OPMI Lumera 700 Instructions for Use Ver 7.6 Aug 2013

OPMI LUMERA® 700

About this manual

Orientation aids

Scope of application

Trademarks

Manufacturer

These Instructions for Use are part of the delivery package. •

Carefully read them before using the device.

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Keep them at the site of use of the device.

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Store them for the entire service life of the device.

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

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The chapter overview at the beginning of these Instructions for Use 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.

The present Instructions for Use apply to the OPMI LUMERA 700 with software release 2.0 and the following identification: –

Reference number 6634 (floor stand)

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Reference number 6726 (ceiling mount)

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OPMI® , LUMERA® , Invertertube® E, CALLISTO eye®, HaMode®, Superlux®, RESIGHT®, VISULUX®, VisionGuard® and MediLive® Trio, Z ALIGN® and K TRACK® are registered trademarks of Carl Zeiss.

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SCI™ (Stereo Coaxial Illumination) and MEDIALINK™ 100 are trademarks of Carl Zeiss.

Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena Germany

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

Subject to changes in design and scope of delivery and as a result of ongoing technical development. Printed in Germany. Copyright

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© Carl Zeiss Meditec AG 2013 All rights reserved. Reprints and reproductions, including excerpts, are not permissible. However, this Instruction for Use 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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Chapter Overview

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Chapter:

Safety Measures

5

Chapter:

System Overview

47

Chapter:

Preparations for use

109

Chapter:

Operation

167

Chapter:

What to do in the event of malfunctions

245

Chapter:

Care and Maintenance

261

Chapter:

System Data

277

Chapter:

Annex / Options

311

Chapter:

Indexes

413

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Safety Measures

Key to symbols ... 7 Hazard symbols ...7 Information symbols...7 Target group ...8 Field of application ... 8 Intended use ...8 Normal use...8 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 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 Labels on the suspension system ...32 Labels on the lamp housing ...42

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Device connector signs ... 44

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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 Instructions for Use. 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 these Instructions for Use: –

Listing

 Requirements for an action •

Prompt for action

 Result of an action Additional information and hints

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Target group These Instructions for Use are intended for physicians, medical and/or technical staff and nurses who prepare, operate or maintain the system after appropriate training. It is the duty of the equipment owner/operator to train and brief all the operating staff. Service work not described in these Instructions for Use must only be performed by specialists trained by ZEISS.

Field of application 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 configure the microscope, the integrated SD 3CCD/HD 3CCD camera or change the SD/ HD video and image acquisition system using the adjustable 5.7" control panel. The fast focus allows rapid movement over a defined travel range and

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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, the data injection system 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 is available as a mobile and as a ceiling-mounted surgical microscope. It can be supplemented by various accessories and can be prepared for sterile use by attaching resterilizable caps, handgrips and sterile drapes. For attachment and alignment of a 22" TFT monitor, CALLISTO eye or an operating light, the ceiling.mounted surgical microscope can be fitted with an additional carrier arm system. The system is intended for use in offices, hospitals or other human medicine institutions. For disposal, please observe these instructions of use as well as the applicable legal regulations in your country.

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Notes for the operator

WARNING

The device must not be modified without any approval! This equipment must not be modified without the manufacturer's approval. If the system is modified after consultation with the manufacturer, suitable inspections and testing must be completed to ensure subsequent safe use. The manufacturer is not liable for damages caused by unauthorized use of the device.

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Prior to using the device for the first time, please read the instructions for use 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 these Instructions for Use where they are 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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Modifications and repairs of this device or any equipment operated together with this device may only be performed by ZEISS service staff or other persons authorized by ZEISS.

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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: –

minimum vibration

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clean environment

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do not use the device under extreme mechanical stresses

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

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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A potential equalization connection can be found on the control unit (according to IEC 60601-1:2005). This connector can be used for placing other active devices at the same ground potential or for redundant grounding to protective earth.

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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 291.

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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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Only transport the device over long distances (e.g. relocation, return for repair) in its original packaging or special return packaging. Please contact your dealer or ZEISS Service.

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In order to prevent any impairment of the device's safety due to age, wear, etc., the user must ensure that the device is subjected to the necessary safety checks (see section "Care and maintenance").

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More specific information about the floor stand: •

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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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.

More specific information about the ceiling mount: •

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Turn the device off whenever you will not use it for a prolonged period of time or intend to clean its surface.

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

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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Safety Measures

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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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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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If you operate the device in a sterile area, make sure that you use the corresponding sterile accessories for the device.

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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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Do not exert any force when plugging in electrical plug-in connections (connectors, jacks). If a connector/plug cannot be plugged in easily, check whether the plug fits the socket. If you discover a plug-in connector is damaged, have the ZEISS service team or an authorized professional repair it.

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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 1).

More specific information about the floor stand: •

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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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During use

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To avoid phototoxic injuries to the patient's eye, reduce the brightness and lower the duration of illuminating the operating field to what is absolutely necessary.

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To avoid phototoxic injuries to the patient's eye, use the built-in retina protection filters (blue blocking filter) and/or the retina protective cover.

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Adjust the intensity of the irradiation and the resulting irradiation time by selecting the appropriate illumination setting in order to prevent phototoxic injuries to the patient's eye. You will find the values recommended by ZEISS in the table "Maximum radiation exposure times" on Page 22. Any deviation from these values is only permissible when medically justified.

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To avoid phototoxic injuries in the eye, avoid looking directly into the source, e.g. microscope lens or light conductor.

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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 500 or RESIGHT 700 fundus viewing system on the underside of the microscope and steeply tilt the microscope, the RESIGHT 500 or RESIGHT 700 fundus viewing system may unintentionally move in and injure the patient. Remove the RESIGHT 500 or RESIGHT 700 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, it may fail suddenly and interrupt its operation. Upon reaching a balance of 50 operating hours, a warning message will appear on the 5.7" operating panel. Once only five hours remain, you will receive a warning asking you to replace the relevant xenon lamp. Swing in the replacement xenon lamp now at the latest. Once the maximum operating period for the replacement xenon lamp is reached, you will need to exchange the xenon lamp insert for the Superlux Eye light sourceand then reset the remaining operating hours meter back to its initial value.

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If you need to 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 system stating it is out of order and contact the ZEISS service staff.

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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 these Instruction for Use can expose the patient or medical staff to a considerable risk of infection.

After every use

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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 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, 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 cause the color of the light to change. 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 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 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 ZEISS by the use of a retina protection device that can be swung into the microscope's illumination beam path and a swingin retina protection filter (blue barrier filter). Brightness control

The brightness control scale of our systems has a linear structure with values ranging from 5% to 100%. The stipulations of standard DIN EN ISO 150042:2007 result in maximum radiation exposure times for the different illumination configurations. They can be taken from the table "Maximum radiation exposure times" (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

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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

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