OPMI Lumera i Instructions for Use Ver 6.0 Jan 2015

OPMI Lumera i

About this manual

Orientation aids

Applicable area

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.

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

Rating label number: 305946-9900-000

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Software release 1.5

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OPMI® , Lumera® , Invertertube®, CALLISTO eye® and HaMode® are registered trademarks of Carl Zeiss.

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SCI™ (Stereo Coaxial Illumination), MindStream™ and EDIS™ 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 2015 All rights reserved. Reprints and reproductions, including excerpts, are not permissible. 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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Chapter overview

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Chapter:

Safety Measures

5

Chapter:

System Overview

35

Chapter:

Preparations for use

61

Chapter:

Operation

85

Chapter:

What to do in the event of malfunctions

121

Chapter:

Care and Maintenance

129

Chapter:

System Data

137

Chapter:

Indexes

161

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Safety Measures

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... 9 Duties of the operator ...9 Requirements to be met by the user ...11 Warranty and liability...12 Requirements for operation... 13 Before every use ...13 During use...13 After every use ...14 Measures to prevent phototoxic injury ... 15 Illumination characteristics (spectral composition)...15 Illumination intensity ...15 Angle of illumination ...16 Focus of the light source ...16 Exposure time to light...16 Safety devices... 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 Labels on the microscope ... 28 Labels on the suspension system... 30

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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 Instructions for Use. Please note this information and be particularly careful in these cases. WARNING

Indicates a hazard which can lead to death or severe injury if it is not prevented.

CAUTION

Indicates a hazard which can cause minor to moderate injury if it is not prevented.

NOTE

Indicates a hazard which can cause damage to material if it is not prevented.

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

Listing

 Prerequisite for an action •

Prompt for action

 Result of an action Additional information and tips. No warnings of hazards are provided.

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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. It is the duty of the equipment owner/operator to train and brief all the operating staff. Extended service tasks are not part of these Instructions for Use. They will be performed by staff specially trained for this purpose by ZEISS.

Field of application 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 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 is intended for use in offices, hospitals or other human medicine institutions.

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Safety Measures

Notes for the operator The correct use of the system is absolutely vital for safe operation. Therefore, please thoroughly familiarize yourself with the contents of these Instructions for Use before starting up the system. Please also observe the respective Instructions for Use of any additional equipment.

Duties of the operator

Legal regulations

Notes on the system

Ambient requirements

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

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If required by the regulations and directives applicable in the country of use, connect the system to a special emergency backup power supply.

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Make sure that the installation conditions and the use of the system meet surgical requirements: low vibration

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clean environment

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avoidance of extreme mechanical stress.

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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) may decrease in the course of time (this is a normal property of the system).

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Do not operate the system contained in the delivery package

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in explosion-risk areas,

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if inflammable anesthetics or volatile solvents such as alcohol, benzine or similar chemicals are present at a distance of less than 25 cm.

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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Safety Measures

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Electrical safety

Transport & Service

Technical Safety Control

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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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Always switch off the system before disconnecting it from / connecting it to line power, for cleaning its surface or if it will not be used for a prolonged period of time.

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

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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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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 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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Do not pull at 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 145.

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

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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 inform 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 scope of the technical safety checks of the system should at least comprise the following points: –

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Availability of the Instructions for Use

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Accessories

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Visual inspection of system and accessories for damage and legibility of 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 system

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Any additional equipment connected to medical electrical devices must demonstrably comply with the applicable standards and directives (e.g. EN 60950:2005 for data processing equipment). In addition, all configurations must meet the standards for medical systems (see EN 60601-11:1990 or Section 16 of EN 60601-1:2006). Anyone connecting additional equipment to medical electrical devices is a system configurer and as such responsible for compliance of the system with the normative requirements for systems. Please note that local legislation takes priority over the above-mentioned normative requirements. If you have any questions, please contact ZEISS Service or your local dealer.

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Do not exert any force when plugging in electrical plug-in connections (connectors, jacks). If connection is not readily possible, check whether the plug fits the socket. If you detect any damage to the plug-in connection, arrange for the damage to be repaired by ZEISS Service.

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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

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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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Please keep these Instructions for Use where they are easily accessible at all times for the persons operating the system.

