1. Manuals
  2. Brands
  3. Zeiss Manuals
  4. Medical Equipment
  5. EXTARO 300
  6. Instructions for use manual

Zeiss EXTARO 300 Instructions For Use Manual

Hide thumbs Also See for EXTARO 300:
Table of Contents

Advertisement

Quick Links

Download this manual
ZEISS EXTARO 300
Instructions for Use

Advertisement

Table of Contents
loading

Related Manuals for Zeiss EXTARO 300

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, 2021. All rights reserved. 1 / 65...

  • 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 ..................
  • Page 4 Table of Contents Instructions for Use Mounting the microscope ..................28 6.2.1 Recommended table specification ....................28 6.2.2 Rotation limiter ..........................29 6.2.3 Mounting procedures ........................30 Preparing sterility ....................34 6.3.1 Attaching asepsis caps ........................34 6.3.2 Attaching the drapes ........................34 Balancing ........................
  • Page 5 11.8.3 Electromagnetic immunity for non-life-supporting ME equipment and ME systemsError! Bookmark not defined. 11.8.4 Recommended safety distances between portable and mobile RF communication equipment and the EXTARO 300 ....................Error! Bookmark not defined. 11.8.5 Use of class A device ......................... 59 Ordering data ......................61 Regulatory information ..................61 Simplified EU declaration of conformity ............

  • 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 (table mount - mobile version) ▪ EXTARO 300 (table mount - stationary version)

  • Page 7: Safety Notes

    Installation and service work that is not described in this user manual must only be performed by specialists from ZEISS or staff specially trained for this purpose by ZEISS. Intended use EXTARO 300 is a surgical microscope intended for the illumination and magnification of the surgical area during surgical procedures (except ophthalmic surgeries). CAUTION! Injury to the patient's eye! •...
  • 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 Mobile version Stationary version 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 Adjust balance of weight;...
  • Page 10 May be harmful to the eyes. 1) Carl Zeiss Meditec Inc. is responsible for the distribution and complaint Distributor handling for EXTARO 300 in the USA information (for and Canada. North America) 2) Rx only: this symbol means the...
  • Page 11 Instructions for Use Stands and labels FCC Conformity FCC Declaration of Conformity label Manufacturer information Serial number Reference number System identification CE mark label (for Authorized representative in treatment unit the European Community only) CSA approval MD labelling Possibly hazardous from this product. To avoid any risk, ensure the table is stable enough and Tipping warning perform properly in line with the operation...
  • Page 12 Stands and labels Instructions for Use The USB port with lightning symbol is Lighting symbol designed only for charging, which shall not be on E-BOX connected to camera control unit. 11 / 65 000000-2466-133 -1.1-2022-06-22 for USA...

  • Page 13: Controls

    Instructions for Use Controls Controls Controls on the microscope Controls on the microscope Item Component name Item No. Component name Pupillary distance adjustment Emergency Knob Knob of Magnification Changer Varioskop 230 for focus adjustment (MC) Mode Control knob Securing screw Diopter setting on eyepiece NOTE Loosening the securing screw may cause the tube to fall off!

  • Page 14: Controls On The Arm And Yoke Assembly

    Controls Instructions for Use Controls on the arm and yoke assembly Controls on the arm and yoke assembly Item No. Component name Item No. Component name Brake of axis 1 for locking the Rotation limiter of carrier arm carrier arm Brake of axis 2 for locking the Brake of axis 3 for locking the suspension arm...

  • Page 15: Connections And Power Button Of E-Box

    Instructions for Use Controls Connections and power button of E-box Connections on the rear side of E-box Item No. Component name Item No. Component name Earth connection LAN connection for iPad OPMI connection for power supply WAN connection for clinic network and signal control USB connection for data storage Camera connection...

  • Page 16: 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 supports the user to control the illuminated-field diameter via the Mode Control knob.

