OPMI Sensera on a S7 Suspension Instructions for Use Ver 11.2 Dec 2013

S7 / OPMI Sensera

About this manual

Orientation guides

Scope

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 section summary at the beginning of these Instructions for Use provides an overview of the topics.

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You will also find a detailed table of contents at the beginning of each chapter.

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The index facilitates searching via keywords.

The following Instructions for Use apply to the OPMI® Sensera® with the following suspension systems and identifications: –

S7 floor stand, reference number: 000000-1087-851

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S7 ceiling mount - rigid, reference number: 000000-1103-022

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S7 ceiling mount with lifting column, reference number: 000000-1226405

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OPMI® and Sensera® are registered 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 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

49

Chapter:

Preparations for use

129

Chapter:

Operation

169

Chapter:

What to do in the event of malfunctions

185

Chapter:

Care and Maintenance

201

Chapter:

System Data

215

Chapter:

Index

241

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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 Reasonably foreseeable misuse...9 Liability and warranty...9 Notes for the operator... 10 Requirements for operation... 13 Prior to the very first use...13 Before every use ...14 After every use ...16 Risk of burn injuries caused by high illumination intensity ...16 Safety devices of the suspension systems...21 Symbols and labels on the device ...26 Labels on the microscope ...26 Labels on the connection panel ...29 Labels on S7 floor stand ...30 Additional labels on S7 floor stand (instrument tray option)...36 Labels on S7 ceiling mount ...38 Additional label on S7 ceiling mount with lifting column ...42 Labels on the light sources of the suspension systems ...44

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Labels on the wall power outlet (optional) ... 47

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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, nurses and other medical and technical staff who prepare, operate or maintain the device after appropriate training. 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 Sensera is a surgical microscope intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures.

Normal use OPMI Sensera is a surgical microscope designed to provide the user with optical magnification and illumination of the surgical area during surgical procedures in ENT surgery. The system is intended for use in clinics and other human medical institutions.

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Reasonably foreseeable misuse CAUTION

CAUTION

Injury to the patient's eye! •

The S7 / OPMI Sensera must not be used for ophthalmic procedures!

•

Make sure that no light enters the patient's eyes.

Live video images and recorded video sequences, video clips (cut sequences) and single images must not be used for diagnosis purposes. Visualized images may contain variations in shape, contrast and color.

Liability and warranty Warranty and liability depend on the applicable contractual stipulations. Loss of warranty! The manufacturer is not liable for damages caused by an unauthorized use of the device. Furthermore, this will this will invalidate any rights to make a claim under the warranty.

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Notes for the operator The correct use of the device is absolutely vital for safe operation. Therefore, please thoroughly familiarize yourself with the content of these Instructions for Use before starting up the system. Please also observe the Instructions for Use of any additional equipment. You can obtain additional information from ZEISS Service.

Legal regulations

Ambient requirements

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

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This device must be used by properly trained personnel only. It is the duty 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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Please observe all symbols and labels attached to the device (see Page 26)!

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Only use original accessories or consumables approved by ZEISS. If you wish to use other accessories ensure that ZEISS or the manufacturer of the accessories has verified and confirmed that these accessories meet the respective safety standards and can be used without risk.

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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 equipment must not be modified without the manufacturer's approval. If the equipment is modified after consulting the manufacturer, appropriate examinations and tests must be performed to guarantee the further secure use of the device. The manufacturer is not liable for any damage caused by unauthorized use of the equipment.

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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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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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Electrical safety

Transport & Service

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Safety Measures

•

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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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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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 system until it has been repaired by our service team.

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A potential equalization connection can be found on the connection panel (see IEC 60601-1:2005). This makes it possible to connect other active devices to the same earth potential or it can be used for the redundant connection with the grounding conductor.

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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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Please note the information on EMC (electromagnetic compatibility) in the chapter "System Data" on Page 232.

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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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This system is a high-grade technological product. To ensure optimum performance and safe working order, we recommend having it checked by our service representative as part of regular scheduled maintenance.

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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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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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Optics and light

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Never directly look into the sun with binocular tube, object lens or an eyepiece.

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Avoid looking directly into the light source, e.g. into the microscope objective lens or into the light guide, in order to prevent damage to the eye!

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Start with the lowest brightness setting and gradually increase brightness up to the necessary and still admissible level.

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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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Requirements for operation

WARNING

The device must not be modified without any approval! This device must not be modified without the manufacturer's approval. If the device is modified, appropriate examinations and tests must be performed to guarantee the further secure use of the device. The manufacturer is not liable for damages caused by an unauthorized use of the device. Furthermore, this will invalidate any rights to make a claim under the warranty.

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 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 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:  The main plug must only be connected to a socket with a faultless protective ground conductor. More specific information about the ceiling mount:  The ceiling anchor has been correctly installed by the competent construction personnel.  This ceiling anchor complies with the specifications contained in our printed "Planning Manual".  The device may only be connected to a power supply network which has a faultless protective ground conductor.

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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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To prevent accessories from falling down, check before every use that accessories are securely locked in position and securing screws are firmly tightened.

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When connecting accessories make sure that sufficient free space is provided and that the surgical microscope does not touch the patient.

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

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Never connect any unknown or defective devices to the electrical interfaces such as video output ports or the foot control panel connector.

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Only connect the components to wall outlets which are provided with a properly connected protective ground conductor.

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When combining your system, please make sure to comply with the requirements of IEC 60601-1:2005.

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Re-attach or close any covers, panels or caps which have been removed or opened.

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If the xenon lamp is used beyond its maximum service life of 500†hours, a sudden failure may occur. Change to the backup lamp (see Page 192) or replace the lamp module in a timely manner (see Page 210). Reset the service hour counter of the xenon illumination.