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

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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).

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

Loss of warranty 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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Safety Measures

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 has a properly connected protective ground contact.  The power cord being used is the one designed for use with this system.

Before every use •

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 chapter "Operation" (see Page 88).

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Note all symbols, notes and labels on the system.

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Do not cover any ventilation openings.

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Using the brake tabs on the base, 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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Only use the system after it has been properly balanced.

During use

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Never operate the system unattended.

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Excessive radiation exposure times may lead to retinal injury in the patient's eye. Never leave a system unattended when the light source has been activated.

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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 on, the light guide must be connected at both ends. Otherwise there is a risk of fire or burn injuries.

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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.

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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. You will find the values recommended by ZEISS in the table "Maximum radiation exposure times" on Page 19. Any deviation from these values is only permissible when medically justified.

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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 the cables in such a way that they do not obstruct the user.

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Always use the main power switch of the instrument to turn it off.

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

After every use

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Safety Measures

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

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

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.

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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 as specified in the table "Maximum radiation exposure times" (see Page 19). The maximum brightness of the lamps decreases in the course of time as a result of normal wear.

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 such as the phaco handpiece, and movement of the eye provide interruption of the exposure and would be expected to significantly lengthen the time before photoretinitis might be expected to occur. Effects of microscope illumination

A prospective study 7) 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 pro-

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vide a bright red reflex at the center of the surgical field using only very small quantities of light. The peripheral field illumination causes higher exposure of the retina, but usually not directly of the macula, depending on the position of the eye. For cataract procedures, we recommend 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 phototoxic risk are:

Maximum radiation exposure times

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Always use the lowest possible brightness setting.

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Use the retina protection 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 40).

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Turn off the microscope's illumination system during pauses in surgery. Either move the surgical microscope to the standby position for this purpose, or cover the patient's eyes.

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

direct illumination,

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uninterrupted 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 recommended occupational health daily exposure limits as defined in 6). 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.

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Maximum radiation exposure times with red reflex illumination Scale display Illumination in %

Max. exposure time in minutes

25

50

50

21

75

13

100

9

Maximum radiation exposure times with surrounding field illumination

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Scale display Illumination in %

Max. exposure time in minutes

25

8.7

50

3.7

75

2.2

100

1.6

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List of references

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1)

H. Stiller, and B. Rassow, "Light hazards to the patient's retina from ophthalmic instruments," Applied Optics-OT 30, 2187-2196 (1991). 2)

American Conference of Governmental Industrial Hygienists, "Documentation of the Threshold Limit Values for physical agents. 7th Edition," (American Conference of Governmental Industrial Hygienists, Cincinnati, 2001). 3)

S. G. Khwarg, F. A. Linstone, S. A. Daniels, S. J. Isenberg, T. A. Hanscom, M. Geoghegan, and B. R. Straatsma, "Incidence, risk factors, and morphology in operating microscope light retinopathy," Am. J. Ophthalmol. 103, 255-263 (1987). 4) G. Kleinmann, P. Hoffman, E. Schechtman, and A. Pollack, "Microscope-in-

duced retinal phototoxicity in cataract surgery of short duration," Ophthalmology 109, 334-338 (2002). 5)

DIN EN ISO 15004-2:2007 Optical instruments -- Fundamental requirements and test methods -- Part 2: Light hazard protection 6)

David Sliney, Danielle Aron-Rosa, Francois DeLori, Franz Fankhauser, Robert Landry, Martin Mainster, John Marshall, Bernard Rassow, Bruce Stuck, Stephen Trokel, Teresa Motz West, and Michael Wolffe, Adjustment of guidelines for exposure of the eye to optical radiation from ocular instruments: statement from a task group of the International Commission on Non-Ionizing Radiation Protection (ICNIRP) APPLIED OPTICS Vol. 44, No. 11, p 2162 (10 April 2005) 7) Byrnes, G.A., Antoszyk, A.N., Mazur, D.O., Kao, T.C., Miller, S.A., Photic

maculopathy after extracapsular cataract surgery. A prospective study, 1992/ 05/01 Ophthalmology, VL - 99, IS - 5, SP - 731, EP - 737, PB - Elsevier

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