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Zeiss EXTARO 300 Instructions For Use Manual

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ZEISS EXTARO 300
Instructions for Use

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Summary of Contents for Zeiss EXTARO 300

  • Page 1 ZEISS EXTARO 300 Instructions for Use...
  • Page 2 Registered trademarks EXTARO, Varioskop and VisionGuard are either trademarks or registered trademarks of Carl Zeiss Meditec AG or other companies of the ZEISS group in Germany and other countries. © Carl Zeiss Meditec AG, 2017. All rights reserved. 1 / 59...

  • Page 3: Table Of Contents

    Instructions for Use Table of contents Table of contents Before you read ..................... 5 Name of product ........................5 Scope ............................5 Symbols in the manual ......................5 Safety notes ....................6 Target group ..........................6 Intended use ..........................6 Notes for operation........................6 Stands and labels ................... 8 Stands ............................8 Yoke ............................8 Labels ............................9...
  • Page 4 Table of contents Instructions for Use Preparing sterility ........................25 6.3.1 Attaching asepsis caps ....................25 6.3.2 Attaching the drapes ....................25 Using the lens protection cover .................... 26 Balancing..........................27 Setting lowest position of microscope for safety ..............28 Finding ergonomic working position ..................
  • Page 5 Electromagnetic immunity for non-life-supporting ME equipment and ME systems ..52 11.8.4 Recommended safety distances between portable and mobile RF communication equipment and the EXTARO 300 ....................54 11.8.5 Use of class A device ....................54 Ordering data ........................55 Regulatory information ......................

  • Page 6: Before You Read

    Before you read Name of product EXTARO 300 is designated as “device” in this Instructions for Use. Scope The Instructions for Use apply to EXTARO 300 with the following identification:  EXTARO 300 (floor stand)  EXTARO 300 (wall mount) ...

  • Page 7: Safety Notes

    Observe the legal regulations for accident prevention and occupational health & safety applicable in the country concerned;  Use original accessories or accessories approved by Zeiss. Use only original Zeiss parts in maintenance work;  The surgical microscope can only be used by properly trained personnel within the scope of its intended use;...
  • Page 8 Use of EXTARO 300 adjacent to or stacked with other equipment may result in improper operation. If such use case cannot be avoided, the user must verify that the EXTARO 300 and its adjacent equipment are functioning normally before operation.

  • Page 9: Stands And Labels

    Instructions for Use Stands and labels Stands and labels Stands Floor stand with short suspension arm Floor mount with long suspension arm Wall mount with long suspension arm Ceiling mount with long suspension arm Yoke Angled (120°) yoke Straight yoke The straight yoke can only be used in combination with a MORA interface.

  • Page 10: Labels

    Stands and labels Instructions for Use Labels Symbol Designation Description Friction Adjust the braking force (friction) of the adjustment movement axis by turning the friction knob. To increase the lifting force of suspension arm: turn the screw in the direction of bigger weight; Adjust balance of suspension arm To decrease the lifting force: turn in the...
  • Page 11 Instructions for Use Stands and labels 1) Carl Zeiss Meditec Inc. is responsible for Distributor the distribution and complaint handling for information (for EXTARO 300 in the USA and Canada. North America) 2) Rx only: this symbol means the product is...

  • Page 12: Controls

    Controls Instructions for Use Controls Controls on the microscope Mode Control knob Varioskop 230 for focus Knob of Magnification adjustment Changer Pupillary distance adjustment Diopter setting on eyepiece Emergency Knob Securing screw NOTE Loosening the securing screw may cause the tube to fall off! 11 / 59 305935-3500-000 –...

