OPMI Lumera 700 on Floor Stand User Manual Ver 3.0 July 2010

OPMI LUMERA® 700

About this manual

Orientation aids

Applicable area

Trademarks

The user manual is part of the delivery package. •

Carefully read it before using the device.

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Keep it at the site of use of the device.

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Store it for the entire service life of the device.

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Pass it on to every subsequent owner or user of the device.

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The chapter overview at the beginning of the user manual provides a summary of all subjects.

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The contents of each chapter are specified in detail at the beginning of each chapter.

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A list of abbreviations, key words and technical terms in the annex facilitates the search for specific terms.

This user manual applies to OPMI LUMERA 700 with the following identification: –

Rating label number: 305953-9900-000

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Software release 1.2

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OPMI®, LUMERA® , Invertertube®, CALLISTO® eye and HaMode® are registered trademarks of Carl Zeiss Surgical GmbH.

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RESIGHT™ and SCI™ (Stereo Coaxial Illumination) are trademarks of Carl Zeiss Surgical GmbH.

Information on the manufacturer: Carl Zeiss Surgical GmbH Carl-Zeiss-Strasse 22 73447 Oberkochen Germany

Fax: + 49 (0) 7364 - 20 4823 Email: [email protected] Internet: www.meditec.zeiss.com

Subject to change in design and scope of delivery and as a result of ongoing technical development. Printed in Germany. © Carl Zeiss Surgical GmbH 2010 All rights reserved. Reprints and reproductions, including excerpts, are not permissible. However, this manual may be digitized and archived for internal use. Access to this data by third parties is not permissible and must be prevented.

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OPMI LUMERA® 700

Chapter Overview

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Chapter:

Safety measures

5

Chapter:

System overview

41

Chapter:

Preparations for use

79

Chapter:

Operation

109

Chapter:

What to do in the event of malfunctions

193

Chapter:

Care and maintenance

207

Chapter:

System data

219

Chapter:

Annex / Options)

245

Chapter:

Indexes

281

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OPMI LUMERA® 700

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Safety measures

Key to symbols ... 7 Hazard symbols ...7 Information symbols...7 Target group ... 8 Field of use ... 9 Intended use ...9 Normal use...9 Notes for the operator... 10 Requirements for operation... 13 Prior to the very first use...13 Before every use ...13 During use...15 After every use ...16 Liability and warranty... 17 Measures to prevent phototoxic injury ... 18 Illumination characteristics (spectral composition)...18 Illumination intensity ...18 Angle of illumination ...19 Focus of the light source ...19 Exposure time to light...20 Safety devices... 24 Symbols and labels on the device ... 30 Microscope labels...30

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Safety measures

OPMI LUMERA® 700

Labels on the suspension system... 32

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Safety measures

Key to symbols We would like to inform you 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.

Hazard symbols The following safety information has been incorporated into the user manual. Please note this information and be particularly careful in these cases. WARNING

Warning label, which may refer to fatal injuries or severe injuries if precautions are not followed.

CAUTION

Indicating a hazard, which may lead to moderately severe injuries if risks are not avoided.

NOTE

Warning label, which may refer to minor injuries and property damages if precautions are not followed.

Information symbols The following information symbols are used in this user manual: –

Listing

9 Prerequisite for an action •

Prompt for action

Æ Result of an action Additional information and tips

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Safety measures

OPMI LUMERA® 700

Target group This user manual is intended for physicians, nurses and other medical staff who prepare, operate or maintain the system after the appropriate training and in accordance with the instructions given in this manual. It is the duty of the customer or institution operating the system to train and instruct all staff using the system. Installation and service work not described in this manual must only be performed by specialists from Carl Zeiss.

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Field of use Intended use OPMI LUMERA 700 is a surgical microscope intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures in the field of ophthalmology.

