Intended use	136
–	Design	136
Foot control panel		138
–	Intended use	138
–	Design	138

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Preparations	143
Attaching the equipment	144
– Mounting the surgical microscope	144
– Mounting the tube, the eyepieces and the objective lens	148
– Changing the microscope accessories	152
Connections	154
– Connecting the surgical microscope	154
– Connecting the light guide	154
– Strain relief device on S88 floor stand	158
– Connecting the S88 floor stand	160
– Relocating the system	162
Adjusting the supension system	164
– Adjusting the balance setting of the suspension arm	164
– Adjusting the limit of downward movement	166
– Positioning the S8 ceiling mount	168
Settings on the control and display panel	170
– Setting up the suspension system	170
Adjusting the surgical microscope	171
– Optimizing the red reflex	172
– Adjusting the tilt angle	174
Preparing the system for sterile use	176

Operation	179
Checklist	180
– When using a wide-angle observation system (e.g. BIOM 3)	183
Positioning the S88 floor stand	184
Using the display and key field	186
– General functions	186
– Operating the OPMI® on the suspension system	190
Procedure	203

What to do in the event of malfunctions	205
What to do in an emergency	206
– Lamp failure of the halogen light source	206

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

– Lamp failure in the Superlux Eye light source	208
– Failure of lamp control	212
– Failure of the focusing function	212
– Failure of magnetic brakes	214
– Failure of the X-Y coupling	214
– Failure of the zoom function	215
Causes of malfunctions and remedies	216
– Malfunctions in the surgical microscope	216

–Malfunctions in the surgical microscope with integrated

assistant's microscope		218
– Malfunctions in the S8, S81 or S88 suspension system		219
– Malfunctions in the video monitor		221
– Malfunctions in the halogen light source		223
– Malfunctions in Superlux Eye light source		224
Care and maintenance		227
– Care of the unit		228
–	Sterilization	229
– Disinfecting the control keys		230
– Changing the halogen lamp		232
– Changing the Superlux Eye xenon lamp module		234
– Balancing the monitor arm		236
System data		239
–	Technical data	240
– Magnifications / Fields of view		256
–	Ordering data	257
–	Spare parts	259
–	Disposal	260
–	Ambient requirements	261
–	CE conformity	261
– Changes to the system		261
Index		263

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Functions at a glance

7

Functions at a glance

OPMI Lumera T with integrated assistant's microscope	8
OPMI Lumera T (option)	9
Light sources	10
S88 floor stand	12
S8 ceiling mount	14
S81 ceiling mount	16

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

8	Functions at a glance

OPMI Lumera T with integrated assistant's microscope

1 Resetting X-Y coupling and focus to their initial positions page 64

2	Adjusting the interpupillary distance	page 72
3	Adjusting the eyecups	page 76
4	Setting your prescription	page 76
5	Unlocking the magnetic brakes	page 66
6	Display of the zoom system's magnification factor	page 66
7	Changing the magnification of assistant's microscope	page 70
8	Setting the inverter function	page 70
9	Focusing the assistant's microscope	page 70
10	Tilting the surgical microscope	page 174
11	Arrows indicating the focusing range	page 64
12	Locking screw for assistant's microscope (vertical)	page 70
13	Zoom adjustment (manual emergency operation)	page 215
14	Adjusting knob for different types of illumination	page 68
15	Connecting the light guide	page 154
16	Locking screw for assistant's microscope (horizontal)	page 174
17	Setting the depth of field (DeepView)	page 68

1

2

3

4

5

6
5
7	9	4	3	10	11	7	8	12 13	14	15	16 17

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Functions at a glance

9

OPMI Lumera T (option)

1 Resetting X-Y coupling and focus to their initial positions page 64

2	Tilting the surgical microscope	page 174
3	Adjusting the eyecups	page 76
4	Setting your prescription	page 76
5	Unlocking the magnetic brakes	page 66
6	Display of the zoom system's magnification factor	page 66
7	Setting the depth of field (DeepView)	page 68
8	Setting the illumination	page 62
9	Arrows indicating the focusing range	page 64
10	Adjusting the interpupillary distance	page 72
11	Zoom adjustment (manual emergency operation)	page 215
12	Connecting the light guide	page 154

1

2

3
4
5
6
5
7	8	2	9	10	11	12

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

10

Light sources

Functions at a glance

	Halogen light source
1	- Closed flap: main lamp is on	page 80
	- Open flap: backup lamp is on
2	Selecting a filter	page 80
3	Opening the lamp module	page 80
4	Manual activation of backup lamp	page 80
	Superlux Eye light source
5	Selecting a filter	page 84
6	Resetting the counter	page 88
7	Opening the lamp module	page 84
8	Manual activation of backup lamp	page 84
9	Red segment is lit - backup lamp is in use	page 84

1		2		3		4		5		6		7		8		9

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Functions at a glance

11

Superlux Eye light source with integrated halogen light source (option)

1	Selecting the filter for Superlux Eye light source	page 93
2	Switching manually to the backup lamp of	page 93
	Superlux Eye light source
3	Resetting the counter	page 38
4	Opening the Superlux Eye lamp module	page 80
5	Additional integrated halogen light source:	page 94