  • Page 13: Controls On The Yoke And Stand

    Instructions for Use Controls Controls on the yoke and stand Brakes Brake of Axis 1 for locking the Brake of Axis 2 for locking the Brake for setting the lowest carrier arm suspension arm position of suspension arm Brake of Axis 1 of wall mount is on wall adapter Brake of Axis 3 for locking the Brake of Axis 4 for locking yoke...
  • Page 14 Controls Instructions for Use Balancing On/Off Power on/off switch Screw for adjusting lifting force of suspension arm Connections (USB, HDMI, LAN, Power) Power inlet socket Strain relief device to prevent Video interface and Ethernet inadvertent cable unplugging connections For wall and ceiling mount, the cables (Power, Ethernet and HDMI) are internally routed from within the system to the ports on the wall, therefore no power socket, Ethernet or HDMI port is offered on the carrier arm for cable connection by the user.

  • Page 15: Description Of System Options

    For details of the eyewear, please contact your authorized ZEISS partner. To lower the risk of phototoxic injury of the patient’s eye, EXTARO 300 also provides a function called SpotLight that allows the user to control the illuminated-field diameter via the Mode Control knob.

  • Page 16: Orange Color Mode And Truelight Mode

    Description of system options Instructions for Use Detection of caries/plaque/calculus (all appear red in Fluorescence Mode) Visual identification of carious lesion enables uninterrupted workflow of excavation. (1) Infected tooth with carious (2) Continuously controlled (3) Excavated cavity lesion (red) excavation Composite detection For most dental composite resins, the contrast between composite and healthy tooth are greater in Fluorescence Mode than in white light mode (...

  • Page 17: Green Color Mode

    Instructions for Use Description of system options 5.2.3 Green Color Mode The Green Color Mode is use to enhance image contrast between blood and tissue so that they can be better distinguished. Blood strain in White Light Mode Blood stain in Green Color Mode 5.2.4 NoGlare Mode By effectively suppressing the obtrusive light reflections from the tooth surface, this mode allows to precisely analyze the color shades of the teeth.

  • Page 18: Ergonomics

    Description of system options Instructions for Use Ergonomics 5.3.1 Foldable tube Foldable tube is used to satisfy the needs of users with different heights and with different postures. It has two axles so that the tube can be both folded and straightened. Folded Stretch out 5.3.2 MORA interface...

  • Page 19: Documentation

    • We recommend the user to use the “SD formatter” software (freely downloadable from https://www.sdcard.org/downloads/formatter_4/index.html) to format their USB disk before using it on the EXTARO 300 system, otherwise the USB disk may not work properly for image and video storage.

  • Page 20: Complete Communication

    Trigger from microscope or with remote control • Network interface (including wireless & wired Ethernet connection) • ZEISS Connect (iPad app) for - Camera control including smart recording - Chair side patient consultation - Media asset management - Essential adjusting of images and video The Connect app is available for download in the Apple app store.

  • Page 21: External Camera Adapter (Photo Adapter)

    Note that the user should also buy a third-party adapter to connect the camera with the photo adapter. Please refer to the product datasheet of EXTARO 300 or consult your authorized ZEISS partner for ordering information of the external camera adapter.

  • Page 22: Asepsis & Drapes

    5.5.1 Reusable asepsis sets For sterile use, the system can be equipped with asepsis rubber caps that can be sterilized in autoclaves. For EXTARO 300, the following new asepsis caps are now available for use: • Asepsis cap (305935-8041-000) for Mode Control knob •...

  • Page 23: Docking Station For Ipad

    An optional iPad docking station can be used to dock, charge and lock the iPad on the backpack of the carrier arm. Please refer to the product datasheet of EXTARO 300 or consult your local dealer for ordering information of the iPad docking station.

  • Page 24: Preparing System For Use

    Preparing system for use Instructions for Use Preparing system for use Relocating the system 1. Turn off the device and 2. Fold the system into a 3. Unlock all casters. unplug power narrow profile, cable. tighten all brake knobs. 4. Move the system to 5.

  • Page 25: Connecting The System

    Instructions for Use Preparing system for use Connecting the system 6.2.1 Connecting the cables Connecting power cable Connect cables to HDMI or Ethernet interface (optional) 6.2.2 Connecting cable relief kit The cable relief kit is used to prevent inadvertent unplugging of the power cable. 1.

