OPMI VARIO on a S88 Stand Instructions for Use Ver 9.0 Nov 2018

S88 / OPMI Vario

About This Manual

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Manufacturer's details

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

Please read them carefully before using the device.

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Keep them at the location where the device is used.

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Keep 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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At the start of each section there is a detailed outline of its contents.

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An index of abbreviations, key words and technical terms at the back of the manual helps you to search for specific terms.

The following Instructions for Use apply to the OPMI® Vario with the following stands/mounts and reference numbers: –

S88 floor stand, reference number: 000000-1154-525

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S88 floor stand with lifting column, reference number: 000000-1169-820

For the purpose of improved readability, the product name "S88 / OPMI Vario" is also referred to as "OPMI Vario" in these Instructions for Use. OPMI is a trademark or registered trademark of Carl Zeiss Meditec AG or other companies 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 Email: [email protected] Internet: www.zeiss.com/med

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

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© Carl Zeiss Meditec AG 2018 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 permitted and must be prevented.

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Section overview

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Section:

Safety measures

5

Section:

Device overview

45

Section:

Preparations for use

105

Section:

Operation

139

Section:

What to do in the event of malfunctions

169

Section:

Care and Maintenance

183

Section:

Device data

197

Section:

Keyword index

221

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Safety measures

Key to symbols ... 6 Hazard symbols ...6 Information symbols ...6 Target audience ...7 Field of use ... 7 Intended use ...7 Normal use ...7 Liability and warranty ... 8 Notes for the operator ... 9 Requirements for operation ...12 Prior to the very first use ...12 Before every use ...13 During operation ...14 After every use ...15 Connecting a laser micromanipulator ...15 Risk of burn injuries caused by high illumination intensity ...15 Safety features on the stand ...18 Symbols and labels on the device ... 26 Labels on the S88 floor stand ...32 Labels on the stand's connection panel ...38 Additional label on the S88 floor stand (instrument tray option) ...40 Labels on the light sources in the stands ...42

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Key to symbols We would like to inform you of the safety aspects that must be observed when handling this device. This section contains a summary of the most important information concerning matters relevant to instrument safety.

Hazard symbols The following safety information is incorporated into the Instructions for Use. Please take note of this information and be particularly careful in these cases. WARNING

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

CAUTION

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

NOTE

Indicates a hazard which may lead to minor injuries or property damage if precautions are not followed.

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

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Target audience 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 device owner/operator to train and brief all operating personnel. Additional service activities are not part of these Instructions for Use. These will be performed by staff especially trained for this purpose by ZEISS.

Field of use Intended use The OPMI Vario is a surgical microscope intended to provide illumination and magnification of the surgical area and to support visualization in surgical procedures.

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

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CAUTION

S88 / OPMI Vario

Injury to the patient's eye! Never use xenon illumination for ophthalmic procedures! •

CAUTION

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

Not for diagnostic purposes! Do not use the recorded video sequences, video clips (cut sequences) and single images for diagnostic purposes. Visualized images may contain variations in shape, contrast and color.

Liability and warranty The warranty and liability depend on the conditions specified in the contract. NOTE

Loss of warranty Modifications to this device are not permitted. The manufacturer is not liable for damage caused by unauthorized modifications to the device. Furthermore, such unauthorized modifications will render the warranty and any claims under warranty invalid.

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Notes for the operator To ensure safe operation, it is absolutely vital that the device is used correctly. Therefore, please familiarize yourself thoroughly with the content of these Instructions for Use before starting up the device. Please also comply with the Instructions for Use of the other system components. You can obtain additional information from ZEISS Service.

Legal regulations

Ambient conditions

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

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The device may be operated only by personnel who are properly instructed and trained. 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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Keep the Instructions for Use accessible to the operating personnel at all times.

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Note the symbols and labels attached to the device! (See Page 26.)

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Only use original accessories or consumables approved by ZEISS.

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Observe the applicable legal accident prevention and occupational safety provisions for your country.

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This device must not be modified without the manufacturer’s approval. If the system is modified after consultation with the manufacturer, suitable inspections and testing must be performed to ensure subsequent safe use. The manufacturer is not liable for damage caused by unauthorized modifications to the device. Furthermore, such unauthorized modifications will render the warranty and any claims under warranty invalid.

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

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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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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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Safety measures

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Electrical safety

Transport & Service

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Do not use or store the device in a damp environment. 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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Ensure that the installation conditions and the use of the device meet surgical requirements: –

Low vibration

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Clean environment

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Avoidance of extreme mechanical stress

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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 device at the power switch if you notice any smoke, sparks or unusual noise. In this case, do not use the device again until it has been repaired by our service department.