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Keep a replacement lamp (only for halogen light source) at hand.

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Never cover any ventilation openings. This may cause the light source of the device 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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Position the suspension system in such a way that you can slide or swing it away from the patient at any time.

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Go through the checklist in the chapter "Operation".

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Depending on the type of application, take appropriate precautions to ensure that the surgical procedure or treatment can still be completed even if the full functionality of this microscope (e.g. illumination) is not available.

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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.

The single-use sterile drapes can be used to cover the device. • When fitting the sterile drape, ensure there is sufficient room for movement of the microscope carrier and surgical microscope. •

Refer to the Instructions for Use for the sterile drape, and attach the drape to the device in such a fashion that your field of view is not compromised.

More specific information about the ceiling mount: •

Move the lift arm or the lifting column down to its lower end position.

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Do not activate the lifting column or the lift arm during surgery. Do not use the lifting column or the lift arm for focusing.

More specific information about the floor stand:

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Use the grab handle on the floor stand for moving.

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Pay attention to the height of doorways when passing through.

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Avoid collisions of any kind.

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To cross over steps and edges, two persons are needed to jointly hold and lift the device: Risk of tipping!

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Be extremely careful when moving over sloped surfaces.

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Do not park the stand on a sloped surface.

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Secure the system in position by pressing at least three of the locking tabs on the stand base to prevent the stand from rolling away inadvertently.

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Do not exceed the instrument tray's load capacity of 13 kg.

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Never look directly into the light source, e.g. a microscope objective lens or a light guide, as this might cause phototoxic injury to the eye.

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Never leave a device unattended with the light source still switched on.

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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 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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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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Never operate the system unattended.

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Risk of crushing fingers! Fingers may be crushed in the areas marked with the "Risk of crushing fingers" label. Do not touch these areas while the machine is being moved.

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

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Step on at least three pedals to secure the floor stand in position. Make sure that the floor stand is stable and cannot roll away.

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Move ceiling mount to its standby position.

After every use

Risk of burn injuries caused by high illumination intensity General The xenon illumination is a light source with high intensity. If used improperly, excessive illumination intensities may lead to third-degree burns. Keep the illuminated tissue moist and make sure it is sufficiently rinsed. Carefully monitor

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the effect of the illumination on the tissue, particularly under the following circumstances: –

During longer interventions on skin and tissue using objective lenses with short focal depth (short working distance),

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During interventions on poorly perfused tissue,

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When the brightness control for the xenon lamp is set to a high illumination intensity. Please bear in mind that the values displayed for the light intensity may not be used as a measuring function. They are intended only as an aid to orientation.

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Only change the xenon lamp module after switching off the system. The igniter generates a high voltage when the lamp is on.

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Any type of radiation has a damaging effect on biological tissue. This is also true for the light illumination of the surgical field. You should therefore reduce brightness, the illuminated field size and the light exposure time to the absolute minimum required. If the brightness can no longer be reduced in the case of malfunctions, you must take this into account in the light exposure time.

Various factors influence the risk of burn injuries: System-related factors –

The wavelength range is limited by filters to the visible range between 400 nm and 700 nm in order to reduce the risk of burn injuries.

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The illumination intensity decreases with increasing number of operating hours of the light source. In case of a lamp exchange, illumination increases to the originally high value.

Surgery-related factors –

The selected intensity of the light source is a major factor for the risk of injury. It should always be set to the minimum required for the surgical procedure to be performed.

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The size of the illuminated field influences the injury risk in two respects: –

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With a large illuminated-field diameter, areas of the skin are illuminated which are not monitored as strictly by the surgeon and which are not moistened sufficiently. These areas represent a particular injury risk. These injuries can be prevented by adjusting the illuminated-field diameter to the smallest size required for that particular operation.

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If the illuminated field is reduced in size, the intensity increases because the light is focused more. So, if possible, the intensity should be lowered as soon as the size of the illuminated field is reduced.

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A long surgical procedure increases the risk of injury, in particular if a standard procedure takes considerably longer than usual.

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Injuries in the peripheral area can be prevented by covering this area with wet, sterile gauze. The risk is increased if dry drapes are used to cover such areas.

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The interaction of heat and antimicrobial substances in incision foils may lead to an increase in the patient's reaction to these substances.

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It should also be taken into account that some areas of the body may be more sensitive than others.

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Certain preparations of the surgical field, local vasoconstrictive medications and incision drapes may also result in a higher risk of injury.

Patient-related factors –

The general condition of a patient's health may contribute to the risk of injury.

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The skin type may also play a major role for the risk of injury.

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Certain medications also affect the sensitivity to light.

Recommendations Due to the large number of different factors involved and the lack of scientific publications on this topic, ZEISS cannot provide guidance on acceptable illumination intensities and exposure durations. However, the surgical microscope has several features that can help the user to reduce the risk of burn injuries: –

Using the buttons on the hand grip or foot control panel, the surgeon can then set the illumination intensity to the value required for the procedure. Please note that the intensity increases with decreasing illuminated-field size if the Spot function is used. For this reason, the intensity should only be set after the size of the illuminated field has been changed.

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Never leave a device unattended when its light source is switched on.

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Switch off the light when the microscope is not used and make sure that it is not aimed at unprotected bare skin.

Please note that most burns affect the skin around the incision. The most important measure for prevention of burn injuries are reduction of the size of the illuminated field by the spot function and the coverage of peripheral areas by sterile, wet gauze. The area of the incision should be constantly moistened.

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Final remark ZEISS recommends that the lighting of the surgical field be reduced as far as is possible for the safety of the patient and for a good microscopic image. Please refer to the warnings and precautions in this case.

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