  • Page 26: Preparing Sterility

    A drape adapter is needed for attaching the drape on Varioskop 230. For details, please see Section 5.5.2. For detailed information on sterilization, please refer to the product datasheet of EXTARO 300 or consult your local authorized ZEISS partner. 25 / 59...

  • Page 27: Using The Lens Protection Cover

    Instructions for Use Preparing system for use Using the lens protection cover Mounting the lens protection cover 1. Slightly press the protection 2. Firmly press the lens protection cover against Varioskop 230 and cover upward to make it clasped by rotate it until you feel a stop the bottom structure of Varioskop position (this is also where the...

  • Page 28: Balancing

    Preparing system for use Instructions for Use Balancing 1. Loosen the friction 2. Insert a 8 mm (M10) hex 3. Slightly lift the suspension adjustment screw of the key into opening of the arm by 10° from its suspension arm. articulated joint cover.

  • Page 29: Setting Lowest Position Of Microscope For Safety

    Instructions for Use Preparing system for use Setting lowest position of microscope for safety (1). Adjust the suspension arm to allowable lowest position that is still safe for operation (2). Tighten the knob on the right of the friction knob to set the lowest position of suspension arm Finding ergonomic working position...

  • Page 30: Adjusting Eyepieces

    Preparing system for use Instructions for Use Adjusting eyepieces Rotate diopter setting ring to Rotate eyecups to define a adjust prescription according to proper position for resting the the diopter scale. eye. The eyepieces provide ametropia compensation between - 8 D and + 5 D. Eyeglass wearers who wear eyeglasses during their work set the diopter setting ring to the zero position.

  • Page 31: Parfocal Imaging

    Instructions for Use Preparing system for use Parfocal imaging Parfocal imaging means that the image will remain sharp under different magnifications once it gets focused under the maximum magnification. Setting the correct diopter of the eyepiece is critical to ensuring parfocal imaging. If you don’t know the diopter of the your eyes and would not like to wear any corrective eyeglasses during operation, you can follow the procedure described below to properly adjust the diopter of the eyepieces.

  • Page 32: Working With The Microscope

    Working with the microscope Instructions for Use Working with the microscope Using the camera 7.1.1 Recording image/video with the Mode Control knob Capturing image Short click (t ≤ 0.8s) at the center of the Mode Control knob to capture an image. Recording video Long click (t>0.8s) at the center of the Mode Control knob to start video recording.

  • Page 33: Adjusting White Balance Of Camera

    Instructions for Use Working with the microscope 7.1.3 Adjusting white balance of camera White balance of the camera ensures that the color of its output image of an object under White Light Mode is close to the true color of the object as seen under normal daylight.

  • Page 34: Adjusting Light Intensity

    Working with the microscope Instructions for Use Adjusting light intensity Rotate clockwise to increase Rotate counter clockwise to light intensity decrease light intensity On the front face of the OPMI, there are 5 white-colored LED indicators arranged in an arc above the Mode Control knob. These LEDs are designed to roughly indicate the set intensity level of the illumination under the corresponding mode.

  • Page 35: Switching Between Augmented Visualization Modes

    Instructions for Use Working with the microscope Switching between Augmented Visualization modes Short press (t<0.8s) the Mode Short press (t<0.8s) the Mode Control knob upward to Control knob downward to activate NoGlare Mode. activate Fluorescence Mode. Press the Mode Control knob Press the Mode Control knob rightward to activate leftward to activate Green...

  • Page 36: Setting The Microscope To Parking Position

    Working with the microscope Instructions for Use Setting the microscope to parking position Move the suspension arm upward until you hear a clear clicking sound; the light source will then be switched off automatically. 35 / 59 305935-3500-000 – 2.1 – 2017-12-15...