-Closed flap: main lamp is on

-Open flap: backup lamp is on

6	Selecting the filter for additional integrated halogen	page 94
	light source
7	Opening the lamp module of integrated halogen	page 94
	light source
8	Manual activation of the halogen light source's	page 94
	backup lamp
9	Superlux Eye light source:	page 94
	red segment is lit - backup lamp is in use

1

2 3 4 5

6

7

8

9

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

12

S88 floor stand

Functions at a glance

1	Control unit	page 186
2	Light source	page 78
3	Unlocking the magnetic brakes of the suspension page 98
	system
4	Limiting the suspension arm's downward movement page 166
5	Removing/mounting the coupling for the	page 98
	surgical microscope
6	Balancing the suspension arm	page 164
7	Locking the stand in position	page 106
8	Locking the suspension arm in its horizontal position page 98
9	Connecting the foot control panel,	page 108
	connecting the remote control connector
10	Rated voltage display	page 108
11	Connector panel	page 108
12	Switching on the suspension system	page 108

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Functions at a glance

13

1		2		3		4					5			6

7

4

8

9

10, 11, 12

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

14	Functions at a glance

S8 ceiling mount

1 Locking the suspension arm in its horizontal position

page 98

2Unlocking the magnetic brakes of the suspension page 98 system

3	Balancing the suspension arm	page 164
4	Light source	page 78
5	Control unit (rotatable through 180° or 70°)	page 186
6	Connecting the foot control panel,	page 124
	connecting the remote control connector
7	Switching on the suspension system	page 124
8	Releasing - moving - locking the lift arm	page 122
9	Removing/mounting the coupling for the	page 98
	surgical microscope
10	Limiting the suspension arm's downward movement	page 166

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Functions at a glance							15

1

2

3

4

5

6

7

8

2

9

10

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

16	Functions at a glance

S81 ceiling mount

1 Locking the suspension arm in its horizontal position

page 98

2Unlocking the magnetic brakes of the suspension page 98 system

3	Balancing the suspension arm	page 164
4	Light source	page 78
5	Control unit (rotatable through 180° or 70°)	page 186

6Connecting the foot control panel if the suspension page 130 system is installed on a ceiling track mount (option)

7	Connecting the remote control connector	page 130
8	Connecting the foot control panel	page 130
9	Switching on the suspension system	page 130
10	Removing/mounting the coupling for the	page 98
	surgical microscope
11	Limiting the suspension arm's downward movement	page 166

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Functions at a glance					17

1

2

3

4

5

6

7

8

9

2

10

11

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

18	Functions at a glance

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Safety

19

Safety

Notes on installation and use	21
When using a wide-angle observation system (e.g. BIOM 3)	25
Phototoxic retinal injury in eye surgery	25
Safety devices of the suspension systems	32
Warning labels and notes	44

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

20

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.

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Safety

21

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: If requested, the instrument can be incorporated into potential equalization measures.

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

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

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

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

•Use this instrument only for the applications described.

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

22

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.

•When mounting accessory equipment, please make sure that the admissible total weight of the surgical microscope is not exceeded. (See label or chapter "Technical data").

•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 system is a high-grade technological product. To ensure optimum performance and safe working order, we recommend having it checked by our service representative as part of regular scheduled maintenance. If a failure occurs which you cannot correct with the aid of the chapter "What to do in the event of malfunctions“, attach a sign to the system 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.

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Safety

23

Requirements for operation

•For ceiling mounts only: Our service staff or a qualified person appointed by us will install the system on ceiling anchors which have been properly mounted by the construction engineers responsible. These ceiling anchors must comply with the specifications contained in our planning manual.

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

–All mechanical connections (details in the user's manual) which are relevant to safety are properly connected and screw connections tightened.

–All cables and plugs are in good working condition.

–The voltage setting on the instrument conforms to the rated voltage of the line supply on site.

–The instrument is plugged into a power outlet which has a properly connected protective ground contact.

–The power cord being used is the one designed for use with this instrument.

Before every use and after re-equipping the instrument

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

•Go through the checklist.

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

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

•Do not cover any ventilation openings.

For every use of the instrument

General

•Never operate the system unattended.

•Excessive radiation exposure times may lead to retinal injury in the patient's eye. Never leave a system unattended when the light source has been activated.

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

24

Safety

•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.

Xenon lamps feature high luminance and a spectrum resembling that of natural daylight. Therefore, only special xenon lamps approved by Carl Zeiss must be used in ophthalmology.

•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.

•Phototoxic effect of light beams. When operating on the eye, always use the yellow protection filter to ensure that the patient's eye is not exposed to unnecessary (blue) radiation (risk of retinal injury).

•Adjust the illumination intensity as required for the type of illumination used and the radiation exposure time. You will find the values recommended by Carl Zeiss in the table "Maximum radiation exposure times" on page 29.

S88 floor stand

•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.

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Safety

25

When using a wide-angle observation system (e.g. BIOM 3)

Risk of collision!

