OPMI Lumera Instructions for use Issue 2.2

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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 Lumera® are registered trademarks of Carl Zeiss. Invertertube™ is a trademark of Carl Zeiss.

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OPMI® Lumera®

Issue 2.2 Printed on 12. 12. 2011

Contents

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– Key to symbols

2

Functions at a glance

7

– Lumera surgical microscope

8

– Light sources

9

– S7 floor stand

10

– S7 ceiling mount with rigid column

11

– S7 ceiling mount with lifting column

12

Safety

13

– Notes on installation and use

15

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

19

– Phototoxic retinal injury in eye surgery

19

– Safety devices of the suspension systems

25

– Warning labels and notes

27

Description

33

Lumera surgical microscope

36

– Intended use

36

– Description of components

36

– Illumination system

40

– Controls, displays, connections

44

– Binocular tubes and eyepieces

50

Light sources

56

S7 floor stand

58

– Intended use

58

– Description of components

59

– Design

60

– Controls and connections

62

– Connector panel

68

– Instrument tray (option)

70

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S7 ceiling mount with rigid column

73

– Intended use

73

– Description of components

73

– Design

74

– Controls, displays, connections

76

– Carrier and suspension arms

76

– Connector panel

80

S7 ceiling mount with lifting column

85

– Intended use

85

– Description of components

85

– Design

86

– Controls, displays, connections

88

– Ceiling flange with lifting column

88

– Carrier and suspension arms

90

– Connector panel

94

Lumera surgical microscope on S7 floor stand

98

– Intended use

98

– Design

98

Lumera surgical microscope on S7 ceiling mount with rigid column

100

– Intended use

100

– Design

100

Lumera surgical microscope on S7 ceiling mount with lifting column

102

– Intended use

102

– Design

102

Foot control panel

104

– Intended use

104

– Design

104

Preparations

107

Attaching the equipment

110

– Mounting the tube, the eyepieces and the objective lens

110

– Changing the microscope accessories

114

Connections

116

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– Connecting the light guide

116

– Mounting the strain relief device

118

– Connecting the suspension system - S7 floor stand

120

– Connecting the suspension system - S7 ceiling mount with rigid column

122

– Connecting the suspension system - S7 ceiling mount with lifting column

124

Adjusting the system - S7 floor stand

126

– Balance setting of the suspension arm

126

– Setting the limit of downward travel of the suspension arm

126

Adjusting the system - S7 ceiling mount with rigid column

128

– Balance setting of the suspension arm

128

– Setting the limit of downward travel of the suspension arm

128

Adjusting the system - S7 ceiling mount with lifting column

130

– Setting an ergonomic working height

130

– Balance setting of the suspension arm

132

– Setting the limit of downward travel of the suspension arm

132

Adjusting the system - General

134

– Adjusting the supension system

134

– Adjusting the tilt angle

136

– Adjusting the surgical microscope

138

– Optimizing the red reflex

139

Relocating the S7 floor stand

140

Preparing the system for sterile use

142

Operation

145

Checklist

146

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

148

Positioning the S7 floor stand

150

Procedure

152

What to do in the event of malfunctions

155

What to do in an emergency

156

– Lamp failure of the halogen light source

156

– Failure of the zoom function

158

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– Failure of the X-Y coupling

159

– Failure of the focusing function

159

Causes of malfunctions and remedies

160

– Malfunctions in the surgical microscope

160

– Malfunctions in the S7 suspension systems

162

– Malfunction of the foot control panel

163

Care and maintenance

165

– Care of the unit

166

– Auxiliaries from Zeiss

167

– Sterilization

167

– Disinfection

168

– Changing the halogen lamp

170

System data

173

– Technical data

174

– Magnifications / Fields of view

182

– Ordering data

183

– Spare parts

184

– Disposal

185

– Ambient requirements

186

– CE conformity

186

– Changes to the system

186

Index

187

OPMI® Lumera®

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7

Functions at a glance

Functions at a glance

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Lumera surgical microscope

8

Light sources

9

S7 floor stand

10

S7 ceiling mount with rigid column

11

S7 ceiling mount with lifting column

12

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Functions at a glance

Lumera surgical microscope 1 2 3 4 5 6 7 8 9 10 11

Resetting X-Y coupling and focus to their initial positions page 62 Tilting the surgical microscope page 136 Adjusting the eyecups page 54 Setting your prescription page 54 Display of the zoom system's magnification factor page 46 Setting the depth of field (DeepView) page 48 Setting the illumination page 42 Arrows indicating the focusing range page 44 Adjusting the interpupillary distance page 50 Zoom adjustment (manual emergency operation) page 158 Connecting the light guide page 116

