S100 Suspension System Instruction of use Issue 10.0

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 provides hints on the use of the instrument or other tips for the user.

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

This user manual applies to the following systems Description

Cat. No.

S100 floor stand

000000-1403-542

S100 wall mount, with long suspension arm

000000-1403-544

S100 wall mount, with short suspension arm

000000-1403-570

S100 ceiling mount

000000-1403-572

S100 Centro suspension system for KAVO Centro 000000-1403-573 column

Contents

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Safety

5

Description

23

S100 Suspension Systems

24

Preparations for use

49

Attaching the equipment

50

Adjusting the documentation unit on S100 (option)

56

Connections

69

Overview of menus

74

Operation

95

Checklist

96

Procedure

99

optional storage of image data

102

What to do in an emergency

106

Maintenance / Further information

111

Technical data

137

Index

145

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Safety

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Installation and use of OPMI® and its power supply unit

6

Safety devices of the suspension system

12

Warning labels and notes

16

Safety

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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. •

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.

Installation and use of OPMI® and its power supply unit Safe working order •

Do not operate the equipment contained in the delivery package in – explosion-risk areas,

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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.

•

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.

•

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. 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 scale, color and shape. Caution: The company Carl Zeiss shall not be liable for any defective USB media and any resultant loss of patient or image data. Arrange for patient and image data to be backed up on a regular basis, if required. In the event of repairs by Carl Zeiss service staff, the recovery of this data is no longer possible. Requirements for operation

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•

Our service staff or a qualified person appointed by us will install the instrument on a ceiling or wall anchor plate which has been properly mounted by the construction engineers responsible. This ceiling or wall anchor plate must comply with the specifications contained in our planning manual. Please ensure that the following requirements are met for further operation:

–

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.

–

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.

Connection of equipment from other manufacturers, e.g. computers If you operate this system within the patient area* in conjunction with devices from other manufacturers which do not comply with the IEC60601-1 standard, you must ensure that either the third-party devices are powered via an isolating transformer, or that each of them is connected with the central ground system via an additional ground terminal (potential equalization). The leakage current may increase if the system is connected with other devices. The resulting new system must comply with the EN 60601-1-1 standard (Safety Requirements for Medical-Electrical Systems).

R

R

1. 5 59 m "

*Fig.: Patient area

Before every use and after re-equipping the instrument

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•

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.

•

Please pay special attention to labels on the instrument, such as warning triangles with exclamation marks or notes.

•

Do not cover any ventilation openings.

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For every use of the instrument •

Never operate the system unattended.

•

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.

•

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.

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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Safety devices of the suspension system Halogen illumination system 1

Flap The flap is the mechanical indicator for the operating status of the halogen lamps. – When the flap is closed, the main lamp is operative. – When the flap is open, the main lamp has failed. The backup lamp is on.

2

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Activating the backup lamp The lamp housing contains a backup lamp which is automatically swung into the illumination beam path when the first lamp fails. If this automatic function fails, you can switch on the backup lamp by pressing this button.

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Xenon illumination system Warning! The xenon lamp has a limited service life of 500 h. If used beyond its maximum service life, the xenon lamp may explode. Change the xenon lamp in good time.

1

Switching to backup lamp The lamp module contains two xenon lamps. The second lamp is used as a backup lamp which has to be swung into the illumination beam path when the first lamp fails. When the xenon lamp fails, open the lamp module as follows: Press button (3). The lamp module is slightly ejected. Pull out the lamp module as far as it will go. Turn knob (1) through 180° until it snaps in. This moves the backup lamp into the illumination beam path. Push the lamp module all the way back into the lamp housing.

2

Indicator: backup lamp is in use When the red segment (2) in knob (1) lights up, the backup lamp is in use. Note: If the first lamp has failed and the backup lamp is in use, make sure to have a backup lamp module (for the Cat. No., please see page 132) ready at hand as a precaution.

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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

Halogen illumination system

2

Xenon illumination system, illustration without column of the suspension system

Type label The type label provides the following information: –

Manufacturing number

– Power consumption

–

Instrument name

– Line frequency range

–

Cat. No.

– Instrument class

–

Serial no.

– Approval, country-specific

–

Rated voltage

– CE labeling

For the technical data, please see the chapter "Technical data". Service Identification Program - SIP label The SIP label contains the following information: –

Service phone number

– Service fax number

–

Service email address

– SIP number = manufacturing number

For user information on the disposal of electrical and electronic devices, please see the chapter "Maintenance / Further information

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Brightness control If the illumination system is on, you can continuously adjust the brightness of the fiber illumination by turning this knob. Balance setting Turn the screw to adjust the balance setting of the suspension arm.

Ceiling and wall mounts: Don't use the mounts to support yourself.

Maximum load When surgical microscopes are mounted on the suspension systems, the overall weight of the microscope including accessories must not exceed a maximum value. Please consult the user's manual for the suspension system about the admissible maximum load.

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Moving position Position of the floor stand for safe transportation.

Caution: Over longer distances (e.g. removal, return for repair, etc), the instrument must always be transported in the original packaging or in special return packaging. For details, please contact your dealer or the Carl Zeiss service team.

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