  • Page 17: Augmented Visualization

    5.2.1 Fluorescence Mode Fluorescence Mode is an optional accessory to EXTARO 300 surgical microscope. Indication for use The Fluorescence Mode is intended to be used by dentist as an aid in the detection of dental caries.
  • Page 18 Description of system options Instructions for Use Short press the Mode Control Adjust the light intensity to Set MC to the magnification knob to activate the 100% by rotating the Mode factor of 1x which will give Fluorescence Mode (for details, Control knob.
  • Page 19 Instructions for Use Description of system options continue the procedure conventionally. The Fluorescence Mode uses color to provide information that may aid in WARNING! the detection/ location of caries by red color of metabolites of cariogenic bacteria. It is not suitable for use by persons who are red/green color blind. This device is not to be used for the diagnosis of caries;...

  • Page 20: Orange Color Mode And Truelight Mode

    Composite resin under Fluorescence Mode 5.2.2 Orange Color Mode and TrueLight Mode Orange Color Mode and TrueLight Mode are both optional accessories to EXTARO 300 surgical microscope. Both Orange Color Mode and TrueLight Mode fall in the category of Delay Curing Mode which prevents the premature polymerization of widely used contemporary light curing composite resins during the modeling process under the microscope.

  • Page 21: Green Color Mode

    Blood strain in White Light Mode Blood stain in Green Color Mode 5.2.4 NoGlare Mode NoGlare Mode is an optional accessorie to EXTARO 300 surgical microscope. The NoGlare Mode aids in reducing specular light reflections from the surface and make sub-surface information more visible.

  • Page 22: Multispectral Mode

    5.2.5 Multispectral Mode The Multispectral Mode is an optional accessory to EXTARO 300 surgical microscope. It is used to enhance contrast between tissue and vasculature. Tissue image under white light...

  • Page 23: Co-Observation Tube & Straight Tube (Optional)

    Instructions for Use Description of system options Folded Stretch out 5.3.2 Co-observation tube & straight tube (optional) With the co-observation tube & straight tube, the operation assistants can observe the surgical areas without affecting the operation of attending physicians. Refer to the following installation steps.

  • Page 24: Documentation

    Description of system options Instructions for Use Documentation In terms of image acquisition and video recording, the EXTARO 300 come with the following package: 5.4.1 Complete Communication package Main features: ▪ Integrated HD (1080p) camera ▪ Video interface - HDMI output to monitor - USB port for image &...

  • Page 25: Asepsis & Drapes & Drape Adapter

    305935-8083-000 Handgrips For detailed ordering information of all asepsis products, please consult your authorized ZEISS partner. These asepsis caps can be used on the parts marked with corresponding numbers shown as below, i.e. using No.3 asepsis caps on knobs marked with ③ on yoke and arm: 000000-2466-133 -1.1-2022-06-22 for USA...

  • Page 26: Drapes

    Clean, disinfect and sterilize asepsis caps before each use. This also applies to the first use after delivery. 5.5.2 Drapes To ensure sterile covering of the EXTARO 300 system, it is possible to use the following three kinds of single-use drapes: Name Drape Type Material No.

  • Page 27: Ipad Holder

    Open the small cover on the left side and insert the power connector into iPad. Please refer to the product datasheet of EXTARO 300 or consult your local dealer for more information of the iPad holder. NOTE Applicable iPad...

  • Page 28: Preparing System For Use

    Preparing system for use Instructions for Use Preparing system for use Unpacking and inspection 6.1.1 Delivery list (basic configuration for mobile version) ▪ Transport boxes (2x) ▪ Table clamp (1x) ▪ Column assembly (1x) ▪ Arm assembly (1x) ▪ Yoke and OPMI assembly with cables (1x) ▪...

  • Page 29: Mounting The Microscope

    Instructions for Use Preparing system for use Lift covers up slowly to its end position. Inspect all the parts for any transport damage. Check for any missing parts against delivery list. Risk of damaging instruments in event of knocking down the CAUTION! cover accidentally! •...

