OPMI Lumera i on the floor stand Instructions for Use Ver 8.1 May 2019

OPMI Lumera i

About This Manual

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Scope

Trademark

Manufacturer's details

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

Please read them carefully 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 any subsequent owner or user of the device.

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At the beginning of these Instructions for Use there is a summary of the different sections; this provides an overview of all the the topics.

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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.

These Instructions for Use apply to the OPMI Lumera i with the following identification: –

Reference number: 6633

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Software Release 1.5

OPMI, OPMI Lumera, Inverter tube, CALLISTO eye, HaMode SCI (Stereo Coaxial Illumination), MindStream, and EDIS are trademarks or registered trademarks of Carl Zeiss Meditec AG or another company of the ZEISS group in Germany and/or other countries. Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena Germany

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

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

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© Carl Zeiss Meditec AG 2019 All rights reserved. Reprints and reproductions, in whole or in part, are prohibited. However, these Instructions 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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Summary of the section

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Section:

Safety measures

5

Section:

Device overview

33

Section:

Preparation for use

59

Section:

Operation

89

Section:

What to do in the event of malfunctions

129

Section:

Care and maintenance

137

Section:

Device data

145

Section:

Indexes

173

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OPMI Lumera i

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Safety measures

Safety measures

Key to symbols ... 7 Hazard symbols ...7 Information symbols...7 Target group ...8 Field of use ... 8 Intended use ...8 Normal use...8 Notes for the operator... 9 Duties of the operator ...9 Requirements to be met by the user ...12 Liability and warranty ...12 Requirements for operation... 14 Before every use ...14 During use...15 After every use ...15 Measures to prevent phototoxic injury ... 16 Illumination characteristics (spectral composition)...16 Illumination intensity ...17 Angle of illumination ...17 Focus of the light source ...17 Exposure time to light...18 Safety features ... 22 Button for backup lamp...22 Filter wheel for the protection filter ...22

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Switch for manual mode... 24 Locking lever for limiting vertical movement ... 26 Position of the microscope with fundus imaging system ... 26 Symbols and labels on the device ...28

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Safety measures

Key to symbols We would like to inform you about safety requirements with which you must comply when working with this system. 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

Indicates a hazard which may lead to fatal injuries or severe injuries if precautions are not followed.

CAUTION

Identifies a danger which, if not prevented, slight or medium injuries may occur.

NOTE

Identifies a danger which, if not prevented, property damage may occur.

Information symbols The following information symbols are used in these Instructions for Use: –

Lists

 Requirements for an action •

Prompt for action

 Result of an action Additional information and tips. These do not contain any warnings of dangers.

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Target group These instructions for use are intended for physicians, nurses and other medical staff who prepare, operate or maintain the device after training by ZEISS personnel. The operator must ensure that the personnel working with the system possess the necessary qualifications and training. Additional service activities are not part of these instructions for use. They will be performed by staff specially trained for this purpose by ZEISS.

Field of use Intended use OPMI Lumera i 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 its intended use, the device can be used for surgical procedures on both the anterior (e.g., cataract, cornea, glaucoma) and the posterior (retina, vitreous) segment of the eye. The system is intended for use in offices, hospitals or other human medicine institutions.

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Safety measures

Notes for the operator Correct operation of the device is required to ensure safe use, •

so please familiarize yourself thoroughly with these Instructions for Use before starting up the instrument.

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Please comply with the Instructions for Use of the other system components as well. You can obtain additional information from ZEISS Service.

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The Instructions for Use contain warnings and safety information that describe the possible residual risks. Follow these instructions carefully to reduce the residual risks for users and patients to a minimum.

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

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Note the labels attached to the system! (See Page 28.)

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Check regularly that the legal regulations applicable in your country with regard to accident prevention and work safety are being complied with.

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If required under the applicable national laws and regulations, connect the device to the “special substitute power supply”.

Notification of the manufacturer and authorities

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If a serious incident occurs in connection with this medical device affecting the operator or another person, the operator (or person responsible) must report this serious incident to the manufacturer or seller of the medical product. In the European Union, the operator must report this serious incident to the competent authority in his country.

Notes on the system

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Ensure that the installation conditions and the use of the device meet surgical requirements:

Duties of the operator

Legal regulations

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Low vibration

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Clean environment

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Avoidance of extreme mechanical stress

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Safety measures

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Ambient conditions

Electrical safety

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

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The maximum brightness of the lamp(s) can drop over time (normal device attribute).

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Do not use the power-operated devices included in the delivery package –

in areas where there is a risk of explosion,

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or at a distance of less than 25 cm from flammable anesthetics or volatile solvents such as alcohol, benzine, or similar substances.

