OPMI 1FC on S100 floor stand Instruction for use Issue 2.0

Key to symbols Different symbols used in this user's manual draw your attention to safety aspects and useful tips. The 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 instrument or other tips for the user.

OPMI®

OPMI® is a registered trademark of Carl Zeiss.

Contents

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Functions at a glance

5

Safety

9

Description

19

OPMI 1 FC on S100 floor stand

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OPMI 1 FC surgical microscope

23

S100 floor stand

32

Preparations for use

41

Attaching the equipment

42

Connections

48

Adjusting the system

50

Operation

55

Checklist

56

Procedure

58

What to do in an emergency

60

Maintenance / Further information

63

Index

83

OPMI® 1 FC on S100 floor stand

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OPMI® 1 FC on S100 floor stand

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Functions at a glance

Functions at a glance

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OPMI 1 FC surgical microscope

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S100 floor stand

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OPMI® 1 FC on S100 floor stand

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Functions at a glance

OPMI 1 FC surgical microscope 1 2 3 4 5 6 7 8

Setting of focus Connecting the light guide Swinging the shutter into/out of the beam path Changing the magnification Adjusting the interpupillary distance Setting your prescription Adjusting the eyecups Connecting the cable for potential equalization

page 24 page 26 page 26 page 24 page 28 page 30 page 30 page 26 page 38

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4

OPMI® 1 FC on S100 floor stand

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Functions at a glance

S100 floor stand 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Adjusting the smoothness of carrier arm rotation page 34 Adjusting the smoothness of suspension arm rotation page 34 Adjusting the smoothness of the suspension arm's page 34 upward/downward movement Adjusting the fiber illumination brightness page 36 Adjust smoothness of the microscope's lateral tilt motion page 34 Balance setting page 50 Adjust smoothness of rotational movement of coupling page 34 shaft Relocate the unit, 2x steerable casters with locks page 34 Connecting the line cable, changing the fuse, page 38 Setting the rated voltage Connecting the light guide page 36 Switching on the instrument (line switch) page 38 Opening the lamp module page 36 Switch to backup lamp. page 36 Display of operating status of halogen illuminator: Closed page 36 flap: main lamp is on - Open flap: backup lamp is on 1 2

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4 5 6

10

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Functions at a glance

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OPMI® 1 FC on S100 floor stand

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Safety

9

Notes on installation and use

11

Safety devices

15

Warning labels and notes

16

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.

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

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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.

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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.

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Use this instrument only for the applications described.

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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.

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Safety

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

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Never look at the sun through the binocular tube, the objective lens or an eyepiece.

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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.

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:

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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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Safety

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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.

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Go through the checklist.

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

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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 •

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.

•

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).

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

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Safety

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Safety

Safety devices Backup lamp The backup lamp permits lamp exchange after lamp failure. The lamp module (in the electronics box of the suspension system) contains a backup lamp. The lamp module contains a second 12 V, 100 W halogen lamp as a backup lamp. If the first halogen lamp fails, you can manually switch to the second halogen lamp. For a detailed description, please see page 60.

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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. Instrument label plate The instrument label plate indicates the following: –

name of the unit

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Cat. No.

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rated voltage and current consumption

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rated frequency range

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serial number.

Brightness control After the illumination has been switched on, you can continuously adjust the brightness of the fiber illumination by turning the appropriate knob. Balance setting Turn the screw to adjust the balance setting of the suspension arm.

Maximum load When surgical microscopes are mounted on the suspension systems, the overall weight of the microscope including accessories and coupling must not exceed a maximum value. The S100 floor stand has been designed for a load on the suspension arm of 2.5 kg to 7.0 kg.

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Safety

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Safety

Moving position Position of the floor stand for safe transportation.

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Description

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OPMI 1 FC on S100 floor stand

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Intended use

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Set-up, OPMI 1 FC on S100 floor stand

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OPMI 1 FC surgical microscope

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Intended use

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Set-up of the OPMI 1 FC surgical microscope

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Binocular tube and eyepieces

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S100 floor stand

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Intended use

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Description of the modules

32

Controls, displays, connections

34

Description

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Description

OPMI 1 FC on S100 floor stand Intended use The OPMI 1 FC surgical microscope on S100 floor stand is an instrument for manual operation. It can be used in all disciplines and in various applications, e.g. as: –

surgical microscope

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diagnostic microscope

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training and dissecting microscope.

The OPMI 1 FC surgical microscope is mounted on the S100 floor stand via a 120° coupling. The 120° coupling makes the instrument ideal for ENT applications. The suspension arm and its adjustable brake function enables you to balance the suspension system, allowing reliable positioning of the surgical microscope.

Set-up, OPMI 1 FC on S100 floor stand The system comprises the following components:

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S100 floor stand

2

OPMI 1 FC surgical microscope

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120° coupling

OPMI® 1 FC on S100 floor stand

Issue 2.0 Printed on 25. 09. 2007