MediLive Trio 3CCD Video Camera Instructions for Use Issue 3.0 March 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.

MediLive™ is a trademark of Carl Zeiss.

Contents –

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Key to symbols

2

Safety

5

–

Directives and standards

6

–

Notes on installation and usage

6

–

Warning labels and notes

12

Description

15

System overview

17

–

Intended use

17

–

Modules

18

Description of modules

20

–

Camera block

20

–

Video objective lenses

21

–

Camera control unit (CCU)

23

Preparations for use

35

–

36

Mounting the camera block on the video objective lens

– Mounting the video objective lens and the binocular tube on the microscope

37

–

Mounting accessories on VOL 442 video objective lens

38

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Electrical connections

40

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Adjusting the video monitor

42

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Overview of menus

48

–

Configuring the CCU

50

Operation

67

Checklist

68

Procedure

69

–

Powering up the system

69

–

Adjusting the video image

69

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Maintenance / Further information

73

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Safe working order

74

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Trouble-shooting table

74

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Changing fuses

76

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Cleaning optical surfaces

77

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Cleaning mechanical surfaces

77

–

Disinfecting surfaces and control keys

78

–

Ordering data

79

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Spare parts

79

–

Accessories

80

–

Disposal

81

Technical data

83

–

Technical data

84

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3 CCD PAL video camera, mono and stereo (option)

85

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3 CCD NTSC video camera, mono and stereo (option)

86

–

Ambient requirements

87

Index

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Safety

5

Directives and standards

6

Notes on installation and usage

6

Warning labels and notes

12

Safety

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Safety

The instrument described in this manual has been developed and tested in accordance with Carl Zeiss safety standards and with national and international regulations. A high degree of instrument safety is thus ensured. We would like to inform you on the safety aspects involved in operating the instrument. This chapter contains a summary of the most important precautions to be observed. Further safety notes are also contained in other parts of this user's manual; they are marked with a warning triangle containing an exclamation mark as shown here. Please pay special attention to these safety notes. Safety is only ensured when this instrument is operated properly. Please read through this manual carefully before turning the instrument on. Also read through the user's manuals of the other equipment used with this instrument. You may obtain further information from our service organization or authorized representatives.

Directives and standards In accordance with Directive 93/42/EEC, the complete quality management system of the company Carl Zeiss, Surgery Products Division, has been certified by the DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen GmbH, a notified body, under registration number 250881 MP21. •

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

–

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

–

For USA: FDA classification Class I.

•

Please observe all applicable accident prevention regulations.

Notes on installation and usage General •

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Do not operate the equipment contained in the delivery package in

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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.

•

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.

•

Potential equalization: If desired, the unit can be incorporated in potential equalization measures. The potential equalization bolt is required for this purpose, see chapter "Description".

•

Modifications and repairs on this instrument used with the MediLive video camera system 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.

•

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.

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Safety

•

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

•

Please do not pull on the cables.

Warning! Do not use the stored video sequences, video clips (cut sequences) and single images for diagnostic purposes, as the video cameras and the monitor have not been calibrated. The visualized images may therefore include deviations in scale, color and shape. This applies in particular if the sequences, clips or images are viewed on a monitor outside the OR, as the transmission to a different monitor may lead to changes in the display. Safe working order •

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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.

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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. Operate the device using only the accessories included in the delivery package. If you wish to use other accessories, make sure that Carl Zeiss or the manufacturer of the accessories has verified and confirmed that these accessories meet the respective safety standards and can be used without risk. Do not use any portable or mobile RF communication equipment in the vicinity of the device as this may lead to an impairment of the device's function. The device meets the RFI requirements of Class A. It cannot be ruled out, however, that interferences may occur in RF receivers (e.g. TV or radio sets) in the vicinity. If such interferences are noticed, please inform the Carl Zeiss Service Dept.

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Safety

Requirements for operation 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.

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All cables and plugs are in good working condition.

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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.