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Do not use or store the device in a damp place. Do not expose the device to dripping water, running water, sprayed water, or splashes.

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Ensure that fluids cannot enter the device.

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Always switch off the device before you plug it into or unplug it from a power socket, if you are not going to use it for a prolonged period of time, or if you want to clean its surface.

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Switch off the system at the power switch if you notice any smoke, sparks, or unusual noise. Do not use the unit until it has been repaired by the ZEISS Service team.

A potential equalization connector is provided on the instrument’s connection panel (see IEC 60601-1). This connector can be used to connect other active devices to the same ground potential or for redundant connection to the protective ground.

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Do not use multiple sockets!

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Do not remove any parts of the housing! The system contains components that carry high voltage and may cause electric shock.

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Do not touch the device if your body is electrostatically charged and the device 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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Do not pull on the light guide, power cord, or any other connecting cables.

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Please note the information on EMC (electromagnetic compatibility) in the chapter "System data" on Page 158.

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Controlling the surgical microscope via CALLISTO eye

Transport & Service

Safety inspection

Medical electrical systems

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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). Only personnel who have been specifically trained are allowed to control the surgical microscope via CALLISTO eye (option). •

The system may be transported over long distances (e.g., during relocation, return for repair, etc.) only in its original packaging or in special return packaging. Please contact your dealer or ZEISS Service for this purpose.

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If there is a failure and you cannot resolve the issue using information in the chapter “What to do in the event of malfunctions”, attach an “Out of order” sign to the system and contact ZEISS Service.

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To prevent any impairment of the system’s safety as a result of aging, wear, etc., the organization operating the system must ensure, in accordance with the applicable national regulations, that the regular technical safety checks defined for this system are performed on schedule and to the stipulated extent. The technical safety checks must only be performed by the manufacturer ZEISS or persons authorized by ZEISS. The safety inspections for the system should at least comprise the following points: –

Availability of the Instructions for Use

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Visual inspection of the device and accessories for damage, as well as legibility of the labels

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Leakage current test

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Test of protective ground conductor

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Function and wear test of the brakes

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Function test of all switches, buttons, sockets, and indicator lamps of the device

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Function test of the manual mode without the patient, at least semiannually.

Any additional equipment you connect to medical electrical devices must demonstrably comply with the applicable standards and directives (e.g., IEC 60950-1 for data processing equipment). In addition, all configurations must meet the standard requirements for medical electrical systems (see IEC 60601-1). Anyone connecting additional equipment to medical electrical devices is a system configurer and as such is responsible for compliance of the system with the normative requirements for medical electrical systems.

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Please note that local legislation takes priority over the requirements of the above-mentioned standards. If you have any questions, contact your local dealer or ZEISS Service. •

Never use force when trying to 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 the Carl Zeiss service team repair them.

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When mounting accessory equipment, please make sure that the admissible total weight of the surgical microscope is not exceeded. (See label “Maximum load” or chapter “Technical data”).

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When mounting non-Zeiss equipment, make sure that sufficient free space is available for focus positioning.

Requirements to be met by the user The device may be operated only by personnel who are properly instructed and trained. The operator must ensure that the personnel working with the system possess the necessary qualifications and training. •

Keep the Instructions for Use available at all times for the operating personnel.

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Modifications and repairs on this device or any ZEISS equipment operated together with this device may only be performed by ZEISS Service.

Liability and warranty The warranty and liability depend on the contractually specified conditions. Loss of warranty The manufacturer is not liable for damages caused by an unauthorized use of the device. Furthermore, such unauthorized modifications will render the warranty and any claims under warranty invalid.

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Not for diagnostic purposes

Safety measures

You must not use stored video sequences, video clips (extracted sequences), single images and live images for diagnostic purposes. Since the video cameras and monitors have not been calibrated, the visualized video sequences, video clips and single images may include deviations in scale, color and shape. Transmission to other monitors, in particular, may change the display of the images. As a result, incorrect data would be used as a basis for subsequent treatment and lead to unnecessary or incorrect surgery. •

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Make sure that stored video sequences, video clips, single images, and live images are never used for diagnostic purposes.

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Safety measures

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Requirements for operation 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 plugs are in perfect condition.  The voltage set on the system corresponds to the rated line voltage on the site of installation.  The power cord has been plugged into a power outlet which is properly grounded.  The device is connected with the power cord supplied.

Before every use

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Make sure that all function tests before use are performed and the requirements specified above fulfilled.

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Go through the checklist in the chapter “Operation” (see Page 93).

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Comply with all symbols, instructions, and labels on the device.

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Never cover any ventilation openings.