  • Page 30: Rotation Limiter

    Preparing system for use Instructions for Use Dimensions: L1 = 50 mm; L2 = 70 mm; L3 = 40 mm. CAUTION! Risk of tipping over! The table legs must be fixed to the ground to prevent the device tip over. 6.2.2 Rotation limiter Rotation limiter shall be set to 90°...

  • Page 31: Mounting Procedures

    4. 6.2.3 Mounting procedures For the stationary version table-mounted microscope, ZEISS service personnel will provide mounting services for you onsite at the appointed time. While for the mobile version table-mounted microscope, it allows to be mounted in anywhere if only 000000-2466-133 -1.1-2022-06-22 for USA...
  • Page 32 Preparing system for use Instructions for Use meets the recommended table and space specification as well as environment requirements. To mount the mobile microscope, please refer to the procedures shown as below and read the safety notes carefully attached: Take the mounting plate out (1) Ensure the mounting plate (1) Take the column of Box B and position it on the...
  • Page 33 Instructions for Use Preparing system for use The arrows are aligned, The Take the yoke out of Box A (1) Attach the yoke to the movement of the carrier arm and ensure that the bayonet suspension arm by aligning should now be limited to the pins and rotatable safety ring the bayonet pins and the green range.
  • Page 34 Preparing system for use Instructions for Use Take the E-Box out of Box A (1) Hang E-box on the hook and connect the cables into underneath the mounting their corresponding plate,route cable and fix it on connections on the backside the E-BOX.

  • Page 35: Preparing Sterility

    6.3.1 Attaching asepsis caps For sterile use, the system can be equipped with resterilizable products. The asepsis sets available from ZEISS contain various caps that can be sterilized in autoclaves. CAUTION! Risk of infection caused by contaminated asepsis caps and drapes •...
  • Page 36 A drape adapter is needed for attaching the drape on Varioskop 230. For details, please see Section 5.5.3 . For detailed information on sterilization, please refer to the product datasheet of EXTARO 300 or consult your local authorized ZEISS partner.

  • Page 37: Balancing

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

  • Page 38: Finding Ergonomic Working Position

    Preparing system for use Instructions for Use Finding ergonomic working position 1. Adjust the height of suspension arm and the chair to bring the microscope to working area. The user should keep his/her back upright while working with the microscope. The working distance (WD) of the microscope can be varied from 200 to 430mm.
  • Page 39 Instructions for Use Preparing system for use 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. Eyepieces with magnetic coupling NOTE Please keep in mind the usual rules for the handling of magnets in regard of eyepieces that have been removed from the tube.

  • Page 40: Parfocal Imaging

    Preparing system for use Instructions 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 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 41: Working With The Microscope

    Instructions for Use Working with the microscope Working with the microscope Recording image/video with Mode Control Mode 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 42: Spotlight Function

    Working with the microscope Instructions for Use SpotLight function Long press (t>0.8s) the Mode Control knob Long press (t>0.8s) the Mode Control knob upward to enlarge the illumination spot. downward to shrink the spot. Release the Release the knob when you get the desired knob when you get the desired spot size.
  • Page 43 Instructions for Use Working with the microscope Press the Mode Control knob rightward to activate Multispectral Mode (Optional). • Availability of some Augmented Visualization modes are hardware and license dependent. • Once a mode is activated by a single press of the Mode Control knob in a certain direction, a second press at the same direction will deactivate the mode and returns to normal white light.

  • Page 44: Cleaning

    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 45: 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 46 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 47: Safety Check

    Instructions for Use Maintenance Safety check The safety checks may only be carried out by the manufacturer or by qualified persons. The scope of the safety checks of the system should comprise at least the following points: ▪ Availability of the Instructions for Use ▪...

  • Page 48: Trouble Shooting

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

  • Page 49: 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 50: Failure Of The Power Socket

    Insert the fuse holder into underneath the triangle replace them with new its original place. plug and then pull out the ones (H250V T3.15A). fuse holder. 3) Contact Zeiss Service if the above-mentioned method doesn’t work. 49 / 65 000000-2466-133 -1.1-2022-06-22 for USA...

