Instructions for Use
268 Pages
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ZEISS
S7 / OPMI® PROergo®
Instructions for Use G-30-1435-en Version 11.0 2018-11-30
S7 / OPMI PROergo
About This Manual
Help with orientation
Scope
Trademarks
Manufacturer's details
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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The index facilitates searching via keywords.
The following Instructions for Use apply to OPMI PROergo 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: 000000-1226-405
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S7 wall mount with short arm, reference number: 000000-1193-109
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S7 wall mount with long arm, reference number: 000000-1254-579
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S7 Centro suspension system, reference number: 000000-1254-580
OPMI und PROergo is a trademark/are trademarks or registered trademark(s) 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 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 permissible and must
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be prevented.
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Summary of the section
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Section:
Safety measures
7
Section:
Device overview
57
Section:
Preparations for use
139
Section:
Operation
179
Section:
What to do in the event of malfunctions
197
Section:
Care and maintenance
213
Section:
Device data
227
Section:
Keyword index
259
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S7 / OPMI PROergo
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Safety measures
Safety measures
Key to symbols ... 9 Hazard symbols ...9 Information symbols ...9 Target group ...10 Field of use ... 10 Intended use ...10 Normal use ...10 Reasonably foreseeable misuse ...11 Liability and warranty ... 11 Notes for the operator ... 12 Requirements for operation ...15 Prior to the very first use ...15 Before every use ...16 During use ...18 After every use ...19 Risk of burn injuries caused by high illumination intensity ...20 Stand safety equipment ...23 Symbols and labels on the device ... 28 Labels on the microscope ...28 Labels on the connection panel ...31 Labels on S7 floor stand ...32 Additional labels on S7 floor stand (instrument tray option) ...38 Labels on S7 ceiling mount ...40 Additional label on S7 ceiling mount with lifting column ...44
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Labels on S7 wall mount and on S7 Centro suspension system ... 46 Additional labels on S7 wall mount ... 51 Labels on the light sources of the suspension systems ... 52 Labels on the wall power outlet (optional) ... 55
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Safety measures
Key to symbols We would like to inform you of the safety aspects that must be observed when handling this device. This chapter contains a summary of the most important information concerning matters relevant to instrument safety.
Hazard symbols The following safety information has been incorporated into the Instructions for Use. Please note this information and be particularly careful in these cases. WARNING
Indicates a hazard which 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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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 OPMI PROergo is a surgical microscope intended for the illumination and magnification of the treatment and surgical area and for the support of visualization in treatment and surgical procedures.
Normal use OPMI PROergo is a microscope designed for dental treatment and for surgical procedures in the field of dentistry. Through its selection of illumination systems (halogen, xenon) and its mechanical construction, it is adapted to the requirements of daily tasks involved in treatment and surgery applications.
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Safety measures
Reasonably foreseeable misuse CAUTION
CAUTION
Injury to the patient's eye! •
The S7 / OPMI PROergo must not be used for ophthalmic 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 shall not be used for diagnosis purposes. Visualized images may contain variations in shape, contrast and color.
Liability and warranty The warranty and liability depend on the contractually specified conditions. Loss of warranty! 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
WARNING
The device must not be modified without any approval! Do not modify the device without approval from the manufacturer. If the system is modified after consultation with the manufacturer, suitable inspections and testing must be completed to ensure subsequent safe use. The manufacturer is not liable for damages caused by an unauthorized use of the device. 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 comply with the Instructions for Use of the other system components as well. 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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This device must be used by properly instructed and 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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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 28.)
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Only use original accessories or consumables 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 system is modified after consultation with the manufacturer, suitable inspections and testing must be completed to ensure subsequent safe use. The manufacturer is not liable for damage caused by an unauthorized modifications to the device.
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If required by 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
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Electrical safety
Safety measures
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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.
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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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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 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.
A potential equalization connector is provided on the instrument's connection panel (see IEC60601-1). This connector can be used to connect other active devices to the same ground potential or for redundant connection to the protective ground.
Transport & Service
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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 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 chapter "System data" on Page 254.
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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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Optics and light
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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 look at the sun through the binocular tube, the objective 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 Prior to the very first use The system is installed by ZEISS Service or by a specialist designated by ZEISS. Make sure that the following requirements continue to be met for subsequent 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 device is connected with the power cord supplied. When connecting the device to a network, make sure that the network does not carry a hazardous voltage. Specific information about the floor stand: The power cord may only be plugged into a power outlet that is properly grounded. 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 outlet that is properly grounded.
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Before every use
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When mounting accessory equipment, please 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 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 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 and that the surgical microscope does not touch the patient.
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Before every use, check the user settings in the software to avoid unexpected behavior of the system.
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Always route cables so that they do not hinder the user.
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Never connect any unknown or defective devices to the electrical interfaces (e.g. for data, video or foot control panel).
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Connect components only to properly grounded outlets.
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When setting up your system, make sure to comply with the requirements of IEC 60601-1, chapter 16 (in some countries IEC 60601-1-1 may still be valid).
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Reattach any covers or caps that have been removed. Close any existing openings with the corresponding caps. Before starting the system, remove the protective cover used for transportation from the objective lens.
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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 204) or replace the lamp module in a timely manner (see Page 222). Reset the service hour counter of the xenon illumination.
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Safety measures
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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 220).
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Keep a replacement lamp (only for halogen light source) ready 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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Never use force when trying to connect any electrical connectors (plugs, sockets). If a connection cannot be made, check to make sure the plug fits the socket. If any of the connectors are damaged, have the ZEISS service team or authorized service representative repair them.
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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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Prior to using the wireless foot control panel (FCP WL), 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 chapter "Operation".
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Depending on how the surgical microscope is being used, take appropriate precautions to ensure that, if necessary, the surgical procedure or treatment can be completed without the full functionality of the microscope (e.g. without the lighting).
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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. •
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Observe the instructions for use for the sterile drapes and make sure that the drape is attached in such a way that your field of view is not obstructed.
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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.
Specific information about the floor stand: •
Use the grab handle on the floor stand for moving.
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Mind the maximum vertical clearance when passing through doorways.
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Avoid any jolting.
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Risk of toppling – only move the device over steps or raised edges if two people are available to hold and lift it!
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Be extremely careful when moving over slopes.Be extremely careful when moving over slopes.
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Do not park the device on sloped surfaces.Do not park the device on sloped surfaces.
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Secure the device in position by pressing down the immobilizers on the stand base to prevent the stand from rolling away by itself.
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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 when its light source is switched on.
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Defective or unidentified accessories may lead to increased leakage current on the device 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 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.
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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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Do not pull at the light guide, power cord or any other connecting cables.
During use
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Constantly monitor the system 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" 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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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.
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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
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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 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 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 –
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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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