OPMI VARIO for S8-S81 Suspension System Instructions for use Issue 7.0 Feb 2005

2

Key to symbols 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 instrument or other tips for the user.

OPMI® is a registered trademark of Carl Zeiss Surgical GmbH.

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

Contents –

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Key to symbols

2

Functions at a glance

5

–

6

OPMI® VARIO

Safety

9

–

Notes on installation and use

11

–

Warning labels and notes

16

Description

19

OPMI® VARIO surgical microscope

20

–

Intended use

20

–

Special properties

21

–

Design

22

–

Controls, displays, connections

24

–

Tiltable binocular tube and eyepieces

32

Preparations for use

37

Assembling the system

38

Mounting the tube and eyepieces

40

Connections

42

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Mounting the light guide

42

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Aligning the X-Y coupling

44

Operation

47

Preparations for use

48

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Balancing the surgical microscope

48

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Adjusting the surgical microscope

50

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Surgical microscope with a laser micromanipulator

51

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Checklist

54

Procedure

56

What to do in an emergency

57

OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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Failure of the zoom function

57

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Failure of the focusing function

58

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Failure of magnetic brakes

59

Maintenance / Further information

61

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Trouble-shooting

62

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Magnifications / Fields of view

64

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Care of the unit

66

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Sterilization

67

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Disinfecting the control keys

68

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Ordering data

70

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Spare parts

70

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Accessories

71

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Technical data

73

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Ambient requirements

74

Index

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension SystemsIssue 7.0 Printed on 02. 12. 2005

Functions at a glance

5

Functions at a glance

OPMI® VARIO

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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6

Functions at a glance

® OPMI VARIO 1

Adjusting the eyecup and setting the diopters

2

Setting the interpupillary distance (PD)

3

Adjusting the friction of the microscope shaft

4

Moving the X-Y coupling to its center position

5

Adjusting the friction of the OPMI® shaft when using an X-Y coupling

6

Manual zoom setting

7

Manual focusing

8

Manual adjustment of the illuminated field diameter

9

Connecting the light guide

10 Balance setting of the front-to-back tilt of the surgical microscope 11 Balance setting of the lateral tilt of the surgical microscope 12 Motorized focusing 13 Motorized zoom setting 14 Display of the zoom system magnification factor 15 Releasing the magnetic brakes 16 Programmable activator buttons 17 Switching off the electrical drive of the focusing system 18 Connecting the mouth switch

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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Functions at a glance

1

2

6

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3

7

8

4

9

10

11 12

13

14

5

15 16 17 18

OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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Functions at a glance

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

Safety

9

Notes on installation and use

11

Warning labels and notes

16

Safety

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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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

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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 mbH, 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.

•

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

OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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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: The instrument can be incorporated into potential equalization measures. For this purpose, contact our service department.

•

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.

•

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.

OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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Safety

•

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.

Connection of a laser micromanipulator The link-up of a laser micromanipulator with the OPMI results in a medical system for which the system manufacturer must meet the necessary requirements (approval, qualification, laser protection, etc.). Please note the user manuals provided by the laser micromanipulator manufacturer and laser manufacturer. Further information is available from our service department or from authorized representatives.

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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Safety

Connection of navigation systems (option) The Carl Zeiss components "Surgical microscope on suspension system" can be integrated into an external navigation system. An optional navigation interface is available. •

•

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The manufacturer of the external navigation system (system supplier) is responsible for the following: –

Confirmation that his navigation systems have been tested and certified for operation with the respective Carl Zeiss surgical microscope on a suspension system in accordance with the requirements specified in the Carl Zeiss interface description "Navigation Interface for Carl Zeiss Surgical Microscopes".

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Meeting all requirements (approval, qualifications, etc.) for the medical system created through coupling via the navigation interface.

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Provision of all accompanying documents required.

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Ensuring that the navigation system is only connected by personnel who have undergone appropriate training and instruction.

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Contacting the local Carl Zeiss representative for any inquiries that may arise.

