OPMI Sensera on S7 Suspension System Instructions for Use Issue 10.0 Jan 2009

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 instrument.

Note: The hand indicates hints on the use of the instruments or other tips for the user.

OPMI® is a registered trademark of Carl Zeiss.

Contents –

Key to symbols

2

Functions at a glance

7

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OPMI Sensera surgical microscope

8

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Illumination systems

10

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S7 floor stand

11

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S7 ceiling mount with rigid column

12

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S7 ceiling mount with lifting column

13

Safety

15

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Notes on installation and use

17

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Safety devices of the suspension system

22

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Warning labels and notes

26

Description

31

Sensera surgical microscope on S7 suspension systems

34

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Intended use

34

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Description of the system

34

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System components

36

OPMI Sensera surgical microscope

38

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Design

38

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Controls, displays, connections

40

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Tiltable binocular tube and eyepieces

46

S7 floor stand

50

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Design

50

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Controls, displays, connections

52

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Suspension arm

52

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Carrier arm, stand column, stand base

54

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Connector panel of S7 floor stand

56

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Instrument tray (option)

58

S7 ceiling mount

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60

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Design

60

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Controls, displays, connections

62

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Carrier and suspension arms

62

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Connector panel of S7 ceiling mount

64

S7 ceiling mount with lifting column

66

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Design

66

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Controls, displays, connections

68

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Ceiling flange with lifting column

68

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Carrier and suspension arms

70

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Connector panel of S7 ceiling mount with lifting column

72

Illumination system

74

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Halogen illumination system

76

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Xenon illumination system

78

Control panel and menu overview

82

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Structure of the menus

84

Foot control panel (option)

104

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Intended use

104

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Design

104

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Foot control panel with 14 functions

106

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Foot control panel with 8 functions

107

Preparations for use

109

Attaching the equipment

112

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112

Mounting the tube and eyepieces

Connections

114

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Connecting the strain relief device

114

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Connecting the suspension system - S7 floor stand

116

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

118

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

120

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122

Connecting video monitor and MediLive ImageBox (option)

Adjusting the system - S7 floor stand

124

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Balancing the suspension arm

124

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Setting the limit of downward travel of the suspension arm

124

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Adjusting the system - S7 ceiling mount with rigid column

126

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Balancing the suspension arm

126

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Setting the limit of downward travel of the suspension arm

126

Adjusting the system - S7 ceiling mount with lifting column

128

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Setting an ergonomic working height

128

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Balancing the suspension arm (ceiling mount with lifting column) 130

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Setting the limit of downward travel of the suspension arm

130

Balancing the surgical microscope

132

Surgical microscope with a laser micromanipulator

136

Adjusting the surgical microscope

138

Configuring the camera settings (config)

139

Configuring Image Capture

144

Relocating the S7 floor stand

152

Operation

155

Checklist for S7 floor stand

156

Checklist for S7 ceiling mount with rigid column

160

Checklist for S7 ceiling mount with lifting column

164

Procedure

168

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Working with the SpeedFokus autofocus option

169

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Display and deletion of images (USB option)

170

What to do in an emergency

172

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Failure of the focusing function

172

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Failure of the zoom function

174

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Failure of the halogen lamp

176

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Lamp failure of the xenon illumination

178

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Failure of the SpeedFokus autofocus option

182

Maintenance / Further information

183

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Trouble-shooting

184

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Replacing the halogen lamp

190

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Changing the xenon lamp module

194

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Magnifications / Fields of view

198

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Care of the unit

200

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Cleaning optical surfaces

200

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Auxiliaries from Zeiss

201

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Cleaning mechanical surfaces

201

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Sterilization

201

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Disinfecting the control keys

203

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Ordering data

204

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Spare parts

207

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Accessories

209

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Disposal

210

Technical data

211

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Technical data

212

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Integrated 1 CCD PAL video camera (option)

219

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Integrated 1 CCD NTSC video camera (option)

219

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Ambient requirements

220

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Changes to the system

220

Index

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7

Functions at a glance

Functions at a glance

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OPMI Sensera surgical microscope