Normal use In line with the intended use of the system, you can use it for surgical procedures on both the anterior segment of the eye (e.g. cataract, cornea, glaucoma) and the posterior segment of the eye (retina, vitreous). The system-integrated SCI illumination provides an optimum red reflex and delivers a sharply defined, high-contrast image of the patient's eye. The freely programmable foot control panel or, alternatively, the handgrips ensure maximum operating comfort for the surgeon who can configure all settings required to meet his/her specific needs. In addition, the OR staff can change the configuration of the microscope and of the integrated camera or USB video recording functions via the adjustable 5.7" control panel. The fast focus allows rapid movement over a defined travel range and enables the surgeon to move the focus very easily over long distances (e.g. for folding lenses) and back to its initial position. Assistant functions such as the keratoscope or the integrated slit illuminator expand the surgeon's scope of work. After completion of the surgical procedure, the system can be reset to the selected, freely programmable starting values via the standby position or reset function to ensure an optimum starting position for the next surgery. The system can be supplemented by various accessories and can be prepared for sterile use by attaching resterilizable caps, handgrips and drapes. The system is intended for use in offices, hospitals or other human medicine institutions. For disposal, please observe the instructions in this manual as well as the applicable legal regulations in your country.

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Safety measures

OPMI LUMERA® 700

Notes for the operator •

Prior to using the device for the first time, please read the instruction manual thoroughly. Also ensure to read the instructions of accessory tools.

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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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Only operate the device within the scope of its intended use.

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Please keep the user manual where it is easily accessible at all times for the persons operating the system.

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Only personnel who have been appropriately briefed are allowed to control the surgical microscope via CALLISTO eye (option). Any change in the focus and zoom setting via CALLISTO eye may lead to unwanted movement at the surgical microscope during application (e.g. in the OP mode).

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Please observe all symbols and labels attached to the device! (see page 30)

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Observe the legal regulations for accident prevention and occupational health and safety applicable in the country concerned.

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This system must not be modified without the manufacturer's approval. If the system is modified, suitable inspections and testing must be completed to ensure that it can still be used safely. The manufacturer is not liable for damage caused by unauthorized persons tampering with the system. Furthermore, this will forfeit any rights to claim under warranty.

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Modifications and repairs of this device or any equipment operated together with this device may only be performed by the Carl Zeiss service team or other persons authorized by CZS.

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Connect the system to a special emergency backup power supply in accordance with the regulations and directives applicable in the country of use.

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Ensure that the installation requirements and the operation of the device concur with the surgical conditions:

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minimum vibration

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clean environment

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do not use the device under extreme mechanical stresses

Do not use any power-operated device that is part of the delivery scope

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Safety measures

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in explosion-hazardous areas,

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do not operate the device close to flammable anesthetics or volatile solvents, such as alcohol, ether/benzene or similar. Stay away at least 25 cm.

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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.

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Do not place any fluid-filled containers on top of the instrument. Make sure that no fluids can seep into 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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Potential equalization: If requested, the instrument can be incorporated into potential equalization measures.

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Do not use multiple sockets!

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Never open the device! The device contains freely accessible live components. If you remove the housing, you run the risk of electric shock.

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Do not touch the system if your body is electrostatically charged and the system is not grounded.

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Before connecting the system to line power, make sure that the power network is free from defects that may lead to dangerous voltage on the power plug.

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Please note the information on EMC (electromagnetic compatibility) in the chapter "System data" on page 227.

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With increasing age of the light source, the actual illumination intensity delivered at the respective setting decreases (this is a normal property of the system).

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The user (IT officer) is responsible for ensuring that no viruses are transferred to the system via the network connection.

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It is the user's responsibility to ensure that the USB storage media used for data communication are free from viruses.

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Should the device be transported over longer distances (e.g., moving, return for repairs etc.), only use the original packaging or special return packages. Please contact your dealer or the Carl Zeiss Service department.

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Always turn off the device before connecting to or removing from the power supply, if the device is not being used for a long time or if the device is being cleaned.

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In order to prevent a decrease in the device's safety due to age, wear and tear, etc., the user must have the device checked for its safe operation (refer to Safety Checks in Chapter "Care and maintenance").

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Safety measures

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Condensation of humid air may occur if you move the system from a cold place (<10°C) to a warm place. Before switching on the system, allow it to adapt to room temperature for at least 1 hour.

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Requirements for operation Prior to the very first use Carl Zeiss Service or an expert authorized by CZS will install the system. Please make sure that the following requirements continue to be met for further operation: 9 The connecting components have been properly connected. The screw connections have been firmly tightened. 9 All cables and connectors are in a perfect condition, i.e. they do not display any worn areas, kinks or other defects. 9 Determine the supply voltage at the place of installation and set the voltage of the device accordingly. 9 Insert the power plug only into a socket that is fitted with a flawless protective earth conductor. 9 The power cord being used is the one designed for use with this system. 9 When connecting the device to any network, please ensure the network is free of dangerous voltages.