1 2

When using a wide-angle observation system (e.g. BIOM 3 from Oculus) which is usually installed between the surgical microscope and the patient, make sure that the patient is neither put at risk nor injured by the motorized focusing system or the movement of the suspension system arm.

Only use accessories expressly certified by the manufacturer for combination with the surgical microscopes described in this manual.

Warning!

•With the wide-angle observation system swung out of position, always position the microscope body in such a way that index dot (1) of the microscope's focus is in the middle of triangle (2) of the marking.

•Select a medium magnification (e.g. 1.0).

•Lower the surgical microscope toward the surgical field until you see the patient's cornea sharply defined.

•Turn the setting screw for limiting the downward movement clockwise as far as it will go and check without the patient that the suspension arm cannot be lowered any further.

It is vital that you read the user manual for the wide-angle observation system used (e.g. BIOM 3 from Oculus).

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

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

26

Safety

In the following, comments on these aspects are given and a description of how Carl Zeiss, as a manufacturer, makes allowance for them in its systems.

Illumination characteristics (spectral composition)

Studies on the exposure of the eye to light of varying spectral composition date back to the early 1950s. These studies suggest that the potential hazard of phototoxic injury to the patient's retina can be reduced by blocking out the blue and ultraviolet light below a wavelength of 475 nm.

For protection of the retina, Carl Zeiss offers the blue barrier filter (retina protection filter) as a standard feature of the OPMI Lumera surgical microscopes. This reduces not only the exposure of the patient's eye to light, but also that of the surgeon's.

An important point to note here, however, is that the use of filters will inevitably change the perceived color of the light. For this reason, the physician may initially have to get used to the changed appearance of the anatomical structures.

Illumination intensity

The majority of researchers suggest that the surgeon should use the lowest light intensity required at the patient's eye to guarantee good viewing during surgery.

Carl Zeiss has addressed this aspect by providing its systems with a device for continuously varying the brightness of the light source. This permits the surgeon to optimally adapt the light intensity at the patient's eye to the conditions existing in each case.

Angle of illumination

A number of publications1)-4) suggest that the microscope should be tilted to reduce the exposure of the macula to direct illumination.

Carl Zeiss ophthalmic surgical microscopes are therefore equipped with the following:

– Tilting mechanism for the microscope body

– Surrounding field illumination with brightness control

– Red reflex illumination (stereo coaxial illumination)

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Safety

27

Focus of the light source

Studies show that injuries are likely to occur if the filament of the light source is imaged on the patient's retina. The peak intensity of a filament is considerably higher than that of an even and extended light source such as a light guide.

This is the reason why Carl Zeiss uses fiber optic illumination in its surgical microscope systems.

Exposure time to light

According to some publications, the phakic and aphakic eye should not be exposed to the light source longer than a few minutes. In all surgical cases, the retinal exposure time depends on the type and duration of the procedure and possible case complications. It is therefore recommended in ophthalmic surgery to keep the light intensity as low as possible, or to use a device which prevents the light from entering through the patient's pupil. It is also recommended 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 microscope's illumination beam path and a blue barrier filter (retina protection filter).

Brightness control

The brightness control scale of our systems has a linear structure with values ranging from 0.5 to 10. The stipulations of standard ISO/FDIS 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 as 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 than longer wavelengths).

–Duration of direct exposure.

–Pupil size.

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

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

28

Safety

–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 photoretinitis might be expected to occur.

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.

The red reflex illumination (stereo coaxial illumination) of OPMI Lumera has been designed to provide a bright red reflex using only very small quantities of light at the center of the light spot. The peripheral field illumination causes higher exposure of the retina, but usually not directly of the macula, depending on the position of the eye. For cataract procedures, we recommend adjusting the surrounding field illumination to be somewhat darker than the central red reflex spot. Not only does this setting minimize phototoxic risk, but it also reduces glare from the patient's sclera.

Other recommendations for minimizing phototoxic risk are:

•Always use the lowest possible brightness setting.

•Use the blue barrier filter (retina protection filter) to block the blue spectrum of light. The blue barrier filter will increase the recommended exposure times by factor three.

•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.

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

Safety

29

Maximum radiation exposure times

The use of the blue barrier filter (retina protection filter) increases the recommended exposure time by a factor of 3 compared with the values specified below.

Red reflex illumination (stereo coaxial illumination)

Scale display		Max. exposure time in minutes
of Illumination
		Halogen	Xenon	Xenon with
				HaMode filter
2.5	50		8.2	28
5	21		4.2	16.5
7.5	13		2.9	10.3
10	9		2.2	8.5
Surrounding field illumination
Scale display		Max. exposure time in minutes
of Illumination
		Halogen	Xenon	Xenon with
				HaMode filter
2.5		8.7	2.5	8.9
5		3.7	1.3	5.2
7.5		2.2	0.9	3.3
10		1.6	0.7	2.7

Note:

The illumination system of the surgical microscope contains a UV blocking filter as a standard feature.

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).

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).

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009

30

Safety

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

G-30-1682-en	OPMI® Lumera® T	Issue 4.0
		Printed on 02. 02. 2009