OPMI PENTERO 800 Instructions for Use Sw Rel 1.3 Ver 4.0 July 2018

OPMI® PENTERO® 800

About this manual

Orientation aids

Scope of application

The Instructions for Use is part of the delivery package. •

Please read it carefully before using the device.

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Keep it at the place where the system is used.

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Keep it for the entire service life of the system.

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Pass it on to any 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 applies to the OPMI® PENTERO® 800 with the following identification: –

Reference number: 302582-9903-000

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Software Release 1.3

Note regarding software licenses:

For certain applications, OPMI PENTERO 800 uses the Apache Xerces-C XML SDK software, which is subject to the copyright of the Apache Software Foundation. Carl Zeiss Meditec AG is a licensee within the framework of the Apache License, Version 2.0. The complete license agreement can be viewed in: http://www.apache.org/licenses/LICENSE-2.0.html.

Trademark

OPMI, PENTERO, AutoDrape, SuperLux, FlexiTrak, MultiVision are trademarks or registered trademarks of Carl Zeiss Meditec AG or other companies of the ZEISS Group in Germany and/or other countries.

Manufacturer

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 and as a result of ongoing technical development. Printed in Germany. Copyright

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© Carl Zeiss Meditec AG 2018 All rights reserved. Reprints and reproductions - including excerpts - are not

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permitted. However, this user manual may be digitized and archived for internal use. Access to this data by third parties is not permitted and must be prevented.

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OPMI® PENTERO® 800

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Chapter Overview

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Chapter:

Safety measures

7

Chapter:

System Overview

43

Chapter:

Preparations for use

99

Chapter:

Operation

203

Chapter:

Procedure in case of trouble

245

Chapter:

Care and maintenance

259

Chapter:

System data

273

Chapter:

Annex (options)

317

Chapter:

Indexes

431

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OPMI® PENTERO® 800

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Safety measures

Safety measures

Key to symbols ... 8 Hazard symbols ...8 Information symbols...8 Target group ... 9 Field of use ... 10 Intended use ...10 Normal use...10 Essential performance...11 Notes for the operator... 12 Requirements for operation... 15 Prior to the very first use...15 Before every use ...15 During use...16 After every use ...17 Warranty and liability...17 Possible burn injuries caused by high illumination intensity ...18 Safety devices of the suspension system ...22 Symbols and labels on the device ... 26

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Safety measures

OPMI® PENTERO® 800

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

Indicates 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 tips

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Safety measures

Target group

CAUTION

Only to be operated by trained personnel! This user manual is intended for physicians, nurses and other medical staff who prepare, operate or maintain the system after appropriate training. It is the duty of the customer or institution operating the system to train and instruct all staff using the system. The first training after installation regarding preparation, operation, warning notices/risks, emergency operation and transport of the device is performed according to training protocol G-30-1714 in connection with the present user manual. Further trainings of the staff operating the system is performed by the operator according to this user manual.

Rx Only

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OPMI PENTERO 800 with INFRARED 800 may be used only by physicians or authorized medical specialists on their behalf.

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Safety measures

OPMI® PENTERO® 800

Field of use Intended use OPMI PENTERO 800 is a surgical microscope intended for the illumination and magnification of the surgical area and for the support of visualization in surgical procedures.

CAUTION

Injury to the patient's eye! The OPMI PENTERO 800 must not be used for ophthalmic procedures. •

Make sure that no xenon light and no laser radiation enters the patient's eyes.

Normal use The overall system comprises a surgical microscope and a floor stand containing the electronics and a graphic touchscreen with video display. The OPMI PENTERO 800 is suited for cranial and spinal applications in neurosurgery, for ENT applications in the area of the auditory nerves and the base of the skull. Further fields of application include R&P procedures in accident surgery, R&P surgery, and oral and maxillofacial surgery. The OPMI PENTERO 800 is also suited for multidisciplinary use in microsurgery. It has been designed for surgical procedures in which an endoscope and a surgical microscope are used simultaneously. The system is equipped for the connection of navigation systems and for data communication with external network systems. It is intended for use in hospitals, clinics or other human medicine institutions. The functions of the surgical microscope and of the suspension system are controlled by the central control unit in the console. An interactive graphic touchscreen permits you to configure all settings. You can trigger these functions using the buttons on the handgrips or on a foot control panel.

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Safety measures

The installation conditions and the use of the system must meet microsurgical requirements: –

low vibration

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dust-free environment

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level, horizontal positioning

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avoidance of extreme mechanical stress.

Essential performance Magnification The system displays at all times a magnified image of the surgical field. Light / illumination The system illuminates the surgical field. A short interruption or disruption of less than a minute is acceptable.

WARNING

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Function deterioration! •

Check the instrument for proper functionality or damage before each use.

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We recommend you take adequate precautions, depending on the application, to enable the surgical procedure or treatment to be finished without using this microscope (for example in case of a system error).

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Safety measures

OPMI® PENTERO® 800

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

NOTE

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

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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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Please observe all symbols and labels attached to the device (see page 26)!

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Use only original accessories approved by ZEISS.