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A potential equalization connector is provided on the instrument's connection panel. This connector can be used to connect other active devices to the same ground potential in accordance with the requirements of IEC 60601-1, or for redundant connection to the protective ground.

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Do not use multiplug strips or extension cords!

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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 device if your body is electrostatically charged and the device is not grounded.

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Please note the information on EMC (electromagnetic compatibility) in the section "System data" on Page 216.

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

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This instrument is a high quality technological product. To ensure optimum performance and safe functioning, we recommend having it checked by our service representative as part of a regular scheduled maintenance program.

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

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Optics and light

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Safety measures

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Modifications and repairs to this device or any equipment operated together with it may only be performed by ZEISS Service or other specialists authorized by Carl Zeiss.

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

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To prevent damage to your eyes, avoid looking directly into the light source, e.g. the light guide or at the microscope objective lens!

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Start with the lowest brightness setting and gradually increase the brightness to the required level, which must still be within the admissible range.

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As the light source advances in its service life, the actual illumination intensity delivered at a particular setting decreases (this is a normal property of the device).

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Requirements for operation Prior to the very first use The system will be installed by ZEISS Service or an expert authorized by ZEISS. Please make sure that the following requirements continue to be met for subsequent operation: WARNING

The device must not be modified without approval! Do not modify the device without approval from the manufacturer. If the device is modified, suitable inspections and testing must be carried out to ensure that it can still be used safely. The manufacturer is not liable for damage caused by unauthorized modifications to the device. Furthermore, such unauthorized modifications will render the warranty and any claims under warranty invalid.

WARNING

Danger! Electrical voltage! •

To avoid the risk of electric shock, this device may only be connected to a power supply network which is equipped with a protective ground conductor.

 Check that the connecting components have been properly connected and the screw connections have been firmly tightened.  Check that all cables and plugs are in perfect condition, i.e. without signs of wear, kinks or other damage.  Check that the voltage setting on the system corresponds to the rated line voltage at the site of installation.  Check that the device is connected using the power cord supplied.  When connecting the device to a network, make sure that the network does not carry a hazardous voltage.

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Never place multiplug strips on the floor.

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Do not connect any additional multiplug strips.

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Only connect compatible components to the system.

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Do not exceed the maximum permissible electrical load for multiplug strips.

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Only use multiplug strips for components of the system.

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Before every use •

When mounting accessory equipment, make sure that the admissible total weight of the surgical microscope is not exceeded (see "maximum load" label or the section "Technical data").

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Before every use, make sure to compensate for any added weight; this will enable the surgical microscope to maintain its balance in all positions within the working range.

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Before every use, limit the downward travel of the suspension arm to prevent any contact with the patient if the surgical microscope is lowered accidentally.

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Check that the surgical microscope can move sufficiently without obstructions. Collisions may cause damage to the device or any accessories mounted to it.

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To make sure that accessories do not fall down, check before each use that they are firmly seated and the securing screws are firmly tightened.

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When connecting accessories, make sure that there is sufficient clearance so that the surgical microscope cannot come into contact with the patient.

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Before every use, check the user settings in the software to avoid unexpected behavior from the system.

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Always route cables so that they do not hinder the user.

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If you are operating the device in a sterile area, make sure that you use the appropriate sterile accessories.

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Never cover any ventilation openings. This may cause the light source in the device to overheat and fail.

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Never use force when trying to connect electrical connectors (plugs, sockets). If the connection cannot be made easily, check whether the plug fits the socket. If any of the connectors are damaged, arrange to have them repaired by ZEISS Service.

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Before using the FCP WL wireless foot control panel, make sure that its batteries are fully charged. Inadequate power supply to the wireless foot control panel may cause the device to malfunction.

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Go through the checklist in the section "Operation".

Sterile single-use drapes can be used to cover the device.

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When draping the device, make sure there is enough slack in the drapes to allow for the movement of the surgical microscope and its suspension system.

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Secure the device in position by pressing down at least three of the immobilizers on the stand base to prevent the stand from rolling away by itself.

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Never look directly into the light source, e.g. at the microscope objective lens or light guide, as this may cause phototoxic injury to the eyes.

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Never leave the device unattended while its light source is switched on.

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Faulty or unidentified accessories may lead to increased leakage current on the device, which may injure the patient. Never connect any faulty or unidentified accessories, and never touch the power outlet or video interfaces while in contact with the patient.