Use with equipment from other manufacturers •

The safe function of the MediLive video camera system is only guaranteed for use in conjunction with accessories offered by Carl Zeiss. Equipment from other manufacturers may only be connected if the manufacturer of this equipment certifies that the resulting system as a whole complies with IEC 60601-1-1 (Safety Requirements for Medical-Electrical Systems) and IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests) and that safe operation is ensured.Take special care to ensure that the equipment provided by other manufacturers complies with the regulations which apply to that type of equipment. The maximum admissible leakage current of the entire system must not be exceeded.

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.

•

Do not cover any ventilation openings.

After every use of the instrument •

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

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•

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

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Warning labels and notes Caution: Observe all warning labels and notes! If any label is missing on your instrument or has become illegible, please contact us or one of our authorized representatives. We will supply the missing labels. 1

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Rating label (PAL or NTSC) The rating label provides the following information: – Manufacturer (company – Manufacturer's address name) –

Serial number

–

System name

–

Rated voltage

–

Line frequency range

–

Connected load

2

"Observe disposal regulations" label Electrical or electronic devices must not be disposed of as normal domestic waste. For details regarding the disposal of electrical and electronic devices, please see the chapter "Maintenance / Further information".

3

Year of manufacture This label indicates the year of manufacture of the device.

4

"Observe the user manual" label Observe the user manual or further applicable documents.

5

"Potential equalization" label This graphical symbol is used to identify the existence of a potential equalization connector which allows another device to be grounded at the same ground potential as MediLive Trio.

6 I

Power supply labels – ON (power supply, connection with line power)

0

–

OFF (power supply, no connection with line power)

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1 2

Video Out

Video Out

T 1.6 A

3

4 5 6

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Description

15

System overview

17

Intended use

17

Modules

18

Description of modules

20

Camera block

20

Video objective lenses

21

Camera control unit (CCU)

23

Description

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Description

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Description

System overview Intended use The video camera system has been developed specifically as a documentation system for Carl Zeiss surgical microscopes. State-of-the-art digital electronics provide a brilliant video image and make the objects displayed on the color monitor appear in natural colors. A compact camera control unit (CCU) ensures easy operation of the video camera. There are many different ways of combining the system components into a video camera system. This creates a 3-chip CCD video camera for mono or stereo operation tailored to the field of application involved and to customer requirements. The following illustration shows the combination possibilities of the modules. Note: – For stereo operation, you need two mono cameras whose video output ports are synchronized using a Genlock function. –

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If the camera heads and CCUs are interchanged, we recommend performing a white balance and a black balance procedure on reconnection in order to ensure optimum image rendition.

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Description

Modules 1

Camera block

2

Integrated CCD video cameras in various surgical microscopes

3

3-chip CCD video camera

4

Video objective lens VOL 802

5

Video objective lens VOL 442

6

Camera control unit (CCU)

7

Video objective lens f = 50 mm, f = 60 mm, f = 85 mm or f = 105 mm

8

Beam splitter 20* or beam splitter 50 *

9

Standard 2D color monitor *

10 LC monitor * 11 Standard video recorder*, video printer*, video projector * *

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Separate user manuals for these units are supplied by us (or the manufacturer).

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Description

1

3 2 OPMI® Neuro

4

7 6

8

5

9

10

11 Video recorder Video printer Video projector MediLive™ MindStream MediLive™ ImageBox

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Description

Description of modules Camera block The camera block contains an optical system which project the image generated by the surgical microscope onto the integrated, compact CCD video camera(s). Depending on the application and customer requirements involved, the camera block is equipped with different video camera configurations: –

one 3-chip compact camera for mono applications,

–

two 3-chip compact cameras for stereo applications.

The camera block can be installed in a video objective lens. A centering piece ensures correct optical alignment. Note: It is possible to insert the camera block rotated through 180° (cable support (1) pointing downward) in a video objective lens. In this case, the video image transmitted will be upside down. 1

2

3

4

Cable support for the connecting cable (system cable) to the camera control unit (CCU). Centering component is used to mount the camera block on the video objective lens. No optical alignment is necessary. CCD compact video camera(s) depending on the configuration chosen, one or two cameras are installed here. Housing contains the optical imaging system.

1

2

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4

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