  • Page 51: Technical Specification

    Instructions for Use Technical specification 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 52: Mechanical Data

    Size of table stand area approx.200mmX200mm approx.210X320X280(WxDxH)(with E-BOX antenna cover) Maximum permissible load With complete microscope equipment, including of suspension arm accessories: must not exceed 8kg Approx. 45 kg (with all accessories). Total weight of EXTARO 300 51 / 65 000000-2466-133 -1.1-2022-06-22 for USA...

  • Page 53: Optics Data

    Instructions for Use Technical specification System dimensions H = 1025 mm L1 = 1262 mm L2 = 1214 mm L3 = 48 mm L4 = 300 mm L5 = 620 mm Optics data Designation Value 5-step apochromatic magnification changer, manual adjustment.
  • Page 54 Technical specification Instructions for Use 6 different operation modes: − White light Mode − Fluorescence Mode (Optional) − Orange Color Mode & TrueLight Mode (Optional) − Green Color Mode − NoGlare Mode (Optional) − Multispectral Mode (Optional) Illumination Option 1:Minimum diameter of luminous spot at a working distance of 200mm: ≤...

  • Page 55: Documentation Package

    Instructions for Use Technical specification Documentation package Complete Communication Image sensor 1 chip 1/3 inch progressive scan Color CMOS Sensor 1920 (H) x 1080 (V) Active pixels (Pixel size: 2.8 μm x 2.8 μm) <60 Hz setting> 1080/59.94p, 1080/59.94i Video output HDMI <50 Hz setting>...

  • Page 56: Ambient Requirements For Transport And Storage

    Technical specification Instructions for Use Ambient requirements for transport and storage Designation Value Temperature - 40°C ... + 70°C Rel. humidity (without condensation) 10% ... 90% Air pressure 500 hPa ... 1060 hPa Wireless communication 11.7.1 Wi-Fi router information ▪ Release version of firmware: V1.2 ▪...

  • Page 57: Conformity Of Fcc Rules

    Instructions for Use Technical specification 11.7.3 Conformity of FCC Rules This device complies with Part 15 of the FCC Rules. Operation is subject to the two following conditions: (1) the device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

  • Page 58: Guidelines And Manufacturer's Declaration For Electromagnetic Compatibility

    Country-specific M/N 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 59: Electromagnetic Emission

    Instructions for Use Technical specification 11.8.1 Electromagnetic emission The device conforms to EN 60601-1-2:2015 / IEC 60601-1-2:2014 for both immunity and emissions. The classification of electromagnetic emission is shown as below: Emission test Compliance RF emissions as per CISPR11 Group 1 RF emissions as per CISPR11 Class A Harmonic emissions as per IEC 61000-3-2...

  • Page 60: Use Of Class A Device

    Technical specification Instructions for Use Immunity test Compliance level Conducted disturbances induced by RF fields as described in IEC 61000-4-6 0.15 MHz – 80 MHz 6V in ISM and amateur radio bands between 0.15 MHz and 80 MHz 80 % AM at 1 kHz Voltage dips as per IEC 61000-4-11 0% U ;...
  • Page 61 Instructions for Use Technical specification The properties of the device determined by emissions permit its use in industrial areas and in hospitals (CISPR 11, Class A). If used in a residential area (for which Class B usually is required as per CISPR 11), the device may not provide the necessary protection with regard to radio frequency communication services.

  • Page 62: 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 63: Simplified Eu Declaration Of Conformity

    Technical specification 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 64: Disposal

    Simplified EU declaration of conformity 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.

  • Page 65: List Of Abbreviations Term

    List of abbreviations term Instructions for Use 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 66 EC REP Carl Zeiss Meditec AG Carl Zeiss Suzhou Co., Ltd Modern Industrial Square 3-B, Goeschwitzer Strasse 51-52 No.333 Xingpu Road 07745 Jena Germany Suzhou Industrial Park, Suzhou Phone : +49 36 41 22 03 33 China 215126 Fax : +49 36 41 22 01 12 info.meditec@zeiss.com...

Table of Contents