MediLive Primo Instructions for use Issue 4.2 Nov 2011

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 use

6

– Warning labels and notes

10

Description

11

MediLive™ Primo

13

– Intended use

13

– Overview

14

– Compact video camera

16

Camera control unit (CCU)

17

– Control panel

18

– Connector panel

24

Preparations for use

29

Mounting the compact camera

30

– Connecting the system cable

30

Mounting the beam splitter

32

– Mounting the camera head

35

– Electrical connections

36

Checking the basic settings

38

Configuring the CCU

38

– Adjusting the camera

42

Operation

45

Checklist

46

Procedure

48

– Powering up the system

48

– Adjusting the video image

48

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Maintenance / Further information

51

– Safe working order

52

– Trouble-shooting table

52

– Recommended cleaning method

56

– Disinfection

57

– Disposal

58

– Ordering data

59

– Accessories

60

Technical data

61

– Technical data

62

– Ambient requirements

63

– 1 CCD PAL video camera (option)

64

– 1 CCD NTSC video camera (option)

64

Index

65

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Safety

5

Directives and standards

6

Notes on installation and use

6

Warning labels and notes

10

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 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. •

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 use Safe working order •

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Do not operate the equipment contained in the delivery package in

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Safety

– 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.

•

Immediately unplug any equipment that emits 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.

•

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.

•

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

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Safety

•

Please do not pull on the cables.

•

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. 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 accessory equipment 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. 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. – 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.

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Use with equipment from other manufacturers •

Equipment such as video printers, video recorders and monitors may only be connected to the MediLive video camera system when this equipment has been supplied by Carl Zeiss. Equipment from other manufacturers and suppliers may only be used if the manufacturer of that equipment certifies that the safety of the system is not impaired and that the system as a whole complies with IEC 601-1-1 (Safety Requirements for Medical-Electrical Systems). Each device must comply with the regulations which apply for 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 system

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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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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.

PAL:

Serial No. Instrument name

Classification Power supply unit:

Rated voltage

NTSC:

Serial No. Instrument name Rated voltage Classification

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Description

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Intended use

13

Overview

14

Compact video camera

16

Camera control unit (CCU)

17

Control panel

18

Connector panel

24

Description

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Description

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Description

MediLive™ Primo Intended use MediLive Primo has been developed specifically as a documentation system for use with Carl Zeiss surgical microscopes for all disciplines. State-of-the-art digital electronics provide a brilliant video image and make the objects displayed on the color monitor appear in natural colors. The compact camera control unit (CCU) ensures easy operation of the video camera. There are different ways of combining the system components into a video camera system. The following illustration shows the combination possibilities of the modules. Note: If the cameras and CCUs are interchanged, we recommend performing a white balance procedure on reconnection in order to ensure optimum image rendition.

Caution: Do not operate the CCU with old video cameras or video cameras from other manufacturers. This may lead to malfunctions or defects.

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Description

Overview 1 1-chip CCD video camera for compact camera 2 1-chip CCD video camera for C-mount adapter 3 Compact camera with 1-chip CCD video camera 4 Camera control unit (CCU) 5 Video objective lens f = 50 mm, f = 60 mm, f = 85 mm or f = 105 mm 6 Beam splitter 20* or beam splitter 50 * 7 Standard 2D color video monitor * 8 LC video monitor * 9 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

2

3 5

6

4

7

8

9 Video recorder Video printer Video projector MediLive(™) MindStream MediLive(™) ImageBox

Video monitor

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LCD video monitor

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Description

Compact video camera The compact video camera can be mounted on all Carl Zeiss surgical microscopes between the microscope and the binocular tube. A beam splitter directs the image generated by the surgical microscope to the video camera and the binocular tube. Splitting ratio e.g. : with beam splitter 20

80 % of the light to the binocular tube 20 % of the light to the video camera

with beam splitter 50

50 % of the light to the binocular tube 50 % of the light to the video camera

1 Connector for the system cable 2 Tube mount A binocular tube can be attached to this mount, permitting the image of the surgical field to be viewed both in the binocular tube and on the monitor screen. 3 Pilot screw for aligning the binocular tube. 4 Securing screw for locking the binocular tube in position. 5 Dovetail ring for mounting the compact video camera on the surgical microscope.

1

2

4

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3

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Description

Camera control unit (CCU) The CCU contains the electronic system for powering and controlling the compact CCD video camera installed in the camera block. State-of-theart digital electronics generate standard-compliant video signals. The controls are arranged in a clear layout and permit fast and convenient adjustment of the video image. All settings (except the freeze setting) are retained when you switch off the device.

1 Control panel Contains the controls for all functions. 2 Connector panel All electrical connections are installed here.

1

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Description

Control panel 1 Power switch for switching the device on and off. When the device has been switched on, the green lamp in the switch is lit. 2 White bal start button (white balance) Press the White Balance start button to perform the white balance procedure for the video image. The system adjusts the video signal in such a way that white areas in the surgical field are also white in the video image. To achieve this, place a suitable white object (e.g. a piece of white paper with a matte surface) under the microscope and focus the microscope on it, using a medium brightness level. Note: Set brightness mode switch (6) to "Auto" before performing the white balance procedure or, when using the "Manu" mode, adjust the brightness manually before starting the white balance procedure. The determined values are stored and are available after every restart. If the video image is overexposed, the white balance procedure cannot be correctly performed. Adjust the brightness beforehand using brightness adjustment knob (8). 3 White Balance indicator light (red) When button (3) is pressed, the indicator light (LED) lights up briefly and goes out when the white balance procedure has been completed. 4 Image Orientation Use this menu to set the screen orientation. The Image Orientation menu permits you to:

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- display the image in normal orientation

Normal

F

- turn the image about the vertical axis

Mirror

F

- turn the image through 180°

Rotate

F

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1

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5 Lightmeter Note: The Lightmeter function is only enabled if Brightness has been set to the Automatic mode. The Lightmeter menu offers you the choice between two metering patterns provided by the video camera : Auto and Spot. – Auto (standard): Light metering is performed across the full video image. The metering points are selected automatically. – Spot: Light metering is performed across the full area or in spots of different sizes at the image center. The small spot metering pattern is suitable for work in narrow channels when a very small illuminated field diameter is being used. You can set the spot size at the DIP code switch on the rear connector panel as follows:

SW 5

SW 6

Full

OFF

OFF

Small spot

OFF

ON

Large spot

ON

OFF

No function

ON

ON

Full

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Small spot

Large spot

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