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Implementation of a procedure that guarantees the calibration of the surgical microscope which is absolutely vital for the use of the Carl Zeiss components "Surgical microscope on suspension system" in combination with a connected navigation system. This allows the calibrated surgical microscope combined with the navigation system to be used like an optical pointer with a variable length (corresponds to the working distance).

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Conducting complete functional testing, alignment and calibration (landmark test) of the navigation system after every subsequent installation or exchange of navigation system components

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Incorporation of a regularly changing icon in the data injection display of surgical microscopes equipped with a data injection system, i.e. the "heartbeat" of the navigation system must be constantly visible for the user to permit data transmission errors to be immediately detected.

To check the accuracy of the overall system, perform the test specified by the navigation system manufacturer, e.g. the landmark test, also using the surgical microscope. This allows you to ensure that the stereotactic data has been correctly generated and transmitted to the navigation system without errors.

OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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Safety

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Do not use any rotatable tube dovetail mounts when operating the surgical microscope with a connected navigation system. If mounts of this type have been attached to the microscope, they must be carefully locked in their central positions (tighten the knurled screws for rotation).

Requirements on the antenna design (non-Zeiss antennas) •

The antenna manufacturer must confirm that his antenna has been tested and certified for operation with the respective Carl Zeiss surgical microscope on a suspension system in accordance with the requirements specified in the Carl Zeiss interface description "Navigation Interface for Carl Zeiss Surgical Microscopes".

•

The following requirements, in particular, apply to the antenna: – The surgical microscope with accessories and the antenna must not exceed the admissible total weight (see label or the chapter "Technical data"). – The antenna must not project over the bottom edge of the microscope body in the direction of the surgical field. – The antenna must neither obstruct the movement and adjustability of the accessories which can be used on the surgical microscope (usually a stereo coobservation tube, a camera adapter, a face-toface tube for spinal surgery, a laser micromanipulator) nor collide with these accessories. – The antenna configuration must be implemented in such a way that the localizer camera can always "see" the diodes or trackballs when the surgical microscope and its accessories are in their usual positions. – When the system's internal antenna wiring is used, the EN606011-2 standard (electromagnetic compatibility) must be complied with. – The output power of the LEDs or infrared LEDs (IRED) must always comply with the IEC 60825 laser safety standard, even in the event of cable defects. – The failure of one or several LEDs of the antenna may impair navigation or lead to navigation failure. Take the necessary precautions.

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

Safety

15

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.

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

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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.

For every use of the instrument

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

•

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.

•

When operating on the eye, always use a GG 475 protection filter to ensure that the patient's retina is not exposed to unnecessary (blue) radiation (retinal injury).

OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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Safety

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.

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

Safety

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

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18

Safety

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

Description

19

OPMI® VARIO surgical microscope

20

Intended use

20

Special properties

21

Design

22

Controls, displays, connections

24

Tiltable binocular tube and eyepieces

32

Description

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005

20

Description

OPMI® VARIO surgical microscope Intended use The OPMI® VARIO surgical microscope has been designed for reconstructive and plastic surgery, neurosurgery and multidisciplinary use. The unit meets the special demands made on a surgical microscope in these disciplines. The unit is intended for use in hospitals, clinics or other human medicine institutions. The unit must only be operated by physicians, nurses and other OR staff who have undergone appropriate training and observe the instructions of the user's manual. The installation conditions and the use of the unit must meet microsurgical requirements: –

low vibration

–

clean environment

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avoidance of extreme mechanical stress

The suspension system provided is used to power and control the motorized functions of the OPMI® VARIO surgical microscope. You can control the motorized functions using a foot control panel or hand control panel. For further information, please contact our authorized representatives. Warning! If a xenon light source is used, the unit must not be used in ophthalmic applications. Severe injury to the patient's eye is possible.

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OPMI® VARIO Surgical Microscope for S8/S81 Suspension Systems Issue 7.0 Printed on 02. 12. 2005