OPMI pico -S100 Suspension Arm Instructions for Use Ver 11.0 July 2021

S100 / OPMI pico

About This Manual

Help with orientation

Scope

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

Please read them carefully before using the device.

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Keep them at the site of use of the device.

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Store them for the entire service life of the device.

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Pass them on to any subsequent owner or user of the device.

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

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The contents of each chapter are specified in detail at the beginning of each chapter.

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A list of abbreviations, key words and technical terms in the annex facilitates the search for specific terms.

These Instructions for Use apply to the S100 / OPMI pico with the following identification label: Package

Reference number

S100 / OPMI pico (floor stand)

000000-1403-542

S100 / OPMI pico (wall mount)

000000-1403-544

S100 / OPMI pico (ceiling mount)

000000-1403-572

S100 / OPMI pico (Centro suspension system)

000000-1403-573

S100 / OPMI pico (support unit)

000000-1420-191

S100 / OPMI pico (support unit for secondary lighting) 000000-1095-094 Trademark

Manufacturer's details

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

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© Carl Zeiss Meditec AG 2021 All rights reserved. Reprints and reproductions, in whole or in part, are prohibited. However, these Instructions for Use may be digitized and archived for internal use. Access to this data by third parties is not permissible and must be prevented.

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Summary of the section

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Section:

Safety measures

5

Section:

Device overview

49

Section:

Preparations for use

89

Section:

Operation

129

Section:

What to do in the event of malfunctions

211

Section:

Care and Maintenance

225

Section:

Device data

237

Section:

Indexes

263

Section:

Keyword index

267

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S100 / OPMI pico

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Safety measures

Safety measures

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Safety measures

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Key to symbols Key to symbols ... 6 Hazard symbols ...7 Information symbols ...7 Target group ... 8 Field of use... 8 Intended use ...8 Indications ...8 Normal use ...9 Clinical benefits ...10 Notes for the operator ... 10 Duties of the operator ...11 Requirements for operation ... 13 Prior to the very first use ...13 Before every use ...14 During use ...15 After every use ...16 Risk of burn injuries caused by high illumination intensity... 17 Safety features ... 19 Symbols and labels on the device... 22 Symbols and labels on the microscope ...22 Symbols and labels on the S100 ...24 Symbols and labels on the light sources ...39 Symbols and video control units (optional) ...46 We would like to inform you of the safety aspects that must be observed

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Safety measures

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 may lead to fatal injuries or severe 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 hints

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Safety measures

S100 / OPMI pico

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

Field of use Intended use The S100 / OPMI pico is a surgical microscope designed to illuminate and magnify the surgical area and to support the visualization of surgical procedures.

Indications Information on the intended medical indications for use, contraindications and the target patient group has been set out in the following table. Intended medical indications for use

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Medical discipline:

Dentistry, ENT, gynecology, general surgery

Indication:

The S100 / OPMI pico is suitable for cranial and spinal surgical procedures as well as ENT applications. Additional areas of application include reconstructive, plastic, dentistry, oral and maxillofacial surgical procedures, as well as other multi-disciplinary procedures.

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Intended medical indications for use Contraindications:

When using the S100 / OPMI pico in accordance with its indications for use, there are no known contraindications.

Patient target group: Age:

No constraints

Gender:

All

Normal use The S100 / OPMI pico is a microscope that is operated manually on a sitting or lying patient. Provision:

The S100 /OPMI pico offers in conjunction with different suspension systems (e.g. floor stand, wall mount, ceiling mount) and flexible carrier arms, an ergonomic working position for the treatment environment or surgery. The system can be securely moved into the working position with the hand grips without any problems.

Treatment / surgery:

The microscope is positioned and roughly focused by the physician or the surgeon. The most frequently used functions as the setting of focus, magnification and light intensity are manually controlled by the physician or the surgeon during treatment or surgery. A video player is connected to the system for educational purposes or to visualize the progress of the treatment / surgery.

After the procedure / operation

Disposal:

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The physician or the surgeon swings the surgical microscope from the treatment or surgical area into its standby position. The S100 / OPMI pico can be cleaned and disinfected. For the disposal of electrical and electronic devices, please observe the relevant national legislation and other regulations applicable in your country.

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Safety measures

CAUTION

CAUTION

S100 / OPMI pico

Injury to the patient's eye! •

The S100 / OPMI pico must not be used for ophthalmological procedures!