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Functions at a glance

Light sources Halogen light source 1

– Closed flap: main lamp is on

page 56

2 3 4

– Open flap: backup lamp is on Selecting a filter Opening the lamp module Manual activation of backup lamp

page 56 page 56 page 56

1

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OPMI® Lumera®

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Functions at a glance

S7 floor stand 1 2

Control panel page 66 Maneuvering handle with hooks on which to hang the page 64 foot control panel 3 Connector panel page 68 4 Steerable casters with brake tabs (4 x) page 64 5 Adjusting the friction of the carrier arm's swivel movement page 64 6 Light source page 56 7 Adjusting the friction of the suspension arm's page 64 swivel movement 8 Balance setting page 126 9 Adjusting the limit of downward travel page 126 10 Adjusting the friction of upward/downward movement page 62 11 Adjusting the friction of the microscope's rotation page 62

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Functions at a glance

S7 ceiling mount with rigid column 1 2 3 4 5 6 7 8 9

Control panel Power switch Connector panel Lamp housing Balancing the suspension arm Adjusting the limit of downward travel Adjusting the friction of upward/downward movement Adjusting the friction of the suspension arm's swivel movement Adjusting the friction of the carrier arm's swivel movement

8

page 66 page 66 page 80 page 76 page 128 page 128 page 76 page 76 page 78

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Functions at a glance

S7 ceiling mount with lifting column 1 2 3 4 5 6 7 8 9 10

Control panel page 66 Power switch page 66 Connector panel page 94 Lamp housing page 90 Balancing the suspension arm page 132 Adjusting the limit of downward travel page 132 Adjusting the friction of upward/downward movement page 90 Lifting/lowering the lifting column page 88 Adjusting the friction of the carrier arm's swivel movement page 92 Adjusting the friction of the suspension page 92 arm's swivel movement

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OPMI® Lumera®

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Issue 2.2 Printed on 12. 12. 2011

Safety

13

Notes on installation and use

15

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

19

Phototoxic retinal injury in eye surgery

19

Safety devices of the suspension systems

25

Warning labels and notes

27

Safety

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Safety

The device described in this manual has been designed and tested in accordance with Carl Zeiss safety standards as well as German and international standards. This guarantees a high degree of instrument safety. The system described in this user manual has been designed in compliance with the requirements of: – EN

– IEC

– UL

– CSA

In accordance with Directive 93/42/EEC for medical devices, the complete quality management system of the company Carl Zeiss Meditec AG, 07745 Jena, Germany, has been certified by DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen GmbH, a notified body, under registration number 263168 MP23CMDR. – As per Directive 93/42/EEC, the unit is a Class I instrument. – For USA: FDA classification Class I. We would like to provide you with information about safety aspects which must be observed when handling this device. This chapter contains a summary of the most important information concerning matters relevant to instrument safety. Important safety information has been incorporated in this manual and is marked with a warning triangle accordingly. Please give this information your special attention. The correct use of the system is absolutely vital for safe operation. Please make yourself totally familiar with the contents of this manual prior to startup of the instrument. Please also observe the user manuals of any additional equipment. Further information is available from our service department or from authorized representatives.

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Please observe all applicable accident prevention regulations.

•

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

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Safety

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.

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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.

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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.

•

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 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.

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Safety

Requirements for operation •

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

Our service representative or a specialist authorized by us will install the instrument. Please make sure that the following requirements for operation remain fulfilled in the future: – All mechanical connections (details in the user's manual) which are relevant to safety are properly connected and screw connections tightened. – All cables and plugs are in good working condition. – The voltage setting on the instrument conforms to the rated voltage of the line supply on site. – The instrument is plugged into a power outlet which has a properly connected protective ground contact. – The power cord being used is the one designed for use with this instrument. Before every use and after re-equipping the instrument •

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

•

Go through the checklist.

•

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

•

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

•

Do not cover any ventilation openings.

For every use of the instrument General • Never operate the system unattended. •

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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.

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Safety

•

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

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

•

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 23.

S7 floor stand • Using the brake tabs on the base, secure the stand in position. Make sure that the stand is stable and cannot roll away. S7 ceiling mount with lifting column • The lifting column is used to move the microscope into position for surgery prior to the surgical procedure. Do not constantly move the lifting column up and down, since a thermal cut-out will then automatically switch off the drive motor. If this occurs, the lifting column cannot be moved again until the motor has cooled down. After every use of the system

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

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

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Safety

When using a wide-angle observation system (e.g. BIOM 3) 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! Risk of collision!

1

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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.

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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.

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Turn the locking lever 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.

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

2

Phototoxic retinal injury in eye surgery General Several papers1)-5) dealing with the problem of phototoxicity in ophthalmic surgery have been published. A comprehensive review of these publications reveals five aspects of particular concern: – Illumination characteristics (spectral composition) – Illumination intensity – Angle of illumination – Focus of the light source – Exposure time to light

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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

1)-4) A number of publications 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 (coaxial illumination)

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OPMI® Lumera®

Issue 2.2 Printed on 12. 12. 2011