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

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

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Modifications and repairs on these instruments or instruments used with them may only be performed by our service representative or by other authorized persons.

Secure network! The user (IT specialist) is responsible for suitable security measures (e.g. firewall) against unauthorized access from outside to the network the system is linked to.

NOTE

Virus free! The user is responsible for keeping the USB medium used for data exchange virus free.

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Ambient requirements

Electrical safety

Safety measures

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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 –

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.

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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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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 device until it has been repaired by ZEISS Service.

A potential equalization connection can be found on the connection panel (see IEC 60601-1:2005 + A1:2012). This connector can be used for placing other active devices at the same ground potential or for redundant grounding to protective earth.

Transport & Service

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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 294.

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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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Safety measures

OPMI® PENTERO® 800

Optics and light

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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 whilst the machine is being moved.

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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 a ZEISS 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 or other specialists authorized by Carl Zeiss.

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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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Safety measures

Requirements for operation Prior to the very first use Our service representative or an expert authorized by us 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 earthed.  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.

Before every use

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Check the system balance before every use. If the system has been correctly balanced, the surgical microscope can be moved in all positions within the working area almost effortlessly.

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

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Only use the device with suitable accessories.

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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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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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Safety measures

OPMI® PENTERO® 800

•

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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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.

The power supply of the device may not be interrupted during use! •

Connect the device to an appropriate power source (e.g. uninterruptible power supply (UPS), institutional stand-by generator.

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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 the chapter "Operation".

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Avoid direct eye contact with the source of the light, e.g. at the lens of the microscope in order to avoid phototoxic damage 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. Never connect defective or unidentifiable accessories. Never touch power outlets or video interfaces while contacting the patient.

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If the xenon lamp is used beyond its maximum service life of 500 hours, sudden failure may occur. Please replace the xenon lamp in due time. The display of the remaining service hours on the touchscreen will be reset automatically.

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Only change the lamp module after it has cooled down (this takes approx. 10 min)! In case of malfunction, the high pressure inside the hot lamp may cause the lamp to burst. The hot surface of the xenon lamp may also cause 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 inform ZEISS Service.

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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.

During use

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Safety measures

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Switch off the unit at the power switch if you notice any smoke, sparks or unusual noise. Start using the device again only after it has been repaired by the ZEISS service.

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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, faulty or wrong methods of cleaning or not disinfecting the device according to this instruction manual may severely increase the risk of infecting the patient and/or medical personnel.

After every use

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

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

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Possible burn injuries caused by high illumination intensity CAUTION

If the xenon light is not used as intended, excessive illumination intensity may result in injuries in the form of third-degree burns! General The OPMI PENTERO 800 is equipped with a powerful xenon lamp. •

A device with light source switched on must never be left unattended.

Various factors contribute to the risk of burn injuries: Device-related factors:

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The wavelength range is limited to the visible range between 400 nm and 700 nm by filters. These filters remain stable over a very long period of time and cannot be exchanged by the user.

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The illumination intensity decreases with increasing number of operating hours of the light source. Once the lamp operating time of 500h has elapsed, the user is prompted (by a message on the touchscreen) to replace the lamp. This note is displayed at start-up of the system and disappears only after the user confirms the message.

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Reduction in the light intensity If the magnification value selected is high, both the diameter of the field of view decreases and the light intensity at the surgeon's eye is reduced whereas the light intensity in the surgical field stays the same. This effect is increased by the use of certain accessories, e.g.: - eyepieces with higher magnification, - 3-step magnification changers or - the foldable tube f170/f260 with tube magnification (PROMAG function). When working at maximum magnification, you should therefore pay particular attention to the set light intensity to prevent burns, especially of the surrounding tissue.

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CAUTION

Safety measures

If the xenon light is not used as intended, excessive illumination intensity may result in injuries in the form of third-degree burns! Surgery-related factors:

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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 more focused. 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 moist, sterile gauze. The gauze must be moistened at regular intervals to avoid the area drying out or heating up. The risk is increased if dry drapes are used to cover such areas.

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It should also be remembered 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 (drapes may heat up to different extents, according to varying degrees depending on their color and moisture content).

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Safety measures

CAUTION

OPMI® PENTERO® 800

If the xenon light is not used as intended, excessive illumination intensity may result in injuries in the form of third-degree burns! 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.

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

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 OPMI PENTERO 800 has several features that can help the user to reduce the risk of burn injuries.

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The initial light intensity can be pre-set to a low value.

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If used, drapes should also be re-moistened at regular intervals in order to prevent heat from accumulating underneath the drape.

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The risk of burns can be reduced by constantly irrigating the illuminated surgical field and by keeping it moist.

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After start-up of the system, the focus-light control is activated, i.e. depending on the working distance that has been set (focus), only one specific maximum illumination intensity can be set, e.g. 25% illumination at 200 mm focus (see page 24).

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The spot function facilitates reducing the size of the illuminated area to the area of observation during surgery.

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Using the buttons on the handgrip 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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The system features "Automatic Light Field Limitation", the feature is activated by default and should not be turned off.

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