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Press the locking tabs on the stand base to secure the stand in position. Make sure that the stand is stable and cannot roll away.

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Check that the movement of the surgical microscope is unobstructed to avoid any collisions and damage to cables.

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Check the user settings in the software to avoid unexpected behavior of the system.

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During use •

Only use the system after it has been properly balanced.

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Constantly monitor the system during use.

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Excessive radiation exposure times may lead to retinal injury in the patient’s eye. Never leave the device unattended while its light source is switched on.

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

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When the illumination is switched on, there is a risk of fire or you may burn yourself if the light guide is not connected at both ends.

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Any type of radiation has a damaging effect on biological tissue. This is also true for the light illumination the surgical field. You should therefore reduce the brightness and the light exposure time to the absolute minimum required.

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Phototoxic effect of light beams. When operating on the eye, always use the retina protection filter (blue barrier filter) installed in the light source and/or the retina protection device to ensure that the patient’s eye is not exposed to unnecessary (blue) radiation.

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Adjust the illumination intensity and the resulting radiation exposure time by selecting the appropriate illumination setting. The values recommended by ZEISS are located in the table “Maximum radiation exposure times” on Page 20. Deviations from these values must be medically justified and are the sole responsibility of the surgeon.

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Cables which are not appropriately routed may lead to an increased risk of tripping during operation of the system. Always route cables so that they do not hinder the user.

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Use the main power switch to switch off the system.

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

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 exposing the eye to light with varying spectral compositions have been conducted since as early as the 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. An important point to note here, however, is that the use of filters 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.

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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 surgery. Brightness control

ZEISS has addressed this aspect by providing its devices with a feature for continuously varying the brightness of the light source. 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 Several publications1)-4) suggest tilting the microscope 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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For this reason, 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 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 swing-in retina protection filter (blue barrier filter) that can be swung into the microscope’s illumination beam path. Brightness setting

The brightness control scale of the ZEISS systems has a linear structure with values ranging from 5% to 100%. The stipulations of standard DIN EN ISO 15004-2:2007 result in maximum radiation exposure times for the different illumination configurations as specified in the table “Maximum radiation exposure times” (see Page 20). The maximum brightness of the lamps decreases in the course of time as a result of normal wear.

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 are 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 of a material without UV/blue filter 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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During cataract procedures, factors such as lenticular material, instruments such as the phaco handpiece, and movement of the eye provide interruption of the exposure This is expected to significantly lengthen the time before photoretinitis might be expected to occur. Effects of microscope illumination

A prospective study7) of the effects of microscope illumination during surgery did not reveal any phototoxic retinal injuries for procedure times of up to 30 minutes if the calculated maximum recommended exposure time was 150 seconds. However, it was also found that at the same brightness setting, phototoxic retinal injury could be expected after approximately 100 min.

Stereo Coaxial Illumination

The Stereo Coaxial Illumination (SCI) of this system has been designed to provide a bright red reflex using only very small quantities of light in the center of the surgical field. The peripheral illumination causes higher exposure of the retina, but, depending on the position of the eye, usually not the macula directly. For cataract procedures, ZEISS recommends adjusting the surrounding field illumination to be somewhat darker than the central red reflex spot. Not only does this setting minimize phototoxic risk but it also reduces glare from the patient’s sclera. Other recommendations for minimizing the phototoxic risk are:

Maximum radiation exposure

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Always use the lowest brightness setting possible.

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Use the retina protective filter (blue barrier filter) to block the blue spectrum of light. The retina protection filter increases the recommended exposure times by a factor of 3.

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When working on the exterior eye, use the retina protection device to prevent light from entering the pupil, especially when the pupil is dilated (see Page 38).

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Always switch off the microscope illumination during pauses in surgery. Either move the surgical microscope to the standby position for this purpose or cover the patient’s eyes.

The following table is intended to provide the surgeon with a guideline in determining the potential hazard. The data has been calculated for the worst case scenario: –

direct radiation exposure,

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uninterrupted radiation exposure, e.g., no surgical instruments in the eye,

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aphakic eye,

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totally immobile eye, which means that only one area is subject to exposure,

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pupil dilated to 8 mm.

The calculations are based on the daily exposure limits recommended for occupational safety as defined in6). A safety factor of 10 has been used in determining these limits. The use of the blue barrier filter increases the recommended exposure time by a factor of 3 compared with the values specified below. Maximum radiation exposure times with red reflex illumination Illumination display Max. radiation time in minutes scale in % 25

50

50

21

75

13

100

9

Maximum radiation exposure times with surrounding field illumination Illumination display Max. radiation time in minutes scale in %

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25

8.7

50

3.7

75

2.2

100

1.6

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