Before every use

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When adding accessories and/or components please ensure the permissible total weight of the device is not exceeded. (see label "Maximum load" or Section "Technical Data").

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Before every use, make certain to compensate for any added weight; this will enable the surgical microscope to maintain its balance in all positions of the working range.

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Before every use, limit the stroke of the suspension arm to prevent any contact with the patient if the surgical microscope is lowered accidentally.

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Check the surgical microscope for sufficient freedom of movement. The device itself or accessories may be damaged if conflicting with each other.

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When mounting accessories (e.g. fundus viewing systems) on the system, make sure that sufficient free space is available for focus positioning and that the surgical microscope cannot touch the patient.

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Safety measures

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Before using a fundus viewing system, make sure that the room for movement is larger than the downward travel path of the microscope.

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In order to prevent an unexpected response by the device, check the user settings of the software before every use.

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The assistant's microscope may swing out of position if you tilt the surgical microscope to the horizontal viewing direction and the assistant's microscope has not been locked. Adjust the assistant's microscope before use and make sure it is properly locked in position.

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Always run cables in a manner that will not impede the user's movements.

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Before every use, switch off the light source for light guides that are not being used and properly attach them on the designated bracket.

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Before every use, check the light source for damages in order to prevent phototoxic injuries to the patient's eye.

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Before every use, check the filter settings in order to prevent phototoxic injury to the patient's eye.

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Use the system in the sterile area. Make sure to use the appropriate sterile accessories for this system.

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Never cover any ventilation openings, as this may e.g. cause the light source of the system to overheat and fail.

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Never attempt to forcefully connect any electrical connectors (plugs, sockets). If connection is not readily possible, check whether the plug fits the socket. If any of the connectors are damaged, have Carl Zeiss Service repair them.

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In order to avoid the device from rolling off inadvertently, use the locking mechanism on the base of the suspension system and secure the device.

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If you are using the RESIGHT 700 fundus viewing system, the external focusing module of the surgical microscope is assigned to the upper buttons of the foot control panel. When configuring your system, do not assign any functions to these buttons (e.g.inversion) which you will need during the use of RESIGHT 700.

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Before using the wireless, foot control panel FCP WL ensure its batteries are fully charged. Inadequate power supply of the wireless foot control panel may lead to malfunctions of the device.

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Go through the checklist in chapter "Operation" (see page 112).

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During use

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In order to prevent phototoxic damages to the patient's eye, reduce the brightness and the light exposure of the surgical area to an amount that is absolutely necessary for the surgery.

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In order to prevent phototoxic damages to the patient's eye during surgery, use a retina protection filter (blue barrier filter) and/or a retina protection device that are integrated into the light source.

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In order to prevent phototoxic damages to the patient's eye, adjust the irradiation intensity and the associated irradiation time by selecting the appropriate illumination setting. The values recommended by Carl Zeiss can be found in table "Maximum radiation exposure times" on page 22. Any deviation from these values is only permissible when medically justified.

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In order to prevent phototoxic damages, never look directly into the light source, e.g. on the microscope or the light guide.

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Never leave a device unattended with the light source still switched on, as excessive radiation exposure times may lead to retinal injury in the patient's eye.

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When operating the handgrips or the zoom knob on the assistant's microscope, do not touch the non-sterile connecting cable to avoid infecting the patient.

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If you have mounted the RESIGHT fundus viewing system on the underside of the microscope and steeply tilt the microscope, the RESIGHT fundus viewing system may unintentionally move in and injure the patient. Remove the RESIGHT fundus viewing system before steeply tilting the microscope.

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Defective or unidentified accessories may lead to increased leakage current on the system and injure the patient. Never connect any defective or unidentified accessories and never touch the power outlet or video interfaces while in contact with the patient.

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If the xenon lamp is used beyond its maximum service life of 500 hours, sudden failure may occur and interrupt operation. Replace the xenon lamp in due time and reset the remaining service hours display on the 5.7" control panel to "0".

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If you change the lamp shortly after it has failed, the lamp will still be very hot. Use heat-resistant protective gloves when replacing the lamp to prevent burns.

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Malfunctions in the motor's electronic system may cause the main functions to fail (XY movement, focus, zoom, light control system) and affect other functions. Change to manual mode.