8

Illumination systems

10

S7 floor stand

11

S7 ceiling mount with rigid column

12

S7 ceiling mount with lifting column

13

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8

Functions at a glance

OPMI Sensera surgical microscope 1 2 3 4 5 6 7 8 9 10 11 12 13 14

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Adjusting the eyecup and the prescription Adjusting the interpupillary distance Manually adjusting the friction of the front-to-back tilt Motorized adjustment of tilt axis B (microscope tilts downward) Motorized adjustment of tilt axis B (microscope tilts upward) Manually adjusting the friction of lateral tilt axis A Manually adjusting the balance of lateral tilt axis A Manually adjusting the friction of the microscope's axis of rotation Locking the handgrip in a convenient position Manually adjusting zoom (emergency mode) Manual focusing Adjusting the spot illumination Triggering motorized microscope functions External focus (option)

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Pages 36/87 Page 34 Page 84 Page 84 Page 84 Page 82 Page 82 Page 82 Page 32 Pages 30/98 Pages 30/96 Page 30 Page 32 Page 30

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Functions at a glance

1

2

3

4

5

6

7

8

A

B

9

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10

11

12

13

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Functions at a glance

Illumination systems

2 3 4

Halogen illumination system Closed flap: main lamp is on - Open flap: backup lamp is on Selecting a filter Opening the lamp module Manual activation of the backup lamp

page 76 page 76 page 76

5 6 7 8 9

Xenon illumination system Selecting a filter Resetting the counter Manual activation of the backup lamp Opening the lamp module Red segment is lit - backup lamp is in use

page 78 page 80 page 78 page 78 page 78

1

1

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3 4

5 6 7

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page 76

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Functions at a glance

S7 floor stand 9 Lamp housing with halogen or xenon illumination 10 Control panel 11 Maneuvering handle with hooks on which to hang the foot control panel 12 Connector panel 13 Casters with locking tabs (4 x) 14 Adjusting the friction of the carrier arm's swivel movement 15 Adjusting the friction of the suspension arm's swivel movement 16 Balancing the suspension arm 17 Adjusting the limit of downward travel 18 Adjusting the friction of upward/downward movement

9

Page 40 Page 54 Page 88 Page 46 Page 44 Page 44 Page 44 Page 80 Page 80 Page 42

18 17 16 15

10

14 S7

11 12

13

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Functions at a glance

S7 ceiling mount with rigid column 9 10 11 12 13 14 15 16

Control panel Power switch Connector panel Lamp housing with halogen or xenon illumination 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 17 Adjusting the friction of the carrier arm's swivel movement

16

Page 50 Page 50 Page 44 Page 46 Page 78 Page 78 Page 42 Page 42 Page 42

17

9

10

11

12

13

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15

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Functions at a glance

S7 ceiling mount with lifting column 9 10 11 12 13 14 15 16 17

Control panel Power switch Connector panel Lamp housing with halogen or xenon illumination Balancing the suspension arm Adjusting the limit of downward travel Adjusting the friction of upward/downward movement Lifting/lowering the lifting column Adjusting the friction of the carrier arm's swivel movement 18 Adjusting the friction of the suspension arm's swivel movement

page 82 page 82 page 72 page 74 page 130 page 130 page 62 page 68 page 62 page 62

18 17 9

10

11 16

12

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14

15

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Functions at a glance

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Safety

15

Notes on installation and use

17

Safety devices of the suspension system

22

Warning labels and notes

26

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 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.

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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 •

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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.

•

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

•

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.

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. •

Observe the labels showing the symbol "Risk of crushing“!

Notes on EMC (Electromagnetic Compatibility) The device complies with the EMC requirements of IEC 60601-1-2. For operating the device, observe the EMC precautions specified below. Only use spare parts approved by Carl Zeiss for this device. Do not use any portable or mobile HF communication equipment in the vicinity of the device, as it cannot be ruled out that the function of the device will be impaired.

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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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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.

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Safety

•

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: – 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.

•

Since the xenon lamp provides high light intensity and generates light with a spectrum similar to daylight, it must not be used for ophthalmic applications.

•

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.

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 instrument

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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.

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