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If the xenon lamp is used beyond its maximum service life of 500 hours, a sudden failure may occur. Replace the xenon lamp in good time and reset the service hour counter to "0".

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If you replace the lamp shortly after it has failed, it will still be very hot. To prevent burns, use heat-resistant protective gloves when replacing the lamp.

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Malfunctions in the motor's electronic system may cause failure of the main functions (focus, zoom, light control) and impair other functions. In this case, switch to manual mode.

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If a failure occurs which cannot be remedied with reference to the section "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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Do not pull at the light guide, power cord or any other connecting cables.

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Monitor the system constantly during use.

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

During operation

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After every use •

Always turn the device off at the power switch when it is not in use.

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Inadequate, flawed or incorrect cleaning or disinfection that does not comply with these Instructions for Use can expose the patient or medical staff to a considerable risk of infection.

Connecting a laser micromanipulator Connecting a laser micromanipulator to a surgical microscope results in a medical system for which the system manufacturer must meet the necessary requirements (approval, qualification, laser protection, etc.). Please note the instructions for use provided by the manufacturers of the laser micromanipulator and the laser. Supplementary information is available from our service department or from authorized distributors.

Risk of burn injuries caused by high illumination intensity General The xenon illumination is a high-intensity light source. 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 the effect of the illumination on the tissue, particularly under the following circumstances:

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During longer interventions on skin and tissue using objective lenses with a short focal length (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 do not reflect actual measured values. They are intended to serve only as a guide.

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Always switch the device off before changing the xenon lamp. 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 illuminating the surgical field. You should therefore reduce the brightness, the illuminated field size and the light exposure time to the absolute minimum required. If the brightness can no longer be reduced due to a malfunction, you must take this into account when considering the length of time tissue is exposed to the light.

The risk of burn injuries is influenced by a number of factors: Device-related factors –

In order to reduce the risk of burn injuries, the wavelength range is limited by filters to the visible range from 400–700 nm.

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As the light source advances in its service life, the intensity of the illumination decreases. When the lamp is replaced, the illumination is restored to its original high value.

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 in order for the surgical procedure to be performed.

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

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 are particularly exposed to the risk of injury. Such injuries can be prevented by adjusting the luminous field size to the smallest size required for that particular operation.

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

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A prolonged surgical procedure increases the risk of injury, especially when 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 considered that some areas of the body may be more sensitive than others.

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Certain preparations of the surgical field, administration of 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 patient's 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 times. However, the surgical microscope has several features that can help the user to reduce the risk of burn injuries: –

The surgeon can use the buttons on the handle or foot control panel to set the illumination intensity to the value required for the procedure. Please note that the intensity increases with decreasing luminous field size if the Spot function is used. For this reason, the intensity should be adjusted after the size of the illuminated field has been changed.

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Never leave the device unattended while its light source is switched on.

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Switch off the light when the microscope is not in use, 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 measures to prevent burns are reducing the size of the illuminated field using the spot function, and the covering the peripheral areas with sterile, moist gauze. The area of the incision should be constantly moistened. Concluding remarks ZEISS recommends that the illumination of the surgical field be kept to the necessary minimum, for the patient's safety and for a good microscopic

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image. Please refer to the relevant warnings and precautions.

Safety features on the stand 1 Release bar Allows non-sterile persons to unlock the stand's magnetic brakes. 2 Adjustment screw for limiting downward travel Serves to set the minimum working distance from the surgical field in the vertical direction. Check this setting before each surgical procedure. 3 Locking knob Locks the suspension arm in the horizontal position. Before removing or attaching a module (microscope, tube, etc.), move the suspension arm into its horizontal position. Pull out the locking knob and turn it clockwise or counterclockwise 180°. At the same time, move the suspension arm up and down slightly until the lock snaps in. Now the suspension arm cannot swing upwards when weight is removed. After mounting the module, unlock the suspension arm and perform the balancing procedure.

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Safety measures

1

2

3

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1

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Stand lifting column 1 Button For setting the optimum viewing height of the surgical microscope or to move it downwards into the working position. As long as you hold the switch (1) pressed down, the lifting column (2) in the stand base moves upwards or downwards, depending on the position of the switch. When you release the switch, the lifting column stops immediately. –

NOTE

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Before raising or lowering the stand, make sure that there is sufficient clearance to avoid collision with other objects.

Risk of injury to the patient! •

Do not operate the lifting column during the operation!

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Do not use the lifting column for focusing.

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