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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.

Clinical benefits Device / Option

Clinical benefits

S100 OPMI pico

Illuminates and magnifies the surgical field and supports the observation of surgical procedures. Improves the view of the surgical field. Enables binocular vision and surgical procedures with both hands. Enables microsurgical procedures that would not be possible without the surgical microscope.

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

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•

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

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

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Safety measures

Duties of the operator •

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

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The device may be operated only by properly instructed and trained persons. 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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For planning the S100 ceiling support or S100 wall support, follow the Planning Manual (publication M-30-1385).

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Note the symbols and labels attached to the device (see Page 22)!

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Only use original components, options and accessories approved by ZEISS.

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

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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 damage caused by unauthorized use of the device. Furthermore, such unauthorized modifications will render the warranty and any claims under warranty invalid.

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

Reporting to manufacturer and authorities

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

Ambient conditions

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

Legal regulations

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in areas where there is a risk of explosion,

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

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

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Safety measures

S100 / OPMI pico

Electrical safety

Transport & Service

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Ensure that fluids cannot enter the device.

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Make sure that the installation conditions and the use of the device meet surgical requirements: See "Ambient conditions" on Page 261.

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

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

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Do not use multiplug strips or extension cords!

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Position the device so that you can disconnect it from the power supply at any time.

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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 pull on the light guide, power cord or any other connecting cables.

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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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A potential equalization connector is provided on the instrument's connection panel (see IEC60601-1). This connector is optional for halogen and xenon lighting. This connector can be used to connect other active devices to the same ground potential or for redundant connection to the protective ground.

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Please note the information on EMC (electromagnetic compatibility) in the chapter "System data" on Page 250.

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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-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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S100 / OPMI pico

Components, options, accessories and additional equipment

Optics and light

Safety measures

Any additional equipment you connect to medical electrical devices must demonstrably comply with the applicable standards and directives (e.g. IEC 60950 for data processing equipment). In addition, all configurations must comply with the standards for medical systems (see IEC 60601-1). 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 requirements of the above-mentioned standards. If you have any questions, contact your local dealer or ZEISS Service. •

Never look into a light source or the sun with the binocular tube, the objective lens or an eyepiece.

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

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Adjust the brightness on the suspension system. Start with the lowest brightness and then slowly increase the brightness until the necessary level is reached but do not exceed the permissible level.

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With increasing age of the light source, the actual illumination intensity delivered at the setting in question decreases (this is a normal property of the system).

Requirements for operation 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:

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Safety measures

WARNING

S100 / OPMI pico

The device must not be modified without any 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 damages caused by an unauthorized use of 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 electrical shock, this device may only be connected to a power supply network which is provided with a protective ground conductor.

 The connecting components have been properly connected. The screw connections have been firmly tightened.  All cables and plugs are in perfect condition, i.e. without signs of wear, kinks or other damage.  Determine the supply voltage at the place of installation and set the voltage of the device accordingly.  The device is connected with the power cord supplied.  Check whether the device fuse used is the correct one as specified on the fuse label.

Before every use

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•

When installing accessories, components, and options please ensure that the total admissible weight of the surgical microscope is not exceeded. (see “Maximum load” label or the section entitled “Technical Data”).

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When connecting components, options, and accessories, make sure that sufficient clearance is provided and that the surgical microscope does not touch the patient at any point.

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Before every use, perform the balancing procedure to enable the surgical microscope to maintain its balance in all positions of the working range.

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Check the surgical microscope for sufficient freedom of movement. The device, installed accessories, components and options may be damaged in the event of a collision.

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To prevent components, options, or accessories from falling off, check that these parts and the locking screws have been secured prior to every use.

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

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If you operate the device in a sterile area, make sure that you use the corresponding sterile components, options and accessories for this specific device.

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Make sure that the operating staff is briefed about the sterile operation of the system.

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Never cover any ventilation openings, as the light source of the system switches off in the event of overheating.

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Never use force when trying to connect any electrical connectors (plugs, sockets). If the connection cannot be made easily, 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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Please refer to the functional test in chapter "Operation" (Page 132).

More specific information about the floor stand: •

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

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Reduce the brightness and duration of light exposure of the surgical area to the absolute minimum level required to avoid burn injuries.