  • Page 37: Cleaning And Disinfection

    8.1.2 Prevention of fogging To protect the eyepiece optics from fogging, we recommend using an anti-fogging agent. Anti-fogging agents provided by eyecare professionals for use with eyeglass lenses are also suitable for Zeiss eyepieces. Please observe the Instructions for Use supplied with each anti-fogging agent.

  • Page 38: Disinfection

    Cleaning and disinfection Instructions for Use Disinfection If the system surfaces need to be disinfected, please note the following: Risk of damaging the paint on the device! CAUTION! The use of unauthorized disinfectants can cause the paint on the device to become damaged.

  • Page 39: Maintenance

    The following table lists the relevant maintenance activities and shows at which maximum intervals they must be performed. All maintenance activities listed here require device-specific knowledge. Please contact your local ZEISS Service or an authorized partner for performing maintenance activities in due time.
  • Page 40 Maintenance Instructions for Use Every 12 months Component Procedure / Criteria Visual inspection: Documentation and identification labels Manuals and identification labels available, undamaged, complete and legible Carrier system Function test: including microscope − Play-free movement of bearings, stops and suspensions mount −...

  • Page 41: Safety Check

    Instructions for Use Maintenance Safety check Risk of injury! WARNING! Cables and plug connections may come loose and parts of the housing may become live. The user and patient may suffer an electric shock. • To prevent any impairment of the system's safety as a result of aging, wear etc., the operating company must ensure, in accordance with the applicable national regulations, that the regular technical safety checks defined for this system are...

  • Page 42: Trouble Shooting

    Trouble shooting Instructions for Use Trouble shooting Causes of malfunctions and remedies Fault Cause Rectification Power plug of stand not Plug in the power cord. No function at all inserted. Power switch of stand not Press power switch. switched on Automatic circuit breaker in Press power switch.

  • Page 43: Failure Of The Mode Control Knob

    Emergency knob to return to normal white light mode (e.g. use a coin to rotate it), and then power on the system again. 3) Contact Zeiss Service. Failure of the motorized filter wheel (optional) In case the motor of the filter wheel assembly cannot move: 1) If user still wants to continue work with the OPMI before fixing the issue, he/she can use the Emergency knob to rotate the filter wheel (e.g.

  • Page 44: Technical Specification

    Technical specification Instructions for Use Technical specification Electrical data Designation Value Only connect the device to wall outlets which are equipped Power connection with a properly connected protective ground conductor. 100VAC – 240 VAC Rated voltage 50Hz/60Hz Power consumption Max. 120 VA 1) Power input：...

  • Page 45: Mechanical Data

    125 kg (with all accessories). (2). OPMI with wall mount long suspension arm approx. 63 kg (with all accessories). Total weight of EXTARO 300 (3). OPMI with ceiling mount long suspension arm approx. 66 kg (with all accessories). (4). OPMI with floor mount long suspension arm approx.
  • Page 46 Technical specification Instructions for Use System dimensions Ceiling mount Range of H: 1261~2176 mm depending on ceiling height Wall mount Floor stand 45 / 59 305935-3500-000 – 2.1 – 2017-12-15...

  • Page 47: Optics Data

    Instructions for Use Technical specification Floor mount Optics data Designation Value 5-step apochromatic magnification changer, manual adjustment. Magnification factors: γ = 0.4x, γ = 0.6x, γ = 1.0x, γ = 1.6x, γ = 2.5x Magnification Total magnification (12.5x eyepiece): • 3.1x - 19.3x at a working distance of 200 mm •...

  • Page 48: Documentation Package

    Technical specification Instructions for Use Documentation package Essential Communication Complete Communication 1 chip 1/3 inch progressive scan 1 chip 1/3 inch progressive scan Image sensor Color CMOS Sensor Color CMOS Sensor 1920 (H) x 1080 (V) 1920 (H) x 1080 (V) Active pixels (Pixel size: 2.8 μm x 2.8 μm) (Pixel size: 2.8 μm x 2.8 μm)

  • Page 49: Ambient Requirements For Operation

    Instructions for Use Technical specification Ambient requirements for operation Designation Value Temperature + 10°C ... + 40°C Rel. humidity 30% ... 75% Air pressure 700 hPa ... 1060 hPa Ambient requirements for transport and storage Designation Value Temperature - 40°C ... + 70°C Rel.