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If a failure occurs which you cannot correct with the aid of the chapter "What to do in the event of malfunctions“, attach a sign to the device stating it is out of order and contact our service representative.

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Do not pull at the light guide, power cord or any other connecting cables.

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Always use the master switch to turn off the device if it is not in use.

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Insufficient, incorrect or wrong cleaning or disinfection not complying with this user manual can expose the patient or medical staff to a considerable risk of infection.

After every use

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Liability and warranty Warranty and liability depend on the applicable contractual stipulations. NOTE

Loss of warranty Modifications to this system are not permissible. The manufacturer is not liable for damage caused by unauthorized persons tampering with the system. Furthermore, this will forfeit any rights to claim under warranty.

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Measures to prevent phototoxic injury Several papers1)-5) dealing with the problem of phototoxicity in ophthalmic surgery have been published. A comprehensive review of these publications reveals five aspects of particular concern: –

Illumination characteristics (spectral composition)

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Illumination intensity

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Angle of illumination

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Focus of the light source

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Exposure time to light

In the following, comments on these aspects are given and a description of how Carl Zeiss, as a manufacturer, makes allowance for them in its systems.

Illumination characteristics (spectral composition) Studies on the exposure of the eye to light of varying spectral composition date back to the early 1950s. These studies suggest that the potential hazard of phototoxic injury to the patient's retina can be reduced by blocking out the blue and ultraviolet light below a wavelength of 475 nm. Integrated protection filters

For protection of the retina, Carl Zeiss offers the swing-in retina protection filter (blue barrier filter) and the stationary UV blocking filter as standard features of the surgical microscope. This reduces not only the exposure of the patient's eye to light, but also that of the surgeon's. An important point to note here, however, is that the orange color of the retina protection filter will inevitably change the perceived color of the light. For this reason, the surgeon may initially have to get used to the changed appearance of the anatomical structures.

Illumination intensity The majority of researchers suggest that the surgeon should use the lowest light intensity required at the patient's eye to guarantee good viewing during

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surgery. Brightness control

For this reason, the brightness of the light source in Carl Zeiss systems is continuously variable. This permits the surgeon to optimally adapt the light intensity at the patient's eye to the conditions existing in each case.

Angle of illumination A number of publications1)-4) suggest that the microscope should be tilted to reduce the exposure of the macula to direct illumination. Tilting mechanism

The surgical microscope features a tilting mechanism for the main microscope to enable indirect illumination.

Focus of the light source Studies show that injuries are likely to occur if the filament of the light source is imaged on the patient's retina. The peak intensity of a filament is considerably higher than that of an even and extended light source such as a light guide. Fiber optic illumination

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This is the reason why Carl Zeiss uses fiber optic illumination in its surgical microscope systems.

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Exposure time to light According to some publications, the eye should not be exposed to the light source longer than a few minutes. In all surgical cases, the retinal exposure time to light depends on the type and duration of the procedure and possible case complications. It is therefore recommended in ophthalmic surgery to keep the light intensity as low as possible, or to use a device which prevents the light from entering through the patient's pupil. It is also recommended to make sure that the patient's eye is not additionally exposed to the light of surrounding light sources. This problem has been solved by Carl Zeiss by the use of a retina protection device that can be swung into the microscope's illumination beam path and a swing-in retina protection filter (blue barrier filter). Brightness adjustment

The brightness of this device can be adjusted on a scale from 5% to 100%. Based on standard DIN EN ISO 15004-2:2007 there are maximum illumination times for various illumination configurations. These values can be found on table "Maximum radiation exposure time" (see page 22). With increasing age of the light source, the actual illumination intensity delivered at the respective setting decreases (this is a normal property of the system).

Phototoxic risk factors

The microscope light source - like any bright light source - may present a potential hazard to the patient's eye both in the form of immediately visible thermal damage to the retina as well as phototoxic chemical reactions which may lead to photoretinitis. The factors which play an important role in determining the phototoxic risk are: –

Lamp brightness

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Spectral distribution of the light (UV and blue light is more dangerous than longer wavelengths)

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Duration of direct exposure

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Pupil size

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Clarity of ocular media (infants and young children, for example, may be at a higher risk)

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Condition of the eye: aphakic and pseudo-aphakic eyes with IOLs are at a higher risk.

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Previous exposure to bright light such as retinal photography, especially within the last 24 hours

During cataract procedures, factors such as lenticular material, instruments

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