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

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

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Any unapproved or faulty components, options, or accessories may cause increased leakage currents in the device. Do not connect the device to unapproved or faulty components, options, or accessories.

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Never touch the video interfaces or other signal interfaces while you are in contact with the patient.

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If you replace 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.

During use

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Safety measures

S100 / OPMI pico

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If the xenon lamp is used beyond its maximum service life of 500 hours (see chapter "Maintenance intervals" on Page 226), sudden failure may occur and interrupt operation. Change to the backup lamp or replace the lamp module in a timely manner.

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If the halogen lamp is used beyond its maximum service life of 50 hours, sudden failure may occur and interrupt operation. Replace the halogen lamp in a timely manner (see chapter "Service and maintenance" on Page 228).

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Do not pull on the power cord or any other connecting cables.

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If there is a failure and you cannot get any help from the chapter "What to do in the event of malfunctions", attach a sign "Out of order" to the system and contact ZEISS Service representative.

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Constantly monitor the system during use.

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Always switch off the system every time before: - connecting it to / disconnecting it from line power - if it will not be used for a prolonged period of time - or if you want to clean its surface.

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If the light guide is not connected at both ends, there may be a risk of fire or burning when the light source is activated.

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Risk of crushing - mind your fingers! Fingers may be crushed in the areas marked with the "Risk of crushing" sign. Do not touch these areas while the device 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 contrary to the instructions of the Instructions for Use may expose the patient or medical staff to a considerable risk of infection. For more information, please see "Maintenance of the device" in the chapter "Care and maintenance".

After every use

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Safety measures

Risk of burn injuries caused by high illumination intensity

CAUTION

Risk of burns caused by high light intensity! In case of a misuse of the light source, a too high illumination intensity may cause tertiary burns. •

All users must have been instructed on how to use the device.

•

Please read and note the following points.

General This device is optionally equipped with a powerful xenon light source. Various factors can contribute to the risk of burn injuries: Device-related factors: –

With increasing service life of the lamp, the actual light intensity delivered at the respective setting decreases. In case of a lamp exchange, illumination increases to the originally 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 for the surgical procedure to be performed.

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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 gauze must be moistened at regular intervals to prevent the area from drying out or heating up.

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Certain preparations of the surgical field, the administration of vasoconstrictive medications and surgical incision drapes may also result in a higher risk of injury (surgical drapes may heat up to varying degrees depending on their color and moisture content).

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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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Safety measures

S100 / OPMI pico

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, this system has several features that can help the user to reduce the risk of burns. –

The start value of the illumination intensity can be set to a low value.

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

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

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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 in most published cases of burns the skin around the incision was affected. The most important measure for avoiding burns is to cover the peripheral area with wet, sterile 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 image. Please refer to the relevant warnings and precautions.

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Safety features Halogen light source 1 Flap The flap is used as mechanic indicator of the operating status of the halogen light source. –

When the flap is closed, the main lamp is operative.

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When the flap is open, the main lamp has failed. The backup lamp is on.

2 Switching to the backup lamp The lamp housing contains a backup lamp. If the first lamp fails, you can switch on the backup lamp by pressing this button. •

Replace the defective lamp at the first opportunity (see Page 228).

Fig. 1: Safety device for the halogen light source

1

2

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Safety measures

S100 / OPMI pico

Xenon light source CAUTION

Limited service life of the xenon lamp! If used for longer than the indicated service life of 500 hours, the xenon short-arc lamp may fail or burst. Falling splinters or fragments may contaminate the sterile area. There is a risk of infection and injury. •

Change the lamp module on time.

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UV / IR heat protection filter The filter protects against UV and IR radiation.

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Temperature monitoring A sensor constantly monitors the lamp temperature.

1 Switching to the backup lamp The xenon light source has a lamp module containing two xenon lamps. The second lamp is used as backup lamp. Manually swivel in the backup lamp into position (Page 221), if the maximum service ;life of 500hours is reached (see chapter "Maintenance intervals" on Page 226). When the red segment (2) in the knob (1) lights up, the backup lamp is in use. Keep the lamp module ready if you work with the backup lamp. If the backup lamp is operated, replace the lamp module in a timely manner (see Page 228) before it is used beyond its maximum service life of 500 hours (see chapter "Maintenance intervals on Page 226). Fig. 2: Safety system xenon light source

1 2 3

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