  • Page 50: Conformity Of Ffc Rules

    Technical specification Instructions for Use − Increase the separation between the equipment and receiver. − Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. − Consult the dealer or an experienced radio/TV technician for help. 11.7.3 Conformity of FFC Rules This device complies with Part 15 of the FCC Rules.

  • Page 51: Guidelines And Manufacturer's Declaration For Electromagnetic Compatibility

    External AC Power Cable Cable length: 5m The following essential performances of EXTARO 300 can still be retained even at the presence of the electromagnetic disturbances mentioned in subsequent sections: - The light source can offer illumination of specified brightness without flashing and the light intensity can be adjusted normally.

  • Page 52: Electromagnetic Emission

    11.8.1 Electromagnetic emission The EXTARO 300 is intended for operation in an electromagnetic environment as specified below. The customer or the user of EXTARO 300 is responsible for ensuring that the device is operated in such an environment. Emission test...

  • Page 53: Electromagnetic Immunity For Non-Life-Supporting Me Equipment And Me Systems

    11.8.3 Electromagnetic immunity for non-life-supporting ME equipment and ME systems The device EXTARO 300 is intended to be operated in one of the electromagnetic environments specified below. The customer or the user of the device EXTARO 300 is responsible for ensuring that it is operated in such an environment.
  • Page 54 Technical specification Instructions for Use IEC 60601 Compliance Electromagnetic environment – Immunity test test level level Guidelines Where P is the output power rating of the transmitter in watts (W) according to the transmitter manufacturer’s specifications and d is the recommended safety distance in meters (m).

  • Page 55: Recommended Safety Distances Between Portable And Mobile Rf Communication Equipment And The Extaro 300

    11.8.4 Recommended safety distances between portable and mobile RF communication equipment and the EXTARO 300 The device EXTARO 300 is intended for use in an electromagnetic environment in which RF disturbances are controlled. The customer or the user of the device EXTARO 300 can help prevent electromagnetic...

  • Page 56: Ordering Data

    Technical specification Instructions for Use Ordering data Only operate the system with the accessories included in the delivery package and proved by ZEISS. You will find the contact responsible for orders in your country on this website: www.zeiss.com/meditec The product configurations, accessories and spare part that are applicable for authorized ZEISS partners are stipulated by contract.

  • Page 57: Simplified Eu Declaration Of Conformity

    Simplified EU declaration of conformity Simplified EU declaration of conformity Hereby, Carl Zeiss Suzhou Co., Ltd., declares that the radio equipment type EXTARO 300 is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.zeiss.com/meditec.

  • Page 58: Disposal

    Disposal Instructions for Use Disposal The device specified on the delivery note must not be disposed of via household waste or communal disposal companies in accordance with the applicable EU guidelines valid at the time the device was placed on the market. For detailed information on the disposal of the product, please contact your local dealer or the device manufacturer or its legal successor.

  • Page 59: List Of Abbreviations Term

    Instructions for Use List of abbreviations term List of abbreviations term Term Explanation Camera Control Unit Communauté Européenne (European Community) Canadian Standards Association (a non-governmental organization that test and certifies product safety) Electromagnetic Compatibility Define non-interference of electrical and electronic devices with their environment EIRP Effective Isotropic Radiated Power...
  • Page 60 EC REP Carl Zeiss Meditec AG Carl Zeiss Suzhou Co., Ltd Modern Industrial Square 3-B, Goeschwitzer Strasse 51-21 No.333 Xingpu Road 07745 Jena Suzhou Industrial Park, Suzhou Phone : +49 36 41 22 03 33 China 215126 Fax : +49 36 41 22 01 12...

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